Health, Technology and Society: Critical Inquiries [1st ed.] 9789811543531, 9789811543548

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HEALTH, TECHNOLOGY AND SOCIETY

Health, Technology and Society Critical Inquiries Edited by Andrew Webster Sally Wyatt

Health, Technology and Society

Series Editors Andrew Webster Department of Sociology University of York York, UK Sally Wyatt Faculty of Arts and Social Sciences Maastricht University Maastricht, Limburg, The Netherlands

Medicine, health care, and the wider social meaning and management of health are undergoing major changes. In part this reflects developments in science and technology, which enable new forms of diagnosis, treatment and delivery of health care. It also reflects changes in the locus of care and the social management of health. Locating technical developments in wider socio-economic and political processes, each book in the series discusses and critiques recent developments in health technologies in specific areas, drawing on a range of analyses provided by the social sciences. Some have a more theoretical focus, some a more applied focus but all draw on recent research by the authors. The series also looks toward the medium term in anticipating the likely configurations of health in advanced industrial society and does so comparatively, through exploring the globalization and internationalization of health. More information about this series at http://www.palgrave.com/gp/series/14875

Andrew Webster  •  Sally Wyatt Editors

Health, Technology and Society Critical Inquiries

Editors Andrew Webster Dept of Sociology, W/231C University of York, Wentworth College Heslington, UK

Sally Wyatt Faculty of Arts and Social Sciences Maastricht University MAASTRICHT, Limburg, The Netherlands

Health, Technology and Society ISBN 978-981-15-4353-1    ISBN 978-981-15-4354-8 (eBook) https://doi.org/10.1007/978-981-15-4354-8 © The Editor(s) (if applicable) and The Author(s), under exclusive licence to Springer Nature Singapore Pte Ltd. 2020 This work is subject to copyright. All rights are solely and exclusively licensed by the Publisher, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. The publisher, the authors, and the editors are safe to assume that the advice and information in this book are believed to be true and accurate at the date of publication. Neither the publisher nor the authors or the editors give a warranty, expressed or implied, with respect to the material contained herein or for any errors or omissions that may have been made. The publisher remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. Cover illustration © SEAN GLADWELL This Palgrave Macmillan imprint is published by the registered company Springer Nature Singapore Pte Ltd. The registered company address is: 152 Beach Road, #21-01/04 Gateway East, Singapore 189721, Singapore

To our grandchildren, for whom the politics and health of the planet and so of its people will be the most fundamental concern

Foreword

Medicine, healthcare and the wider social meanings and management of health are continually in the process of change. While the ‘birth of the clinic’ heralded the process through which health and illness became increasingly subject to the surveillance of medicine, for example, surveillance has become more complex, sophisticated and targeted—as seen in the search for ‘precision medicine’ and now ‘precision public health’. Both surveillance and health itself emerge as more provisional, uncertain and risk-laden as a consequence, and we might also ask what now constitutes ‘the clinic’, how meaningful a concept of a clinic ultimately is and where else might we now find (or not find) healthcare spaces and interventions. Ongoing developments in science and technology are helping to enable and propel new forms of diagnosis, treatment and the delivery of healthcare. In many contexts, these innovations both reflect and further contribute to changes in the locus of care and burden of responsibility for health. Genetics, informatics and imaging—to name but a few—are redefining collective and individual understandings of the body, health and disease. At the same time, long-established and even ostensibly mundane technologies and techniques can generate ripples in local discourse and practices as ideas about the nature and focus of healthcare shift in response to global debates about, for instance, One Health and Planetary Health. vii

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The very technologies that (re)define health are also the means through which the individualisation of healthcare can occur—through, for instance, digital health, diagnostic tests and the commodification of restorative tissue. This individualisation of health is both culturally derived and state-sponsored, as exemplified by the promotion of ‘self-­ care’. These shifts are simultaneously welcomed and contested by professionals, patients and wider publics. Hence they at once signal and instantiate wider societal ambivalences and divisions. This Series explores these processes within and beyond the conventional domain of ‘the clinic’ and asks whether they amount to a qualitative shift in the social ordering and value of medicine and health. Locating technical use and developments in wider socio-economic and political processes, each book discusses and critiques the dynamics between health, technology and society through a variety of specific cases, and drawing on a range of analyses provided by the social sciences. The Series has already published more than 20 books that have explored many of these issues, drawing on novel, critical and deeply informed research undertaken by their authors. In doing so, the books have shown how the boundaries between the three core dimensions that underpin the whole Series—health, technology and society—are changing in fundamental ways. Since 2006, this Series has been edited by Andrew Webster (University of York) and Sally Wyatt (Maastricht University). Through their stewardship, it has broken new empirical and conceptual ground. This volume takes stock of the Series to-date, and its contents provide a vivid demonstration of the vitality of the scholarship that Andrew and Sally have convened these last 14 years. It is also, then, a tribute to their work, dedication and thoughtfulness in cultivating research and writings that have had deep traction with a range of disciplines (not least, science and technology studies), and which have cast a bright light on the transformations in health, technology and society that are experienced by millions. This volume draws together all of the books from across the years of the Series, organised around five key themes identified by Andrew and Sally to reflect the rich and diverse landscape the HTS Series has covered. Selecting key books and highlights from these, Andrew and Sally asked authors to provide reflections on their work. As such, the volume not

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only brings together an overview and highlights of the Series but through the reflection pieces also gives a wider context and a form of history of the field during this time. Including fascinating stories of book development, response following publication, changes to the field and other directions such books may have taken, the reflection pieces illustrate the added value of bringing together the diverse works highlighted by this collection: the HTS Series does something in itself—books lead and tie into each other and a landscape of work and thinking in this field becomes greater than the sum of its parts. We look forward to being able to continue to build on the hard work undertaken by Andrew and Sally in developing the Series, and to working with, what we hope will be, a wide range of authors and novel topics. London, UK Edinburgh, UK

Rebecca Lynch Martyn Pickersgill

Contents

I ntroduction  1 Andrew Webster and Sally Wyatt Early Days and the Focus of the Series    3 The Normative and Methodological Contributions of the Series    5 Structure of the Book    8 Looking Ahead  10 References  11 Section 1: Innovation 15 Marianne Boenink, Harro van Lente, Ellen Moors, Nelly Oudshoorn, John Gardner, Ellen Balka, Eileen Green, Flis Henwood, Rebecca Lynch, and Conor Farrington Introduction  15 Marianne Boenink, Harro van Lente and Ellen Moors. (Eds.) (2016). Emerging Technologies for Diagnosing Alzheimer’s Disease. Innovating with Care. Winner of the 2018 Chris Freeman Award, European Association for the Study of Science and Technology   19 Nelly Oudshoorn. (2011). Telecare Technologies and the Transformation of Healthcare. Winner of Foundation for the Sociology of Health and Illness Book Prize 2012   32 John Gardner. (2017). Rethinking the Clinical Gaze: Patient-­ Centred Innovation in Paediatric Neurology  37 xi

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Ellen Balka, Eileen Green and Flis Henwood. (Eds.). (2009). Gender, Health and Information Technology in Context  43 Rebecca Lynch and Conor Farrington. (Eds.). (2018). Quantified Lives and Vital Data. Exploring Health and Technology Through Personal Medical Devices  56 References  69 Section 2: Responsibility 75 Kirstine Zinck Pedersen, Gerard de Vries, Klasien Horstman, Simone Bateman, Sylvie Allouche, Jérôme Goffette, Michela Marzano, Roma Harris, Nadine Wathen, and Sally Wyatt Introduction  75 Kirstine Zinck Pedersen. (2018). Organizing Patient Safety: Failsafe Fantasies and Pragmatic Practices, pp. 128–131, 221, 240–244   79 Gerard de Vries and Klasien Horstman. (Eds.). (2008). Genetics from Laboratory to Society. Societal Learning as an Alternative to Regulation  91 Simone Bateman, Jean Gayon, Sylvie Allouche, Jérôme Goffette and Michela Marzano. (Eds.). (2015a). Inquiring into Human Enhancement. Interdisciplinary and International Perspectives 105 Roma Harris, Nadine Wathen and Sally Wyatt. (Eds.). (2010). Configuring Health Consumers. Health Work and the Imperative of Personal Responsibility 119 References 131  Section 3: Locus of Care135 Alan Petersen, Megan Munsie, Claire Tanner, Casimir MacGregor, Jane Brophy, Nadine Wathen, Roma Harris, Sally Wyatt, Bernike Pasveer, Oddgeir Synnes, and Ingunn Moser Introduction 135 Alan Petersen, Megan Munsie, Claire Tanner, Casimir MacGregor and Jane Brophy. (2017). Stem Cell Tourism and the Political Economy of Hope. Winner of Stephen Crook Memorial Prize awarded by The Australian Sociological Association 2018  139

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Nadine Wathen, Sally Wyatt and Roma Harris (Eds.). (2008). Mediating Health Information. The Go-Betweens in a Changing Socio-Technical Landscape 152 Bernike Pasveer, Oddgeir Synnes and Ingunn Moser. (Eds.). (2020). Ways of Home Making in Care for Later Life 167 References 179  Section 4: Knowledge Production181 Caragh Brosnan, Jenny-Ann Brodin Danell, Pia Vuolanto, Mike Michael, Marsha Rosengarten, Margaret Sleeboom-Faulkner, and Jessica Mesman Introduction 181 Caragh Brosnan, Jenny-Ann Brodin Danell and Pia Vuolanto. (Eds.) (2018). Complementary and Alternative Medicine. Knowledge Production and Social Transformation 185 Mike Michael and Marsha Rosengarten. (2013). Innovation and Biomedicine: Ethics, Evidence and Expectation in HIV 196 Margaret Sleeboom-Faulkner. (2014). Global Morality and Life Science Practices in Asia 204 Jessica Mesman. (2008). Uncertainty in Medical Innovation. Experienced Pioneers in Neonatal Care. Winner of Foundation for the Sociology of Health and Illness Book Prize 2009  212 References 225  Section 5: Regulation and Governance229 Alex Faulkner, Courtney Davis, John Abraham, Andrew Webster, Brian Salter, and Catherine Waldby Introduction 229 Alex Faulkner. (2009). Medical Technology into Healthcare and Society 232 Courtney Davis and John Abraham. (2013). Unhealthy Pharmaceutical Regulation 245 Andrew Webster. (Ed.) (2013). The Global Dynamics of Regenerative Medicine: A Social Science Critique 259

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Herbert Gottweis, Brian Salter and Catherine Waldby. (2009). The Global Politics of Human Embryonic Stem Cell Science. Regenerative Medicine in Transition 273 References 290 References297 Index315

Notes on Contributors

John Abraham  is Professor of Sociology in the Department of Global Health and Social Medicine at King’s College London, UK. He has led numerous Economic and Social Research Council (ESRC)- and Wellcome Trust-funded research projects on various aspects of pharmaceuticals and health policy. As Specialist Expert Adviser to the UK House of Commons Parliamentary Health Select Committee, he was centrally involved in its Inquiry into the Influence of the Pharmaceutical Industry (2005), which was the most comprehensive and wide-ranging Parliamentary investigation of the pharmaceutical sector since 1914. He has chaired many ESRC Research Grants Assessment Panels, as well as serving on the ESRC’s Grants Delivery Group, and as Vice-­ Chair of the ESRC Research Seminars Competition Panel. He has also delivered lectures to the World Health Organization, Social Science & Health Research Councils of Canada (GIERSO), International Society of Pharmacovigilance, Royal College of Psychiatrists, European Congress of Toxicology, European Science Foundation, British Medical Association, INFARMED, the International Society of Social Pharmacy, Basel Institute on Governance, European Commission MEDUSE programme at University of Liege and the All-Party UK Parliamentary Group on Corporate Responsibility. Sylvie Allouche  holds a PhD in Philosophy and has worked as an assistant professor or researcher in various French and European universities xv

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Notes on Contributors

(Paris, Lyon, Budapest, Toulon, Bristol, Troyes). She is an associate professor at the General Biology Laboratory (Ecole Pratique de Hautes Etudes/Universite Catholique de Lyon (EPHE/UCLy)), Lyon Catholic University, France, where she is also a co-holder of the Chair ‘Innovation, Responsibility, Humanity’ and coordinator of the Erasmus+ Jean Monnet programme ‘Europe in Interculturality’. Her research develops along two complementary directions: (1) the various philosophical issues raised by the prospect of engineering living organisms, with a special interest for human enhancement, geo-­engineering and digital ethics; and (2) the relations between philosophy and fiction, science fiction and TV series in particular. Ellen  Balka is a professor at Simon Fraser University’s School of Communication and the associate dean (Research) of the University’s Faculty of Communication, Art and Technology, Vancouver, Canada. Early in her career, her interest in gender and technological change led her to the health sector, where she has conducted numerous ethnographic studies focused on the challenges of designing, implementing and using varied technologies in healthcare. Her most recent work has focused on participatory design of an adverse drug event reporting system which bridges the informational continuity of care gap between acute care settings and community pharmacies. The system is currently being implemented in one of British Columbia’s health authorities. Simone Bateman  is a sociologist and is an Emeritus Senior Researcher at the Centre for Research on Medicine, Science, Health, and Society (CERMES3) of the French National Centre for Scientific Research (CNRS), Paris, France. Her research focuses on how societies deal with the practical and moral controversies raised by innovative medical and scientific practices, especially in the areas of fertility and reproduction and other closely related areas (neonatology, embryo research, genetics, genomics, human experimentation). Her work also examines bioethics as a historically specific social phenomenon. She was a member of the French National Ethics Committee from 1992 to 1996. Marianne  Boenink is an associate professor in the Department of Philosophy, University of Twente, the Netherlands, specialising in phi-

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losophy and ethics of emerging biomedical technologies. Her research concerns the conceptual and normative analysis of visions and trends in biomedicine, with a particular focus on diagnostic and prognostic technologies. In addition, she has an interest in responsible innovation, for example by developing methods for meaningful involvement of stakeholders in societal and ethical deliberations on technologies in the making. She is the director of the international MSc programme in Philosophy of Science, Technology and Society at the University of Twente. Jenny-Ann Brodin Danell  is Associate Professor of Sociology at Umeå University, Sweden. Her research focuses on different aspects of complementary and alternative medicine, especially on knowledge production, and how different kinds of actors (such as users, researchers and politicians) are involved in negotiations on scientific and medical credibility. Her recent project on this matter was funded by the Swedish Science Foundation. Jane  Brophy  is Postdoctoral Research Fellow in Public Policy at the University of Melbourne School of Government, Australia. Her interdisciplinary research spans medical sociology, science and technology studies and Asian studies. Her research explores the social dynamics that underpin the development of markets for new and emerging biotechnologies in the context of globalisation. Her PhD research examined the moral economy of the market for unproven stem cell treatments in China, and her current work focuses on the social and policy implications of the birth of genetically edited babies in China. Caragh Brosnan  is Associate Professor of Sociology at the University of Newcastle, Australia. Her work explores identity, power and the construction of legitimate knowledge in the scientific and health professions. Her recent projects have focused on complementary and alternative medicine in the university. She has written three edited collections: Handbook of the Sociology of Medical Education (2009, with Bryan Turner), Bourdieusian Prospects (2017, with Lisa Adkins and Steven Threadgold) and Complementary and Alternative Medicine: Knowledge Production and Social Transformation (Palgrave Macmillan, 2018, with Pia Vuolanto and Jenny-Ann Brodin Danell).

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Notes on Contributors

Courtney Davis  is a reader in the Department of Global Health and Social Medicine at King’s College London, UK. She undertakes international comparative research on trends in the regulation of pharmaceutical safety, efficacy, cost-effectiveness and innovation, and has broad research interests in the intersections of science and technology policy, business regulation and public health. Conor  Farrington is a senior research associate at THIS Institute, University of Cambridge School of Clinical Medicine, UK.  His work focuses on the medical, sociological and philosophical implications of new medical technologies, especially wearable technologies such as ‘artificial pancreas’ systems for people with Type 1 diabetes. He is particularly interested in the application of organisational theories, such as Karl Weick’s ‘sensemaking’ approach, to pressing questions of variable technology experience on the part of multiple stakeholders. His current work extends research on user experience of medical devices to embrace clinician perspectives, attempting to explore the range of clinical opinion regarding the introduction of future machine-­learning technologies into mainstream care in England. Alex Faulkner  is Professor of Sociology of Biomedicine and Healthcare Policy at the Centre for Global Health Policy, University of Sussex, UK. His research theorises the regulation, valuation and uptake of technologies such as regenerative medicine, biomedical devices, bioinformatics and 3D bioprinting in the UK, EU and India. He has recently investigated bio-therapies in elite sport and collaborated with a patient organisation to analyse Lyme disease policy in the UK. John  Gardner  is a senior lecturer in the School of Social Sciences at Monash University, Melbourne, Australia. He is trained in sociology and STS (science and technology studies) and his research focuses primarily on the social dimensions of medical innovation in healthcare. His research investigates how social values and expectations shape innovation processes, and it examines the social and ethical aspects of new medical technologies. Much of his work has focused on translational neuroscience, particularly neurotechnologies such as deep brain stimulation (DBS). The aim of his research is to draw on social science methodologies to facilitate responsible research and innovation.

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Jérôme Goffette  is Associate Professor of Philosophy at Claude Bernard University Lyon 1, France, and a member of the research unit on Environment, City and Society (EVS) of the French National Centre for Scientific Research (CNRS), Lyon. His research focuses primarily on anthropotechnics and human enhancement, a topic to which he has dedicated many articles and a book Naissance de l’anthropotechnie [Birth of anthropotechnics] (2006). His other areas of research concern the body schema, the imaginary of the body and the significant development of prosthetics. His present work explores the impact of human modification practices on our concrete lives. Eileen Green  is Emerita Professor of Sociology at Teesside University, England, UK, where she was the Founding Director of the Centre for Social and Policy Research which specialised in community action projects. Her research interests include gender studies, young people and risk, women’s health and leisure and digital sociology. She has written widely in the area of women and gendered technology. She is a past Chair of the British Sociological Association and holds an Honorary Professorial Fellowship at the University of Warwick. Green has been a fellow of the Academy of Social Sciences since 2001 and is an elected member of Academy of the Social Sciences (AcSS) Council. Roma Harris  is Professor Emerita retired from the Faculty of Information and Media Studies at the University of Western Ontario in London, Canada. She lives in a small tourist village on the shores of Lake Huron in a sparsely populated rural area where she is witness to the power of info(r)mediation on the health and well-being of local people, particularly as it is facilitated by the presence of a much-loved public library. Using the library’s meeting space, interested ­community members have launched a wide range of activities, events and programmes, all of which, in unique ways, reduce isolation and loneliness, strengthen social networks and build connecting ties of information exchange and caring. Flis Henwood  is Professor of Social Informatics in the School of Applied Social Science, University of Brighton, UK. Her early research focused on gender-technology relationships and, later, on sociotechnical critiques of digital health. The edited collection Gender, Health and Information

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Notes on Contributors

Technology in Context (co-edited with Ellen Balka and Eileen Green in 2009) sits at the intersection of these two areas of interest. She has written widely on the relationship between information, technology and care and is the Joint Chief Editor of the journal Sociology of Health and Illness and co-editor of the 26th SHI monograph Digital Health: Sociological Perspectives, published in 2019. Klasien Horstman  is Full Professor of ‘Philosophy of Public Health’ at the Faculty of Health, Medicine and Life Sciences, Maastricht University, the Netherlands. She studies the dynamics of science, politics and society in diverse public health practices, like (work place) health promotion, vaccination, antibiotic resistance prevention and urban health. She coordinated the Erasmus programme Bridging Innovations, Health and Societies: Educational Capacity Building in the Eastern European Neighbouring Areas (2015–2018) and was the co-editor of the book Health, Technologies, and Politics in Post-Soviet Settings: Navigating Uncertainties (Palgrave Macmillan, 2018). She has written several Dutch reports for the Municipality of Maastricht about policies and practices of safety, health, care and housing, and developed an urban health living lab in a disadvantaged neighbourhood, University with the Neighborhood. Harro  van  Lente  is Professor of Science and Technology Studies and head of department at the Faculty of Arts and Social Sciences, Maastricht University, the Netherlands. He is one of the founding fathers of the Sociology of Expectations, which studies how representations of the future shape current socio-technical developments. His research concerns how emerging technologies—such as nanotechnology, hydrogen and medical technologies—produce novelties and needs. This involves technology assessment, foresight, politics of knowledge production and philosophy of technology. He is also Chair of the board of the Netherlands Graduate Research School of Science, Technology and Modern Culture (WTMC). Rebecca Lynch  is Research Fellow in Medical Anthropology at King’s College London, UK. She completed her PhD in Social Anthropology at University College London (UCL) and has undertaken ethnographic work in Trinidad and in the UK. Among other areas she has written on

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different socio-cultural, moral and scientific constructions of the body, health and illness (including in public health and health services), and on bodily interaction with the non-human. She has edited three books that seek to expand approaches to the body and health through examinations of relations between human health and the non-human and through post-human approaches. Casimir MacGregor  is a medical anthropologist who specialises in the examination of science, technology and society (STS). His research draws upon theory and methods of anthropology, science and technology studies, and public health. To date his research has focused on ‘compassionate caring’ amongst emergency clinicians and their patients, ‘vulnerability’ in relation to pandemic influenza and ‘hope’ in relation to stem cell research and therapies. Recently his research has focused on ‘energy ethics’ in hospitals. His goal is to create dialogue between disciplines and co-create research with end-users to confront contemporary health challenges and pursue innovations in the practice of social science. Michela  Marzano  is a philosopher and head of the Department of Social Sciences at the Paris Descartes—Paris V University. After studying Philosophy in Pisa and Rome, she obtained a PhD with a thesis on the status of the human body in contemporary society. In 1999, she moved to France and joined the Centre National de la Recherche Scientifique in 2000. She is particularly interested in moral philosophy and politics. Jessica  Mesman is Associate Professor of Science and Technology Studies (STS) and is the vice-dean at Maastricht University, the Netherlands. She has more than 25 years of experience in ethnographic studies in various countries in healthcare settings (mainly ICU, Surgery and Emergency). Her work on patient safety and that on ‘exnovation’, in particular, is nationally and internationally recognised as progressive by focusing on strengths of practices since the early 2000s. She has written widely on the topic and has been a visiting scholar at several international universities around the world. Mesman is considered to be one of the leading scholars in the area of video-reflexive ethnography (VRE). Besides her scholarly work she also offers master courses and team-­training in this method for professionals in healthcare and education. Her publication

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Notes on Contributors

list includes several books and articles on this subject in close collaboration with other experts in this area. In addition, she is one of the initiators of establishing the VRE International Association (VREIA). On the basis of her expertise she is also officially affiliated with the Mayo Clinic in the USA. Mike Michael  is a Sociologist of Science and Technology, and a professor in the Department of Sociology, Philosophy and Anthropology, University of Exeter, England, UK. Research interests have touched on the relation of everyday life to technoscience, the use of design to develop a ‘speculative methodology’ and the role of aesthetics and affect in the making of publics. Recent publications include (co-authored with Andy Boucher et  al.) Energy Babble: Entangling Design and STS (2018) and Actor-Network Theory: Trials, Trails and Translations (2017). Ellen  Moors is Professor of Innovation and Sustainability at the Copernicus Institute of Sustainable Development, Utrecht University, the Netherlands. Her research focuses on the dynamics and governance of technological innovations in science-based sectors in which emergent technology development occurs. She focuses especially on user-­driven innovations and changing institutional arrangements in health, life sciences and novel food-related innovations. She also studies innovation-­ regulation issues, sustainable healthcare practices and responsible innovation. Moors is Director of Research of the Copernicus Institute of Sustainable Development and a member of the Dutch Advisory Council for Science, Technology and Innovation (AWTI). Ingunn Moser  is Professor of Sociology and Social Studies of Science, Technology and Medicine at VID Specialized University, Oslo, Norway. Her research is centred on uses of knowledge and technology in healthcare practices, and on relations between subjectivity, embodiment, materiality and different knowledge practices. These theoretical interests have been explored in empirical fields, ranging from disability via e-health and telecare to care for the elderly and dementia care in particular. Megan  Munsie  is an associate professor and Deputy Director of the Centre for Stem Cell Systems at the University of Melbourne, Australia, where she leads the Ethics, Legal and Social Implications Program. She is

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also head of the Engagement, Ethics and Policy Program of Stem Cells Australia, a national research initiative funded by the Australian Research Council. Munsie is a recent recipient of the highly esteemed International Society for Stem Cell Research 2018 Public Service Award. Nelly  Oudshoorn  is Professor Emerita of Technology Dynamics and Health Care at the University of Twente, Netherlands. Her research interests and publications include the co-construction of technologies and users, with a particular focus on medical technologies. She is the author/ co-editor of the following award-winning books, including The Male Pill: A Biography of a Technology in the Making (2003), Telecare Technologies and the Transformation of Healthcare (Palgrave Macmillan, 2011) and The New Production of Users: Changing Innovation Collectives and Involvement Strategies (2016, co-edited with Sampsa Hyysalo and Elgaard Jensen). Bernike Pasveer  is an assistant professor at the Faculty of Arts and Social Sciences, Maastricht University, the Netherlands. Her work focuses on analysing the socio-cultural, technological and biomedical specificities of handling the human body’s so-called natural achievements such as becoming pregnant, giving birth, being talented, dying and ­belonging— which are also the topics of her past and current research projects. She is developing a research project into (mundane) practices of refuge and belonging. Kirstine Zinck Pedersen  is an associate professor in the Department of Organization, Copenhagen Business School, Denmark. Her research attends to the organisational, practical and ethical implications of recent managerial and technological transformations of the public sector and in particular to the constitutive effects and unintended consequences of quality and safety programmes in healthcare. Methodologically, these are studies that often combine ethnographic investigation or historical analysis with an analytical interest in American pragmatism, classic organisation theory and sociological perspectives on professional work, clinical judgement and public office holding. Alan Petersen  is Professor of Sociology and Gender Studies, School of Social Sciences, Monash University, Melbourne, Australia. His research areas cover the sociology of health and medicine, science and technology

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Notes on Contributors

and gender studies. His recent work, which is funded by the Australian Research Council, has focused on patients’ use of digital health and on testing in healthcare. He is a fellow of Academy of Social Sciences, UK, and fellow of Academy of Social Sciences, Australia. Marsha  Rosengarten  is Professor of Sociology in the Department of Sociology, Goldsmiths, University of London, UK. She is the author of HIV Interventions: Biomedicine and the Traffic Between Information and Flesh (2009), co-author with Mike Michael Innovation and Biomedicine: Ethics, Evidence and Expectation in HIV (Palgrave Macmillan, 2013) and with Alex Wilkie and Martin Savransky an edited collection Speculative Research: The Lure of Possible Futures (2017). Brian  Salter is Professor of Politics in the Department of Political Economy at King’s College London, UK.  His research deals with the political sociology of power in the domains of science, health and education focusing on the role of the state, ideology and markets in the control and governance of knowledge and innovation, applied to national and global contexts. In biomedicine he explores the global politics driving the governance response to new health technologies, the impact of the emerging economies and the role of bioethics in that process. Taking assisted reproductive technology as its empirical focus, his current research examines the politics driving the relationship between cultures, religions and global markets. Margaret  Sleeboom-Faulkner is Professor of Social and Medical Anthropology at the University of Sussex, Brighton, UK. Her work concerns processes of nation-state building in China and Japan and biotechnology and society in Asia. Her research projects concern international life science networks in the fields of biobanking and biomaterials, and stem cell therapies and experimentality (funded by the European Research Council (ERC) and Economic and Social Research Council (ESRC) respectively). In these projects she combines anthropological approaches and social studies of science. Oddgeir Synnes  is an associate professor at VID Specialized University, Oslo, Norway, and an associate professor II at Molde University College, Norway. His main research interests lie in the fields of health humanities,

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narrative medicine and existential care. For several years, he has worked in practical as well as research projects on the use of creative writing and storytelling in palliative care, elderly care, dementia care and among young adults with psychosis. Claire  Tanner is a research fellow in the Ethics, Legal and Social Implications (ELSI) programme in the Centre of Stem Cell Systems at the University of Melbourne, Australia, where she coordinates an interdisciplinary research programme on science in society and the socio-­ ethical implications of new and emerging technologies. Her most recent research focus is on the emerging scientific field of mammalian cell synthetic biology and the socio-cultural and ethical meanings, discourses and scientific practices surrounding its development. Gerard de Vries  was Professor of Philosophy of Science at the University of Amsterdam, Netherlands, from 1997 to 2013, when he retired. From 2006 to 2014 he served as a Council Member at the Scientific Council for Government Policy, the think tank for long-term policy issues of the Dutch government in the Hague. He is a visiting fellow of Wolfson College, Cambridge. Previously, De Vries has also been Professor of Philosophy at Maastricht University (1987–1997) and Dean of the Netherlands Graduate Research School in Science, Technology and Modern Culture (1988–1997). His most recent book is Bruno Latour, published in 2016. Pia  Vuolanto  is a sociologist and Scholar in Science and Technology Studies and Medical Sociology at Tampere University, Finland. Her research concentrates on the boundaries of biomedical and social scientific knowledge, health-related controversies and interdisciplinarity in the health research field. She works on sociology and history of CAM (Complementary and Alternative Medicine) and vaccine hesitancy, the development of CAM research, sociology of science and belief as well as the pressures of ignorance on expertise. She has publications in Science and Technology Studies, Minerva and Scandinavian Journal of Public Health. Catherine Waldby  is Director of the Research School of Social Sciences at the Australian National University, Australia. Her researches focus on social studies of biomedicine and the life sciences. She is the author of 55

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research articles and 7 monographs in this area. Her recent books include Clinical Labor: Tissue Donors and Research Subjects in the Global Bioeconomy (with Melinda Cooper, 2014) and The Oöcyte Economy: The Changing Meaning of Human Eggs (2019). With Nikolas Rose and Hannah Landecker, she is the editor of BioSocieties: An Interdisciplinary Journal for the Social Studies of Life Sciences. Nadine Wathen  is a professor and Canada Research Chair in Mobilizing Knowledge on Gender-Based Violence at Western University, Canada, and is a research scholar at Western’s Centre for Research and Education on Violence Against Women and Children. She is a member of the College of the Royal Society of Canada. Her research examines responses to gender-based violence, interventions to reduce health inequities and the science of knowledge mobilisation, with a focus on the use of research in policy and practice. Andrew  Webster is a professor in the Sociology of Science and Technology at the University of York, UK. He was founder and director of SATSU for 30 years. He has also directed various national research programmes on novel biomedical technologies and regenerative medicine. His main interest is in understanding how emergent technologies are, or are not, adopted in clinical settings, and through this work developed, with his colleague John Gardner, the model of ‘institutional readiness’ which is now adopted by National Health Service (NHS) Trusts introducing advanced therapies in the cell and gene therapy area. He is also Executive Secretary of Association for the Study of Innovation, Science and Technology (AsSIST-UK). Sally Wyatt  is Professor of Digital Cultures at Maastricht University, the Netherlands. Together with Anna Harris and Susan Kelly, she co-­authored Cybergenetics, Health Genetics and New Media (2016). This book was awarded the Foundation for the Sociology of Health and Illness book prize in 2017. Wyatt’s research focuses on digital technologies, and their use in healthcare and in the production of knowledge. She has been involved in the Netherlands Graduate Research School of Science, Technology and Modern Culture (WTMC), first as a coordinator of PhD training (2006–2010) and later as an academic director (2011–2017).

Introduction Andrew Webster and Sally Wyatt

This book is both a celebration and a reflection: it celebrates and captures examples of the excellent scholarship that the Health, Technology and Society (HTS) Series has published since 2006, and it reflects on how the field has developed over this time. As editors of the HTS Series who, in 2020, handed over the reins to our UK-based colleagues, Rebecca Lynch and Martyn Pickersgill, we thought it timely to create a text that told a story of the field, drawing from a variety of disciplinary perspectives and empirical domains. We also wanted to reflect on this work and so invited the authors and editors to describe how their original ideas have developed, how their specific areas of interest have moved on and to consider how their books were produced and received. This volume then is both a retrospective and prospective commentary on health and technology, one of the major areas of debate in the social sciences.

A. Webster (*) University of York, York, UK e-mail: [email protected] S. Wyatt Maastricht University, Maastricht, The Netherlands e-mail: [email protected] © The Author(s) 2020 A. Webster, S. Wyatt (eds.), Health, Technology and Society, Health, Technology and Society, https://doi.org/10.1007/978-981-15-4354-8_1

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All the books in the Series address a number of broad themes. They show that medicine, health care and the wider social meaning and management of health are undergoing major changes. In part this reflects developments in science and technology, which enable new forms of diagnosis, treatment and the delivery of health care. It also reflects changes in the locus of care and burden of responsibility for health. Genetics, digital technologies, imaging and integrative technologies, such as nanotechnology, are redefining our understanding of the body, health and disease. Furthermore, health is no longer simply the domain of conventional medicine, nor the clinic. The ‘birth of the clinic’ heralded the process through which health and illness became increasingly subject to the surveillance of medicine. Although such surveillance is more complex, sophisticated and precise as seen in the search for ‘predictive medicine’ as well as ‘personalised medicine’, it is also more provisional, uncertain and risk laden. The social management of health itself is losing its anchorage in collective social relations and shared knowledge and practice, whether at the level of the local community or through state-funded socialised medicine. This individualisation of health is both culturally driven and state sponsored, as the promotion of ‘self-care’ demonstrates. The very technologies that redefine health are also the means through which this individualisation can occur—through self-monitoring, diagnostic tests and the commodification of restorative tissue, such as stem cells, cloned embryos and so on. The books in the HTS Series have explored these processes within and beyond the conventional domain of ‘the clinic’ and asked whether they amount to a qualitative shift in the social ordering and value of medicine and health. Locating technical developments in wider socio-economic and political processes, each book has examined recent developments within health technologies in specific areas, drawing on a range of analyses provided by the social sciences. The Series has already published 21 books (plus 4 in preparation) that have explored many of these issues, drawing on novel, critical and deeply informed research undertaken by their authors. In doing so, the books have shown how the boundaries between the three core dimensions that

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underpin the whole Series—Health, Technology and Society—are changing in fundamental ways. How then to explore these changes? We decided that the best way would be to identify a number of themes that would help us to marshal the material across the empirical and conceptual range of material found in the Series. These have enabled us to organise the books by theme and so help the reader navigate the rich and substantively diverse landscape of HTS.  The five themes are Innovation, Responsibility, Locus of Care, Knowledge Production and Regulation and Governance. We will present these in more detail below, but first we reflect on the origin of the Series and on some of its normative and methodological contributions.

Early Days and the Focus of the Series The origin of the Series goes back to the beginning of this century, when a major UK research programme (2000–2005), jointly funded by the Economic and Social Research Council and the Medical Research Council, brought together over 32 projects and almost 130 researchers to explore what were called ‘Innovative Health Technologies’. That research programme not only produced a very large number of papers but also culminated in a book, New Technologies in Health Care (2006), that somehow managed to convey the rich and diverse work that the programme supported. Both editors of the HTS Series were involved: Webster as coordinator of the programme and Wyatt as one of the project-based researchers. The Series was launched at an international event hosted by the Royal Society in London, and the story of that day can be found here: https://www.york.ac.uk/res/iht/events/htsbooklaunch.htm. The impetus behind the programme then was a growing recognition that the social sciences needed to address in a more sustained and holistic way the current and future implications of innovative health technologies, the effects of which are mediated by wider processes of social change. Innovative health technologies (IHTs)—such as genetics, cloning, xenotransplantation and the internet—presented policy-makers and the public with major new concerns. For example, the then UK House of Commons Select Committee (3rd) Report on Human Genetics

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recommended that there be a programme of research that examines the social implications of IHTs in a robust and detailed way. The Wellcome Trust also called for a specifically social science agenda to be developed which could complement the Trust’s work on bioethics. The research programme subsequently funded by the ESRC and MRC did much to address these issues, and indeed many others, and the results are still available at https://www.york.ac.uk/res/iht/introduction.htm. The HTS Series grew out of this earlier work, but with a much broader intellectual and geographical canvas at its disposal. Whereas the IHT programme was UK focused, the HTS books have seen contributions by authors from a wide range of countries, not just from Europe, but also North America, Australia and South East Asia. Moreover, some of those engaged in the IHT research programme have had the opportunity to develop their ideas more fully and more critically in the Series texts. In the Introduction to the IHT book, Webster wrote that biomedical technologies can be characterised as having four key features. First, they can be embedded within the body, via prosthetics or pacemakers. Second, they can be projective of the body, as happens when patient data and information are digitised and then circulated and given new form via large-scale biobanks and clinical databases. Third, biomedical technologies can become hybrid as they pull together differing fields, such as in tissue and cell engineering. Finally, they can be representational, for example through increasingly sophisticated visual imaging and as biomarkers for disease become standardised and framed in specific ways. In many ways these four features can still be seen today, and all are touched on or indeed form the principal focus in one or more of the books in the Series. But taken together the HTS Series offers new insights into how these are shaped by and made more complex through a much more fine-grained analysis of the contexts in which they are found. This throws light on the play of social hierarchies (associated with ethnicity, gender and age for example), on the organisational dynamics that shape the adoption of innovative therapies, on the discourses and claims associated with so-called personalised medicine and so on. More broadly, the books help us to see healthcare and its meaning, development and use as part of a wider ecosystem, a regime of governance and accountability, resource and its allocation and so how an apparently similar therapy can

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have very different meanings and enactment in different national and global settings. This is particularly visible in the volume by Alan Petersen and his colleagues in their analysis of stem cell ‘tourism’. Moreover, the Series title is ‘Health, Technology and Society’, and that comma between ‘health’ and ‘technology’ serves an important purpose. Health as such is contested and highly contextualised, and as many books in the Series demonstrate, although ‘health technologies’ form their core focus, these can be and often are outside of the formal institutional and clinical, practice-based structures of formal healthcare itself. Another important feature of the books taken together is that we learn much about the ways in which health and health technologies are given ‘value’, and how this value is never self-evident or a given. For example, the books that we have brought together in the ‘Knowledge Production’ theme all touch on this issue in one way or another. This is not surprising since all forms of knowledge are based on implicit or explicit value judgements reflecting the assumptions and forms of authority on which they depend. These in turn often hide or fail to see the uncertainties and risks that accompany them.

 he Normative and Methodological T Contributions of the Series In many of the books, the authors offer suggestions and even recommendations about how the matters of concern they have explored might be better understood or handled more effectively. Jessica Mesman, for example, in the Knowledge Production section, explores neonatal clinical practices. She not only reveals hidden aspects of these practices but shows how they can be brought to the fore and so enable more effective and accountable clinical management of the premature baby. In the specific area of genetic testing, Gerard de Vries and Klasien Horstman, in the Responsibility section, make a strong case for much greater transparency about such tests and the traces they leave behind as they travel across patients, their families and into state programmes based on national screening and testing, such as the 100,000 Genome Programme in the UK that appeared after de Vries and Horstman’s book was published.

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Elsewhere, Courtney Davis and John Abraham, in their book on pharmaceutical regulation, show very clearly how regulation often fails those it is supposed to protect. They make a strong case for being more reflexive and challenging of patients’ and patient groups’ strong desire to have early access to medicines, showing how, contrary to conventional wisdom, this often produces very unhealthy outcomes, sometimes with severe drug toxicity. Instead they call for a new approach to the regulation of drugs which would be based on a weighing up of the ‘potentially competing needs in the objective interests of public health’ (p.284) (rather than private profit). With a similar focus on patient safety, Kirstine Zinck Pedersen calls for a new approach to medical practice which prioritises in practice, training and general care, safety as a ‘moral’ issue rather than one that can be codified in the form of stable and predictable systems and ‘failsafe design’—which are often harmful in their effects. These two books, among others in the Series, show how the actual effects of provisions established through (regulatory) policy and (technological) systems operate contrary to their supposed intentions. Another theme seen in the Series is the importance of place and space—not only in the locus of care section where space is clearly a primary focus but in other contributions where understanding the context in which health technologies are used is of paramount importance. Nelly Oudshoorn’s book on telemedicine designed primarily for home-based use shows how, through her ‘techno-geographical’ method, the value and utility of telemedicine is highly space-dependent. As she says, ‘the same technological device can do different things in different places’ (p.205). When those places are public—outside of the home (when shopping or with friends at a restaurant)—the bleeping and other features of ‘mobile’ self-monitoring devices can be very disconcerting for all concerned. As a result, and contrary to the purpose of such devices to enable constant monitoring of a patient’s health, the effect will be that ‘patients will use these devices only at home, which undermines the very aim of this new generation of telecare technologies’ (p.205). Here again we see how Oudshoorn’s work and that of others in the Series brings to the fore the unintended effects of the deployment of novel health technologies. Only through the sort of detailed empirical work seen here can we begin to rethink precisely what needs to be done to make a technology that is

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apparently technically ‘working’ (the monitor bleeps) to one that is actually ‘workable’, that is makes sense and is valued in appropriate contexts. Marianne Boenink, Harro van Lente and Ellen Moors make a strong plea for this in their moving and often disturbing account of how patients and their families cope with and understand Alzheimer’s Disease (AD). They show how the formal biomedical approach to early onset of AD diagnostics is not fit for purpose precisely because it fails to take into account these non-biomedical interpretations of AD. The richness of the empirical work seen in all of the books reflects their strong methodological contribution. Whether in the single monographs or the edited collections, the authors show how approaches that draw on medical anthropology, sociology of health, science and technology studies and rich ethnography can reveal often hidden processes at work in the HTS relationship. A focus on practice(s) and the discursive registers surrounding them is a common feature of these stories. At the same time, forensic attention to documentary sources and ‘grey literature’ found especially in government policy arenas can be equally rewarding (as seen in the Davis and Abraham text on drugs and the Michael and Rosengarten text on clinical trials and HIV). Finally, although some of the books are now over ten years old, their broad message is still important, even if some of the empirical context has changed. Understanding the HTS relationship still requires the mix of critical and methodological insight the books bring to the fore. Moreover, we can learn from developments in the past—such as early days in genetics or in internet technologies. Even if these are superseded today by ever more novel techniques and the explosion of ‘datafication’ in biomedicine and health surveillance, the historical story is there to provide lessons for the future. The extracts included in this volume provide only a glimpse of these normative and methodological contributions, so readers are encouraged to delve deeply into the texts themselves. In the next section we explain how we have put this volume together and then look ahead to forthcoming texts, some of which started their publication journey under our watch, but will appear under the auspices of Lynch and Pickersgill, our two new editors.

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Structure of the Book The remainder of this volume is divided into five thematic sections: Innovation, Responsibility, Locus of Care, Knowledge Production and Regulation and Governance. Each of the already published books is allocated to one section, even though many books address multiple themes. Each section includes a short introduction by us, followed by extracts from the books which illustrate the theme. We invited authors and editors to reflect on their books and how ideas have developed. These short reflections appear after the relevant extracts. Our hope is that these extracts can stand alone, and perhaps provide a useful resource for teaching and for researchers new to this field. We also hope that some readers will be stimulated to return to the original books, to savour their full richness. All the references are gathered together at the end of the text, those cited in the original extracts as well as those introduced in the authors’ reflections. This provides an invaluable resource for further reading. Innovation is our first theme. Innovation in medical devices, diagnostics and treatments offers many benefits to patients and to healthcare systems but is also accompanied by uncertainty and risk. Moreover, innovation never speaks for itself, as somehow inherently superior to what exists, but must always be spoken for, mobilised and secured value across a range of different social actors. That also points to its co-production and non-linear route to the users, who in fact are themselves directly implicated in making innovations ‘work’ and gain meaning (Balka et al. 2009; Boenink et  al. 2016; Gardner 2017; Lynch and Farrington 2018; Oudshoorn 2011). The second theme is responsibility. This captures the ways in which the burden of responsibility for health and wellbeing is being shifted onto individuals, via developments such as personalised medicine, as well as becoming increasingly distributed across a range of actors. Genetic diagnostics, for example, creates a diverse range of risks and uncertainties and so loci of responsibility for all involved, from patients and their families, through various clinical practitioners to state agencies charged with genetics services and its resourcing, and in privatised healthcare,

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insurance companies too. Health as a body project produces new senses of being responsible as moves towards, and the possibilities of self-­ enhancement grow (Bateman et al. 2015a; Harris et al. 2010; De Vries and Horstman 2008; Pedersen 2018). We then move to the locus of care. Healthcare is no longer primarily the preserve of the clinic. Globalisation, digitalisation and the growing emphasis on personal responsibility mean that more and more healthcare is taking place in non-medical settings. The ‘patient journey’ is typically used to describe the in-clinical pathway a patient takes as they receive different stages of treatment. But the books in this section illustrate how patients may ‘journey’ across many different landscapes—a global one as they seek treatment not available locally, a digital one in seeking health information and a domestic one in creating a ‘home’ for care and the twists and turns that can involve (Pasveer et al. 2020; Petersen et al. 2017; Wathen et al. 2008). Knowledge production is the fourth theme. In this section, we focus on the responses to the challenges of medical expertise and the ways in which patients and other stakeholders produce and mobilise data and evidence to construct new forms of knowledge. We see this for example in complementary and alternative forms of medicine, in the ways in which clinical trials can be challenged and reconfigured to serve patient interests, how the apparently same knowledge can actually mean quite different things as you move across countries and how localised practices bring knowledge to life (Brosnan et  al. 2018; Mesman 2008; Michael and Rosengarten 2013; Sleeboom-Faulkner 2014). Finally, we address regulation and governance of healthcare. These have traditionally been seen as the prerogative of the nation state, but many of the developments raised in the preceding sections challenge this. Not only companies (producing pharmaceutical and medical devices) but also individuals seeking treatment and support are crossing national boundaries. Moreover, regulation itself is moving towards a risk-based, adaptive governance model which reflects the epistemic and practical uncertainties associated with innovative health technologies (Davis and Abraham 2013; Faulkner 2009; Gottweis et al. 2009; Webster 2013).

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The Series has been fortunate enough to see some of its books receive major prizes from national and international bodies, reflecting the value its books have made to academic, practitioner and policy communities. Four books have won awards: Alan Petersen et al. (2017) Stem Cell Tourism and the Political Economy of Hope was the 2018 winner of the Stephen Crook Memorial Prize awarded by The Australian Sociological Association; Jessica Mesman’s book Medical Innovation and Uncertainty in Neonatology and Nelly Oudshoorn’s Telecare Technologies and the Transformation of Health both received the Foundation for the Sociology of Health and Illness book prize in 2009 and 2012 respectively; and finally, Marianne Boenink et al. and their book Emerging Technologies for Diagnosing Disease were awarded the EASST Chris Freeman prize ‘for a collective contribution to the interaction of STS with the study of innovation’.

Looking Ahead Although as editors we are stepping down, the Series will continue to grow and be overseen by the new editors, Martyn and Rebecca. Forthcoming books already contracted and due to appear in the near future include texts relating to body implants and their implications for the meaning of health, comparative analyses of health care systems and human-machine relations in the context of medical devices and medicine in Japan (especially how this differs from Europe and the US), how navigating digital knowledge landscapes is to be understood and can be made more socially robust and a book exploring commercial surrogacy in India. We welcome especially this increasing focus on international contexts outside of ‘western’ healthcare systems as an important dimension to the Series as a whole. We would like to take this opportunity to thank all those who have made this Series so successful: our authors whether of monographs or the edited collections who have responded quickly and effectively to any queries we raised, and of course the team at Palgrave Macmillan, especially our commissioning editors over the years since we began, Jill Lake, Philippa Grand, Harriet Barker, Holly Tyler and currently Joshua Pitt. It has been a pleasure working with them, always helpful, speedy and

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considerate to our authors and to us. We know that Martyn and Rebecca will enjoy collaborating with them too. Finally, we would like to recognise the important contributions made by those authors who have passed away. Herbert Gottweis (1958–2014) co-authored The Global Politics of Human Embryonic Stem Cell Science with colleagues Brain Salter and Catherine Waldby. Gottweis was a professor in the Department of Political Science at the University of Vienna. He founded and headed the research platform ‘Life-Science-Governance (LSG)’ dedicated to the interdisciplinary research of the impacts of biotechnology, biomedicine and molecular biology. Among his many responsibilities, in 2005 he was appointed Vice-President of the Austria Science Fund (FWF), coordinating the funding of social-scientific research. He was a man of great intellect, scholarship and charm, and he is much missed. Jean Gayon (1949–2018) co-edited with Simone Bateman and colleagues Inquiring into Human Enhancement and Enquiring into Animal Enhancement. Gayon was a well-known philosopher and historian of science. He was a professor at Paris 1 Panthéon-Sorbonne University and Director of the Institute of History and Philosophy of Science and Techniques (IHPST) from 2010 to 2016. His research covered many fields: the history of modern biology (evolutionary theory, genetics, biometry), philosophy of biology (concepts of species, gene, function, chance, model organism) and the history of philosophy of science. His book on the history of selection theory (Darwinism’s Struggle for Survival 1998) has become a classic in his discipline. He also wrote on the social and political aspects of the life sciences (eugenics, the notion of race, conservation biology, human enhancement). His keen analytic mind and stimulating arguments are much missed by his colleagues and his students in France and abroad.

References Balka, E., Green, E., & Henwood, F. (Eds.). (2009). Gender, health and information technology in context. Basingstoke: Palgrave Macmillan.

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Bateman, S., Gayon, J., Allouche, S., Goffette, J., & Marzano, M., (Eds.). (2015a). Inquiring into human enhancement. Interdisciplinary and international perspectives. Basingstoke: Palgrave Macmillan. Boenink, M., van Lente, H., & Moors, E. (Eds.). (2016). Emerging technologies for diagnosing Alzheimer’s disease. Innovating with care. Basingstoke: Palgrave Macmillan. Brosnan, C., Vuolanto, P., & Brodin-Danell, J.-A. (Eds.). (2018). Complementary and alternative medicine. Exploring health and technology through personal medical devices. Basingstoke: Palgrave Macmillan. Davis, C., & Abraham, J. (2013). Unhealthy pharmaceutical regulation. Innovation, politics and promissory science. Basingstoke: Palgrave Macmillan. Faulkner, A. (2009). Medical technology into healthcare and society. A sociology of devices, innovation and governance. Basingstoke: Palgrave Macmillan. Gardner, J. (2017). Rethinking the clinical gaze: Patient-centred innovation in paediatric neurology. Basingstoke: Palgrave Macmillan. Gottweis, H., Salter, B., & Waldby, C. (2009). The global politics of human embryonic stem cell science. Regenerative medicine in transition. Basingstoke: Palgrave Macmillan. Harris, R., Wathen, N., & Wyatt, S. (Eds.). (2010). Configuring health consumers. Health work and the imperative of personal responsibility. Basingstoke: Palgrave Macmillan. Lynch, R., & Farrington, C. (Eds.). (2018). Quantified lives and vital data. Exploring health and technology through personal medical devices. Basingstoke: Palgrave Macmillan. Mesman, J. (2008). Uncertainty and medical innovation: Experienced pioneers in neonatal care. Basingstoke: Palgrave Macmillan. Michael, M., & Rosengarten, M. (2013). Innovation and biomedicine. Ethics, evidence and expectation in HIV. Basingstoke: Palgrave Macmillan. Oudshoorn, N. (2011). Telecare technologies and the transformation of healthcare. Basingstoke: Palgrave Macmillan. Pasveer, B., Synnes, O., & Moser, I. (Eds.). (2020). Ways of home making in care for later life. Basingstoke: Palgrave Macmillan. Pedersen, K. Z. (2018). Organising patient safety. Failsafe fantasies and pragmatic practices. Basingstoke: Palgrave Macmillan. Petersen, A., Munsie, M., Tanner, C., MacGregor, C., & Brophy, J. (2017). Stem cell tourism and political economy of hope. Basingstoke: Palgrave Macmillan. Sleeboom-Faulkner, M. (2014). Global morality and life science practices in Asia. Assemblages of life. Basingstoke: Palgrave Macmillan.

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Vries, G. d., & Horstman, K. (Eds.). (2008). Genetics from laboratory to society. Societal learning as an alternative to regulation. Basingstoke: Palgrave Macmillan. Wathen, C. N., Wyatt, S., & Harris, R. (Eds.). (2008). Mediating health information: The go-betweens in a changing socio-technical landscape. Basingstoke: Palgrave Macmillan. Webster, A. (Ed.). (2013). The global dynamics of regenerative medicine. A social science critique. Basingstoke: Palgrave Macmillan.

Section 1: Innovation Marianne Boenink, Harro van Lente, Ellen Moors, Nelly Oudshoorn, John Gardner, Ellen Balka, Eileen Green, Flis Henwood, Rebecca Lynch, and Conor Farrington

Introduction Innovation is one of the major processes shaping the health-technology-­ society relation: innovation of technologies, of healthcare systems, of the very meaning of health and its absence. This section draws on extracts from five of the HTS books, which, in their different ways, examine innovation and its meaning, especially how innovation processes are

M. Boenink (*) Department of Philosophy, University of Twente, Enschede, The Netherlands e-mail: [email protected] H. van Lente Faculty of Arts and Social Sciences, Maastricht University, Maastricht, The Netherlands E. Moors Copernicus Institute of Sustainable Development, Utrecht University, Utrecht, The Netherlands © The Author(s) 2020 A. Webster, S. Wyatt (eds.), Health, Technology and Society, Health, Technology and Society, https://doi.org/10.1007/978-981-15-4354-8_2

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shaped by different contexts and practices. Other books in the Series also explore innovation processes. But these five have been selected as they cast particularly valuable light on some of the most important issues and challenges we need to consider when thinking about innovation. The first text, by Marianne Boenink et al. (2016), takes as its primary focus what is meant by diagnosis? Considerable innovation-led effort is devoted to finding new diagnostic markers for all forms of disease—biomarkers for cancer, for example. Far from a straightforward matter however, the authors show, through a rich and detailed exploration of Alzheimer’s disease, that what the disease is, how it is measured, experienced and treated are shot through with uncertainties and risks. We encounter stories about boundaries—between practitioner and patient, between the normal and abnormal, between the clinic and everyday experience: all sites where what it is itself never easily settled. The development of novel drugs, diagnostic N. Oudshoorn University of Twente, Enschede, The Netherlands e-mail: [email protected] J. Gardner School of Social Sciences, Monash University, Melbourne, VIC, Australia E. Balka Faculty of Communication, Art and Technology, Simon Fraser University, Vancouver, BC, Canada E. Green Teesside University, Middlesbrough, UK University of Warwick, Coventry, UK F. Henwood School of Applied Social Science, University of Brighton, Brighton, UK R. Lynch Anthropology of Health and Medicine, King’s College London, London, UK e-mail: [email protected] C. Farrington THIS Institute, School of Clinical Medicine, University of Cambridge, Cambridge, UK

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techniques or measures of ‘ageing’ while of value in their intent raise new questions about what counts as a responsible innovation regime in this field, especially with the push towards ‘earlier diagnosis’. The notion of ‘responsible research and innovation’ (RRI) has gained prominence in recent years and opened up debate within the social sciences, regulatory agencies and policy-making. These chapters (and others in the Series) stress the need to understand the values and practices in the lab, the clinic and the healthcare system more broadly: innovation never ‘speaks for itself ’ but has to be spoken for. So whose voices are heard and why? This takes us towards a second major problem in the HTS relation— the adoption of innovation in clinical settings. Who speaks for them? We know that innovation has to be adapted before it is adopted: contexts of use and localised understanding shape what an existing and a new technology mean and how they will be deployed (May et al. 2016). In this regard, innovation and its material incarnation are best understood as a ‘distributed effect’ (Sørensen 2007: 45), that is material innovation is defined through the relationship between things and ‘moulded by the intersection of natural and social factors’ (Law 2010). The extracts from Nelly Oudshoorn’s book on telemedicine show this distributed effect very clearly as innovation here depends on the distributed labour and interpretation of imaging and data by diverse clinical and non-clinical actors, including, very importantly, patients themselves. The spatial implications this has Oudshoorn describes as the ‘technogeography of care’. John Gardner’s book, Rethinking the Clinical Gaze (2017), our third text, examines the process of innovation in the field of ‘deep brain stimulation’. His book shows how this relatively new therapy used to treat a complex and very debilitating disorder, dystonia, reveals the ways in which the traditional clinical gaze has become broader in scope and power. He shows too that this is a result of the arrival of ‘patient-centred innovation’ and the creation of complex innovation platforms that are created through clinicians and other professionals working in this area, platforms that disturb conventional organisational structures and processes associated with the delivery of medical therapies and through which the adoption of innovation is made possible. A key feature of innovation in health and other sectors—its digital character—is of central importance today (and reflected in Oudshoorn’s own text). Our fourth book, edited by Ellen Balka et al. (2009), describes how

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what they call the ‘computerization of health care’. This goes far beyond saying ‘the digital’ has a growing presence—for example, in diagnosis, screening, visualisation and imaging, patient management, organising care at the hospital level and so on. The extracts we have selected from across the different chapters show how the everyday use of ICT systems not only reflect and shape organisational and professional practices and structures, but also mediate and often reproduce gender and racial relations and hierarchies. In understanding these processes we are in a much better position to develop not only critical but also constructive engagement with the ‘computerisation’ process, by being then able to describe how to improve on the implementation of information systems in hospitals and elsewhere and to do so such that these hierarchies begin to collapse. The final text, edited by Rebecca Lynch and Conor Farrington (2018), continues this focus on ‘the digital’ but here in regard to the rapid growth of ‘personalised medical devices’ (PMDs) often used outside of (and indeed counterposed to) conventional medical settings. The extracts we have selected illustrate both the use of PMDs in clinical and non-clinical contexts. The growth of PMDs reflects the huge commercial investment in self-monitoring devices (such as Fitbits) and the push (by government and professions) to more self-reliance and personal responsibility for one’s own health. This echoes Foucault’s notion of governmentality whereby the embrace of personal responsibility for health is a form of social control. However, as this text shows, ‘control’ overstates the provisional, uncertain status given by users to PMD information and device-­generated reporting. The chapters show too how the ‘health’ of the individual is dependent on the ‘health’ of the device itself, and the ‘health’ of both is given wider definition and meaning from the array of other social actors and networks with which people are involved. What the ‘quantified life’ and the data that records this actually means is far from straightforward. This drive towards personalised medicine seen in many countries reflects another broader aspect of innovation that is seen in the HTS series and wider STS, social science scholarship. This is the need to give as much attention to wider regimes of healthcare. For example, in 2018/2019, the UK introduced a ‘Genetics Health Service’ within the broader NHS to reflect the growing use of genetic data, gene therapy and post-genomic modelling of disease. Such a move both reinforces the ‘personalised’ (DNA-susceptibility) form of medicine we can expect, and the

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continued growth of commercial activity to exploit this via the provision of kits and ‘DIY’ biology online and in private clinics. In other words, to understand innovation we need to understand health as an eco-system based on older and newly emergent social and technical platforms that redefine the very meaning of health and its delivery, and who delivers it. This also raises questions about how society oversees, governs and regulates such innovative socio-technologies: this is the key question we explore in a later Theme Section on Regulation itself. We now move to a selection of extracts chosen from the four books in the Series. Each set of extracts concludes with a new, short reflection on the book and how the authors now see their work and its contribution developing further.

 arianne Boenink, Harro van Lente and Ellen M Moors. (Eds.) (2016). Emerging Technologies for Diagnosing Alzheimer’s Disease. Innovating with Care. Winner of the 2018 Chris Freeman Award, European Association for the Study of Science and Technology

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F rom: Peter Whitehouse. The Diagnosis and Treatment of Alzheimer’s: Are We Being (Ir)Responsible?, pp. 21–29 Within a given society, who gains power to try to assist people trying to improve their memory depends on concepts of how body and brain relate to each other and what the respective roles of healers and educators (e.g. shamans, psychiatrists, neurologists, school teachers, parents etc.) are. In twenty-first-century Western culture, diet, general health, cognitive activity, education, income, and social relations have all been tied to ‘brain health’ and clinical conditions, such as dementia (George et al. 2013). In this chapter, I call for a radical re-examination of the factual and value issues surrounding this critical issue of our times—cognitive and behavioural ageing—in the context of the other complex challenges of our modern world. … I set the stage for a consideration of responsible research, innovation, planning, and use of resources in addressing dementia and brain health, including discussing linguistically contested concepts, such as ‘Alzheimer’s disease (AD)’ and ‘mild cognitive impairment (MCI)’. I will examine shifts over time in perspectives about both diagnosis and therapeutics …. The current state of Alzheimer’s is one of quite widespread dissatisfaction with available diagnostic and therapeutic approaches from patients, families, physicians, and policymakers. A shift in emphasis from systems to molecular neuroscience occurred as genetic mutations in early-onset AD pointed to problems in amyloid-related proteins that are associated with neurotic or senile plaque …. The genetic revolution in medicine influenced the dementia field to raise their expectations for more powerful therapies based on understanding cause and pathogenesis. There are, however, significant challenges to this attempt to develop molecular and genetic diagnostics and therapeutics. Alzheimer’s is heterogeneous at any level at which it is examined— genetic, pathological, neurochemical, or clinical (Whitehouse and George 2008). Several hundred causative genetic mutations and a few risk-­ modifying genes have been described in different patient populations. The relative distribution of cell loss and pathological features can vary

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across different individuals. It is a truism in the field that: ‘once you have seen one patient with Alzheimer’s you’ve seen one patient with Alzheimer’s’. So where are we today? Some people—perhaps the majority of researchers and their advocates—think that the march to progress continues even at a slower pace. For them, the model and hope of the future is more money, leading to more hypotheses, panels of biomarkers, bigger data sets, more efficient drug development (through less regulation and centralized, and perhaps, relaxed ethical review), and ultimately, a cocktail of therapies. Yet, many studies are not even replicated in the lab and the hope is found to be false. … Just as we are culturally reinventing ageing to be viewed as a time of opportunity, not just loss, Alzheimer’s remains the elephant in the room, causing fear and mental blocks. That said, an alternative, more geriatric, public health, social science, and arts/ humanities-based perspective about dementia is emerging. The social sciences, such as anthropology, can provide new critical perspectives (Whitehouse et  al. 2005). In this view, dysfunction and disability are more important than precise diagnosis; quality of life trumps cognitive enhancement; community engagement is key; and population health perspectives gain influence over individual health (Whitehouse 2010). Behind the standard view of AD and the dominant ways of presenting this perspective to the public lies much irresponsibility. The concept of Alzheimer’s has changed over time, is changing now, and perhaps, even needs elimination or significant revision. … Does being irresponsible increase the costs of missed opportunities, such as investment of resources else-where in a non-medical way (Katz and Meller 2014; Whitehouse 2010; Portacolone et al. 2014)? … I have argued here that at least some behaviours in the Alzheimer’s field are irresponsible. Individual scientists who self-promote, and, for example, publish studies in animals that claim dramatic implications for human disease (i.e. breakthroughs) are individually irresponsible. They raise false expectations and hope and drive resources in inappropriate directions to irresponsible actors …. Efforts to improve the quality of life of people with cognitive impairment and their care partners are undergoing dramatic transformation. Although some hope is held out for molecular reductionist, genetically

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based therapies, more evidence is emerging that psychosocial and public health measures may be more effective …. A deeper and broader understanding of dementia in the context of community-based brain health could lead to huge advances in the development of our human species and its ability to address the challenging future. Education and lifelong cognitive activities have consistently shown in population studies to be protective factors against getting dementia later in life. Intergenerational education may be one social innovation relevant to community brain health and resiliency. At The Intergenerational Schools in Cleveland, local elders, including those with dementia, contribute to their own brain vitality as well as the long-term brain health of children by serving as mentors in an elementary school (George and Whitehouse 2010). Moreover, dementia-friendly communities should be part of lifelong age-friendly communities for all of us. Attending to the cognitive harms of air and water pollution and income inequity could motivate us even further to address these global issues. Asking deeper, more critical questions about ‘Alzheimer’s’ will expose profound challenges and dilemmas surrounding and embedded in the current role of science in society, the effects of commodification in healthcare, the nature of ageing, and, in fact, our very humanity. Addressing such more fundamental probing questions about our cultural beliefs and the distribution of power in our societies should also lead to more responsible innovations and actions.

F rom: Julia Swallow. Understanding Cognitive Screening Tools: Navigating Uncertainty in Everyday Clinical Practice, pp. 123–140 Aside from innovation in research, what has been easily overlooked within the promotion of early diagnosis [of Alzheimer’s] is the role of existing low-technological cognitive screening tools in clinical practice. Clinical practice relies on the use of low-technological cognitive screening tools for detecting initial cognitive decline. These tools, which are pervasive across healthcare practice, are used to assess initial cognitive

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decline, and also, review levels of cognitive function for individuals with an established diagnosis (Ismail et al. 2010) …. Prior to exploring the role of these cognitive screening tools in initiatives promoting early diagnosis, the first part of this chapter captures their role in everyday clinical practice for navigating uncertainty associated with measures of cognitive decline. In the clinician–patient interaction, three significant dimensions of uncertainty manifest. First, there is uncertainty associated with the difficulty in categorizing AD in the clinic through any one technique or technology. Second, the tools are at times ambiguous, and third, there is uncertainty around the meaning of a diagnosis for patients. In order to navigate uncertainty, I demonstrate the ways in which clinicians are able to approach and perform these tools as provisional devices in the clinician–patient interaction …. Despite the tools emerging as provisional devices, I do not suggest, how-ever, that these tools are redundant in the classification process. In fact, drawing on the work of Berg (1996), who describes the constitutive role of the medical record, I argue that the practices of the clinic ‘bring [the tools] to life’ (p. 501), shaping how cognitive decline and AD are approached and measured. Developing this point further, it could be argued that as clinicians are able to approach and perform these tools as provisional devices, the technologies have failed to reach a level of certainty in the clinic. Therefore, as scholars such as Atkinson (1984) have previously addressed, this lack of certainty leads at times to the privileging of clinical judgement. As a result, with the active manipulation of cognitive screening tools to account for ambiguities in situ or ‘situational exigencies’ (Berg 1996: 515), clinical judgement plays a key role in configuring how the tools perform …. In this chapter, I have explored the role of existing, low-technological cognitive screening tools in the clinic. I have demonstrated the ways in which clinicians are able to engage with mediation and manipulation practices framed around what Mol et al. (2010: 15) describe as ‘persistent tinkering in a world full of complex ambivalence and shifting tensions’, in order to account for uncertainty. Overall, I did not explore whether cognitive screening tools were succeeding or failing to sort uncertainty and produce knowledge about AD. Rather, the purpose of this chapter was to reflect on the articulation of the tools in practice, and the ways in

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which clinicians grappled with and adapted them to make sense of the classification process. I have adopted the concept of tinkering work to encompass the often ad hoc and informal ways in which clinicians are able to approach and use the tools as provisional devices. Despite the making of the tools as provisional devices, however, they emerge as central mediators for navigating the uncertainties that have the potential to disrupt the classification process. As I mentioned at the start of this chapter, the values associated with cognitive screening tools are enacted and constituted in practice, shaped by the conditions in which they operate. With respect to the emergence of biomarker technologies, exploring their role within these conditions would be fruitful since they are assumed to sort the uncertainties existing in current practice. The contribution of this chapter to responsible innovation of diagnostics, therefore, is to elucidate the myriad ways in which clinicians are already anticipating and affected by frameworks promoting early diagnosis …. [Here] I captured the ways in which [this] framework constrained the anticipation work of clinicians, constrained discretion, and therefore, mediation and manipulation practices, and produced anxieties around patient futures in terms of what AD might bring, and the availability of resources post-diagnosis. These concerns are interrelated since the ways in which professionals approach assessment rely on anticipating the anxieties it causes for patients, as observed in practice, and recognizing that care is an under-resourced material practice. In this sense, it is perhaps only possible to explore the values associated with more innovative diagnostic technologies in existing practice. Diagnostic innovations are likely to produce further and different uncertainties; their promissory claims for sorting uncertainty associated with current practice may only be realized through extensive use in practice (see also Ulucanlar et  al. 2013). The question remains then as to what might shift, be improved, or lost by the emergence of diagnostic innovation overall, which aims to more accurately detect AD in its earliest stages. To innovate diagnostics responsibly requires logical thought about future technological development and its anticipated uncertainties (see Stilgoe et  al. 2013). It is anticipated and expected that biomarker technologies, which are the focus of this book as a whole, will ‘reveal’ AD at earlier stages, be more accurate at revealing AD, and thus, sort the uncertainties and inefficiencies associated with the

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technologies currently in use. However, the constitutive values of the low-technological tools explored in this chapter is that they can be adapted and made provisional for the purpose of navigating uncertainty since they are not upheld as the panacea for producing knowledge about AD. … Categorizing AD is not simply a task of being able to ‘reveal’ AD, (this is of course a contested issue in itself related to how AD is defined overall) and determine the normal from the pathological; it is also about navigating the meaning of a diagnostic label. As a number of clinicians suggest, some patients do not always seek a diagnosis and clinicians, patients, and family members do not necessarily always value early diagnosis. It is not necessarily the case that earlier is better.

F rom: Jeanette Pols and Amade M’charek. Responsible Innovation: The Case of Alzheimer Diagnostics, pp. 205–224 Biomedical innovations are often envisioned as a linear process that translates results from laboratory research to the social world of professionals, patients, carers, and values. Both the directionality of innovation and the assumed separateness of social and scientific spheres foster the hope that scientific work will actually be helpful to the society we live in (Brown 2003). … In this chapter, we question the directionality of innovation as well as the idea that scientific and social practices are separated, with the social practices waiting, as it were, for science to innovate them. Our aim is to think through the idea of ‘responsible innovation’, here, in the case of innovations of Alzheimer’s diagnostics [AD]. … We do this by analysing documents and by bringing together analytical work done by colleagues. We first analyse the position of advocacy organizations (Alzheimer Societies) and their entanglements with research practices. Second, we … look at clinic–laboratory entanglements through analysing a research proposal that got funded to improve early Alzheimer diagnostics. Third, we analyse a paper on diagnostic work on what is here called dementia in Dutch General Practice, and trace the built-in assumptions about how the laboratory (which is also a clinic) functions. Here, the problem of dementia or AD manifests itself in quite different ways

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than in the research practice of the [proposal] we analysed. … These sites represent practices that are nodes in the complex network around AD diagnostics, research, and innovation. These practices showed different entanglements between the meaning of AD and its early diagnosis, the concerns that were deemed worthy of scientific attention, as well as the policy that is hence implied, and the people who should be represented. The different practices did not only contain specific ideas about the other practices, they also directly interfered with them by supporting the lobby for funding, by mixing clinical practice and research practice, or by making care prevail over diagnosis. Who is represented by what practices is already shaped in the practices that provide and support particular innovations. In other words, society and its values already exist in the lab, and are being co-produced with science and technology. These practices ‘innovate’ one another, even before the targeted innovation sees the light of day. There is no one-­ directional chain that sequentially moves from bench to bedside. The chain loops between different configurations of science-care-and-­ representation that are heavily intertwined from the start and interfere with each other in discontinuous ways. What does this entanglement imply for responsible innovation? First, we suggest a further exploration of alternative science-clinic-­representation entanglements, not only in places marked as ‘laboratory’. One may then look how innovation might take place at different sites, or what innovations are already being made. This also suggests that innovations may take place elsewhere, and may deserve dissemination or development. This is both a matter of political priorities and epistemological choices about what kind of scientific knowledge would fit what kind of concerns. For instance, AD as a problem of ‘early diagnostics’ is but one particular way of framing what the problem with AD is. It is related to concerns of the practice of research. Foregrounding this definition and set of concerns is a political move. It might trivialize the concerns of other sites or make them inaccessible for research, such as the GP practices that are concerned with patient care. Innovation does not start when a lab delivers a tool. Innovation starts with the framing of concerns, the financing or prioritizing of (research into) some concerns and not others, the ways in which patients can be

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made to participate, and so on. All ways in which research, clinical practice, and social concerns interfere deserve ethical scrutiny, particularly in the absence of a clear and predictable end point. The ethical questions, then, are not about (slight) re-shapings of technologies and innovations from the lab that leaves their goals and problem definitions intact. Rather, these are questions about what are proper ways for improvement. This discussion includes research methods to assess and bring about this improvement (see also Moser 2010; Mol 2006; Moreira et  al. 2014; Rabeharisoa et al. 2014). Care research demands different scientific practices and expertise than biomarker research. The incompatibility of the different entanglements demands particular ethical caution as to which practices to support. Our suggestion for responsible innovation is to turn the sequence of translational medicine and innovation around, and start with the question of what kind of knowledge clinicians, patients, and carers need to support their practices (Moser 2010; Pols 2014)? How— and what type of—research can support these practices? Again, this is a question that involves different locations. It would need innovative research supported by methods from different disciplines. It needs responsive research practices that can deal with complexity and may venture into the wild, rather than new technologies that are designed from the molecular disease logic in the lab only. It asks for responsible entanglements between science, clinic and representational practices that starts from problems that are urgently felt, but not yet addressed well in research. It would mean taking responsibility for practices, rather than for particular scientific problem.

F rom: Marianne Boenink, Harro van Lente and Ellen Moors. Diagnosing Alzheimer’s Disease: How to Innovate with Care, pp. 263–275 This volume has explored the global attempts to innovate the diagnostics of Alzheimer’s disease (AD), by means of biomarkers or otherwise. This exploration exceeded the confines of memory clinics and research centres, but also included sites such as newspapers, policy documents, patient groups, general practitioners, and online diagnostics tools. The diversity

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of sites reflects the many faces and manifestations of AD: it is not just one thing but many. This diversity brings along that the very notion of the dis-ease and how it should be addressed are elusive. Concerning the desirability of AD diagnostics innovation, new technological tools, and their use practice, the first point to make is that several innovations are aimed for at the same time. In the biomedical domain, molecular biomarker tools raise high hopes, but as Boenink shows, such tools can still have multiple functions. Outside biomedical R&D, we see governments introducing national screening policies using low-tech cognitive tests (Swallow). And Egher and Wyatt discuss how outside the traditional medical domain, a myriad of (self-) diagnostic tools has become available on the Internet. Interestingly, all these (aimed for) innovations focus on earlier diagnosis. This fits, as Leibing and Whitehouse show, with the trend towards Alzheimer prevention, whether by pharmaceutical, lifestyle, or environmental interventions. A recurrent theme throughout the preceding chapters is, nonetheless, that earlier diagnosis is not necessarily better—partly because the possibilities to act on diagnosis are rather limited, but also because a diagnosis is often not necessary to take action, and because not all people feel the need for early diagnosis and taking preventive action. The preceding chapters also show, however, that when discussing the desirability of early diagnosis, it is crucial to ask what exactly is being diagnosed. All these tests diagnose different phenomena, and may serve different purposes. Before passing judgement on the desirability of any diagnostic innovation, them, we had better determine first what precisely is being diagnosed, how reliable the resulting information is, but also how relevant and how useful. As the authors discussing them made clear, each of these innovations has its own advantages and limitations. This also implies that in each case, different conditions for responsible innovation are required, which have been discussed in the separate chapters. Together, these chapters point out that the question ‘is it desirable?’ cannot be answered in the same way for all innovations and all practices involved. What does this observation imply for the ambition to make Alzheimer diagnostics innovation more ‘responsible’? Should we give up on the attempt altogether? Not at all, but it does show that stimulating responsible innovation is more complicated and harder than is sometimes

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suggested. Let us reiterate first how we already modified some basic tenets of responsible innovation literature in our introductory chapter, before harvesting the insights gained from the set of chapters. Responsible innovation, we said in our introduction, means innovation contributing to acceptable societal goals and values. We referred to Stilgoe and colleagues, who pointed out that such innovation requires anticipation, reflection, stakeholder inclusion and deliberation, and responsiveness. We also indicated, however, that responsible innovation in our view should be approached in a practice-based way. Both values and innovations are not simply there, but are expressed and sustained in practices. One of the implications is that to stimulate responsible innovation, one should not focus only on potential future impacts of a promised (but uncertain) innovation. In this volume, we therefore investigated how emerging innovations already impact the present. For instance, R&D practices are based on ideas about what existing diagnostic practices look like, what problems they encounter, and how to improve diagnostics. While these ideas may hold or not in the future, they already have consequences for diagnostics practices now. At the same time, actors involved in existing practices of diagnosing, caring for, and living with AD are often also working on innovation themselves, actively trying to improve that practice. Our practice-based approach of responsible innovation stresses, moreover, that the values at stake in innovation do not exist as abstract entities, apart from and prior to practices. Nor are they just ‘there’, easily accessible to stakeholders. Instead, values are enacted in ways of doing within existing practices as well as within attempts to innovate these practices. To make the values implied in diagnosing AD accessible for reflection and deliberation, we investigated which values are made to matter in both current practices dealing with AD and dementia and in R&D practices dedicated to innovate diagnosis. This is the epistemic and normative starting point of all chapters in this volume …. To summarise, what does our exploration of care and responsiveness in practice offer for the specific question about the desirability of emerging technologies for the diagnosis of AD, and for the general ambition of responsible innovation at large? About the specific concern—the desirability of early diagnosis of AD—four conclusions stand out. First, given

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the elusiveness of concepts and the feeble bridge between biology and clinic, it is unlikely that novel techniques for early diagnosis of AD will bring clarity and certainty for all. Second, given this lack of certainty and the lack of medical cure, but also given alternative, non-biomedical approaches of AD, the very idea of early diagnosis is not uniformly welcomed as an improvement. Third, the wide variety of alternative, non-­ biomedical ways to deal with AD in (daily) practice often tastes defeat in the competition with the dominant biomedical routes of framing and solving ‘the’ problem of AD—conceptually, morally, financially, and politically. Fourth, any meaningful attempt to do justice to the many stakeholders in the case of AD has to account for this fundamental dis-­ parity between biomedical and non-biomedical approaches of AD. Just inviting patients and informal caregivers to stakeholder deliberations about any biomedical innovation will not do. The interpretative frame-­ works and values implied in non-biomedical practices need to be sup-­ ported and strengthened for these stakeholders to acquire an equal say in the deliberations.

 eflection by Marianne Boenink, Harro van Lente R and Ellen Moors One and a half years after the publication of our edited volume Emerging Technologies for Diagnosing Alzheimer’s Disease—Innovating with Care, the volume received the Freeman Award—a prize awarded by the European Association for the Study of Science and Technology for a ‘significant collective contribution to the interaction of science and technology studies with the study of innovation’. When we notified the contributing authors of this achievement, one of them somewhat spoiled the festivities by wondering if the book had had any considerable impact in the Alzheimer’s field itself. A valid question indeed for a book that seeks to contribute to ‘responsible innovation’ in that field. In its turn, it raises the general question how to identify such impact. Clearly, our book did not radically alter funding policies or diagnostic guidelines. However, it did start conversations between medical, social science and ethics researchers that continued since then, even though the intricacies of

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multidisciplinary collaboration in the domain of ‘responsible innovation’ are multiple. We want to share a few experiences with this collaboration that seem relevant to the field of Health, Technology and Society (HTS) more generally. The volume resulted from a research project of social scientists and humanities scholars reflecting on technoscientific innovation in the Alzheimer field—specifically, a biomedical project on early diagnosis of Alzheimer’s Disease that had been independently funded by a medical research organisation. The collaboration with the medical researchers was complicated: Firstly, the medical researchers were, at the same time, partners in the project, study object and target audience. All were aware, for instance, that whatever they told us might be used for critical comments. One medical research leader noted afterwards that the medical researchers were somewhat anxious what we would come up with. A second complication was that the medical research project had already been started and was not dependent on our work (although the project leaders did label us as an ‘asset’ at their mid-term review). In contrast, our work depended on their willingness to collaborate. While we were allowed to do interviews, observe or present, the level of engagement of the medical researchers was quite low. Thirdly, research times diverged. Typically, socio-ethical research does not provide fast and simple answers, but adds to an ongoing reflection process. Techno-medical developments, in contrast, continue at a fast pace. Finally, even willing medical researchers—and we truly met some who shared our concerns and perspectives—are bound by targets and deliverables, set by their own funders, institutions and disciplines. So if we found a hearing with some, these individuals were not always able to change track because they could not adapt the rules of the game—at least not at the short term. Do these typical HTS complications imply that socio-ethical research like this is eventually in vain? No, but we should not be naïve: organising a critical reflection process and sustaining the necessary relations and

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interactions is a long-term, uncertain endeavour. The relevance may be less in specific projects or books and more in the continuous attention and exploration. The practice of HTS research, then, is in itself a form of (never-ending) care.

 elly Oudshoorn. (2011). Telecare N Technologies and the Transformation of Healthcare. Winner of Foundation for the Sociology of Health and Illness Book Prize 2012

From: Chapter 1, Who Cares?, pp. 4–9 In the past decade, the healthcare sector in modern societies has witnessed the testing and introduction of an increasing number of telecare applications aimed at monitoring and diagnosing a variety of chronic

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diseases, including diabetes, respiratory insufficiency, and heart diseases. The introduction of these new technological devices has major consequences for healthcare. The most drastic change involves a transformation in the order of care …. Telecare technologies imply that patients perform tasks previously delegated to healthcare professionals. The telecare devices for heart patients investigated in this book require that patients conduct their own electrocardiograms (ECGs), take their own blood pressure, or measure their weight themselves. The use of telecare devices disciplines patients to inspect their own bodies regularly and to integrate these activities into their daily routines at home. … Telecare technologies thus imply multiple sites, multiple actors, and multiple technological objects. Consequently, the seemingly straightforward question of ‘who cares?’ does not have a simple answer. Telecare technologies require complex interactions and create multiple interdependencies between people and things which transform healthcare as we used to know it …. The use of the telecare technologies investigated in this book involves cardiologists, heart-failure nurses, general practitioners, home-care nurses, telenurses, telephysicians, health-insurance companies, telemedical firms, and, last but not least, patients. Diagnostic and monitoring work thus becomes dispersed over an extensive network of actors, including technical devices that connect previously separated locations such as the consulting rooms of general practitioners and clinicians, the offices of home-care nurses and heart-failure nurses, polyclinics and the emergency departments of hospitals, telemedical centres, and patients’ homes. This distributed character of healthcare challenges the traditional role of the care, … distributing care over multiple places and actors and creating networks between people and things. However, these networks do not operate by themselves: the technology works only when all the actors and technical devices perform the actions delegated to them. Telecare technologies cannot thus be considered as mere instrumental tools for the more efficient delivery of healthcare. On the contrary, they should be considered as active agents that participate in changing the order of healthcare and what care is all about. This kind of agency of technology is not taken into account in the instrumental view of technology ….

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F rom: Chapter 2, Theorizing Technology and the Transformation of Healthcare, pp. 20, 26–27 This study of telecare technologies not only builds on insights developed in science and technology studies (STS) but is also inspired by human geography. This field of expertise recognizes the importance of place in defining human relationships. … Adopting a focus on place is thus important to understanding how technologies participate in changing the landscape of healthcare. … The view that places matter thus provides an important point of departure for investigating how reciprocal relationships between places and technologies enable or constrain the creation of specific professional and patient identities and forms of care. … The most crucial way in which telecare technologies affect the spatial dimensions of healthcare is that acts of care such as diagnosis and monitoring take place when healthcare providers and patients are not in the same place …. To capture, and further explore, this changing spatial configuration of healthcare, I introduce the notion of technogeography of care. The concept provides a useful tool for understanding how the spatial dynamics of the relationships between healthcare professionals, patients and technologies constitute specific professional and patient identities and forms of care. … In contrast to the rhetoric on telecare, which emphasizes spatially unbounded care practices, telecare technologies still largely depend on locally grounded, situated care acts. [The concept] is also useful in pointing to] the distribution of responsibilities takes place between actors and places that are not equally situated in healthcare. In contrast to the metaphor of a network which assumes non-hierarchical relations between humans and technological objects, the term ‘geography’ makes us sensitive to distributions of responsibilities which grant agency and power to specific actors while restricting or silencing the agency of others. … The promises of telecare technologies articulated by innovators often silence the work and perspectives of major actors, particularly patients and telecare workers, although telecare technologies delegate major responsibilities to them. The research presented in this book provides a critical intervention in these discourses by rendering visible the work of these silenced actors. Equally importantly, my account of telecare technologies addresses resistances to the new technology. Advocates of telecare technologies often

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argue that ambivalences and resistances towards these technologies can be understood in terms of a generational problem. Resistances are usually explained by referring to the older generation of healthcare professionals and patients who are not yet familiar with ICT-based devices. In this line of thinking, reluctant attitudes towards telecare technologies will disappear by themselves when the older generation of healthcare professionals and patients is replaced by the younger generation. However, the expectation that a decrease in resistance is just a matter of time ignores reluctances that may be related to other than cognitive or behavioural differences ….

From: Conclusions, p. 210 [T]he introduction of telecare technologies is related to a neo-liberal political agenda, which aims to modernize and rationalize healthcare, decrease costs, and increase the profits of healthcare. Controlling and decreasing healthcare spending is a major concern for healthcare insurers, government agencies, and managers of healthcare organizations in Western industrialized countries in order to reduce fears that the provision of healthcare is no longer affordable. In this political economy of healthcare it seems likely that increasing pressures will arise to restrict healthcare services to telecare that is considered more cost-effective than the alternative healthcare provisions based on face-to-face contacts between healthcare providers and patients. … A desirable future for … patients would be if the move towards empowering patients to play an active role in healthcare included the provision of telecare and face-to-­ face care as different, but equally important and affordable, forms of care.

Reflection by Nelly Oudshoorn When I wrote Telecare Technologies and the Transformation of Healthcare, telemedicine was still in its infancy. I vividly remember that it took quite some effort to find appropriate case studies because most hospitals did not use any telecare technologies yet and I wanted to study practices of use. A focus on use is crucial to understand innovation because technology simply does not exist without users. The perspective that the fate of a technology is in the hands of the users is quite

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challenging, both for innovators and for social scientists. Who are the users of new technologies and who speaks for them? In contrast to common views of innovation, users are far from passive consumers or adopters of technologies. As STS studies on users have described, users may actively engage in shaping technologies in all phases of innovation by (re)appropriating, resisting, modifying and even designing new technologies on their own accord (Hyysalo et  al. 2016; Lie and Sørenson 1996; Oudshoorn and Pinch 2003). Equally important, users not only shape innovation but are simultaneously transformed by new technologies themselves. In this respect, healthcare provides a complex case when thinking about digital innovation because of the multiple users involved in making these technologies work. Telecare technologies may be used by doctors, nurses, technicians, teleworkers and patients. However, these actors are not equally situated in healthcare. Accounting for these differences was my major incentive for developing the technogeography of care approach. In Telecare Technologies and the Transformation of Healthcare, I argued that the working of these technologies largely depends on locally grounded, situated care acts which are dispersed over different spaces and involve a (re)distribution of tasks and responsibilities. I preferred to use the term geography rather than network, since the latter assumes non-hierarchical relations between humans and technological objects, because the term geography makes us sensitive to distributions of responsibilities which grant agency and power to specific actors while restricting or silencing the agency of others. Because of the growing presence of telecare technologies in healthcare as we know it today, this perspective is still very relevant to understand how digital innovation transforms healthcare and what it means to be a patient. Importantly, recent digital innovations in healthcare challenge us to rethink some other important themes as well. Because of the growing trend towards developing technological implants, telecare technologies are no longer restricted to devices external to the body. Implantable cardioverter defibrillators (ICDs) and self-tracking chips, for example, make the question of what actually happens when technologies move under the skin into an important new theme for understanding health-­ technology and society relations. (Tele)technologies inside bodies may introduce new forms of vulnerabilities. People living with tele-implants may not only become vulnerable to the hacking of their bodies, but

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also because they become dependent on technologies that are beyond their control, which is problematic in case these technologies are not properly adjusted or break down. These vulnerabilities invite us to rethink dominant approaches to cyborgs that consider human-machine hybrids merely as linguistic or metaphorical entities, which is problematic because they silence the lived experiences of cyborgs (Sobchack 2006). Inspired by feminist approaches that urge us to take into account, and account for, the intimacy of human-technology relations as material and normative (Dalibert 2016), my current research therefore aims to understand the material practices involved in becoming resilient cyborgs (Oudshoorn 2015, 2016, 2018). In Resilient Cyborgs. Living and Dying with Pacemakers and Defibrillators (in press), I will trace what sensory experiences and resilience techniques assist people living with these implants to diminish the new vulnerabilities of their technologically transformed bodies.

J ohn Gardner. (2017). Rethinking the Clinical Gaze: Patient-Centred Innovation in Paediatric Neurology

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From: Chapter 1, Introduction, pp. 1–4, 9–10, 12–17, 21 Dystonia is a neurological disorder characterised by uncontrollable muscular contraction. In severe cases, this results in painful and crippling body postures. In 2003 the medical device manufacturer Medtronic gained regulatory approval to market their deep brain stimulation (DBS) technology as a therapeutic intervention for dystonia. Other, more standard interventions for managing severe dystonia are generally considered to be crude and ineffective. Medications provide some relief for a small number of sufferers, but for many they are ineffective or the side effects are intolerable. Ablative surgery, which involves carefully destroying a specific section of brain tissue, may have some therapeutic effect, but this is often short term; the surgery will need to be repeated, and as more brain tissue is incrementally destroyed, important functions will be irreversibly impaired. As the recent report Novel Neuro-technologies by Nuffield Council on Bioethics (2013) states, dystonia is one of many neurological conditions for which there is ‘a great need’ for new, safer, and more effective therapies. There is a considerable hope among clinicians and sufferers, then, that DBS will prove to be such a therapy. According to proponents, it is adjustable and reversible (unlike ablative surgery), and it has proved to be remarkably effective in managing the symptoms of other neurological disorders such as Parkinson’s …. [There are, however,] some uncertainties surrounding these promising innovations. Despite having undergone clinical studies as part of the regulatory approval process, there is a perceived insufficiency in data concerning the safety and clinical effectiveness of DBS for dystonia …. For clinicians who wish to provide DBS therapy as a routine clinical intervention, these uncertainties present considerable challenges. This book is based upon a study, using observations and interviews, of a specialist team of clinicians as they attempt to address a ‘great clinical need’ while managing such ‘great uncertainties’. The team, which will be referred to as the Paediatric Motor Disorder Service (PMDS), is based in the UK and is one of a few teams worldwide that are currently providing DBS therapy to children and young people with dystonia. This book explores several specific challenges encountered by the PMDS team

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members, and it explores how team members attempt to manage and overcome these challenges during their day-to-day clinical work. A premise of this book is that the team’s response to these challenges is a vital part of the innovation process. Indeed, the team represents what has come to be understood as a crucial and problematic stage in the translation of biomedical science into effective clinical therapies: the clinical adoption and implementation stage. There has been an emerging interest in the ‘adoption’ of new therapies and systems within ‘the clinic’ among policy makers and health service researchers, prompted by various concerns relating to, for example, the failed uptake of officially mandated innovations, perceived technology creep, and variable clinical service quality across healthcare providers. Actors tasked with facilitating innovation in highly promising, emerging areas of medicine (such as regenerative medicine) have also delineated ‘adoption’ as a key concern. The activities of the PMDS team, therefore, can provide some important insights into the specific types of challenges that may be associated with ‘adoption’, and how such challenges are managed during day-to-day clinical work. Hence, in this book I use the PMDS as a case study for examining innovation at the adoption stage …. [The] second premise of this book is that if we want to understand the social implications of new medical technologies, we need to explore the organisational forms—or [what I shall call] proto-platforms—that emerge around them as they are adopted and implemented. Contrary to some of the more speculative commentary on the impact of novel neuro-­ technologies on perceptions of health and illness, this book provides an account of clinical work in which, due to the influence of patient-centred medicine, dystonia is enacted in multiple ways; in some practices as a ‘biomedical’ phenomenon, and in other practices as a ‘social’ concern. In light of this, and as a way of anticipating the social impact of the much-­ championed ideals of patient-centred medicine more generally, the book introduces the notion of the broad clinical gaze as a way of rethinking the clinical gaze described by Foucault. The broad clinical gaze, I suggest, represents an extension of medical power; power that is disciplining, and that has both constraining and productive effects …. DBS is not only the source of great promise and hope, it is also the subject of apprehension. Indeed, it exemplifies the complex tensions

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associated with biomedicine in contemporary society more generally: a conviction in technology-orientated solutions, a drive to alleviate suffering, a suspicion of commercial interests, doubts over the ability of regulatory initiatives and anxiety over a precarious future. For these reasons, DBS is an excellent topic of sociological investigation. For those of us who are interested in exploring the dynamics of medical innovation, such as how the social and technological aspects of medicine may shape one another and intertwine, the relationship between developments in medicine and wider social and political context, and the ethical challenges presented by new medical technologies, DBS provides an illuminating case study …. The case study in this book is of a service providing DBS for children and young people with dystonia; a movement disorder that has a relatively low public profile. It is defined as ‘a neurological syndrome characterized by ‘involuntary, sustained, patterned, and often repetitive muscle contraction of opposite muscles, causing twisting movements or abnormal postures’ (Jankovic 2007) …. In 2005, the PMDS was established to provide DBS therapy to children and young people with dystonia … [and it] is one of very few groups that specialises in providing DBS exclusively for children and young people with dystonia. It is also the only group that has this multi-disciplinary structure: the other prominent specialist team (based in the USA) does utilise the services of a physiotherapist, an occupational therapist, a neuropsychologist, and a ‘child life specialist’, but their specific roles differ from those of the PMDS members. The PMDS is therefore unique, and along with the US team, it is perceived to be pioneering DBS therapy for dystonia in children and young people. … As ‘pioneers’, team members have had to assemble new patient pathways and care plans and new protocols and practices. Team members have, in other words, engaged in various forms of innovation work aimed at routinising DBS for dystonia in a paediatric setting. This is within an institutional context, the National Health Service (NHS), which can provide little flexibility due to financing pressures and staffing issues. The PMDS team, which itself represents a novel multidisciplinary arrangement, has drawn upon and adapted elements from, as well as adapting to, a challenging institutional environment, to create a bespoke infrastructure for delivering DBS ….

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F rom: Chapter 2, Understanding Innovation and the Problem of Technology Adoption, pp. 38–39 This book [also] takes as its focus the organisational form that has emerged to deliver DBS in a paediatric context. … If, for example, we are to understand the way in which a novel technology is actually implicated in reconfiguring understandings of health and disease, then we need to explore the organisational form which has emerged around it, and how health and disease are enacted, or rendered intelligible, within this form. … What is particularly important about the organisational form of the PMDS is that it has been heavily influenced by the values of patient-­ centred care, and this, subsequently, is reflected in the way in which movement disorders—and the patients themselves—are rendered intelligible. By focusing on the PMDS, our analytical gaze is thus drawn to particular social-technical effects that we might not otherwise associate with an invasive biomedical neurotechnology such as DBS.

Reflection by John Gardner Rethinking the Clinical Gaze can be described as study of patient-centred innovation. The clinical team that forms the case study of the book (The PMDS) is pioneering the use of deep brain stimulation in a paediatric setting, and it provided a valuable opportunity to examine patient-­ centred care in-action. It provided an opportunity to explore how ‘patient-centeredness’ can become embedded in socio-technical dimensions of a clinical service, such as the institutional setting and the multidisciplinary structure of the team, the team’s weekly schedule and their use of clinical measures and other tools from occupational therapy, physiotherapy and psychology. The PMDS also provided an opportunity to explore the impact of these various patient-centred sociotechnical dimensions: how, for example, is disease, illness and the patient actually understood in this context? What sort of child-parent-clinician-technology power dynamics emerge? Ultimately, in the book I suggested that the team’s focus on the social and psychological well-being of their patients had the effect of

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reinforcing particular norms relating childhood and families. In Foucauldian terms, their clinical practices had disciplining effects. I argued in the final chapter of the book that this is not a problem in distinct clinical settings where families are desperate for some semblance of normality, but that it could become problematic if, for example, patientcentred disciplinary techniques become entrenched in wider social and community care settings. I concluded that we might make a normative distinction between totalising disciplinary techniques and non-totalising disciplinary techniques. The latter (which we should champion) facilitates self-affirmation and self-exploration and multiplicity, whereas the latter (which we should avoid) is akin to a total institution. Now, when I reflect on the book and its presence in my more recent research on medical innovation in Australia, these concerns with the potentially controlling dimensions of a comprehensive patient-centred medicine seem much less relevant. Narelle Warren (an anthropologist), Adrian Carter (a neuroethicist) and I have been investigating the implementation of DBS within clinical services treating Parkinson’s disease. Here in Australia, the prominent role of private healthcare means that these DBS services are subject to a different set of logics compared to those in the UK, creating what one neurologist described as ‘a wild west’ of neurology care. Patient-centred medicine has been equated with a patient’s opportunity to choose between different private and public services, and this has implications for how new medical technologies have been implemented within the healthcare system. In some specific cases, this has meant that DBS recipients and their families have received no psychosocial support, resulting in considerable emotional turmoil and suicide. We have argued that DBS has been implemented within some Australian clinical services as if it were a technological fix and as if Parkinson’s can be reduced to a delineable biomedical problem (Gardner et al. 2017b). In light of this, the relevance of Rethinking the Clinical Gaze has somewhat changed: it has become a useful account of responsible innovation in healthcare. The PMDS team has provided a valuable and robust example of how innovation—at the point of technology adoption—can be done well, and we have used it as a guide for thinking about the sociotechnical assemblages needed to ensure that neurotechnologies are implemented and used ethically. PMDS team members recognise that in clinical settings, a chronic neurological disorder cannot be reduced to a biomedical

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problem. They recognise that technologies such as DBS will only have a genuinely meaningful impact if they are embedded within practices that monitor and enhance relations of care. We have therefore used the example of the team as a springboard for exploring and advocating sociotechnical assemblages that constitute a regime of care. Drawing on Annemarie Mol’s influential reflections, we have defined a regime of care as: a set of practices which aim to foster the social and technological relations necessary for a meaningful quality of life as perceived by the patient (Gardner and Warren 2018). Hence, I see Rethinking the Clinical Gaze as the beginning of a research trajectory which broadly aims to promote a particular form of ‘patient-centred’ innovation that is orientated towards care, and which challenges the ideology of technological solutionism that seems to animate much of the hype around emerging neurotechnologies.

 llen Balka, Eileen Green and Flis Henwood. E (Eds.). (2009). Gender, Health and Information Technology in Context

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F rom: Flis Henwood et al. Introduction: Informing Gender? Health and ICTs in Context, pp. 1–16 Throughout the world, information and communication technologies (ICTs) are increasingly being used in health care delivery. Information systems to support a wide range of health care activities including the collection of health information, the distribution of health information to citizens, and improved diagnoses and care have been developed to reflect the new political priorities of increased accountability, patient and public involvement, and evidence-based medicine. As the computerization of health care occurs, new social and political issues and challenges arise. The introduction of information systems into health sector workplaces may change the way that work is under-taken. Increased availability of online health information may change doctor–patient relationships and raise a plethora of jurisdictional and legal issues. New imaging technologies such as magnetic resonance imaging (MRIs) may reveal previously unseen parts of bodies, giving rise to new questions for both practitioner and patient alike. As new information systems are developed, important decisions are also being made about what data they should be used to collect—decisions that will influence what we are able to ‘know’ about the health of populations for many years to come. A key area of social change associated with new health information systems is the changing boundaries and relationships between traditional ‘producers’ and ‘users’ of health information. … As boundaries and relationships between producers and consumers of health information become ever more complex, interesting new work about health information ‘intermediaries’ (Wathen et al. 2008) points to the ways in which both human (professional and lay) and technological intermediaries are becoming increasingly important in mediating the relationship between producers and consumers of health information …. However, despite this burgeoning of literature on social aspects of ICTs in health care, there has, as yet, been no systematic collection of essays that address the gendered dynamics of these socio-technical changes. This book breaks new ground, therefore, in addressing how gender mediates the socio-technical relations surrounding the use of ICTs in

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health care. As the title to this introductory chapter suggests, the book explores how the cases addressed here can be helpful in ‘informing gender’. This title speaks to the two key questions that chapters in the book seek to address: how can our understandings of gender be informed by exploring the socio-technical relations of ICTs in health care, and, conversely, how far can an appreciation of the ways in which gender works, inform, and improve our understanding of how ICTs are being developed, implemented, and used in health care contexts? … Reflecting the eclecticism of gender studies more generally, contributors take a range of disciplinary and theoretical approaches to the study of the gendered dynamics of both ICTs and health. For example, some contributions emphasize structural factors such as gendered divisions in both formal and informal health care work. Here, issues explored include how the implementation and use of ICTs affects where and how the boundary between formal and informal care work is drawn, or how the distribution of such work between women and men is made. Other contributors are more concerned with the performance of gendered identities and other forms of agency, especially in relation to the consumption of health information and ICTs. Examples here include explorations of how gendered identities are articulated in discourses surrounding the uptake and use of the Internet for health information seeking and in the negotiations that occur when health care workers try to achieve a ‘fit’ between a new technology and their preferred work practice. Health, too, is treated in diverse ways in this collection. Some contributions are firmly rooted in a ‘social determinants of health’ perspective, and others emphasize a more constructivist approach to health, social care, and well-being. More often, however, contributors are keen to try and understand how experiences of health that may appear as individual are actually shaped in the context of wider social structures and discourses. This is particularly important in the context of current government health policies that tend to stress individual responsibility for the maintenance of health and well-being whilst downplaying the wider social and environmental factors that contribute to ill-health. The concluding chapter reflects on the chapters described above and returns to our original questions: How can our understandings of gender be informed by exploring the socio-technical relations of ICTs in health

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care, and, conversely, how far can an appreciation of the ways in which gender works inform and improve our understanding of how ICTs are being developed, implemented, and used in health care contexts? The concluding chapter begins to provide some answers to these questions whilst simultaneously drawing out the ongoing contestations in terms of how best the gender, technology, and health relations maybe theorized. Another key goal of the concluding chapter is to explore the practice and policy-based implications of this new work and make suggestions for future research.

F rom: Ellen Balka. Gender, Information Technology, and Making Health Work: Unpacking Complex Relations at Work, pp. 104–121 Virtually all health sector work requires a high degree of interaction with technologies, ranging from medical devices such as defibulators to electronic medical records. Although this chapter focuses on information technologies specifically, the definition is a broad one and includes any technologies that provide a means through which health information is made visible to, and circulated between, staff and practitioners who then act on that information as they manage patients’ health. Within this definition, heart monitors, which convey information about heartrate and heart rhythms over time, alerting practitioners to problems requiring action may be thought of as information technologies. More conventional definitions of information technologies would include electronic patient record systems which record test values and data about patients over time, in support of diagnosis and care planning. When successfully embedded in work practices, health information technologies can support managerial, clinical, and/or administrative staff as they work together with patients to produce health. Studying the use of health information technologies by health sector workers brings numerous intersecting issues to light. Such technologies may play a role in altering work organization, professional practice, and the movement and use of information among members of care teams who cooperatively manage patients’ health. Where technologies are

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introduced without due care being given to the work practices involved in health care, there can be resistance to, and/or sub-optimal use of the technologies. In this chapter, I explore information technology implementations that presented problems in relation to work practices and analyse the problems from a gender perspective. Most health sector workplaces are characterized by a gender-segregated labour force, where certain occupations (such as nursing) are filled predominantly by women, while other occupations (ranging from medical specialties to maintenance) are filled largely by men. Results from field-work undertaken through the Assessment of Technology in Context Design Lab1 since 1997 suggest that gender dynamics can prevent technology from being implemented to support the delivery of adequate patient care. In this chapter, I illustrate how information technologies contribute to the gendering of work in the health sector, how gender relations in health sector work come to bear on how technologies are implemented in health sector workplaces, and how an understanding of how gender works in health care contexts can assist in understanding (and ultimately, resolving) problems with technology implementations in the health sector …. I begin by introducing four vignettes that each describe a problematic IT implementation. I then draw systematically on these three substantive bodies of literature—STS, gender studies, and organizational studies—to analyse these problems in more depth, identifying the contribution that each body of literature can make. I conclude by reflecting upon how such insights might be used to improve the practice of IT implementation in health sector workplaces. The empirical material that I draw on for this analysis was gathered during observationally based field work that was conducted in hospital settings over a four-year period between 2003 and 2007 …. In each of the vignettes discussed in this chapter, organizational factors contributed to what were often construed as technology or user failures. Curious about why no one had called the maintenance department about the cord in the drawer, the research team queried staff members. We learned that the procedures in place in the maintenance department were incompatible with nursing schedules. Maintenance would not act on a work order unless they could locate the person who had requested assistance. Although most maintenance staff worked days, nursing staff

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worked in shifts and, often, by the time the maintenance department responded to a problem, the nurse who had reported it was working night shifts or was off duty—between night shifts and her next round of day shifts. Consequently, when maintenance came to address a problem, they would be unable to find someone who could shed light on it, and they would depart from the unit, leaving the problem unaddressed. Nurses quickly learned that taking the time to report a maintenance problem detracted from whatever tasks they immediately faced on the unit and did not result in the resolution of the problem they had reported. This situation offers a good illustration of the point made by Mills and Tancred (1992). Organizations and organizational settings contribute to the maintenance of gender roles. Clearly, such a disregard for nursing schedules—and we could speculate women nurses—could not have persisted had it not been condoned by the organization. The fact that the nurses’ complaints about the system were either ignored or viewed as user problems could signal stereotypical attitudes towards women as technologically incompetent …. Organizations exist within a gendered context, and individuals who together make up an organization do not leave their gender at the door when they go into work each day. Hence, to the extent that technical expertise is generally associated with masculinity (Benston 1989), within organizational contexts it will be similarly associated with masculinity. … Within the complexity of health care organizations, technology is implicated in gender construction and reconstruction through the work of organizations. As women simultaneously seek to identify themselves with activities such as management, and artefacts such as information technology and, at the same time, navigate complex gender relations within the organization by maintaining symbolically female gender identities in public settings, some aspects of women’s stereotypical gender roles (as the inept user) are re-inscribed, while other aspects of traditional gender roles are challenged …. Developing a more in-depth understanding of the complex gender dynamics associated with the introduction of information technologies into health sector workplaces could well lead to improvements in IT support in the health sector. … Accounting for women’s work when decisions are made about which system to purchase and how that system

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should be configured can improve the success of health sector IT projects. Furthermore, to the extent that such health sector technologies produce information that helps us both deliver care and make sense of people’s health, attending to these issues can also contribute indirectly to improved health outcomes …. Understanding the ways that gender, technology, and organizational dynamics work in health care workplaces could support the development of strategies aimed at mitigating gender dynamics at work which interfere with the solution of problems. Although scholarship about women’s paid work, gender, and technology has been limited in recent years, the vignettes here suggest that technology continues to contribute to the gendering of women’s work, at the same time as it creates opportunities to symbolically escape one’s gender identity for some women (nurse IT specialists) under some circumstances (when interacting with other women in equal or subordinate roles). The high costs and low rates of success associated with information technology implementations in the health sector may present a strategic opportunity for researchers and practitioners to intervene in the complex relations of gender, technology, organization, and work in the interest of improving both women’s work lives and the chances of success in IT implementation projects.

F rom: Pat Armstrong et al. Gendering Work? Women and Technologies in Health Care, pp. 122–137 In this chapter … we explore health information technologies defined as those technologies that support officially sanctioned information impinging on health care work. They encompass the architecture of technologies along with the data they produce and their use. Our space is Canadian health care in the current context of performance measurement, accountability defined in numerical terms, and managerial control aimed at efficiency defined primarily in terms of faster throughput. Our conceptualization of work combines two linked theoretical approaches. From a determinant of health perspective, all who work in the health care sector are health care workers, including those who provide unpaid care in homes and community settings. This may seem obvious, but

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increasingly those who cook, serve food, clean, do laundry, clerical and maintenance work are labelled as hospitality workers and defined out of health services. Historically those who do the unpaid care work have been excluded. From a feminist political economy perspective, women’s work is characterized by relations of power and inequality, as well as by integration of their paid and unpaid work (Armstrong and Armstrong 1990, 2001, 2004) …. Our conceptualization of health care starts with these approaches. The work in [the health care sector] is highly segregated and female dominated, yet women form a distinct minority of those with decision-making power. This is particularly the case for women from racialized and/or immigrant groups. At least four kinds of information technology are relevant to women’s health care work. One sort is the data related to resources such as numbers of hospital beds, employees, and patients, or to the categories of hospital ‘separations’. A second form produces and uses data on how work should be done; the protocols, guidelines, task definitions, and care pathways. A third kind of information technology measures and uses data to determine how many employees work for how long, at what speeds, and with whom. Finally, there are the technologies that record the consequences of health care management and practices; the data on such items as return rates and patient outcomes. For ease of discussion we term these various forms administrative, prescriptive, workload, and outcomes data, respectively …. [For example], outcomes data document the consequences of medical treatment, which are defined as the results of the health care system. For the most part, patients alone are the focus of outcomes data. The emphasis is primarily on death, disease, and direct costs to the system. But changes to health care system have other consequences, such as the shift to com-munity and home care, and altered injury and illness rates for providers. Both affect primarily women. The shift to community and home care is a shift of responsibility and work to women (Grant et al. 2004). Most of this additional work is unpaid, and research indicates that it often has negative consequences for the health of the women who

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perform it (Morris 2001). There are also significant differences in the extent to which women have choices about providing unpaid care, choices related to their financial and other resources. These consequences are rarely treated as outcomes data. Injury and disease rates are rising among health care providers. Indeed, health care is the most dangerous industry in Canada in terms of workplace-related disease and injury, with rates two and a half times those of the next highest rated industry (Canadian Institute for Health Information 2002: 87). Needless to say, most of those who are injured and become ill are women. … Data analyses (Lippel 1999, 2003) suggest that women who are injured or diseased at work have a significantly more difficult time having their disease or injury recognized as work-related. This denial both reflects and reinforces assumptions that women’s work is safe and that female complaints are the result of female biology or psychology rather than of women’s exposures at work (Messing 1998). As a result, even the high, recorded numbers of work-related illness and injuries in health care may understate the problem of gendered health and safety issues at work and its long-term effect …. This chapter has explored four forms of health information technologies in order to raise questions about their gendered construction and use. Our case study data lead us to conceptualize health information technologies as active tools rather than as passive ingredients, tools that need to be understood within a context of unequal, gendered socio-­economic relations. This means beginning with the contexts in which technologies are developed and used, contexts characterized by resource inequalities, gender segregation, and racialization. We must also ask what can be changed in terms of both the architecture and content of information technologies in order to better reflect the interests of women and of different groups of women. We need to assess what can-not be achieved within existing health care technologies but instead requires different methods and means. In addition, we need to ask how these technologies are used, in what context, by whom, and for what purpose.

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F rom: Eileen Green et al. ‘It can see into your body’: Gender, ICTs and Decision Making about Midlife Women’s Health, pp. 157–176 Recent research reflects the increasing dependency of medicine on technologies (Webster and Brown 2004), a form of ‘techno-medicine’ (Pickstone 2000) driven by pharmaceutical and medical device industries. … Although such technologies provide new and what may be perceived as ‘cutting edge’ information about disease and illness, they also deliver new forms of risk and uncertainty. Medical imaging technologies in particular can redefine our relationship toward sour own bodies and our sense of control over its parts. As Webster argues, ‘Technologies perform or “work” within the context of, as well as through, such relationships’ (Pickstone 2000: 2). This chapter argues that the use of technologies that offer visual representations of the body, paradoxically, tend to both produce and obscure such uncertainties. By appearing to illuminate what has hitherto been an uncertain, invisible risk, the image created becomes an artefact, or one of what Haraway (1990) refers to as ‘the crucial tools re-crafting our bodies’ (205). In addition such imaging may inadvertently represent normal bodily changes or ‘innocent lumps’ as risky prior to them (ever) becoming so. This may not be a problem for health professionals who are aware of the complexities of reading medical imaging technologies but when shared with lay women the uncertainties involved may be interpreted differently. We will explore these issues through the examples of mammography screening and follow up ultrasound looking for breast cancer, and bone densitometry, a health technology used to screen for risk of osteoporosis. We characterize mammography and bone densitometry as information technologies because of their potential to provide information about bones and breasts within a technological process, information that is used in health decision making …. Theoretical debates about risk and body management have provided useful conceptual frameworks through which to address women’s experiences of ageing. Pivotal to our understanding of such experiences are the ways in which women are represented as bodies that need to be carefully managed, whether it be by medical experts or by themselves, through a

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mixture of personal care and ‘self-surveillance’. Women’s bodies are routinely subjected to screening throughout their adult lives but entering the menopause appears to increase the imperative to take part in surveillance. However, this focus upon the deterioration of specific body parts such as bones and breasts encourages women to experience their bodies as fragmented and increasingly risky with age. Similarly, in producing images that obscure the social context of their construction, the screening technologies themselves become implicated in both a privileging of the technological image over other considerations and the reinforcement of popular perceptions of the image as authoritative and the body as potentially transparent (Treichler et al. 1998) …. Although health practitioners, through their training and work practices, know that such images do not make the body transparent, our data gathered during clinical consultations demonstrates that nevertheless, practitioners use popular phrases in their observations about scan or ultrasound images that obscure this in everyday discussions with patients. Narratives that conflate technologically produced anatomical images with the actual body invited women to believe that such technologies provided unmediated access to a body which can be fully known in ways that were previously not possible. … The interpretation of such pictures is dominated by the authority and expertise of the health professional and imbued with the hierarchical status of the clinic where patients are subject to the medical gaze and dependent on the experts to interpret the pictures …. Both the representation of midlife women’s bodies as risky and in need of surveillance—which is reinforced by public health information—and the immediacy of the visual image compel the women to see themselves as ‘at risk’ and to accept, maybe even demand treatment. Although machines cannot, of course, speak for themselves, the interaction of the seductive powers of imaging technologies and representations of the female body as in need of surveillance meant that women saw their bodies as sources of increased disease risk, while at the same time desiring certainty that they did not have breast cancer, or that they would not become stooped old ladies. Health professionals, while aware of the impossibility of these wishes, colluded with them by not challenging this desire. Most recent research highlights increasing debate about the

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potential of screening to do harm by increasing anxiety and unnecessary invasive treatment (Gøtzsche and Nielsen 2006), challenging the widely accepted ‘it’s better to go and know’ mantra. As our examples illustrate, a conflation of material bodies and technological images, alongside gendered discourse of risky female bodies can combine to construct a certainty of harm, with the attendant potential to reduce women’s confidence in what may be normal ageing bodies.

 eflection by Ellen Balka, Eileen Green R and Flis Henwood In the years that have passed since publication of Gender, Health and Information Technology in Context was published, much has changed, and yet, much has remained the same. Technological innovation, healthcare system change and the meaning of health and illness continue to be inextricably bound in what at times resembles (and feels like) a Gordian knot, with ideas about gender hidden deep inside that portion of the knot that it always seems so tough to loosen, deep inside the tangles, invisible in the core of the knot. We used the term ‘the computerization of health care’ to frame our inquiries of innovation, in order to signal a broad approach to information technology in healthcare. In the years which have passed since our volume was published, then nascent areas of inquiry have evolved into sub areas, which in turn have given rise to new vocabularies and nomenclatures. Terms such as mHealth and personalised medicine moved from academic literature into more common use, and concepts such as the quantified self—a term barely in use as our book went to press—have garnered the attention of major funding bodies, application developers and policymakers. As we edited our volume, we were aware that there was diversity not only in how authors viewed technology and innovation processes, but also in how authors viewed sex and gender. A decade ago, we were working largely in a world where gender binaries were the norm in academic publishing. As technological change evolved and fuelled new application areas in healthcare, in a parallel universe, notions of sex and gender too have evolved, also giving rise to new ideas and new vocabularies (e.g., CISgender, self-identification as they/them rather than he or she).

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As boundaries continue to blur (e.g., between health data producers and data users, between paid and unpaid care providers, between health and illness, between men and women), the very notion of boundaries seems almost too rigid, fixed and impermeable to describe the kinds of changes popular press, software vendors, device manufacturers and health sector innovation champions assure us will come. Although on the surface—looking at the outside of the Gordian knot—it appears that much has changed in the arena of health, information technology and society, a few things have remained the same. For example, although there continues to be a robust social science literature which crosses into computer science addressing issues which the Health, Technology and Society series has addressed, there continues to be limited evidence that those whose primary affiliations are in the medical sciences have integrated insights from this literature into planning or practice. And, in spite of the spread of methods to more meaningfully engage users in health IT design (e.g., participatory design; co-design), we continue to see little uptake of these methods among and within dominant software companies in the health sector. We see less evidence still that the insights raised through critical academic inquiry focused on the complex relations which together comprise ‘computerization of the health sector’ have been realised in software which has been integrated into the health sector. We know even less about how emergent relations of technology design and use are interacting with gender roles, as the gendering of work—both paid and unpaid—continues to garner little intellectual attention. As Green and Singleton (2013) noted, ‘gender is often rendered invisible in macro-theorising about social and technological change and indeed in many empirical studies of ICT use’—an observation which holds true when it comes to explorations of computer-supported cooperative work in the health sector as well (Balka and Wagner Submitted). Yet hopeful signs exist: In 2017, a group of (women) scholars held the third of a series of workshops at the annual Computer Supported Cooperative Work conference, in order to discuss feminist approaches to computer-supported cooperative work (Fox et al. 2017). They viewed the workshop as an opportunity to develop feminist research and practice generally, and an intersectional feminist approach specifically—one that

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goes beyond understanding ‘women’ as a single monolithic category. Elsewhere, colleagues are working on a book about the challenges (and how to overcome them) arising in moving software developed through participatory design methods into software in use. And, a recent national webinar held in Canada for health sector administrators which used a concept from science-technology and society to outline the challenges associated with academic-industry-health sector partnerships to design and implement health information technology (see Small et  al. 2019) drew a large crowd. There is cause for optimism, but vigilance—and a focus on how to move academic insights into practice environments— will also be required.

 ebecca Lynch and Conor Farrington. (Eds.). R (2018). Quantified Lives and Vital Data. Exploring Health and Technology Through Personal Medical Devices

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F rom: Conor Farrington and Rebecca Lynch. Introduction—Personal Medical Devices: People and Technology in the Context of Health, pp. 3–16 In recent years … there has been a notable proliferation of medical technologies tailored to individuals, often drawing on developments in digital technology, and frequently for use out-side ‘traditional’ medical locations. We have termed these technologies ‘personal medical devices’ (PMDs)—devices that are attached to, worn by, interacted with, or carried by individuals for the purposes of generating biomedical data and/or carrying out medical interventions on the person concerned. Such technologies have become increasingly significant in both clinical and extraclinical contexts, creating new sites and occasions for intervention, and arguably extending the purview of medicine into other locations and aspects of everyday life. The general (if tentative and uneven) shift towards technological healthcare solutions in wealthy countries reflects the increasing sophistication and miniaturisation of personal devices themselves, in addition to wider shifts towards personalised, patient-centred medicine …. The concept of PMDs may be described as a portmanteau concept, bringing together a number of elsewhere separated aspects. We coordinate the terms ‘personal’, ‘medical’ and ‘device’ in order to focus attention on technologies that may be ubiquitously present, in one way or another, in an individual’s everyday environment as well as clinical settings, and whose functions either include, or are entirely devoted to, the diagnosis, monitoring and/or treatment of illness (for ‘medical’ devices) or the tracking of activity and biometrics (for ‘well-ness’ devices, although these two categories of devices may not be straightforwardly separable). This approach consciously casts a wider net than many analytical approaches, since it includes devices that are both digital and non-digital in kind, and both medical and wellness in focus. Consequently, a smartphone app or pen and paper diary that an individual carries with them to monitor diet and exercise can be just as much a PMD as the latest digital activity wristband or cutting-edge medical device. Furthermore, the concept does not exclude any specific kind of interaction with the body: PMDs can be

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carried in clothing or baggage, worn on the body and implanted or ingested within it. As such, the silos that tend to characterise existing research on PMDs—e.g. research on wearables, ‘insideables’ (implantable devices), ‘smart’ garments, smartphone apps and paper diaries—can be overcome by utilising a concept that unites these seemingly disparate technologies through their shared focus on personal wellness and its obverse, illness.

F rom: Ava Hess. In/visible Personal Medical Devices: The Insulin Pump as a Visual and Material Mediator between Selves and Others, pp. 71–96 An insulin pump is a small medical device about the size of a mobile phone that is worn on the body for twenty-four hours a day, every day. Whether hidden under clothing or worn visibly, this piece of technology accompanies its user to school, to bed, to work, on vacation and even possibly during sex or in the shower. The small machine communicates with the individual who wears it, sometimes loudly and sometimes through vibrations that can only be felt. It can be decorated with stickers, jewels or ‘skins’, and it may have been given a name or gender by the user. As far as medical devices are concerned, the insulin pump is especially personal …. Drawing primarily on ethnographic accounts of three women living with type 1 diabetes, I use the concept of in/visibilities to reflect the pump as an enigmatic object that can be seen on or felt through the body, while simultaneously being unseen and unfelt—sometimes separate to the body, at others literally incorporated. These case studies exemplify how individuals reconcile the tensions and contradictory impacts introduced by this PMD, which offers flexibility in travel, exercise and diet while limiting flexibility in other ways through its constant attachment to the body. A crucial question articulated in the beginning of the chapter is whether the dissolution of bodily boundaries between human and machine is necessary for personal well-being. I explore how the insulin pump is felt on and through the individual body by examining strategies in how it is worn that help provide a necessary distinction between the

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‘diseased self ’ and the ‘true self ’. The relationship between person and pump inextricably informs the relationship between person with pump and other people …. Personal identity is constantly shifting and negotiated through changing practices as a person with diabetes moves through different social and material environments. However, through such practices, boundaries between body and technology also shift, being at times dissolved and at times visible. The pump may be worn so that it is hidden, thereby deemphasising a diabetic individual’s differences, or it may be made more conspicuous through personalised decoration. I discuss how the pump, whose in/visibility can be manipulated, acts as a visual and material mediator in relationships between self and other …. When needles are used to administer insulin, a person must inject both a long-acting insulin that should last around 24 h and fast-acting insulin used to counteract meals or to correct elevated blood glucose levels. The insulin pump more closely mimics a functioning pancreas through the use of only fast-acting insulin. The insulin is released in micro-doses through a continuous but adjustable ‘basal’ rate, with user-­ prompted ‘boluses’ given for meals and corrections …. By allowing users to adjust insulin doses spontaneously and precisely, pumps provide more flexibility when travelling, exercising and eating— or not eating—as desired. In other ways, the flexibility offered by the pump is severely limited as a treatment in which the patient is, quite literally, tethered to another entity. However, it is not the flexibility of the pump as treatment that I focus on here, but rather the socio-material practices it allows. In this context, the insulin pump emerges as a marker and a mediator between body and non-body and between self and others, making itself and the presence of diabetes in/visible …. Ultimately, my participants saw bodily awareness of the pump as decreasing over time and often located this unawareness within certain sensory modalities or body parts. Evie, a research professional in her twenties, suggested she no longer felt the weight of the OmniPod on her arm in the same way she used to and would even forget its location on her body: ‘sometimes when I’m taking off trousers I’ll think, “don’t hit the pump,” but actually I’m not wearing it there, it’s on my arm’. Or, in response to a question about the noises her pump makes, Patricia, another

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interviewee who uses a Roche Accu-Chek pump, referred to the sound of pumping insulin as the ‘“ch-ch-” noise you ignore most of the time’ …. Positioning one’s self-identity as close to those of peers can also be achieved through non-visual manipulations of the pump, as Patricia explained: ‘I have all sounds and alarms turned off on mine. I don’t want to be the beeping person in the corner of the office’. Ironically, the best strategy for downplaying differences can also be acknowledging them directly and moving on, as when Patricia has to use her pump at a restaurant and explains what she is doing rather than risk social alienation or offending others in being mistaken for texting at the table …. Whereas in these contexts the pump was de-emphasised through practice to achieve commonality, at other times it is manipulated to emphasise visible differences. When I asked Patricia how she would characterise her relationship with her pump, her first response was that the Accu-­ Chek pump she has ‘is the ugliest pump. It just comes in black’. She followed this by showing me her solution: leopard-print stickers. In describing her sticker collection, Patricia repeatedly stressed two ways in which decorating changed her relationship with her pump. ‘As soon as I stuck it on, it became mine’, she said, hinting at the process by which an ‘ugly’ and impersonal commodity-like object can be made inalienable through active, creative consumption …. Through this chapter, some of the work that my interviewees undertook has been brought out, with participants continually ‘making’ their diabetic bodies in different ways and, following Mol (2002), making different diabetes. While such differences do not reflect a common experience of diabetes, pump selfies allow a means of constructing a shared diabetes through person, pump and photograph. The pump selfie movement—with its crowned, and tethered, mascot—simultaneously resists normative beauty standards of the pure and able-bodied while creating its own normalising discourse on diabetes pumps that should be seen. This narrative implies that making the pump (and therefore diabetes) visible is empowering and helps to build a collective, whereas a focus on the everyday practices of people with diabetes suggests rather that the ability to choose when, where, how and in front of whom the pump is made visible is more important to individuals.

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F rom: Rebecca Lynch. Slippery Slopes and Trojan Horses: The Construction of E-cigarettes as Risky Objects in Public Health Debate, pp. 179–200 The availability and use of electronic, or ‘e’, cigarettes have grown extensively since 2012, and it is estimated that approximately 2.8 million people use them in the UK alone (ASH 2016). Over this time, shops devoted to selling e-cigarettes and cafes for e-cigarette use have sprung up across the UK, Internet messaging boards and social groups have been formed through the identity of being an e-cigarette user, and new language has developed around the practices of e-cigarette use, with ‘e-cigs’ and ‘vaping’ being added to the Oxford Online Dictionary in 2014. The spread and development of e-cigarettes are being undertaken both by big tobacco companies and by smaller and (at present) independent companies …. This chapter examines the ways in which biomedicine, in this case public health science, has sought to understand and locate e-cigarettes as a new development, which may, or may not, be a personal medical device (PMD). While earlier book chapters considered the personal relationships of individual users to PMDs, this chapter looks at the impact and positioning of a possible PMD within a wider area of concern—how medical research conceptualises e-cigarettes in relation to their impact on health …. Situated as an anthropologist in a multi-disciplinary public health research team that sought to add to the growing evidence on the impact of e-cigarettes, my argument is drawn both from participation observation within the team and from analysis of scientific papers and commentaries produced by the scientific community which were emerging on this topic between 2013 and 2015. [There are two competing perspectives on e-cigarettes]. The technology of e-cigarettes … requires engagement and use of different smoking paraphernalia such as chargers or refills. … Inherent in the logic of this side of the argument, and again reinforcing the idea that these are the same sorts of objects as tobacco cigarettes, is the notion of the ‘slippery slope’ that leads individuals from one object, or substance, to another. This viewpoint suggests a single continuum of substances,

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with people being seen to migrate from e-cigarettes to tobacco cigarettes with relative ease. The same argument has been applied in terms of drug use, with people moving from cannabis to harder drugs along this one continuum. [In contrast] through their mimicry of tobacco cigarettes, e-cigarettes may ‘seem’ to be cigarettes but actually, they are quite different objects. While on the outside resembling a cigarette, they are actually delivering something else, like a Trojan horse. Through being a convincing copy, they have the potential to be subversive and useful objects in making changes to health behaviour …. A key problem with the debate on e-cigarettes is that both [these] sides assume that they know how to conceive of these objects and establish what e-cigarettes are—slippery slopes or Trojan horses. But based on these assumptions, we might consider other possibilities of what an e-­cigarette might be. Abrams suggests that ‘[i]ndependent manufacturers of e-cigarettes could compete with tobacco companies and make the cigarette obsolete, just as digital cameras made film obsolete’ …. E-cigarettes are becoming even less like tobacco cigarettes as they are being made to taste different, look different, and be more personalisable. E-cigarette development is linked to technological changes and may be limited and/or led by the technology itself. Some commentators see a new generation of e-cigarettes being developed which will cause those presently in circulation to appear old-fashioned and obsolete. New relationships are formed with new objects and there is a huge and expanding range of e-cigarettes varying not only by design and chemical ingredient but also in contexts of use. These objects, and the practices that go alongside them, are far from stable, so that the entrenched arguments held up from within public health already make little sense to many users and non-users of e-cigarettes. [There are] multiple interactions between people, e-cigarettes, places, other people and other objects, and the ways in which these may contribute to actions. Indeed, rather than being situated in the head, health practices can instead be seen to emerge from assemblages of elements— objects, people, places, etc. which act together. Through these understandings, e-cigarettes are not one thing, separate from space and time, but rather are objects that emerge relationally from particular

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circumstances, potentially shaping not only the relationships held with tobacco cigarettes, but also the varied relations which compose healthy, moral ‘bodies’ and indeed what addiction might mean and how this is experienced. Practices around e-cigarettes may configure new kinds of socio-­material relations and lead us to ask new questions, not only about e-cigarettes but also about health, mind–body relationships and morality. Disagreements within the public health e-cigarette debate are unlikely to be resolved because both sides are in the end talking about different things. Different sides in the debate enact different objects through their practices and discourses, even if they draw on similar conceptualisations of objects, people and their relationship to do so. The e-cigarette-objects that emerge from each side may not be recognisable to e-cigarette smokers themselves. These practices and discourses set up their own socio-­ material relations. PMDs emerge from and impact on material-semiotic practices within medicine as well as outside it, no matter how static and separate medicine might frame these as being. Neither what an object ‘is’ nor whether it is ‘risky’ are therefore elements intrinsic to a particular technology, as technologies are not singular things. Instead, the qualities of objects are relational and emerge from how these are enacted in practices. ‘Riskiness’ emerges as an attribute ascribed by medicine as a future trajectory of just one of the multiple objects made through these different constructions.

F rom: Christopher Till. Commercialising Bodies: Action, Subjectivity and the New Corporate Health Ethic, pp. 229–250 The focus of this chapter is on the use of particular kinds of commercial personal medical devices (PMDs) which track activity. It will be suggested that these digital self-tracking (DST) devices1 enable the broad commercialisation of bodies through their transformation of exercise activity into data and their integration of personal wellness activities into corporate structures. While evidence has shown that many users quickly abandon devices (Ledger and McCafrey 2014), there is still optimism regarding their potential to instigate healthy behaviour change (Campbell

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2015) and significant growth in investment in DST, indicating a clear push from corporations (Davies 2015 …). The use of corporate wellness (CW) programmes has also increased dramatically in the last few years … [and] there are expected to be 13 million self-tracking devices used in CW by 2018, implemented on the assumption that they will increase productivity through better engagement and motivation at work. … These initiatives are attempts by employers to improve the ‘wellness’ of their employees through the improvement of morale and the creation of a ‘culture of health’ at work, which, it is proposed, will ultimately increase the ‘bottom line’ of the employer …. This chapter will suggest that a conflation between work and health is being achieved through a reorientation of wellness as a topic falling within the remit of employers and as an issue best tackled through management strategies. … I will [also] propose that companies are taking a ‘philanthropic’ interest in health and well-being that is not reducible to the profit motive but which is nevertheless inseparable from it. The health of the individual and the health of the economy/organisation are increasingly intertwined, but the definition of health (through a focus on ‘wellness’) is being aligned with productive capacity. This is happening on both a practical and conceptual level. Practically, the digitisation, accumulation and analysis of bodies through fitness tracking enable the detached management of health and exercise practices. Also, the use of CW programmes encourages the kinds of exercise practices which are conducive to corporate or organisational interests …. [A]core, although only partially acknowledged, rationale for these programmes is the generation of ‘productive bodies’ through engaging the subjectivity of the individual. … Through behavioural tactics and automated prompts and reminders, the devices and programmes discussed in this chapter attempt to constitute a reactive subject smoothly integrated with their productive context. The qualities and behaviours which are encouraged are those which enable the integration of bodies into capital accumulation rather than those associated with health per se. Intervention through these means enables corporations and organisations to fulfil their aims of doing social good through constituting healthy subjects while creating conditions for greater productivity ….

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The philanthrocapitalist intervention of corporations and organisations into the intimate lives of individuals is primarily predicated not on the improvement of health as such but on the increase in activity. This can be seen in the focus on the reduction in sedentarism and the emphasis on devices and initiatives built around walking and running, as exemplified by the slogan of Global Corporate Challenge: ‘Get The World Moving’. It is my suggestion that DST devices and CW programmes using such technologies function to constitute productive bodies while achieving social ‘goods’ in a manner consistent with capitalist enterprise, and that the main way in which this is done is through the promotion of ‘activity’. A function of corporate wellness initiatives is to conflate work and non-­ work life and practices. ‘Activity’ and being ‘active’ are here thoroughly integrated across the whole approach to workplace wellness. This emphasis on increasing activity is mirrored in the advice provided by Fitbit on their website: Doing the dishes? Multitask when you stand at the sink and load the dishwasher. Do calf raises while rinsing, and pause to do a squat for every plate, bowl, or glass you put in the machine.

Using the kinds of technologies currently available, movement is much easier to track than other forms of wellness-promoting behaviour; as such, it is becoming one of the key organising principles of contemporary capitalism. This is because it is useful for increasing the productivity of workers (for directly generating income through sales of devices and the production of valuable data), in addition to the virtuous aura which justifies the spread of capitalist logics to increasing areas of life …. Activity is here presented as beneficial for the improvement of health and productivity. The promotion of activity by corporations is thus deemed to be a social good in itself, as it will increase the health and well-­ being of the individuals who engage in it at the same time that it helps those individuals to be more productive at work. The promotion of activity is also useful for the producers of DST and employers who implement them as part of wellness activities. The former benefit from the generation of valuable data and the latter from a more productive and engaged

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workforce. While there are other means through which to achieve health and wellness, these devices and initiatives are helping to constitute an increasing alignment between activity, morality and health …. When technologies and management systems built for the maximisation of productivity are applied to exercise, it makes sense that the latter will start to seem more like work. Employers and corporations have shown a growing interest in promoting exercise activity as a moral good. Simultaneously, digital technologies such as PMDs have enabled the kinds of measurement, standardisation and incentivisation often associated with work to seep into everyday lives. In the process, health and exercise are coming to be judged in terms of productivity, and work is being presented as a means of achieving wellness and self-­fulfilment. Work and non-work seem to be blurring with productivity, which is increasingly the key measure of both.

Reflection by Rebecca Lynch and Conor Farrington In putting together this edited volume we sought to foreground the relationships between people, technology and health. Against the backdrop of continuous technological innovation and the promotion of new devices as panaceas for a range of medical conditions, we were keen to examine how new health technologies (such as ‘artificial pancreas’ systems for people with type 1 diabetes) are used in practice, and in the relations, networks and possibilities they open up or close down. We also wanted to recognise ‘analogue’ (i.e. non-digital) and established technologies with relevance to health—such as stethoscopes, syringes and blood pressure monitors—alongside established technologies that are now being used differently (such as keep-sake pregnancy ultrasounds) and technologies that are not conventionally placed in the health context (such as e-cigarettes). To collate and draw out commonalities between this wide range of technologies, we created a portmanteau concept—‘personal medical devices’ or PMDs—as a way of providing an analytical lens on the relations and tensions between people, health and technology in this broad family of objects. In so doing, we also sought to bring together a range of

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theoretically informed analyses from multiple disciplines and perspectives (such as design, regulation and medical ethics), and in the process located new settings beyond the clinic where health:individual:technology interactions were being ‘done’. The collection opened up for re-­ examination and reassessment of the very categories we had started with, raising questions as to where the person, or the individual body, starts and ends; how we might define health and the medical as we move further from the clinic and into everyday living; what ‘counts’ as a technology; and how technologies are ‘made’ in relation to, and/or delineated from, the wider structures and other technologies on which they are dependent or tethered to. There were, of course, other kinds of technologies and technological relations we could have focused on, including some fields that have arguably become more prominent since we put the book together, such as technologies associated with notions of precision medicine and artificial intelligence. Indeed, one way to extend the concept of PMDs, and also encounter new analytical dimensions, is to interpret machine-learning and artificial intelligence algorithms as a kind of virtual or metaphorical device. Metaphorical devices are ultimately found to be embedded in material contexts (e.g. servers or other computing devices) and can be incorporated in wearable technologies with clinical applications (e.g. artificial pancreas systems). However, they can also be thought of as transcending materiality insofar as the rationales for their diagnostic and therapeutic operations are masked by layers of ontological complexity and context-specific adaptations, such that no two machine-learning PMDs are exactly alike in process and outcome. This ‘black boxing’ denotes a kind of digital agency that is frequently mysterious and inaccessible in character, but that nevertheless increasingly brings about material consequences in clinical contexts. As a result, the ethical dimensions of machine-learning and artificial intelligence call for critical attention: while algorithmic operations are often interpreted as ‘objective’ and value-free, a growing body of research reveals the subtle biases and priorities incorporated into coding, with potentially discriminatory effect. At the same time, a growing ‘techlash’ against intrusive surveillance and excessive personalisation of digital experiences highlights genuine social

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concern regarding unfathomable digital agency and its impacts on social life. The relationships between PMDs and global equity, likewise, did not explicitly feature in Quantified Lives and Vital Data, but nevertheless raises highly significant questions relating to the relationships between health and new technology. Pressing concerns in this regard include fears of a global ‘digital divide’ and ways in which PMDs might reinforce existing health inequalities. As our chapters illustrate, health technologies produce new and diverse relations, forms of use, constructions of the personal, health and medicine and diverse understandings of what a device might be said to ‘be’. From one perspective, these new possibilities can be understood as empowering. Yet, in common with many technologies, PMDs can also lead to oppressive outcomes through uneven distribution, the embodiment of discriminatory logics and reliance on antecedent and inequitable configurations of data, computation and networking infrastructure, all of which may contribute to inequality around health. While offering the potential to transform existing structures of healthcare delivery, current technology trends suggest that distribution of benefits from the next generation of PMD technologies will continue to disadvantage those in particular age groups and in more socio-­ economically deprived areas who might already have poorer health, as well as many in the Global South. Technologies designed for one context may not be easily transferrable to another. Furthermore, ‘successful’ transference may only serve to reinforce structural domination by corporate and semi-public interests within the Global North. New relations and dynamics are always possible, as demonstrated by the ‘leap-frogging’ of technologies that has occurred in some African countries, where transitions to mobile cellular telephone networks occurred more rapidly than many countries in the Global North due to lower sunk costs in landline networks. As we know, technologies and relations that emerge from the use of devices can be very different to those imagined in development and design. Consequently, the excitement and promise around the development of PMDs, and our various approaches to analysing effects in practice, would benefit from situating our findings not only in different contexts of use but within wider power dynamics and inequalities, and how these may, or may not, link to health.

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Nuffield Council on Bioethics. (2013). Novel neurotechnologies: Intervening in the brain. Oxford: Nuffield Council on Bioethics. Oudshoorn, N. (2015). Sustaining cyborgs. Sensing and tuning agencies of pacemakers and ICDs. Social Studies of Science, 45(1), 56–76. Oudshoorn, N. (2016). The vulnerability of cyborgs. The case of ICD shocks. Science, Technology & Human Values, 41(5), 767–793. Oudshoorn, N. (2018). Hybrid bodies and the materiality of everyday life. How people living with pacemakers and defibrillators reinvent everyday routines and intimate relations. Sociology of Health & Illness, 40(1), 171–187. Oudshoorn, N., & Pinch, T. (Eds.). (2003). How users matter. The co-­construction of users and technology. Cambridge, MA: The MIT Press. Pickstone, J. (2000). Ways of knowing: A new science, technology and medicine. Manchester: Manchester University Press. Pols, J. (2014). Knowing patients: Turning patient knowledge into science. Science, Technology & Human Values, 39(1), 64–68. Portacolone, E., Berridge, C., Johnson, J., & Schicktanz, S. (2014). Time to reinvent the science of dementia: The need for care and social integration. Ageing & Mental Health, 18(4), 269–327. Rabeharisoa, V., Moreira, T., & Akrich, M. (2014). Evidence-based activism: Patients’, users’ and activists’ groups in knowledge society. BioSocieties, 9(2), 111–128. Sobchack, V. (2006). “A Leg to Stand On: Prosthetics, Metaphor, and Materiality.” In M. Smith and M. Morra (eds.). The Prosthetic Impulse: From a Posthuman Presence to a Biocultural Future, 17–41. Cambridge, MA: MIT Press. Sørensen, E. (2007). The Time of Materiality, Qualitative Social Research, 8(1), Art. 2, http://nbn-resolving.de/urn:nbn:de:0114-fqs070122. Small, S. S., Hohl, C. M., & Balka, E. (2019). Organizational implications of implementing a new adverse drug event reporting system for care providers and integrating it with provincial health information systems. Healthcare Management Forum, 32(4), 208–212. Stilgoe, J., Owen, R., & Macnaghten, P. (2013). Developing a framework for responsible innovation. Research Policy, 42, 1568–1580. Treichler, P., Cartwright, L., & Penley, C. (Eds.). (1998). The visible woman: Imaging technologies, gender and science. New  York, NY: New  York University Press. Ulucanlar, S., Faulkner, A., Peirce, S., & Elwyn, G. (2013). Technology identity: The role of sociotechnical representations in the adoption of medical devices. Social Science & Medicine, 98, 95–105.

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Wathen, C. N., Wyatt, S., & Harris, R. (Eds.). (2008). Mediating health information: The go-betweens in a changing socio-technical landscape. Basingstoke: Palgrave Macmillan. Webster, A., & Brown, N. (2004). New medical technologies and society: Reordering life. Cambridge: Polity Press. Whitehouse, P. J. (2010, Spring). Taking brain health to a deeper and broader level. Neurological Institute Journal, 3(1), 17–22. Whitehouse, P. J., Gaines, A., Lindstrom, H., & Graham, J. (2005). Dementia in the anthropological gaze: Contributions to the understanding of dementia. The Lancet Neurology, 4, 320–326. Whitehouse, P. J., & George, D. R. (2008). The myth of Alzheimer’s: What you aren’t being told about today’s most dreaded diagnosis. New  York: St. Martin’s Press.

Section 2: Responsibility Kirstine Zinck Pedersen, Gerard de Vries, Klasien Horstman, Simone Bateman, Sylvie Allouche, Jérôme Goffette, Michela Marzano, Roma Harris, Nadine Wathen, and Sally Wyatt

Introduction The single word, responsibility, captures the ways in which the burden of responsibility for health and wellbeing is being shifted onto individuals, via developments such as personalised medicine. In most Western countries, current laws and regulations require individuals to be fully informed

K. Z. Pedersen Department of Organization, Copenhagen Business School, Frederiksberg, Denmark e-mail: [email protected] G. de Vries Wolfson College, University of Cambridge, Cambridge, UK K. Horstman Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, The Netherlands © The Author(s) 2020 A. Webster, S. Wyatt (eds.), Health, Technology and Society, Health, Technology and Society, https://doi.org/10.1007/978-981-15-4354-8_3

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about some medical procedure and to be offered the choice either to consent to it or to opt out. But as the books included amply demonstrate, we are witnessing not only the promotion of individual responsibility but also a reconfiguration of responsibility between different groups. Policymakers, clinicians, insurance companies and employers also have responsibilities for the health of their citizens, patients, customers and workers. These too are being reconfigured as new policies are implemented, new diagnostic tests are developed and new technologies make it possible for people to enhance their bodies and minds. S. Bateman Centre for Research on Medicine, Science, Health, and Society (CERMES3), French National Centre for Scientific Research (CNRS), Paris, France e-mail: [email protected] S. Allouche General Biology Laboratory (EPHE/UCLy), Catholic University of Lyon, Lyon, France J. Goffette Department of Philosophy, Université Claude-Bernard Lyon 1, Lyon, France Research Unit on Environment, City and Society (EVS), French National Centre for Scientific Research (CNRS), Lyon, France e-mail: [email protected] M. Marzano Department of Social Sciences, Paris Descartes University, Paris, France R. Harris Faculty of Information and Media Studies, The University of Western Ontario, London, ON, Canada N. Wathen Mobilizing Knowledge on Gender-Based Violence, The University of Western Ontario, London, ON, Canada S. Wyatt (*) Maastricht University, Maastricht, The Netherlands e-mail: [email protected]

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The first book in this thematic section focuses on the international patient safety programme, designed to shift responsibility from clinicians to systems. The second analyses genetic testing, an emerging technology, with consequences for the ways in which responsibilities change and shift between different actors, including patients, health care professionals, employers and insurers. The last two books highlight the shift to personal, individual responsibility to be one’s best self via enhancement techniques and to be one’s best informed self with the assistance of digital technologies. Kirstine Zinck Pedersen (2018) focuses on a programme that aims to improve patient safety. Moving away from the traditional approach to recognising that medical practice necessarily involves uncertainty and fallibility from which doctors must learn, the international patient safety programme is based on principles of accountability and risk management. Pedersen examines what happens when such a programme is institutionalised into clinical settings and incorporated in the practices of health care professionals. The patient safety movement is international, but Pedersen focuses on Denmark. The country has been a pioneer in adopting patient safety legislation and thus provides an excellent case for understanding its implementation and the consequences for clinicians accepting responsibility for their mistakes and learning from them. She demonstrates how the effort to eliminate risk and promote failsafe systems inhibits the possibilities for practical reasoning in clinical settings with implications for the training of doctors. One of the first volumes in the series was the collection edited by Gerard de Vries and Klasien Horstman (2008) about genetic testing for a range of diseases and even lifestyles, and the emergence of risk-oriented, preventive medicine. The editors and their collaborators provide careful empirical analyses of, at the time of their writing, already existing practices of genetic testing, in health care and policy, insurance and the labour market. Arguing that current laws and regulations locate key normative decisions behind the closed door of consultation rooms, to advance broader reflections and discussions, their volume aimed at making public what goes on in a variety of genetic testing practices. Their chapters lay out how responsibilities for being informed, making diagnostic and treatment decisions are being reconfigured between patients, family members,

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health care professionals, insurance companies and policymakers. The authors argue that genetic testing is to a large extent still an ‘unknown’ practice, and that, hence, to learn collectively how to use genetic information in a responsible way, apart from the ‘exit option’ now offered by law, society has to better organise ‘voice options’ to allow a wider register of experiences. By opening the black box of genetic practices, their chapters raise important questions about how genetic testing may transform relations between the state, professionals and citizens, with profound and far-reaching consequences for identity (as patient and professional), responsibility and solidarity. The collection of thought-provoking essays by Simone Bateman and her colleagues (2015a) explores the issues raised by human enhancement.1 The editors and contributors—from different countries and from different disciplinary backgrounds—reveal the ambiguities, debates, controversies, hopes and fears around the meanings and practices of human enhancement, also sometimes called post- or trans-human. Even though ‘human enhancement’ has become a common term, the contributors clarify its definition, scope and limits in order to clarify what ‘improving people’ is all about. The volume includes a section that addresses the role art, literature, especially science fiction have played in imagining worlds in which human enhancement is no longer exceptional. In the extracts below, we focus on what human enhancement may mean for the responsibility of individuals to be their ‘best’ selves and for those medical and other professionals facilitating therapeutic, pharmaceutical and surgical interventions. In the collection edited by Roma Harris et al. (2010), the emerging imperative of personal responsibility raised by Bateman et al. comes to the fore. Different chapters explore how technological developments  The same group also produced a shorter companion volume addressing animal enhancement as a possible prototype but also a counterexample of human enhancement. The book aims to identify similarities and differences in the way enhancement is conceptualized and applied to animals and humans. It is published as a Pivot book, is not formally part of the HTS Series and thus not included here (Bateman et al., 2015b). 1

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facilitate changes in the burden of responsibility for health [and in locus of care—cross reference]. The editors and contributors explore the tensions between the social and individual management of health. The first is traditionally anchored in collective social relations and shared knowledge and practice. The individualisation of health is driven through cultural representations and state-sponsored promotion of self-care and personal responsibility. The contributors to the book examine to how economic, moral and technical imperatives intersect to shift the burden of health care away from the collective and on to the individual. Different chapters examine how patients have become positioned as clients or consumers and how health care professionals become service providers (also a theme in Bateman et al.).

 irstine Zinck Pedersen. (2018). Organizing K Patient Safety: Failsafe Fantasies and Pragmatic Practices, pp. 128–131, 221, 240–244

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F rom: Chapter 1, Studying Patient Safety: An Introduction, p. 19 This book can be defined as an inquiry into the problem of patient safety. Throughout the chapters, this problem is attended to by analysing the patient safety programme and the assumptions that constitute its faith in failsafe systems, its ideological and technological components and its enactment in—and unintended consequences for—situated clinical practices, practical types of reasoning, redistribution of risks and the subtle and often invisible transformations of responsibility structures and the particular modes or ways of the clinician.

F rom: Chapter 4, Blame and Responsibility in Patient Safety, pp. 104–107  ll the ‘Greys’ of Responsibility: The Consequences A of Banning Blame An important lesson to be drawn from the sociological accounts of error management and professional self-regulation presented in this chapter [4: ‘Blame and Responsibility in Patient Safety’] concerns the large number of grey areas that fall between the clear-cut ‘systemic error’ and the clear-cut case of negligence, as well as the hard work that goes into identifying and classifying what type of errors would lead to what type of responses. One of the main constituents of the problem of incompetence concerns exactly this difficulty of identifying what is to count as incompetence in particular cases, which is why some of the presented accounts argue for safeguarding and strengthening the processes of and abilities to identify malpractice within the professional community. In opposition to this, it is often presupposed with a blame-free perspective that it only makes sense to address issues of personal responsibility and blame in rare cases of negligence. Equally important, the safety programme is built on the assumption that the few cases of negligence are so easily identified that they can be determined as negligence before they are treated within the programme. This is, for example, the case in

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relation to root cause analysis processes that are not conducted in clear cases of impairment or negligence. When conducted, they are specifically designed to not assign blame or liability to individuals and as such the possibility of identifying incompetence, misconduct or simply different kinds of responsibility and obligations are most often hindered during these sessions with a reference to its blame-free ideal (this dilemma is further discussed in Chap. 5). Thus, as a consequence of the blame-free perspective, it is expected that in order to be managed, acts must be so clear-cut negligent that they naturally fall outside the patient safety programme’s systems for dealing with errors systemically and can be handled by other authorities. This happens in rare cases where, for instance, alcoholism or unlawful activities are easily identified as the causes of errors. Consequently, there are—roughly speaking—two possible positions a healthcare professional can hold in relation to error: either you are guilty of negligence or the error is to be understood as systemic and you are then not to be blamed. … With only two possible convictions for the health professional, guilty or not guilty, which are often to be identified before the investigation of an incident takes place, blame-free strategies are likely to interfere with and inhibit processes of identifying malpractice because they remove the possibility of addressing different sorts of professional, moral and individual involvement with and responsibility for errors. In this way, the delicate structures for professional identification, regulation and self-control of errors and malpractice—which have earlier been identified as such an elementary part of medical practice— risk being obscured. … This chapter has … [shown] how important tensions come to the forefront when relating accounts of medical practice, safety cultures and responsibility structures comprised in previous studies of medical error and error management with contemporary modes of safety management. First, it is found that the image of a dominant culture of ‘naming, blaming and shaming’, which unequivocally summons both earlier and current narratives of medical practice, dissolves when looking closely at actual accounts of medical practice. Instead, a fragile ecology of

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co-­collegial and informal error management is found consisting of processes of monitoring, sorting and managing error, which might result in forgiveness, understanding or, in some cases, the assignment of blame and self-blame. Such mechanisms are anything but problematic. Rather, they are necessary and important measures in the training of clinicians and in dealing with both forgiveness, which is likely to generate a sense of responsibility in the person who is forgiven, and problems of moral and clinical incompetence, which help set the limits of office. Conclusively, the main problem is not too many internal professional control mechanisms. Because, what follows from a shared understanding of the fallible nature of medical work and the shared vulnerability of the medical ethos is an environment where understanding and forgiveness is easy, sometimes too easy. And, as such, the main challenge consists in, first, determining and setting apart different sorts of errors, mistakes and acts of incompetence and, second, making sure professional structures are in place to manage these various kinds of failure in gentle, yet effective and decisive ways. As the vocabulary of the mistake and the problem of incompetence have disappeared from today’s safety methodology and discourse, it is reasonable to think that conditions for sorting and managing various forms of error, mistake and incompetence within the professional community have weakened. Here, the problem of incompetence is only one concern of many which relates to changing the clinical situation by weakening or even dissolving the constitutive relationship between the medical error and the responsibilities and obligations of the healthcare professional.

F rom: Chapter 5, The Distributed Risks of Safety Management, pp. 128–131 Responsibility Risk: Blurring of Roles and Responsibilities In Rationalizing Medical Work (1997), Marc Berg shows how ‘rationalizing technologies’ in healthcare causes a disciplining of medical practices to fit the specific formalisms of the technologies, with a transformation of medical work as a consequence: ‘The intriguing feature of these systems

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is that they alter the work that allows them to exist’ (Berg 1997: 170). Introducing a safety technology, a new failsafe procedure or a safety device is not just a neutral process of adoption, but also an active transformation of the practices it meets: practices that have been internalized by the health professionals and that have often developed over a long time, through trial and error. Therefore, any introduction of patient safety technology into healthcare is likely to cause rearrangements of roles, responsibilities and earlier practices of both more formalized and invisible or informal character. With the notion of ‘responsibility risk’ I attend to this type of role and responsibility redistribution and blurring caused by the introduction of safety technologies. To illustrate this problematic, another case from the university hospital can be helpful. After several incidents of undetected worsening leading to cardiac arrests, the hospital introduced a new safety arrangement: Medical Emergency Teams with the goal of identifying and treating a sudden worsening and deteriorating of patients in general wards. … The teams are centralized units consisting of emergency physicians and nurses, and their goal is to ensure safe, timely, professional and standardized emergency care to patients who are, for instance, suffering from unexpected organ failure or cardiac arrest. But while the emergency teams are introduced in order to increase the safety of patients, the practices they bring with them might become a safety issue in themselves, and I experienced during fieldwork that the introduction of emergency teams occurred occasionally as the topic for discussion in quality meetings or incident analysis sessions. From these discussions, it became obvious that the implementation and use of the emergency teams did not go as smoothly as expected. An incident of cardiac arrest in a non-intensive ward can demonstrate this point: First, and for reasons not altogether clear, the new emergency team was not called immediately when the patient stopped breathing as the procedure would have it. Rather, a phone call to an attending physician was made before the call to the team. Second, considerable confusion arose about who was in charge of the resuscitation efforts until the team arrived. In the subsequent RCA session, one of the participants described the situation as a ‘chaotic and headless operation where no one and everyone were taking charge’. Third, when the team arrived, the ward personnel were disorganized and

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confused about their roles and responsibilities, right down to simple questions such as whether they were supposed to stay in the room or not. Another issue concerned the documentation of the episode; as a nurse mentioned, ‘[i]n the old days, a cardiac arrest would immediately compel someone to grab a pen and start documenting. Now we all rush out of the room when the emergency team arrives.’ So with the introduction of emergency teams, roles and responsibility structures have changed considerably with role confusion, blurred responsibility and failure to live up to certain professional obligations (such as documentation) as a result. Before the new teams were introduced, the ward had developed a number of well-established routines and procedures (spoken as well as unspoken) for emergency situations but with the new ‘safety system’ new guidelines had been introduced and the implicit annulment of the ‘old ways’ had not been taken into account and neither had the fact that such roles, responsibilities and routines are often developed over a long period of time and that it might take a while to re-­ establish work practices and responsibility structures that function as effectively, swiftly and safely as the old ones (see also Holmes 2009 and Chap. 8). The presented case of redistribution of responsibility is not specific for patient safety technology and can in many ways be said to represent what has been determined as classic problems of ‘centered managerialism’ (Law 2000:15), of the implementation of evidence-based knowledge or standardized systems into situated healthcare practices (see for instance Zuiderent-Jerak 2007); or of innovation when innovation is understood and conducted separately from the practices that it seeks to innovate (Mesman 2008). But there are also problems of responsibility and blurring of roles that are more specific to the programme and that attest to what could be described as patient safety’s ambivalent relationship with notions such as accountability, responsibility, sanctions and blame. On the one hand, and in line with questions of addressability and accountability raised earlier in relation to critical incident reporting, it can be argued that the transformation of clinical situations into reportable incidents—that is, the creation of new risk objects to be managed—is essentially about making actors and organizations responsible and accountable (Hilgartner 1992; Douglas 1992; Power 2007; Power et al. 2009). In line

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with this argument, the safety agenda’s strong emphasis on risks and errors (in contrast to, for instance, danger, chance, complications and accidents) inevitably raises issues of blame and responsibility (McDonald et al. 2005). But this quest for accountability sits alongside the blame-­ free ethos of the programme that is designed to help realize the goal of creating a learning environment where professionals can talk openly about errors with the result that they can be reported and corrected. As I attend to in greater lengths in Chaps. 4 and 6 of this book, this blame-­ free principle that is supposed to increase institutional accountability and learning might well disturb traditional and situated ways of taking responsibility for and acting upon failure. Thus, blame-free patient safety technologies such as the RCA can have serious unwanted effects equally for preventing the more formal attributions of responsibility as well as more informal discussions about limits of office.

F rom: Chapter 8, A Pragmatic Stance on Safety Management, p. 221 [I]n some instances, the obvious consequence of critical incidents or medical error is to do nothing (in terms of new interventions). However, as Law (2000) indicates in his analysis of the Ladbroke Grove disaster, this is a difficult argument to maintain—especially if people are hurt or even killed. Doing nothing in terms of system optimizations, action plans or new safety protocols is not, however, the same as ignoring the incident. Instead, processes of formal or informal incident analysis can function as possibilities for taking responsibility for what went wrong, generate learning experiences for the people involved and result in willingness of the involved personnel to modify their future responses. Today, a less interventionist position is hardly an easy position to hold, and it does not make it easier that patient safety representatives, quality coordinators and risk managers have become part of a distinct profession within healthcare. For a profession eager to maintain its position and worth by ‘innovating’ healthcare, advice such as ‘do nothing’ or ‘use the rules already in place with more discretion’ is, for obvious reasons, not preferable compared with a more interventionist position. The problem,

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however, of the interventionist faith in failsafe systems is not only that it is unattainable. The problem is that striving towards system perfection can make systems more unsafe. Clever safety management therefore means accepting that systems can fail and that so can management efforts. As argued by Law, ‘the art of management is that of accepting some failures by wisely choosing which to try to put right’ (2000: 11).

F rom: Chapter 9, Patient Safety as Trained Dispositions and Moral Education, pp. 240–244 Failsafe Fantasies The failsafe vision [of the patient safety programme] is indeed tempting. It is appealing to imagine that no matter whether you meet an experienced, well-trained or competent health professional or an inexperienced, tired, stressed, clumsy or ill-prepared one, the system will keep you safe and eliminate the possibility of error. This vision is easily sold to the public who are accustomed to the typical anti-variation argument such as ‘any patient must receive the same treatment no matter who is on call’. It is also convenient for politicians because it supports a general improvement and efficiency agenda, where increased pressure on health systems and personnel is addressed as a question of smarter and more optimized designs. And it has, perhaps surprisingly, even proven eatable to the health professions. Surprisingly, because the vision challenges their authority considerably, not least by making safety into something outside of their professional expertise and thereby paving the way for system engineers to become the new ‘experts’ on something that was earlier solely within the health professionals’ jurisdiction. When health professionals do accept the programme, and often endorse it, there are several possible explanations. To name some, one concerns the programme’s image and language of ‘science’ (see Chap. 3); a second that the alternative to human factors and systems thinking is understood to be even more malpractice claims and liability suits; and a third, for some at least, that safety and systems thinking as a discipline have led to the establishment of a new area of competence, even a new profession.

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However, the failsafe vision is a fantasy; no matter how cleverly we design health systems and no matter how many failsafe systems we introduce, safe care is dependent on expertise and therefore it does matter who is on call— and it should matter. This book has further attested that although the failsafe vision is a fantasy, it has very real unwanted effects for the attention given to those on call, and the skills, discretionary abilities, practical knowledge and safety dispositions they need in order to deliver safe care and detect and avert unsafe situations. And it has unwanted consequences for the focus given to the delicate professional structures of detection and regulation of error and malpractice in clinical practice that was earlier identified as the foundation of safety management in healthcare (Bosk 2003; Rosenthal 1995). From this perspective, regulating error and discriminating between appropriate and inappropriate behaviour are part of the moral education of becoming a clinician and learning the rules and the limits of office. …

Medicine as Moral Practice In this book, I have argued for the dangers of dogmatically pursuing [no-­ blame, failsafe] principles, as they are likely to interfere with the delicate structures for handling and regulating error within medical practice and with the training of safety dispositions and uses of practical types of reasoning in concrete clinical situations. It can even be held that the principle-­based view of safety management challenges the understanding of medicine as a moral practice. According to Dewey, moral can be defined as any kind of conscious valuation of alternative possibilities. This stance on moral ‘saves us from the mistake which makes morality a separate department of life’ (Dewey 1922: 279). Moreover, it determines morals as an ongoing achievement that entails revising one’s judgements and acts based on the consequences of earlier actions: ‘When we observe that morals is at home wherever considerations of the worse and better are involved, we are committed to noticing that morality is a continuing process not a fixed achievement’ (Dewey 1922: 280). …

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With a practical and pragmatic stance, then, the better clinician is not he or she who follows guidelines or safety standards dogmatically or who excels in systems thinking but he or she who is a good judge of relative values in particular instances; it is he or she who, when met with problems or uncertainties, is able to use procedures, guidelines, existing practices and earlier experiences with discernment and discretion; and it is he or she who engages in consistent work on the self to modify inappropriate habits. To illustrate that morals, disclosure, learning and individual accountability can be combined in medical practice, let us recall Charles Bosk’s study (1979/2003) of the internal regulation of error between residents and attending surgeons in a US hospital in the 1970s. Bosk found that approval, disapproval and taking responsibility for incidents and errors were all vital parts of the moral education of the residents. As the title Forgive and Remember indicates, both condemnation and forgiveness of different types of error inculcate responsibility in the resident, and demonstrate to him or her professional codes of conduct and the formal and informal limits of office. A crucial thing here is the hierarchical relation between attending physicians and residents—a relationship that is made possible within the institution of the clinical hospital, and through which both medical expertise and ethical attitudes are transmitted. In the so-­ called Mortality and Morbidity Conferences, such transmissions were particularly evident. Here the attendings would ‘put on a hair shirt’ and take full responsibility for mortality cases in order to show their subordinates the importance of disclosure, the appropriate amount of regret and self-blame, that medical practice is uncertain and that errors can happen to everyone—and lastly just how seriously they take their responsibility for the patients. In this way, the Mortality and Morbidity Conferences combine learning, disclosure and responsibility in a way impossible for the blame-free incident analysis methodologies of today (see Chap. 6; Iedema 2007; Mengis and Nicolini 2011). Processes of co-collegial identification, control and regulation of misconduct; appointing and taking responsibility for things going wrong— and even blaming oneself and others; as well as forgiveness, understanding, restitution and learning from one’s mistakes are all ideally constituents of a moral education of clinicians who must learn through training, trial, error and apprenticeship how to fulfil a particular type of office. To

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approach, and to have a language to talk about, medical practice as a moral practice, and the training, nurturing and modifications of safety dispositions as moral education is an important step towards creating safer health organizations. And in this context, disapproval and approval, blame and forgiveness, disapprobation and approbation are all ‘ways of influencing the formation of habits’ (Dewey 1922: 121); they are ways of trying to influence ‘the development of character and conduct’ (Dewey 1922: 121) of the clinicians as a foundation for the delivery of safe care.

Reflection by Kirstine Zinck Pedersen It is a quite a difficult task to comment on Organizing Patient Safety with any reasonable amount of analytical distance. Although it is only two years since it was published, it has been more than 10 years since I started researching the topic. While slowly and unevenly building an argument that would become a book, these were also the years when I developed a scholarly identity and experienced the most influential events of my adult life—I became a mother (twice) and I lost a mother. These events are thoroughly intertwined with the development of the book. Doing observational studies as a new mother on a semi-intensive paediatric ward acquainted me not only with a devastating insight into the terrible illnesses and injuries that can happen to small children, but also with health professionals who were more than ordinarily devoted to their vocation and took seriously the virtues, duties and responsibilities of their office. This left me with admiration and amplified respect for the strengths and vulnerabilities of the medical ethos that is at the heart of my book and which is a main focus of my current research on discretion, office-holding and professionalism (e.g. Du Gay and Pedersen 2019; Pedersen and Roelsgaard 2019). My mother’s illness provided me with yet another, much unwelcomed, insight into the dynamics of safety, risk and professional responsibility, this time from a patient’s perspective. This was an insight that amplified my growing scholarly concern about the discrepancy between practices of safe care in the clinic and practices of patient safety as a managerial discipline. Thus, while my mother’s experiences of safe and unsafe care were predominantly linked to the conduct, competences, ethical attitudes and sense of responsibility of the professionals or

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teams she met, the patient safety programme understood safety to be a property of systems, and thus, a question of failsafe system-design. As the subtitle ‘failsafe fantasies and pragmatic practices’ indicates, my book is an inquiry into this discrepancy and its unintended consequences. In order to describe this discrepancy I, on the one hand, investigated the rationalities underpinning current patient safety efforts, and, on the other, conducted a qualitative analysis of the practical implications of organising for safety in everyday clinical situations. This analysis led me to suggest that mainstream patient safety thinking is built on a faith in failsafe systems, where medicine is often approached as a blame-culture, risk as eliminable, humans as essentially fallible and health systems as rather stable and predictable entities that are easily optimised and reengineered. Such presuppositions, however, continuously produce unintended consequences and pose a number of new problems and safety threats in medical practice by challenging practical forms of reasoning and by devaluating the ethical comportment and trained safety dispositions of clinicians. Combining insights from, for instance, American pragmatism with detailed analysis of empirical cases, the book is more than just a critical inquiry into the dominant modes of patient safety and the predilection for centralised systemic solutions to safety issues. By proposing a pragmatic and more situated approach to patient safety, I also wanted to offer the reader—practitioners and academics alike—an alternative vocabulary and attitude for refocusing attention towards the importance of conduct, training and experience-based learning in accomplishing safe care. Much has happened in the field of patient safety since I started my research. For instance, the non-blame paradigm that I critically engage with in my book is slowly being supplemented with concepts like ‘fair blame’ and ‘just culture’ that indicate a reassuring refocus towards responsibility and blame in error management. Simultaneously, however, it seems that the particular kind of rationality inherent in safety science and systems thinking is not becoming less dominant in current ways of approaching safety management, quality improvement and organisational development in healthcare organisations and beyond. This is a rationality that is often reproduced in newer alternatives to mainstream perspective on safety management, such as resilience engineering (see Pedersen 2016). And, as Charles Bosk and I have recently summarised in a critical commentary, it is a rationality with worrying but highly

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performative blind spots (Bosk and Pedersen 2019). Concretely, we stress how a reliance on safety science and system optimisation might lead to a confusion of accounting for accountability; a disdain for the role of human training, thinking and acting as reliable features of safe operation; and an incapability to capture the normative, experiential and situated dimensions of safe care in the clinic. In line with the arguments of my book and based on Charles’ life-long engagement with patient safety (Bosk 1979/2003), we attain that accomplishing safety and avoiding harm depend on stable and well-functioning medical teams, on experience-­based discretion and case-based rationality on behalf of the clinicians, and on acquired habit, stabilised routines and local knowledge on how things work in specific clinical settings.

 erard de Vries and Klasien Horstman. (Eds.). G (2008). Genetics from Laboratory to Society. Societal Learning as an Alternative to Regulation

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F rom: Gerard de Vries. Chapter 1, The “unknown” Practice of Genetic Testing, pp. 15–16 Genetic testing involves decision-making by a wide variety of actors, professionals as well as others, and may also have consequences for those not directly involved—the public. Instead of unreflectively accepting that the existing institutions and procedures are adequate to settle the issues involved, this volume seeks ways to make things public and to reasonably and democratically decide on the proper course to be taken (Latour and Weibel 2005). The currently dominant piecemeal approach that situates technical issues in medical circles and delegates ethical problems to the ‘autonomous’ choices of patients is only one of many possible ways of dealing with the public issues in this domain. This volume starts from the premise that to discuss seriously the public issues involved in the practice of genetic testing, society at large first has to learn more about what in fact is going on. The public may be ill-suited to the premature adoption of this piecemeal approach. This book is written from the view that collective learning requires knowledge about variation. Accordingly, it tries to render such variation visible by articulating how medical professionals and their clients experience genetic testing, and how specific institutions have differed on how to evaluate this practice. The analyses found in this book reveal a large number of uncertainties that are inherent to laboratory work, clinical genetic diagnostics, usage of genetic tests in medical examinations, technology development and the ways in which innovations lead to institutional changes. The emphasis is on showing plurality, the articulation of uncertainties and differences. Studying existing practices, we zoom in on the work that is actually done and try to make visible the responsibilities that divergent parties have to take on. The descriptions of the various practices involved in genetic testing reveal that choices involving genetic testing are not made by a single party—the medical profession, or the medical profession in dialogue with government. Other parties—such as insurance companies, employers, unions, patients and their relatives— also have their stakes. They make decisions, explicitly or implicitly, and thus take on responsibilities. Our analyses emphasize how such

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responsibilities are taken and constructed, as well as how developments in genetic testing are linked to shifts in the attribution and distribution of responsibilities. This book thus distinguishes itself in several respects from the currently dominant approach to the public problems that we have to face in relation to genetic testing. First, the development of genetics is couched explicitly in terms of the rise of a predictive, risk-oriented medicine. Second, attention is devoted to changes in the meaning and use of technology, notably to how technology is accompanied by changes in the ways in which risks are defined and responsibilities shift. Third, we study how genetic information has implications for relationships within the medical-professional world as well as for related sectors (notably insurance and labour relations), whereby social developments that occur outside of health care are taken into account as well. In our closing chapter, finally, normative questions are approached in a different way than those suggested by the usual frames for normative discussions on genetic testing—which are strongly informed by doctor–patient relations. Before we can start discussing detailed matters of regulation, the question of how society can learn to deal with genetic testing has to be addressed.

F rom: Marianne Boenink. Chapter 3, Genetic Diagnostics for Hereditary Breast Cancer: Displacement of Uncertainty and Responsibility, pp. 37–39, 60–61 Questioning the Language of Autonomous Decision Making … It sounds quite straightforward: women who suspect a high occurrence of breast cancer in their family simply do a genetic test that predicts their chance of contracting it. As such, predictive DNA diagnostics seems comparable to doing a blood test in order to establish anaemia or a urine test to identify a bladder infection. Unfortunately, things are a little more complicated in the case of breast cancer. For one thing, the test involved does not determine whether you

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are ill or not, but whether you will fall ill at some point in the future. Predictive diagnostics thus raises the issue whether women have any desire to know that they have an increased risk of breast cancer. If so, what can they do with that information? In the case of a genetic defect for breast cancer anyway, the options for prevention are limited and drastic: either regular monitoring or preventive mastectomy. … In the practice of DNA diagnostics these tough questions are often answered with reference to the autonomy of the client. Professional geneticists usually feel that it is the client who must decide whether she wants to have DNA diagnostics and how she wants to respond to the potential results. Their own role consists of providing information, explaining the various options and elucidating their implications; they refrain from normative judgments on the decisions taken by their client. … The thinking in terms of autonomy is tied to two assumptions that deserve further scrutiny. First, there is the assumption of a fully developed test or technique that is ready to be deployed and that it is unproblematic. Starting from this assumption, ethical reflection on predictive DNA diagnostics applies to the choices someone has to make before and after taking the tests, while the technology itself does not become an object of reflection. Second, emphasis on the client’s autonomy implies a specific distribution of roles and responsibilities between the clinical geneticist and the client: the geneticist provides relevant information in a neutral way, after which the client weighs that information and decides what to do. In other words, the thinking in terms of autonomy presupposes a technology that is ready for use and a client who takes the responsibility for choices with respect to such use. … In this chapter, based on observations of clinical-genetic practice and interviews with those involved, I will reconstruct the practice of predictive DNA diagnostics for hereditary breast/ovarian cancer as a lengthy and complex trajectory, in which uncertainty is not reduced, but constantly displaced and transformed. This I will illustrate on the basis of three elements: pedigree analysis [incidence of breast cancer in direct family], DNA testing and the ways in which decisions are taken. My argument will reveal that there is no ready-made predictive DNA

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diagnostic ‘test’ for breast/ovarian cancer, but only a test-in-the-making that is incapable of generating results on its own. For this diagnostics to supply relevant results, clients have to fulfil an active role before and during the test, yet this particular task conflicts with the autonomy model. Thus they are not simply users of a ready-made test; in order to function, the test-in-the making is dependent on the active input of clients. By pursuing this line of reasoning, I will show that clients are made coresponsible for muting, and thus minimizing, the uncertainties that belong to the ‘test’. By foregrounding the technology’s practice, it becomes clear that such a distribution of responsibilities raises various normative issues. Is it acceptable that clients have to compensate for the technique’s shortcomings? Is the language of autonomy in fact appropriate for articulating those responsibilities? … …

Responsibility of Clinical Geneticists Predictive DNA diagnostics for breast and ovarian cancer relies today on an all but ready-made ‘test’. This form of diagnostics implies analysis of body material in the lab, but as such the ‘test’ does not produce useful information. DNA diagnostics is a comprehensive social practice that aside from DNA analyses comprises the mobilization of family histories, records, genetic knowledge and definitions and, last but not least, family members, whereby commonly more than one person needs to have their blood tested before something can be said about the risk of the individual client. Speaking of a ‘breast cancer test’ obscures how much work is needed to generate an informative result. … To overcome the uncertainties and limitations of this genetic technology, the clinical geneticist and client have to muster many resources. Accordingly, the counselling trajectory can be conceptualized as a shared tinkering with divergent tools and means to fight a host of uncertainties. The trajectory arrives at a (preliminary) conclusion when in some form or another closure is achieved. This closure does not so much involve certain or definite diagnosis, but a pragmatic balance between the possibilities for acquiring yet more knowledge on the one hand, and the burden

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associated with the effort needed on the other. Such balance is achieved when the nature and amount of remaining uncertainty is deemed acceptable by both client and physician. According to the ideal of autonomy in genetics, the distribution of roles between client and geneticist, in the construction of that balance, should be such that the geneticist supplies the relevant information and the client makes the moral choices. My argument has demonstrated, however, that this picture does not coincide with actual practice. Contrary to the suggestion of the autonomy ideal, in the diagnostic trajectory there is no neat distinction between facts and values, or between providing information and making decisions. Moreover, the decision process is highly pragmatic; decisions often depend more on what the client and the geneticist both deem ‘feasible’ or ‘doable’ than on what clients consider morally desirable. Therefore, what is usually presented as a highly personal moral choice between, for instance, knowing and not-knowing, involves language that is much too strong. This said, it should also be observed that the work and responsibilities involved in this pragmatic process are not equally distributed between geneticist and client. While the geneticist can do only little in terms of providing information, and finally does not have to decide on DNA testing and possible preventive measures, their female clients ultimately have to make the decisions as well as do the preliminary work. Notably the healthy client who goes to a clinic for clinical genetics as the first of her family is expected to turn much in her life and family upside down in order to allow for the subsequent successful application of DNA diagnostics. The specific predictive value of DNA testing depends in fact on the degree to which she is able or willing to mobilize family members. Clients, it turns out, consider this a heavy responsibility. One might argue that the information needs to be much more explicit on this point. As already suggested, there is certainly much to improve in this respect. And yet this is an unsatisfactory solution because it puts the burden of an imperfect technology one-sidedly on the client. This is worrisome, all the more so because DNA diagnostics for breast/ovarian cancer in most cases provides no more certainty on someone’s risk of contracting these diseases than the ‘old’ pedigree analysis. While the burden of DNA testing is substantial to women, the benefit is but slight: the

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preventive options are the same. It seems unjust that clients largely bear the burden of a test-in-the-making and its uncertainties, while gaining so little from it.

F rom: Ine van Hoyweghen. Chapter 6, Genetics and Insurance: New Technologies, New Policies, New Responsibilities, pp. 130–131, 135–137 Risk Carriers Versus Risk Takers … [I]nsurance is a normative technology and practice. Normative judgements are disseminated in insurance on who ‘deserves’ solidarity and which criteria citizens have to fulfil to be included as members of the insurance pool. The introduction of predictive medicine in underwriting contributes in this regard to new standards for the distribution of responsibilities between the applicant, the insured and the insurer. On a wider front, such practices reflect how we, as a society, consider the criteria for solidarity with the sick. As indicated in Chap. 4 [Horstman 2008], the ‘discovery’ of genetic knowledge is associated with ‘genetic essentialism’ or ‘geneticization’ in our thinking about disease. … [Horstman] claims that genes are often attributed an overly deterministic role. This means there is a tendency to distinguish people along genetic characteristic lines and to categorize diseases into genetic and non-genetic ones, resulting in different levels of responsibility attributed to genetic and non-genetic diseases. So where genes are linked to fatalism or lack of control, lifestyle is associated with individual control or responsibility. This is illustrated by a recent comment in the British Medical Journal on the fault-based approach that such geneticization of disease entails. The author asked whether the discovery of genetic defects in particular individuals does not automatically make those people powerless. He argues that a geneticized approach brings these people ‘to a learned and licensed helplessness’ (Smith 2002). The new biomedical distinctions implied by the ‘discovery’ of genetics thus result in normative effects in the distribution of

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responsibilities. The same approach is found in Belgian insurance companies. The Belgian legal prohibition on using genetic information in insurance policies can be considered the institutionalization of ‘genetic essentialism’. Where genetic risks are seen as ‘fate’, as ‘involuntary’ or ‘uncontrollable’, lifestyle risks are considered as self-induced, voluntary and one’s ‘own responsibility’. The outcome is a financial solidarity or collective responsibility for the genetic risk carriers—the collective risk pool is prepared to pay for them—and individual financial responsibility for lifestyle risk takers—they have to pay for their risk-taking themselves via higher premiums. …

Responsibilities In this chapter, I have shown how the introduction of predictive medicine in the Belgian underwriting practice goes together with a fault-based approach. This in turn has generated a new attribution of responsibilities: while genetic ‘risk carriers’ are attributed responsibility collectively, lifestyle ‘risk takers’ are expected to take their responsibility individually. As noted, this approach is the result of a ‘genetic essentialism’ in Belgian legislation on genetics in the insurance industry. As such, I explained how regulatory initiatives in the context of genetics can determine a certain practice. In this sense, this legislation is accompanied by major, unanticipated side-effects. The legal imposition of a ‘wall’ between genetic and non-genetic information raises new questions for the general insurance branch in particular. One of the side-effects discussed here is that moral judgements on the controllability of disease, which are institutionalized through law, can have ramifications for the general disease concept in insurance. My argument shows that it is questionable whether legislative initiatives can provide adequate solutions to the issue of genetics. It even appears that such initiatives, instead of solving particular problems, may actually cause new ones. This becomes visible when we consider the feasibility of the transformation of socio-normative judgements into legal distinctions or definitions. What does it mean to have control over one’s

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own health? And how do we define the dividing lines between risks that must be carried and risks that are actively sought out? In this respect, the further development of genetics may confront us with new surprises. It may put additional emphasis on lifestyle and individual responsibility. Current developments in behavioural genetics, for example, suggest that genetic factors are partially the cause of many behavioural traits and psychiatric diseases. If one assumes that genetic factors contribute to disorders such as alcoholism … or nicotine addiction … the question arises whether people who smoke or have alcohol problems are in fact responsible for the health effects of their behaviour. Ironically, today smoking and alcoholism are presented as the primary examples of bad lifestyles. But this view can also be reversed: The discovery and ‘spread’ of genetic disease could actually strengthen the notions of lifestyle and individual responsibility. Consider, for instance, a genetic mutation for smoking. Recent studies have aimed at establishing genetic factors for smoking, nicotine-­ dependency and the inability to quit smoking. This implies not only that the involuntary smoker—the gene carrier—is seen as a victim, but also that in the case of those who smoke and who are not gene carriers the issue of responsibility for their behaviour is likely to be highlighted. Detection of genetic components of lifestyle diseases, then, causes the voluntary aspect of non-genetic lifestyle diseases to be emphasized even more. … Individual responsibility for managing one’s risk factors becomes the gold standard for assessing one’s fitness for membership in the insurance pool. In this way, insurers increasingly assess insurance applicants with respect to decent citizenship as the basis for their ultimate insurability. These developments present society with some important challenges. Aside from questions on the desirability of a fault-based approach as access criterion for insurance, it also seems hard to define how someone’s control over health or individual responsibility is to be determined. Where, in this matter, do we locate fate, blame or bad luck? Who should or should not be held responsible for their health?

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F rom: Rein Vos. Chapter 8, Genetic Risks and Justice in the Workplace: The End of the Protection Paradigm, pp. 155–157, 167–169 New Tests, New Responsibilities In recent years different groups and organizations have made a plea for the restriction of the opportunities for genetic testing of the susceptibility to occupational diseases of incoming employees. These pleas have led to laws and regulations which aspire to prevent new forms of discrimination and social exclusion, and express the undesirability of lifting the obligations of employers to maintain a healthy work environment. Specific and sensitive tests to determine the genetic susceptibility for health risks in the workplace are still not available …. Nevertheless, the various normative questions involved need to be raised. Is it really unreasonable, for instance, that people starting their baker training are tested on their susceptibility to developing baker’s eczema? Or that future painters or upholsterers are tested on their susceptibility for what is called painter’s disease? Why lock the stable door after the horse has bolted? But who has to decide upon these issues? What are the responsibilities of employers, employees and the government with respect to workplace health? …

The Protection Paradigm The protection paradigm starts from the notion that risks can be objectified, calculated, standardized and influenced. It is assumed that one can measure the exposure to substances, identify the effects on health, establish dose-effect relationships and subsequently determine standards— limit values, mostly expressed as maximally acceptable concentration (MAC) values—that constitute the basis of measures aimed at excluding and preventing risks. This simultaneously defines the responsibilities of the protection paradigm’s various parties: the government develops a legislative frame for preventive measures, the details of which may be

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negotiated by employers and employees; employers implement prevention policies, which the [1983 Dutch] Occupational Health and Safety Act formulates as their ‘duty to provide care for’ (i.e., the obligation of the employer to take care of all necessary measures to guarantee a safe and healthy workplace); and the employees, finally, appear as the quasi-­passive object of those policies and merely have the responsibility not to behave recklessly or carelessly. …

The Future of Genetics and Work In this chapter I argued that the way in which the field of work and health deals with protection against risks, and hence with ‘damage’ and ‘suffering’, renders visible the implicit assumptions on the responsibilities of stakeholders. These assumptions are based on a distinction between the individual and social factors of occupational disease: the individual responsibility of employees for their health versus collective protective measures for their health. Insisting on this distinction, the protection paradigm hides from view a practice in the field of work and health in which new relationships are developing between the individual and social factors of occupational diseases. This practice entails new responsibilities for employers, employees and other parties and the emergence of new normative issues. By contrast, the paradigm of protection puts a brake on social learning processes to do with genetics, prevention and the workplace, as well as on the development of, and dealing with, the new responsibilities of the parties involved. … The paradigm of individual responsibility does not allow for organizing solidarity. Similarly, the more modern forms of individual responsibility for health are hardly attractive, but are nevertheless making headway both in the clinical context, in which the autonomy principle is put centre-­stage, and in the ‘health promotion’ context, which has embraced the notion of the individual’s responsibility and attention to lifestyle. It is but a further step to attributing responsibility to individuals for their health on the job without supplying them the means to be able to do so.

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An analogy may be helpful here. In many respects people are responsible for their safety at home: they are expected to lock doors, install smoke detectors, put in proper wiring and so on. On airplanes, however, others are in charge of safety measures; airline companies and governments organize all sorts of regulations such as air traffic control and monitoring, without plane passengers having any input. The situation of many employees is more similar to that of a passenger on a plane than that of a homeowner who bears responsibility for a safe home (Mertens 2003). However, changed working conditions and changed scientific/technical means together may change the position of employees, which may cause their responsibility to shift from that of the passive plane passenger to that of the active automobile driver who has to buckle up and adapt his speed to the traffic situation. This, however, requires new models of thinking and acting in the field of work and health. And it calls for new forms of facilitating social learning rather than merely via legislation and jurisprudence.

F rom: Chapter 9, Gerard de Vries and Klasien Horstman. Learning from the Work that Links Laboratory to Society, p. 189 There is still much to be learned about genetic testing, both scientifically and politically. The scientific side of that learning process is well organized, but the political, normative, dimension is much less so. Public learning processes, however, require another institutional or administrative model, not the usual one. The question of how one has to select and which rules and laws are needed to offer protection on the one hand, and enable autonomous individual choices on supply on the other, is simply too general for the issues at stake in genetic testing. Too little is yet known about the practice of genetic testing to make responsible policies. It is in many respects still unclear what particular shifts the new methods of diagnostics will bring about in the interrelation of the risks of biological destiny and lifestyles and how the various responsibilities implied will be distributed. We still have to invent what constitutes a sensible way of giving shape to the relationship between individual responsibility and solidarity in various sectors of social life. There is an urgent need to rethink

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the practice of patient autonomy in predictive medicine. The current notion that in the end, patients have an exit option is little more than an illusion in the face of the long trajectory in which they become entangled. Of course, once in a while, patients will decide to terminate testing in the final stages of the testing process, or to take on the consequences of test results (such as an abortion). They should have the right to do so. But given the often immense problems that they have to cope with, new forms of exit should be actively developed. The reassurances in the folder that patients receive when they enter the long trajectory of genetic testing that ‘at any stage you can decide to opt out and you will have the final say when it comes to deciding on further action’ is simply not enough. New combinations of loyalty, exit and voice have to be developed for the sectors that involve genetic testing, such as health care, work and insurance. Again, the way to go is to prudently experiment.

Reflection by Gerard de Vries and Klasien Horstman Published in 2008, Genetics from Laboratory to Society was researched and written in the aftermath of the announcement, in June 2000, of the nearly complete sequencing of the human genome. Unsurprisingly, the announcement had intensified the ongoing public discussions about the potential impact of advances in genetics on medicine, healthcare and society at large. While many envisioned a future in which medical science would be able to advise individuals how to substantially reduce the risk of diseases their genetic make-up had predisposed them, others emphasised that the deployment of genetic techniques did raise substantial ethical issues, up to the point of reawakening the spectre of eugenics. In the two decades since the June 2000 announcement, sequencing techniques have greatly advanced. The relation between an individual’s genetic make-up and (non-monogenetic) diseases turned out to be far more complex than had been foreseen, however. As a consequence, the scale at which genetic diagnostic techniques have been deployed has been more limited than was expected in the early 2000s. The prospect that—as we wrote in 2008—‘over the next decade or two, it is likely that entire populations or specific subgroups will be screened for genetic information in order to target interventions on individual patients that will

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improve their health and prevent disease’ has not yet materialised. Nor did the prospect that tests for genetic defects would be widely deployed in the insurance industry and for job hiring. In fact, so far, the main context in which genetic diagnostics is deployed is clinical therapy, where for a number of serious conditions it is used to help to tailor therapies and medication to individual patients. To assess genetic diagnostics in the clinical context, the established normative framework for distributing responsibilities among medical professionals and individual patients—known as the principle of ‘informed consent’—has become leading. The responsibility to assess the clinical merits and risks of a specific genetic test is delegated to the medical profession. Subsequently, for tests deemed eligible, clinicians have to follow protocols which include the obligation to fully inform their patients about the procedure and to grant them the right to either consent to the procedure or opt out. Genetics from Laboratory to Society took issue with both discussions based on more or less educated guesses of future developments and the idea that the principle of informed consent would be adequate. By conducting case studies of practices of genetic testing already in use by the time of our writing, we showed that the ‘informed consent’ framework fails to cover a wide range of aspects relevant to a public assessment of genetic diagnostics. They include the involvement of (possibly remote) relatives whose cooperation may be needed for a test, the roles of professionals from various non-clinical medical disciplines (such as statisticians, communication experts, epidemiologists) and non-medical institutions (e.g. databanks, population registers and insurance companies), as well as the long-term, secondary effects of genetic diagnostics—like the increasing permeability of the institutional borders between clinical medicine and research (a development which is likely to accelerate with CRISP Cas being available). We concluded that by confining the normative debate to the privacy of consultancy rooms where an individual patient and a physician disciplined by protocols address the decisions that have to be made, the practice of ‘informed consent’ substantially limits the public—ethical and political— debate about genetic diagnostics and its social consequences. Arguing that genetic diagnostics is to a large extent still an ‘unknown practice’, Genetics from Laboratory to Society suggested that as a society we had better first learn how to benefit from genetic diagnostics and how to

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cope with the normative questions it raises. This, we argued, firstly, requires further, detailed empirical studies into the extended networks of people and institutions involved in genetic diagnostic practices to make public the involvement in these practices not only of clinicians and their patients, but also of many others. Secondly, we argued, that as societal learning requires comparison, variation of practices need not only to be allowed but even stimulated. When everybody follows the same protocols, little is to be learned. Although the course genetic diagnostics has taken so far diverges from what was expected in the early 2000s, this conclusion, we think, still stands. We commend the idea of societal learning as an alternative to regulation and ‘informed consent’ to scholars interested in other domains of health, technology and society as well.

 imone Bateman, Jean Gayon, Sylvie Allouche, S Jérôme Goffette and Michela Marzano. (Eds.). (2015a). Inquiring into Human Enhancement. Interdisciplinary and International Perspectives

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F rom: Simone Bateman, Jean Gayon, Sylvie Allouche, Jérôme Goffette and Michela Marzano. Introduction, pp. 2–3, 5, 12 Human Enhancement: What Do We Mean? A common feature of many concrete practices identified today as forms of human enhancement, such as off-label prescription of growth hormone or blood-doping in sports, is that they are often proposed in the context of medical care and are supported by scientific and technical progress in biology and medicine. Understandably, many scholars have therefore attempted to understand human enhancement from the perspective of what distinguishes these practices from standard medical care, usually referred to as the ‘therapy-enhancement distinction’. However, a number of enhancement practices are now developing in arenas increasingly disconnected from the medical world, making this approach too narrow to provide a full view of what human enhancement might be. The first part of the book therefore proposes novel perspectives for exploring the meaning of human enhancement, with special regard to the set of practices, goals and justifications that are implied by this term. Each chapter proposes a unique point of view from which the field of human enhancement can be comprehensively understood. … In their introductory essay, Simone Bateman and Jean Gayon explore the meaning—or rather meanings—of human enhancement while keeping in mind the question ‘What is at stake?’ They observe that ‘human enhancement’—precisely that term and not other ordinary or scientific uses of the term enhancement—emerged in the mid-1990s, becoming widespread in the early 2000s. The spectacular dissemination of the term benefited, in their view, from the superposition of three different uses, most often not clearly distinguished, but conceptually distinct: improvement of human capacities, self-improvement and improvement of human nature. The enhancement of capacities seems to have emerged as a first usage in the context of bioethics, as an expansion of previous intense debates over the genetic enhancement of humans. In 2002, the publication of the National Science Foundation report, ‘Converging

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technologies for improving human performance’, gave a decisive impulse to this trend, because it introduced a new set of technologies, which extended the vision of what human enhancement might be far beyond the medical arena. The second layer of meaning, self-improvement, entails the idea that enhancement technologies may also serve a personal quest for identity and authenticity. Self-improvement is not so much an explicit doctrine as it is a subjective posture regarding the desirability of enhancement. The aspiration to improve oneself is in fact so deeply rooted in contemporary culture that it could become an important driving force in the promotion of these technologies. In contrast, the third semantic layer, improvement of human nature, refers to explicit doctrines claiming that modern technologies make it possible for humans to radically alter their capacities, improve their condition and even, according to some authors (especially the transhumanists), transform the human species. … In his assessment of the ethical issues involved in human enhancement, Ruud ter Meulen [see more below] offers a comprehensive view of human enhancement (practices and discourses) in terms of the kinds of moral concerns that they generate. He points to three major ethical challenges commonly discussed in the literature: a decrease in solidarity, a reinforcement of individualism and a weakening of individual responsibility. The first challenge might result from an unequal distribution of enhanced capacities, thus creating divisions within a society: people without enhanced capacities would be at risk of being seen as inferior and possessing fewer human rights. The second challenge is a possible loss of the sense of community with others, derived from a culture obsessed by self-improvement. The final challenge is that technological enhancement might lead people to replace individual agency and responsibility by a slavish use of drugs and other technologies to enhance their capacities. Even if these moral challenges are real, ter Meulen emphasises that these pessimistic moral scenarios are in no way inevitable. Enhancement technologies might also improve sociability (if equally shared) and generate new forms of authenticity and dignity. This will depend on the kind of society that individuals will be able to build together. Therefore, ter Meulen’s attitude towards enhancement technology resembles the

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classical neutralist argument: technological resources are neither intrinsically good nor bad, they are what human collectivities decide to do with them.

F rom: Jérôme Goffette. Enhancement: Medicine or Anthropotechnics?, pp. 48–49, 56–57 Medicine and Anthropotechnics We now have to answer the following question: does the word ‘enhancement’ cover a homogeneous field of activities? What practices do we have in mind when we talk about enhancement, improvement, pursuit of happiness, aspirations to be ‘better than well’, biotechnologies that are ‘beyond therapy’, smart drugs, and so on? … This new area, which is not biology (because its purpose is not knowledge about life), not biotechnology (because biotechnology is only a means towards various ends and applications) and not medicine (because it does not fight against illness), is very specific, with a particular finality: to give us the power to change ourselves, improve facets of our being or choose certain traits. … [A] new kind of activity is being born [anthropotechnics], that is to say, the art of modelling, shaping the human being, the art of changing and improving one’s being by bodily modification for non-medical purposes (Goffette 2006: 169). … [I]n France, the jurisprudence concerning aesthetic surgery is unclear and sometimes incoherent, and the law allowing the termination of pregnancy involves ad hoc articles in the medical code of ethics (such as a conscience clause that goes against the traditional medical imperative to perform medical acts). To turn to a different field of medical deontology,

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anti-doping laws are being enforced all over the world and are constantly under discussion, while the problem of doping at school and in other educational contexts—once almost unheard of—now seems to be on the rise. Finally, the distinction we are drawing between medicine and anthropotechnics implies, we believe, a need to separate what appears to be two distinct professions. Furthermore, this would imply two different sets of professional codes of ethics and laws. Even if the same practitioner works in the two fields, it is important to clearly differentiate the two roles and their accompanying framework of responsibilities. Besides establishing clearer deontological standards and rules for physicians, we would have to devise a professional code of ethics for the practice of anthropotechnics, based on distinct principles, possibly including new forms of the principles of autonomy, respect of human dignity, the meaning of humanity, and so on.

The Sequence of Consultation Another concrete example of the tension between medicine and anthropotechnics is offered by the different scenarios for a consultation. Traditionally, in medicine, a consultation follows this sequence: • • • •

taking of the patient’s medical history; auscultation; diagnosis; treatment and prognosis.

It is clear that this pattern is completely unsuited to anthropotechnics, because there is no illness to diagnose. The medical practice of establishing the patient’s history aims to identify the disease through the symptoms. In anthropotechnics, there is no disease and no symptoms are presented, but rather a demand, a desire, or a wish for ‘more’. In

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anthropotechnics, the word ‘diagnosis’ makes no sense. Even though it might be possible to talk about treatment in this context, anthropotechnics does not cure an illness with appropriate treatment, but simply suggests a certain choice of realisations, indicating risks and expected results. There is, of course, always the possibility of choosing to do nothing. Here is a comparable sequence for a consultation in the context of anthropotechnics: • • • • • • • • • • • •

expression of the client’s request; auscultation in order to assess the risks and the contraindications; presentation of the various means available to satisfy the request, and explanation of the physical and psychological implications and the pathogenic risks relevant to each possibility; discussion concerning the ‘real’ request (making explicit a possible hidden reason for the request and consequently a reformulation of that request) and information about the implications of the various modifications; time for reflection; final choice by the client; technical intervention.

We should note that in this case, the ‘patient’ is not even a patient, in the etymological sense of this word, but rather a client. Furthermore, the physician is not considered a physician, but rather a service provider who must follow specific rules due to the risks generated by interventions that modify the bodies of human beings. Thus, the professional relationship engaged in anthropotechnics differs from the medical relationship between doctor and patient. The distribution and nature of ethical responsibilities is also very different, with practitioners being under no obligation to perform the services they offer, for example.

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F rom: Ruud ter Meulen. The Moral Ambiguity of Human Enhancement, pp. 91–92 Proponents of [transhumanism or post-humanity] claim that enhancement of existing human capacities will make us overcome our current vulnerability, and will result in a post-human state which is no longer dependent on our natural surroundings (Bostrom 2005). The possibility, for example, of uploading our brains like computers and growing new organs by using human stem cells will eventually make us able to deal with human vulnerability to disease and damage. However, such radical alterations will change the core nature of Homo sapiens and turn us into post-humans. However, such a development may create new divisions in our society. This view is taken by Francis Fukuyama in his book Our Posthuman Future (2002). He is worried about the emergence of new genetic classes, which could lead to increasing inequality in our society. Fukuyama thinks that genetic enhancement may lead to a more egalitarian society, particularly when access to these technologies is funded for everybody, but there is also a serious danger that it will divide our society into different genetic classes. Genetic enhancement will ‘not be a threat to the dignity of normal adult human beings but rather to those we have defined as characterising human specificity. The largest group of beings in this category are the unborn, but it could also include infants, the terminally sick, elderly people with debilitating diseases, and the disabled’ (Fukuyama 2004: 174). Genetic enhancements then will put increasing emphasis on intelligence, cognitive capacities and sensitive emotions as defining characteristics for dignity and humanity. Humans that do not have these (enhanced) capacities will be seen as inferior and as possessing fewer human rights. Fukuyama’s analysis raises serious concerns about the quality of our future relationships in the ‘posthuman society’. If genetic enhancement and other kinds of enhancement are not integrated in a broader moral worldview on human personhood and dignity, they might indeed result in an increasing individualisation of our society and a decrease of solidarity with the weaker and vulnerable groups. A similar concern can be

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found in the book The Case against Perfection by Michael Sandel (2007). Sandel argues that we have become too responsible for our own fate. ‘Parents have become responsible for choosing, or failing to choose, the right traits for their children. Athletes become responsible for acquiring, or failing to acquire, the talents that will help their team win’ (Sandel 2007). This ‘explosion of responsibility’ has come at the expense of an attitude of acceptance of our limitations and of the notion of ‘giftedness’. Sandel argues that there is a connection between the notions of ‘giftedness’ and ‘solidarity’: as soon as we are aware of the contingency of our gifts, we will develop our capacity of seeing ourselves as sharing a common fate. Bioengineering our children and ourselves is not just a matter of autonomy, individual rights and power: ‘changing our nature to fit the world, rather than the other way around, is actually the deepest form of disempowerment. It distracts us from reflecting critically on the world, and deadens the impulse to social and political improvement’ (Sandel 2007). In a comparable way, Habermas (2003) argues that the use of pre-­ implementation diagnosis to select an embryo according to the wishes of the parents is an instrumentalisation of the creation of human life and an intention to master the contingency (or ‘giftedness’ in Sandel’s words) of human nature by a third party (the parents). Such intergenerational control is a serious breach of the self-understanding of the individual that has come into existence by way of this procedure. For transhumanists, the human body is not part of our fate (or what is given to us) but is ‘brute matter’ which we can manipulate and change without any impact on our self-understanding (Edgar 2009). Habermas, Sandel and Fukuyama argue instead that intervening in the body for the purpose of enhancement is not a morally neutral procedure: it is an attempt to control the contingency of our nature with important consequences for the self-understanding of the individual and for interpersonal relations in our society. …

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Enhancement and Human Dignity One of the key criticisms raised against enhancement is that it may hinder the development of individuals into moral agents who are capable of developing their own set of values and of entering into meaningful social relationships. According to this view, enhancement technologies may come to dominate people’s lives replacing individual agency and responsibility by a slavish use of drugs and technologies to enhance their capacities. An example is the critical paper by Darren Shickle (2000) who argues that genetic enhancement technologies may ‘bypass’ the struggle involved in many activities. … Shickle argues that struggle is involved in many activities and that human activities are valued in relation with the amount of suffering involved: ‘Struggle is a measure of human activity, and even pleasurable activities require efforts that result in pain. […] The more that we have to struggle to attain a thing, the stronger the claim to possession. It is the process of striving that makes things worthwhile’ (Shickle 2000). In other words, the use of enhancement technologies results in eliminating struggle in our existence, and by consequence an inability to develop a sense of value and of meaningful relationships with others. Similarly Fukuyama (2003) argues that the reduction of human qualities for utilitarian purposes will affect our dignity, which he defines as a range of human qualities and abilities that connect us to other human beings. The utilitarian goal of minimising suffering leads to a destruction ‘of the way we react to, confront, overcome, and frequently succumb to pain, suffering and death’ (Fukuyama 2002). In the absence of these human evils, we lose qualities like sympathy, compassion, courage, heroism, solidarity or strength of character which are essential for human dignity. These comments remind us of the analysis by the German sociologist Max Weber [1978], and later on by the Frankfurter Schule, of the role of technology and of rationalisation in modern society. According to Weber, our social life is increasingly dominated by the laws of instrumental reason, which means the emphasis on calculation, prediction, effectiveness, bureaucracy and control as the basic principles of social life. According to Weber, instrumental reason has resulted in a greater control and

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improvement of our economic and social circumstances. However, it has also resulted in a disappearing of the sense of meaning in our natural and social world (‘Entzauberung der Welt’). We are deprived of the capacities to experience meaning in the world, but also to share moral values with each other. But does this process necessarily lead to a diminishing of human dignity? … Dignity in modern society means that one’s identity is recognised by significant others, including the differences one has developed compared to other individuals. This policy of recognition means also that every individual, no matter how different its identity, is treated with equal value. Modern accounts of dignity acknowledge the connection between dignity and equality, but they generally ignore the moral background we need for doing so.

F rom: Selim Eskiizmirliler and Jérôme Goffette. Brain-­Machine Interface (BMI) as a Tool for Understanding Human-Machine Cooperation, pp. 138, 140, 155–156 The abbreviation of the expression ‘Brain Machine Interface’ (BMI), represents a popular research area generating media excitement over a great number of promising applications. Even though medical applications are the most researched, the decision makers in the world of industry (including those interested in military applications), entertainment, security, and so on, are not simply observing what is happening in this field but are also investing in their own research. In fact, science fiction has often preceded scientists and engineers in imagining the technologies of the future. For example, what from the Star Trek television series of the 1960s can still be considered an improbable or unbelievable image, other than the presence on board of Mr Spock, a scientist who was a hybrid of the human and Vulcan species? The image of Captain Kirk talking to Dr McCoy through his mobile phone has already become a trivial, even a troubling picture of daily life. Robot factories may not be visible to everyone but they mass produce, maybe not the clever R2-D2 or C-3PO droids of the film Star Wars, but powerful, precise, high speed

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manipulators that can increase production while decreasing the necessary manpower. Talking to computer screens, like Mr Scott in Star Trek, though not widespread, is no longer a dream …. The BMI is an interrelated set of hardware and software tools that records brain activity, decodes the activity through interfacing techniques that control machines or final active devices called ‘end effectors’. The end effectors can be anthropomorphic devices (such as biomimetic robotic arms, forearms, hands) or devices of any other type (such as an on/off electrical switch, a wheelchair, clippers, a joystick or a cursor on a computer screen) that can be driven directly through recorded cortical signals. The BMI can thus be seen as a means of bypassing the spinal cord to establish a direct relation between the brain and an attached device, making it possible to restore lost motor functions when the spinal cord is damaged. … [U]sing prosthetics generates possibilities in favour of both freedom and alienation. On the one hand, they offer powerful means to perceive and act, which tends to favour autonomy. On the other hand, the use of prostheses could generate three kinds of problems: their cost and the social inequalities affecting access, dependency on software updating and material maintenance, and the need to cope with breakdowns. As in the case of other forms of enhancement, the cost of acquisition or rental and of maintenance could create a gap between the rich and the poor; moreover, in a work setting, it might generate dependency of the employee on the employer who assumes the cost. A possible solution to this problem could be a new form of State health insurance system, but even if the State accepts the principle of cost redistribution, it would probably only assume the cost of devices selected on the basis of criteria to be established. Dependency on software updating and material maintenance introduces a new relationship between the human body, industry and service. With very deeply integrated prostheses, the human body may be partly owned by or dependent on a firm, generating a real problem with heteronomy. The last problem, that is the unavoidable breakdown of specific body parts, involves a new type of complication in human life. Not

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only will one have to consult a physician in case of illness, one will also have to consult specialists in prostheses and in body-prosthesis interfaces in case of breakdown (cf. the situation of disabled persons and their devices). Given that medical practitioners must obey a code of ethics and practice guidelines, what should the status and the professional rules of these new practitioners be? How can one protect the client from abuse, in a relationship that is far from equal? … [I]t is interesting to remember what the German philosopher Hans Jonas stated at the beginning of The Imperative of Responsibility: the capacity human beings have to change themselves is one of the new ethical problems of our era (Jonas 1979). According to Jonas, normally, the shape of a human being is fixed and cannot be modified. The present and future situation of human beings calls for a new responsibility, requiring what Jonas called the ‘principle of responsibility’, better known as the ‘precautionary principle’. As they modify the human body through a new connection with the brain, BMI prostheses introduce potentially important changes for human beings, at a social, economic, cultural and anthropological level. The technique is not in itself good or bad and must therefore not be condemned. From an ethical point of view, it is important to distinguish the uses that increase autonomy and the uses that engender heteronomy. A prospective effort must be promoted to prepare judicious humanist choices for humanness to come.

 eflection by Simone Bateman, Sylvie Allouche, R Jérôme Goffette and Michela Marzano The desire to improve oneself is as old as human existence, and has always required the use of techniques (education to improve knowledge, cosmetics and exercise to transform physical appearance, use of machines to increase human capacity for work and travel, etc.). The forms of human improvement discussed in our book focused on a narrower group of practices characterised by the following: (1) an explicit aim to improve a physical or mental capacity; (2) a strategy based on direct and deliberate interventions on the human body; and (3) reliance on technical means referred to as converging technologies. These practices are controversial,

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not because these forms of human improvement might be bad in themselves, but because the situations in which they are proposed, the invasiveness of the strategies, and the possibility of irreversible harm ultimately raise doubts about the legitimacy of the goal of enhancement itself. When our project began, many books had already been published on human enhancement, mostly on its moral and political aspects. Most of these books were written by philosophers who live and write in the UK and the US. And yet, despite sharing a common language, disciplinary background and thematic focus, we were struck by the ambiguity of the concept that emerged from these books and by the absence of consensus on what enhancement means. Our book thus arose from the need to explore these ambiguities, an enterprise we took on with colleagues from different countries and linguistic backgrounds, with varied disciplinary training and experience. Our book focuses on the multiple conceptual issues raised by the emergence of the notion of human enhancement, and attempts to determine what distinguishes an enhancement practice from other forms of human improvement. It explores these issues in diverse practical settings where forms of human enhancement seem to be already in existence (medical prostheses, doping in sports and in education, etc.), but also in essays and fiction that imagine a society where enhancement technology and practices have become a reality. Self-improvement appears as a theme in our book, both as a motivation but also as an imperative to improve one’s appearance and capacities in an increasingly competitive world. However, in highlighting the idea of self-improvement as an individual quest and responsibility, the crude reality of the relationships between the patient-consumer and the service providers required for the modification, surveillance and maintenance of the enhanced body are obscured. Whereas individuals seek and expect an increase in autonomy and well-being, the complexity of the technology required for self-transformation generates risks for the person being enhanced as well as new forms of heteronomy and of dependence on the medical and industrial providers of this technology. The way in which some of these practices are already changing foundational principals of our health systems, how they will extend (or not) medicine’s remit, and how these changes will affect our expectations concerning what we consider to be good health all require greater scrutiny from the social

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sciences. They are also generating questions about possible litigation involving these practices and posing unfamiliar regulatory problems for policymakers and for health insurance. A shorter companion volume examines animal enhancement, not as a separate problem in its own right, but as both a possible prototype and a counterexample of human enhancement. It explores similarities and differences in the way enhancement has been conceptualised and applied to animals and to humans, in the hope of better understanding the specific ways in which human enhancement is going forward. The most striking difference is that animals are rarely enhanced to improve their own well-­ being; on the contrary, animal enhancement most often fulfils the goals of those who enhance them. The book ultimately emphasises the paradoxes inherent to all enhancement practices, whether they involve humans or animals, as well as the relative nature of any improvement: for from whose point of view has someone or something or a situation been improved? Understanding the context of an enhancement project, as well as its goals and strategies, is fundamental in defining how responsibility will be shared for a desired—or undesired—outcome.

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 oma Harris, Nadine Wathen and Sally Wyatt. R (Eds.). (2010). Configuring Health Consumers. Health Work and the Imperative of Personal Responsibility

F rom: Sally Wyatt, Roma Harris and Nadine Wathen. Health(y) Citizenship: Technology, Work and Narratives of Responsibility, pp. 1–3, 5 As health care costs continue to rise, public health policy in advanced industrialised countries increasingly emphasises the importance of citizens’ personal responsibility for their own health. Strategies to encourage members of the public to lessen their reliance on traditional forms of health care are often entangled with the introduction of new technologies

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that are intended to facilitate better access to health information and enable opportunities for self-care. New service delivery models based on primary health care provided in the community by multidisciplinary health care teams and supported by home-based health care programmes have emerged hand-in-hand with discourses of ‘patient-centred care’, ‘shared decision making’, ‘consumer health information’ and patient ‘autonomy and empowerment’. … ‘Empowerment’ and ‘consumerism’ are two of the central concepts embedded in the narrative of personal responsibility. Providing health information, especially via the internet, through e-health initiatives such as government-financed health web portals, is expected to ‘empower’ members of the lay public (often described as consumers) not only to participate more actively in their own care, but also to take more responsibility for their health-related decisions (even those as significant as selecting treatment options). Information delivered via health promotion programmes is also expected to result in behaviour changes, specifically, the adoption of ‘healthier lifestyles’, including improved dietary habits and avoidance of risky activities, such as smoking and excessive sun tanning, that are intended to improve public health and reduce health care costs. Other examples of strategies intended to empower health system consumers include training patients to ask their doctors more questions, teaching patients to ‘self-manage’ chronic illnesses, providing family members with results of genetic testing for heritable health conditions and encouraging the home use of self-monitoring equipment …. … [A] central theme in this book is that of health ‘work’ particularly work that arises from the emphasis on personal responsibility for health, as a result of which citizens are expected to perform additional, and, in some cases new, health-related tasks. This work, at times enabled by new technologies, is often invisible, frequently assigned (explicitly or implicitly

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through new structures and work arrangements) to particular actors (often women) and positioned as the obligation of individual citizens rather than the collective responsibility of communities, or society as a whole. … In this book contributors elucidate the ways in which technologies and policies affect both the visible and the invisible work undertaken by patients and professionals. In a previous collection [Wathen et al. 2008— see Locus of care theme], we focused on various configurations of people and technologies that perform the mediating work involved in enabling information seekers to locate, retrieve, understand, cope with and use health information. In addition to traditional mediators, such as doctors and nurses, we explored the role of new mediators that have emerged with the widespread diffusion of information and communication technologies (ICTs), such as software designers, web site producers and makers of digital images. These themes are taken up again in this volume. Health care policies in industrialised countries are appropriating the language of choice and empowerment to shift the burden of care from the collective to the individual. Technologies play a variety of roles in this shift, including use of the internet for information and communication, new devices for monitoring and treatment and new forms of bureaucratic control through the collation of myriad data for assessing individual and institutional performance in the health care sector. Like Mol (2008), we are concerned with how, in her terms, the ‘logics’ of ‘choice’ and ‘care’ interact. Whereas she focuses on practices, we use ‘work’ as a lens through which to examine the ways in which patients and professionals cope with competing pressures. While she does not explicitly address the (re)emergence of empowerment discourses within neo-liberal policies, in her analysis of how individual patients and professionals are embedded within collectives of family, friends, colleagues and so on, she also hints at the policies and politics foregrounded in this volume.

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F rom: Leslie Bella. In Sickness and in Health: Public and Private Responsibility for Health Care from Bismarck to Obama, pp. 13–15, 23–24, 26–29 Publicly supported health care was created over a century ago and by the mid-twentieth century had become a reality in most industrialised countries. In recent decades, however, health care has become increasingly marketised and ‘health’ is again being reconfigured as a personal rather than a collective responsibility. … This chapter provides a brief history of the development of health care policy in three countries: the UK, Canada and the US. … The third section traces the reconfiguring of the patient as an empowered consumer responsible for his or her own health. The concluding section draws together evidence from health policy in the three countries to show how ‘health’ is being reconfigured as an individual rather than a collective responsibility. …

 e Responsibilities of the Good Citizen: Th Patient Empowerment Although the term ‘empowerment’ has been used in recent years to bolster arguments in favour of marketising public health care, the idea of empowerment in relation to health and illness originates much earlier, in the women’s health movement, which evolved from within second wave feminism. A catalyst was the Boston Women’s Health Book Collective (BWHBC) who published Women and our Bodies, a Course in 1970 (a precursor to the well-known, Our Bodies, Ourselves, published in 1973). This first edition was intended to empower and was ‘meant to be used by our sisters to increase consciousness about ourselves as women and to build our movement, to begin to struggle collectively for adequate health care’ (BWHBC 1970: 4). The book, and its successors, provided accurate and accessible health and medical information for women and countered

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the then dominant pathological approach to normal life events such as birthing, menopause and ageing. For the Collective, ‘empowerment’ continues to be understood as a political process through which women are inspired ‘to become engaged in the political aspects of sustaining good health for themselves and their communities’ (BWHBC 1970). While women comprised ‘the largest segment of health workers, health consumers, and health decision-makers for their families and communities’ (BWHBC 1970), the Collective argued that they were under-represented in positions of influence and policy making. Empowerment, according to these feminist understandings, was and is both collective and political, and intended to achieve broadly based social change …. Policy makers who were developing public health strategies soon saw parallels between the ideas of ‘health promotion’, namely ‘the process of enabling people to increase control over, and improve their health’, and ideas of empowerment defined as ‘the process by which people, organizations and communities gain mastery over their lives’ (Labonté 1994: 253). Subsequently, the idea of empowerment, as it emerged within second wave feminism, was co-opted in support of health promotion, but with transformations in meaning. The women’s movement in general, like the Boston Collective, saw empowerment as something coming from within, facilitated by collective processes and overtly political. In the hands of health promotion professionals, empowerment became instead a process of working with individuals and groups to help them reach state-sanctioned health promotion objectives. Labonté articulates this distinction as that between to empower as an intransitive verb, in which one can only empower oneself, and to empower as a transitive verb, which provides for one to empower another person (or organisation). While the intransitive meaning is dominant in the rhetoric of the women’s movement, the transitive meaning is strongly represented in health promotion literature, policy and practice. In addition, bureaucratically sanctioned health promotion had to abandon political nuances in the term as used

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by the women’s and other social movements. Empowerment was thus highjacked into the service of prevention and health promotion, which in turn was reconfigured as the responsibility of individual citizens and citizen groups. As the idea of patient empowerment and choice entered clinical discourse, it was used to justify the relocation of nursing care from hospitals back to private homes through early discharge and home care programmes. This cloaked the reality that increasingly complex care work was being reprivatized to the home and that illness care was now reconfigured as an individual rather than a collective responsibility. … Although the government of Canada has invested well over a billion dollars in the Canada Health Infoway since its inception [in 2001], much of the agency’s effort has gone towards the development of (yet to be implemented) electronic health records systems. The early emphasis on providing the public with health information, manifest initially in the now defunct Canadian Health Network (a federal online health information service), is largely absent and the responsibility for consumer health information now rests with the provincial governments. Within the chaotic system of private and public health care in the US, ‘empowerment’ is conceived primarily in terms of individual patient responsibility and freedom of choice, with both the private and public sectors providing patients and caregivers with health information needed to make ‘good’ choices. In this context, the internet is the primary means for supporting citizens in their search for both health and health care. For example, a 2001 text for hospital managers explains how the digital age has transformed health care, providing health care ‘shoppers’ with report cards on various services and institutions, transforming business practices and purchasing arrangements and providing new ways of communicating with existing and potential clients (Coile 2001). …

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I ndividual and Collective Responsibilities for Health and Health Care Each of the countries discussed in this chapter has developed some form of public health care. The UK introduced health insurance for workers in 1911 and achieved a universal public programme with the introduction of the NHS in 1948. Canada introduced universal hospital care in 1957 and the physician care programme, Medicare, in 1966. The US achieved public insurance for the old and the needy in 1965, and, President Obama will expand coverage further. As I have shown, health care in all three countries is increasingly marketised, reflecting their governments’ ideological preferences for private sector solutions, often masked in the rhetoric of cost-effectiveness and efficiency and under the guise of personal or ‘consumer’ choice and empowerment. As a result, the idea of public health care as a right of citizenship has been overtaken by the idea that, as informed consumers, patients should make their own health care choices and be personally responsible for their own health and that of their families. … [M]ost of the health policies and programmes described in this chapter are concerned with diagnosing and treating illness, rather than promoting ‘health’ per se. For instance, even though the NHS, as introduced in 1948, included public health as well as hospital care and physician care under the umbrella of ‘public health care’, illness services receive most of the ‘political and media attention, professional lobbying, resource flows and public concern’ (Hunter 2008: 2). As such, ‘public health’ remains a Cinderella. And, while the WHO advocates health policy that includes collective responsibility for guaranteeing access to all the determinants of health (including clean water, pure air, safe and adequate food, employment, homes in safe and supportive communities), this notion of public health is de-emphasised in health policy, at least in the three countries discussed in this chapter. In the US, Canada and the UK, the rhetoric of patient

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empowerment has been used to recast much of health-related public policy into individual responsibility for making informed lifestyle choices.

F rom: Tiffany Veinot. Power to the Patient? A Critical Examination of Patient Empowerment Discourses, pp. 30, 40–41 Patient ‘empowerment’ is widely positioned as a good thing for patients because, as they become more informed, they are able to make their own health care and treatment choices. … However, as Bella [see above] argues, the nature of this ‘health care revolution’ may be somewhat different than its advocates claim. The empowerment mandate has resulted in a number of government initiatives directed at health ‘consumers’ in Canada, the UK and the US. These initiatives assume the following: it is valuable to increase the responsibility of patients/consumers to understand and manage their own health; patients want to become empowered and thus more involved in their health; and they seek health information for this reason. Moreover, empowerment discourses assume that power is something which can be given to a person, an idea which Foucault (1980) called a ‘commodity’ model of power, in which power is seen as something which one can possess or acquire. Thus empowerment discourses treat the verb ‘to empower’ as intransitive [see Bella, Chap. 2, above]. …

Health, Individual Power and Social Control The analysis presented above reveals that both initiatives [HealthyOntario. com in Canada and the Expert Patients Programme in the UK] are situated in discourses of power that differ considerably from what a simple reading of patient/consumer empowerment might suggest. Health is discursively constituted as something that is under individual control. Broader power issues are reduced to matters of individual confidence, commitment and ability to engage in a programme of work, whether it

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be exercising to reduce risk of heart disease or adhering to a physician’s directions. In Ontario, health care is constituted as a fragile collective resource and, through a discourse of economic rationality, individuals are exhorted to be healthy and engage in risk reduction behaviours so as to reduce the burden on the health system. In contrast, in the UK, moral pressures to reduce use of the health care system are less pronounced. Patients are enticed with a self-help discourse that suggests that patients are the leaders of the EPP. However, individuals are encouraged to treat their illness as a project to be managed in a way that complies with medical regimes, thus extending the reach of medical power. In both initiatives, specific behaviours become moral imperatives, acting as a form of discipline that citizens are encouraged to follow, thus reflecting and enacting what Rose (1996) has called the ‘regime of the actively responsible self ’ (p. 57). Drawing from Foucault’s (1991) concept of governmentality, Rose (1996) argues that in ‘advanced liberal’ nations, such as Canada and the UK, governance is increasingly accomplished through techniques that focus on ‘the regulated choices of individual citizens, now construed as subjects of choices or aspirations to self-actualization and self-fulfilment’ (p. 41). Accordingly, current forms of governmental rule rely on the discursive constitution of the ‘actively responsible self ’ (p.  57), an idea which finds much application in discourses of patient/consumer empowerment. This suggests that patient/ consumer empowerment initiatives typify a pervasive, yet subtle, mode of social control in Canada and the UK.

F rom: Samantha Adams. Sourcing the Crowd for Health Experiences: Letting the People Speak or Obliging Voice through Choice, pp. 179, 188–189 In this chapter, I position four websites that invite patients to share their stories and write a review of received care within ongoing discussions about institutional transparency and personal reflexivity. The experiences being shared on these sites focus less on medical content (facts about a disease, coping with an illness, composition of prescribed medications etc.) and more on the provision of care (information provided,

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interactions with physicians or institutions, reactions to treatments, quality of services etc.). … My shift in focus towards the latter is important because, as I discuss below, when individuals are invited explicitly to review an institution, service or provider, there is a secondary expectation (more overt than in the case of constructions of illness) that the information gathered can be used by the organisations that operate these sites for other social and political purposes. …

Loci of Political Action and Symbolic Exchange By asking individuals to write a public review of services, ‘share your experience’ websites promote individual practices of monitoring professional behaviour and institutional practice. The language of these sites demonstrates, however, that ‘reflexive’ consumerist behaviour related to monitoring practice does not automatically come from individuals, but is encouraged by website creators, who position themselves as spokespersons for a ‘collective’ and enrol site visitors into said collective, in whatever form. While encouraging individual participation and voice, they nonetheless stand between patients and other actors, enacting and mediating relationships (Wathen et al. 2008—see Locus of Care theme section). By targeting individuals who do not necessarily fit into a specific patient group, such as those with an acute medical problem, these sites also add to this collective those in society who are unorganised and, possibly, unheard. Such websites can therefore be viewed as loci of political action, where actions and events are made available in the public domain through a process of symbolic exchange. … Individuals are asked not just to share their stories, but also to reveal what choices they have (or have not) made and why. … This affirms Gouldner’s (1976) claim that mass media and ‘the public’ mutually construct one another and Naiditch’s point that patient organisations, by mediating between actors, play an important role in shaping collective identities. Not only do they endorse new social responsibilities, but they also serve as instruments to help individuals organise the ‘citizen’ (voice/responsibility) and ‘consumer’ (choice/right)

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aspects of their lives (Naiditch 2007). The websites, therefore, are used to order relationships between organisations, groups and individuals through specific forms of dialogue …, and can also be viewed as attempts to repair rifts resulting from increased individualisation, the erosion of professional status and the weakened authority of the nation-state.

F rom: Roma Harris, Nadine Wathen and Sally Wyatt. Working to be Healthy: Empowering Consumers or Citizens, pp. 212–213 Central to health promotion policies that encourage personal responsibility for health is the idea that if people are provided with ‘good’ information they will be ‘empowered’ to make ‘good’ choices. ‘Informing’ is also central to the marketising of health wherein patients, as well as healthy citizens, are positioned as consumers of health care services and health-­ related products. Vendors of medical insurance, pharmaceuticals, specialty foods, exercise programmes, individualised genetic testing and a wide range of other services and products attempt, through various marketing strategies, especially involving the internet, to ‘inform’ potential customers about why they should choose their products. Canny consumers may elect to keep themselves (and their animals) healthy by purchasing nutritional supplements, energy drinks and exercise machines and by hiring instructors to learn new skills, such as animal ‘telepathy’ and ‘how to consciously create everything you desire in life’. They are also encouraged either to volunteer or to make money by marketing these products to others, often through online gimmicks reminiscent of pyramid sales schemes. People who are ill are also encouraged to ‘choose’ their way to better health ‘through empowerment’, by creating a personal health record or purchasing the services of ‘coaches’ who claim to teach their clients, including those with serious, chronic illnesses, how to ‘attract greater health’. That there is little, if any, evidence to support links between ‘health’ and many of these products, services and schemes (and even empowerment itself ) appears to be no barrier to the promotion of these ‘opportunities’. …

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The Imperative to be Healthy When health is depoliticised and constructed as a private, personal responsibility and a matter of consumer choice, collective attention is diverted away from health threats posed by social and environmental conditions, such as poverty and pollution, which require remedies beyond the responses of single individuals. Positioning the state of ‘being healthy’ as a ‘choice’ also implies that illness is something that can be avoided by the responsible behaviour of ‘good’ citizens.

 eflection by Roma Harris, Nadine Wathen R and Sally Wyatt This volume arose from a workshop we organised in May 2009, held at the University of Western Ontario in Canada where two of us (Harris and Wathen) were working at the time. The effects of the 2008 financial crisis were beginning to become visible, though Canada was less severely affected than many other western countries. One of our central concerns was to examine the tensions between the social management of health, traditionally anchored in collective social relations and shared knowledge and practice, and the individualisation of health through the promotion of self-care. Since the workshop, after ten years of austerity and further pressure on state-supported healthcare, those tensions have become even more prominent. We deliberately chose to use ‘consumers’ in the title of the book in order to highlight the ways in which the language of markets and management has permeated healthcare. Throughout the book, contributors drew attention to the myriad ways such language obscures the lived experiences of patients, carers, healthcare professionals and citizens. All of these words capture different aspects of the ways in which people engage with health, care and information about health. ‘Responsibility’ was a key theme in many of the chapters. We were concerned that new technologies were being used to shift responsibility from healthcare professionals to patients and their carers. And, with the individualisation of responsibility comes ‘blame’ for those in poor health

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(see, e.g., Harris et al. 2016). That process has intensified over the past decade, especially with the rise of big data, personalised medicine and self-tracking devices such as Fitbit. While we used the term ‘information’, many of the same questions and analyses raised by our contributors apply equally well to what is now discussed under the label of ‘big data’. For example, there is much excitement in the health insurance industry that self-tracking has the potential to revolutionise the industry by providing more precise risk prediction and thus increased profits. Concerns are expressed about how the widespread take-up of big data in healthcare could lead to greater surveillance, exploitation of individuals’ data, and the breakdown of solidarity (Prainsack 2014; Sharon 2017; Blassime et  al. 2019). Direct-to-consumer genetic testing provides patients and other stakeholders with data that can be difficult to interpret for individuals but can be a valuable resource for the companies offering such services (Harris et al. 2016). In many ways, self-tracking is not particularly new—people have long recorded their weight and calorie intake, drug reactions, and menstrual cycles. What is new are the possibilities for those data to be shared and analysed for private gain by the insurance and pharmaceutical industries, and for public gain by medical researchers and patients. We also have learned that we need to wait to see if the reality lives up to the promises. Over the past decade, we have also witnessed several high-profile projects, such as Google Flu Trends and IBM’s Dr Watson, fail to live up to their initial promises in predicting disease outbreak or automating diagnosis.

References Bateman, S., Gayon, J., Allouche, S., Goffette, J., & Marzano, M. (Eds.). (2015a). Inquiring into human enhancement. Interdisciplinary and international perspectives. Basingstoke: Palgrave Macmillan. Bateman, S., Gayon, J., Allouche, S., Goffette, J., & Marzano, M. (Eds.). (2015b). Inquiring into animal enhancement. Model or countermodel of human enhancement. Basingstoke: Palgrave Macmillan. Berg, M. (1997). Rationalizing medical work: Decision-support techniques and medical practices. Cambridge: The MIT Press.

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Hilgartner, S. (1992). The social construction of risk objects: Or, how to pry open networks of risk. In J. F. Short & L. Clarke (Eds.), Organizations, uncertainties and risk (pp. 39–53). Boulder: Westview Press. Holmes, S. (2009). In case of emergency. Misunderstanding tradeoffs in the war on terror. California Law Review, 92(2), 301–356. Horstman, K. (2008). Lifestyle, genes and cholesterol: New struggles about responsibility and solidarity. In G. de Vries & K. Horstman (Eds.), Genetics from laboratory to society (pp. 64–89). Houndmills: Palgrave Macmillan. Hunter, D. (2008). The health debate. Bristol: Policy Press. Iedema, R. (2007). Critical incident reporting and the discursive reconfiguration of feeling and positioning. Journal of Applied Linguistics, 2(3), 343–364. Jonas, H. (1979). The imperative of responsibility. In search of an ethics for the technological age. Chicago: University of Chicago Press. Latour, B., & Weibel, P. (Eds.). (2005). Making things public: Atmospheres of democracy. Cambridge: The MIT Press. Law, J. (2000). Ladbroke Grove: Or how to think about failing systems. Centre for Science Studies, Lancaster University. Retrieved June 29, 2013, from http:// www.comp.lancs.ac.uk/sociology/papers/Law-Ladbroke-Grove-FailingSystems.pdf McDonald, R., Waring, J., & Harrison, S. (2005). ‘Balancing risk, that is my life’: The politics of risk in a hospital operating theatre department. Health, Risk & Society, 7(4), 397–411. Mengis, J., & Nicolini, D. (2011). Challenges to learning from clinical adverse events: A study of root cause analysis in practice. In E. Rowley & J. Waring (Eds.), A socio-cultural perspective on patient safety (pp. 171–188). London: Ashgate Publishing Ltd.. Mertens, F. J. H. (2003). Pech onderweg. In F. J. H. Mertens, R. Pieterman, C. J. M. Schuyt, & G. de Vries (Eds.), Pech moet weg (pp. 13–28). Amsterdam: Amsterdam University Press. Mesman, J. (2008). Uncertainty and medical innovation: Experienced pioneers in neonatal care. Basingstoke: Palgrave Macmillan. Mol, A. (2008). The logic of care: health and the problem of patient choice. London: Routledge. Naiditch, M. (2007). Patient organizations and public health. European Journal of Public Health, 17(6), 543–545. Pedersen, K. Z. (2016). Standardization or resilience? The paradox of stability and change in patient safety. Sociology of Health & Illness, 38(7), 1180–1193.

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Section 3: Locus of Care Alan Petersen, Megan Munsie, Claire Tanner, Casimir MacGregor, Jane Brophy, Nadine Wathen, Roma Harris, Sally Wyatt, Bernike Pasveer, Oddgeir Synnes, and Ingunn Moser

Introduction One of our assumptions when we started this Series is that medicine, health care and the wider social meaning and management of health are undergoing major changes. In part, we argued, this reflects changes in the locus of care and burden of responsibility for health. In this section, we focus on the

A. Petersen • C. Tanner Department of Sociology and Gender Studies, School of Social Sciences, Monash University, Melbourne, VIC, Australia e-mail: [email protected]; [email protected] M. Munsie Centre for Stem Cell Systems, University of Melbourne, Melbourne, VIC, Australia e-mail: [email protected] C. MacGregor School of Political and Social Inquiry, Post-Doc, Monash University, Melbourne, VIC, Australia © The Author(s) 2020 A. Webster, S. Wyatt (eds.), Health, Technology and Society, Health, Technology and Society, https://doi.org/10.1007/978-981-15-4354-8_4

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locus of care (responsibility is addressed in Section 2). Genetics, informatics, imaging and integrative technologies, stem cell therapies are all contributing to redefining our understanding of the body, health and disease. At the same

J. Brophy Melbourne School of Government, University of Melbourne, Melbourne, VIC, Australia e-mail: [email protected] N. Wathen Mobilizing Knowledge on Gender-Based Violence, The University of Western Ontario, London, ON, Canada R. Harris Faculty of Information and Media Studies, The University of Western Ontario, London, ON, Canada S. Wyatt (*) Maastricht University, Maastricht, The Netherlands e-mail: [email protected] B. Pasveer Faculty of Arts and Social Sciences, Maastricht University, Maastricht, The Netherlands e-mail: [email protected] O. Synnes VID Specialized University, Oslo, Norway Molde University College-Specialized University in Logistics, Molde, Norway e-mail: [email protected] I. Moser VID Specialized University, Oslo, Norway e-mail: [email protected]

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time, health is no longer simply the domain of conventional medicine, nor the clinic. The ‘birth of the clinic’ heralded the process through which health and illness became increasingly subject to the surveillance of medicine. In this theme section, we draw from three books in the Health, Technology and Society series in which locale plays an important role. Locus of care refers to the ways in health care is no longer primarily the preserve of the clinic. With digitalisation, globalisation and a growing emphasis on personal responsibility, more and more health care is taking place in non-medical settings. The three books we have chosen for this theme take place in different locations, and we start by travelling the world to visit places of advanced technology and medical intervention. Alan Petersen et al. (2017) follow people from one clinical location to another in pursuit of stem cell treatments that are available in some parts of the world but not others. The book explores and challenges many of the assumptions underpinning ‘stem cell tourism’, and it is based on research done by the authors over many years and in many locations, including Australia, Germany and China. The analysis is framed around the concepts of the ‘political economy of hope’ and the ‘patient journey’. The search for stem cell therapies to treat or even cure disease takes place in an increasingly commercial and globalised market. The authors follow patients on their journeys, from informing themselves (via online spaces) to long-haul air travel, to clinics far away and then home again. Patients thus encounter multiple locations, some familiar and some very strange. Those online spaces are the focus of the second volume in this theme section, edited by Nadine Wathen et  al. (2008). Contributors to the volume focus on how digital technologies make it possible for people to find health information in all sorts of places, including libraries, rural and Indigenous communities in Canada and Australia. Sometimes the online spaces themselves are important sources of health information, especially for groups who may be marginalised, such as those living with HIV/AIDS. Contributors to the book go beyond the simple equation often embraced by policymakers that making more information

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available faster will automatically lead to better informed and empowered patients. Instead, the editors and contributors highlight the complexities of people, systems and policies that serve to ‘mediate’ the huge quantity of health information that can be found online, information that is often vague, uncertain, controversial and contradictory. Finally, Bernike Pasveer et al. (2020) bring us ‘home’, the traditional site of health care, and the place where many older people wish to remain. The contributors go beyond the clinic to examine what happens at home, but also examine how the norms of the clinic shape informal, home-­ based care. Drawing on examples from around the world, the volume explores how ‘home’ is made when it intersects with new forms of care as a result of ageing. The contributions go beyond conceptualising home as a place, as a noun, and argue that home is something that needs to be made. By treating ‘home’ as a verb, the authors and editors are able to make visible the elements required to make home possible. Home-­making always requires relations and arrangements between very different actors: older people, care workers, family members, stairs, walkers, wheelchairs, spaces, policies and health care systems. How home emerges from these practices cannot be taken for granted, and by paying attention to the range of actors and activities new ways of home-making may become possible. Together, these books in the Series explore health, care and technology within and beyond the conventional domain of ‘the clinic’. We now move to a selection of extracts chosen from the three books introduced above. Each set of extracts concludes with a new, short reflection on the book by the author/s and how they now see the further development of their work.

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 lan Petersen, Megan Munsie, Claire Tanner, A Casimir MacGregor and Jane Brophy. (2017). Stem Cell Tourism and the Political Economy of Hope. Winner of Stephen Crook Memorial Prize awarded by The Australian Sociological Association 2018

F rom: Chapter 1, Stem Cell Tourism in Context, pp. 1–2, 6–10, 16 In Australia, in recent years, there have been a number of news reports of patients and carers travelling overseas for stem cell treatments (e.g. Donaghey 2013; MacLennan 2014). Their journeys are part of a wider international trend, commonly referred to as stem cell tourism, whereby patients and carers of patients travel across geographical borders and jurisdictions to receive treatments that are experimental or clinically

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unproven, and hence, may not be available to them where they live. The stories which the articles tell are framed within a now-familiar narrative—desperate patients full of hope investing in treatments that promise much, and scientists and doctors voicing frustrations about entrepreneurial ‘charlatans’ or ‘cowboys’ operating at the margins of medicine and exploiting ‘regulatory loopholes’ to sell ‘snake oil’. Why, authorities ask, do patients and carers embark on such treatments that are unlikely to provide benefit, are expensive, and potentially inflict great harm? This book explores the stem cell tourism phenomenon in all its complexity, so as to cast light on the various sociocultural factors that shape patients’ and carers’ decisions to embark on journeys to pursue such treatments as well as the nature of current responses to this issue. We wish to go beyond simplistic portrayals of ‘the problem’, how ‘it’ arises, who is to ‘blame’, and what should be ‘regulated’, which characterises much of the academic and media portrayal of stem cell tourism, to uncover the dynamics of a rapidly evolving treatment market. We question the current ways of understanding the stem cell tourism phenomenon including some underlying premises shaping the terms of recent discussion and the language used to frame stories such as those above, and ask, what is left out of the frame? And, how may ‘stem cell tourism’ be re-framed so as to offer a better appreciation of why individuals pursue these treatments and whether authorities’ concerns are justified and their responses are appropriate and proportionate to the purported risks or concern over lack of demonstrated benefit. … Stem cell tourism is part of a growing and highly diverse global health and medical travel industry, including specialties such as spa and wellness tourism, cosmetic and dental tourism, organ transplant tourism, and reproductive tourism. This sector comprises, apart from the doctors, hospitals and clinics themselves, and supporting staff, various advisory, insurance, marketing, and conference and events management services, interpreter and ‘concierge’ services (e.g. arranging accommodation and pickup from airport), and travel agencies. …

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While ‘stem cell tourism’ can be considered to be an integral element of a burgeoning global health and medical travel market, its contribution to total patient traffic is unknown and, given the definitional and technical challenges in collecting such data, it is probably unknowable. In terms of qualitative criteria, however, stem cell tourism has some characteristics that distinguish this form of medical travel. First, while the term ‘tourism’, which implies some recreational activity (usually in some purportedly exotic location) accompanying treatment, may apply to some forms of health and medical travel—perhaps most notably cosmetic tourism and spa and wellness tourism—this is generally not the case with stem cell tourism. As we shall see, those patients who embark on such treatments typically are those suffering severe, life-threatening or life-limiting conditions and have generally exhausted conventional treatment options where they live. … Second, unlike many if not most varieties of health and medical travel, stem cell tourism involves the use of interventions that are not considered by the mainstream medical community to be clinically proven. That is, the stem cell ‘treatments’ being offered by these ‘stem cell’ clinics are yet to be fully evaluated in clinical trials to show if they work or are even safe. It is generally expected that a novel treatment, whether using stem cells or any other approach, will be supported by evidence collected in clinical trials and gain regulatory approval, before it is made widely available to the public and eligible for funding through national health and medical benefits schemes or private health insurance. … Third, the idea that stem cell treatments necessarily involve travel, generally outside a patient’s or carer’s home country, to a destination with more lax regulations is challenged by the rapid rise of autologous treatments involving the use of the patient’s own cells—generally adipose tissue obtained from liposuction …—that may not involve travel across state or other jurisdictional borders. The provision of these treatments, which has increased in a number of countries (e.g. the USA, Canada, and Australia) in recent years, are undertaken as a consequence of regulatory

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ambiguity, adventitious regulatory exemptions, and/or government-­ backed initiatives to foster a local ‘stem cell’ industry. … Finally, our research suggests that stem cell travellers tend not to use the services of health and medical tourism facilitators that have emerged in recent years to help locate providers of treatments, advise on treatments, and assist with travel arrangements, accommodation, and recuperation. The rise of such companies, which advertise their services via the internet, reflects growing consumerism in health and an emphasis on offering ‘personalised’ facilitation services to consumers whom, it is assumed, are to be too busy and/or potentially too overwhelmed by options to make a properly ‘informed choice’ from the mass of information on the different types and costs of medical travel in the healthcare marketplace. … In short, contemporary healthcare is characterised by globalisation, commodification, marketisation, mobility, and constant change, under relentless pressures of competition and the drive for profit and the influence of discourses of hope, self-care, personal empowerment, and freedom of choice that are strongly attached to the personal consumption of technologies. It is in this context that a growing number of technological innovators and providers have emerged, using the language of promise and hope to promote and sell new treatments. Patients have mobilised, building communities of the like-minded and similarly placed that advocate for the development of or access to new treatments, raise funds to support patients’ endeavours to undertake treatments, and develop their own research programs and patient-based resources and forums. This patient activism is expressive of a new form of citizenship—one that is active, entrepreneurial, optimistic, and oriented to the consumption of technologies that are seen to offer much but for which evidence of any kind is often lacking. The stem cell tourism phenomenon is a manifestation of this citizenship and its emphasis on individual choice and rights— including ‘right to try’ when no other options exist (Chap. 7). Further, growing responsibilisation in healthcare, whereby individuals are held

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accountable for decisions, means that individuals are liable to be blamed when their decisions prove to be ‘wrong’ (Chap. 2).

F rom: Chapter 2, ‘Choice’, Hope, and Stem Cell Treatments, pp. 51–54 Country of Destination As with the decisions about the treatment itself, those concerning the country of destination are rarely based on a ‘rational’ consideration of the various ‘pros’ and ‘cons’ of all the options presented to them for the patient’s condition at a fixed point in time. Impressionistic information, national/cultural stereotypes, and third-person accounts and hearsay evidently played a role in decisions. Again, in line with our earlier research (Petersen et  al. 2014), convenience, English language proficiency, and confidence and trust in the providers played a role in decisions. Accounts suggested that these decisions were partly shaped by existing biases in favour of or against particular countries or regions, which may be reinforced or sometimes challenged by early communications with providers, such as about what the treatment entailed. A combination of factors was often evident in decisions to travel or not to travel to a particular country. For example, Stephen, who had a spinal cord injury, chose Germany above India for treatment which he had also considered, citing a range of factors in his decision, revealing the influence of national stereotypes, concerns about the quality of treatment, and pragmatic considerations. When asked, ‘what was important to you in weighing up … a decision whether or not to travel?’ he responded: ‘Pretty much I think Germany’ cause obviously the Germans that do stuff there are obviously pretty adept at what they do. It was, you know, the European country where we were going looked … professional.’ Stephen also said that he decided against India because ‘you had to go for like three months which for me I had three kids as well. And so it put me off … a bit, and that it was embryonic stem cells, so I was like … didn’t really know where they came from or whatever they may be.’

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Regardless of their decision about the destination, individuals typically reasoned that what the preferred country offered was better than what was available or presented to them in Australia. Personal contact and providers’ demonstration of receptiveness and empathy for the patient’s or carer’s concerns were commonly cited factors shaping decisions. … [T]he establishment of confidence and trust was crucial in the decision to travel—here, evidently achieved by the providers’ demonstration of concern for the child and apparent thoroughness in the treatment regime, which inspired a sense of safety. As Vlasta explained, the doctors ‘were very careful’ in that ‘before they would consider any treatment, they would double check and triple check. … They wouldn’t even trust the parent with information. … So, that sort of made us feel safe to be in their hands.’ Ivan added, ‘They even performed an MRI [magnetic resonance imaging scan] before we started any treatments just to see what state our [child’s] brain is in.’ An MRI was also contemplated by their Australian neurologist, but that would have entailed a general anaesthetic, whereas in China they ‘just gave him a mild sedative’, which the parents saw as ‘non-invasive’. In this particular case, practical considerations again played a role in the treatment decision. As Ivan noted, ‘It was quick and easy whereas in [capital city in Australia] … it would have had to be planned ahead, general anaesthetic, recovery, this, that ….’ The couple said they returned to China six months later for a second infusion of stem cells from umbilical cord blood after having noted ‘a lot of little improvements’. They said that they were at a ‘crossroad’, commenting that they were ‘sitting back and trying to work out exactly what we want, what we should be doing, and now we’re considering all the different stem cells and all the different things that are available.’ They asked us whether we could suggest someone to assist them in answering their questions. Evidently recognising the biased nature of online information available to them, they commented that they were a ‘bit over’ searching the internet and felt that ‘the main world-wide suppliers of stem cell products are monopolising … the search engines and their … rankings, and there’s too much of them popping up instead of the sort of more medical and forum-based information.’

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F rom: Chapter 4, Hopeful Journeys of Stem Cell Tourists, pp. 84–85, 90–91 This chapter seeks to … contribute to the emerging body of work that considers patients’ experiences by taking as its central focus the journeys of people who have travelled to different countries to receive treatment. Given the significant role that family members/carers play in supporting and facilitating these journeys, this is as much a story about their experiences as it is about the patients who travel for treatment. The chapter is divided into key stages of people’s journeys: travel to the destination country; first impressions and experiences of the clinic and care; the treatment regimes people underwent, and people’s experiences and reflections upon returning home, including the response of family, community, and healthcare providers in Australia, and travellers’ reflections in the light of the treatment received and perceived benefits or harm (if any). Each step demonstrates the profound practical challenges that travellers face in undertaking these journeys as well as the more abstract challenges they pose with respect to the management of competing risks, claims, and models of healthcare, and the significance of hope and trust in travellers’ negotiation of them. We consider the significance of shifting dynamics of trust and distrust, expectation and hope, fear, uncertainty, and investment as inherent characteristics of people’s journeys. As the following discussion demonstrates, these dynamics are highly variable and co-exist in often seemingly contradictory and complex ways in people’s journeys. …

Difficult Leaps of Faith: Journeys to the Clinic As discussed in Chap. 2, a range of factors may influence people’s decisions to travel for treatment, including the severity of illness and/or condition, experience of diagnosis and medical care in Australia, response to provider websites and by providers after initial contact, and communication with others who had travelled. Travellers and non-travellers alike express their frustration with being forced to travel overseas for treatment.

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This relates to the great expense and risks involved in long-haul flights to destination countries while acutely unwell or with reduced mobility. Invariably, multiple tickets are needed so carers and/or families are able to travel together, with some travellers having no choice but to travel business class due to the nature of their illness and condition (e.g. people with severe spinal cord injuries or those travelling with ventilators and other equipment). Many individuals describe the practical challenges and associated stresses involved in preparing to fly with their condition and/or illness, which include the need for assistance for walking (e.g. wheelchairs at each airport and flight interchange), and concern over health risks. …

At the Clinic For those travelling to other countries, which included China and India, individuals recounted a greater diversity of experiences of facilities and care. In particular, their long-term stay in clinics (typically four weeks to three months) invariably shaped their experiences and the demands and rewards of treatment journeys. For example, some told ‘horrific’ stories of unsanitary conditions, including rats, poor care, unsatisfactory equipment required for day-to-day care, especially for spinal cord injury patients, and being billed for ongoing equipment and supplementary medicines such as vitamins, syringes, and IV drips, in addition to the high cost of the stem cell treatment/s. Other challenges that were raised included cultural differences, for example, language barriers and differences in food. Safety, pollution, temperature, distance from home, lack of support to navigate cultural differences, and the boredom of day-to-day living in the confines of a clinic, were also featured in people’s accounts as negative aspects of their experiences.

F rom: Chapter 8, Re-framing ‘stem cell tourism’, pp. 191–193, 200 During the course of our Australian research, undertaken between 2012 and 2015, the dimensions and operations of the stem cell treatment market changed in a number of respects. Changes included shifts in policies

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in provider destinations, seemingly in response to factors such as concerns about public representations (e.g. ‘Brand China’ in Chap. 6) and the rapid rise of ‘on-shore’ providers of autologous treatments marketed as an ‘ethical medical treatment’ option (Chap. 7). … The imperative for researchers to take their findings from ‘bench top to bedside’ as quickly as possible, and yet meet established standards of evidence and ethical practice, provides the backdrop against which stem cell clinics offering novel treatments have flourished. Many patients and their families are evidently frustrated by the apparent slow pace of science and, consequently, turn to novel options—a situation that is ripe for exploitation. Recent developments in the stem cell field highlight the significance of positive public representations for those with an investment in the future of stem cell science as well as those with a stake in the current treatment market. As governments, scientists, and clinicians recognise, the question of how treatments are portrayed in the public arena is crucial for the future of the field of stem cell science—especially in establishing and maintaining community confidence in the potentially decades-long scientific endeavour that will be required to realise the hoped-for treatments. Providers, too, have an investment in the management of public representations, and evidently wish to distance themselves from the negative portrayals of their practices (Chap. 7). Thus, the question of whether providers are seen as exploiting ‘loopholes’ in order to ‘dupe’ ‘vulnerable’ patients, or offering a relatively safe option and, consequently, ‘hope’ to those who otherwise have none, becomes crucial in the battle of representations regarding the provision of autologous stem cell treatments. The concept of the ‘political economy of hope’ that has underpinned our analysis acknowledges the close linking of individual outlooks, aspirations, and practices with wider sociocultural and politico-economic processes, which can only be sustained by the actions of many actors and their networks, including scientists, clinicians, the biotechnology industry, governments and, crucially, the enrolling of individual patients and patient communities into fundraising efforts. In this respect, digital media is playing an increasingly critical role. As these developments reveal, the economy of hope underpinning the market of stem cell treatments can only be sustained insofar as there is a supportive socio-political environment. It is here that the media, including increasingly digital

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media, has come to play a vital role: for providers in advertising their treatments directly to consumers (‘direct-to-consumer advertising’), and for individual patients and groups of patients in sharing stories and creating optimism regarding the promises of stem cell treatments. We, and others, have explored the techniques of direct-to-consumer advertising, which include the use of carefully crafted images and text, including patient testimonials, and the failure to offer scientifically verifiable data to support claims (e.g. Petersen and Seear 2011; Lau et al. 2008). … Our analysis of the various dimensions of ‘stem cell tourism’, including rapidly evolving strategies of marketing and de facto advertising enabled by digitalisation (patients’ promotion of particular clinics or providers), has led us to question current ways of understanding and responding to this phenomenon, including the very terms and language used to frame debates. In particular, the simplistic characterisations and dichotomies that have typified discussion and that shape responses, particularly in popular media portrayals, need to be challenged, since they limit appreciation of the issues at stake—which go beyond the provision of stem cell treatments, to public representations of and responses to new and emerging biomedical technologies in general. The contending metaphors of stem cell science to describe the treatments (‘magic bullet’ or ‘miracle cure’, or alternatively, ‘snake oil’, depending on one’s evaluation) and the providers (typically ‘quacks’, ‘rogue operators’, or ‘cowboys’) are not limited to this field. Similar metaphors are found, for example, in portrayals of cloning and genetics and reflect widely shared hopes, expectations and fears attached to scientific research, especially where this involves ‘tampering with Nature’. The image of Mary Shelley’s Frankenstein’s monster and Aldous Huxley’s Brave New World scenario of embryonic engineering find parallel in contemporary concerns about the ramifications of individuals submitting themselves to unproven treatments. However, we are entering a new era where the stakes regarding the public definition of the significance of new technologies are especially high, since citizens have been ‘empowered’ via the internet and their social media-enabled communities to influence, if not establish, the terms of debate about treatments and their value. From the perspective of those contemplating treatment, the clinics and doctors

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offering hope and help may be highly regarded, even considered pioneers, as they are at least ‘prepared to do something’ to help. This is particularly acute for those patients and carers who believe they are running out of time or, in the case of children, have only a narrow window of opportunity in which to change the course of the condition from which the patient is suffering. … [W]e suggest that those who develop policies and strategies in relation to ‘stem cell tourism’ need to pay much greater attention to how early treatment markets operate in contemporary global healthcare and to the significance of the emergent forms of citizenship and sociability enabled or facilitated by the internet and social media. It needs to be asked, what forms of governance should be developed for the early global market of stem cell treatments? Should particular authorities take the lead on initiatives? Do national governments still have a role to play or should this be left to supranational bodies (e.g. science organisations, the World Health Organization, the World Trade Organization)? What strategies are needed to bridge the often-adversarial views, both offline and online, of science-­ based professionals and patients in order to encourage a more sophisticated understanding of the stem cell tourism phenomenon? How can consumers be more empowered to ensure their rights, in the event of an unsatisfactory outcome, are upheld? While we have no clear answers to such questions, they urgently need asking and demand careful consideration since the stakes are high—for individual patients and families considering treatments and for scientists, clinicians, and others who are committed to advancing human health.

 eflection by Alan Petersen, Megan Munsie, Claire R Tanner, Casimir MacGregor and Jane Brophy Like most large research projects, ours has a long history and has involved many people. Our book was the culmination of two Australian studies: one which explored 16 patients’ and carers’ perspectives on stem cell

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travel, and a subsequent larger project (led by Alan Petersen, in collaboration with Megan Munsie, and funded by the Australian Research Council) involving interviews with 24 Australian patients and carers who had undertaken treatments and 27 individuals who, at the time of interview, had contemplated embarking on stem cell treatments but had not done so. The latter study also involved interviews with providers, scientists, clinicians, representatives of patient advocacy groups, as well as regulators in two countries to which Australians had travelled for stem cell treatments, namely Germany and China. Claire Tanner and Casimir MacGregor were the research fellows, and Jane Brophy undertook fieldwork (as part of her PhD) in China. Our research commenced in 2009 with a small project undertaken by Alan Petersen and Kate Seear, involving interviews with stem cell researchers and an analysis of online advertising on stem cell treatments. Subsequently, we (including Megan Munsie) applied for and were awarded funds by the Australian Government to undertake our research, which was published as a report (Hopeful Journeys) in 2010. This work was undertaken against a background of growing international interest in ‘stem cell tourism’ by media, scientists, clinicians and regulators. While our fieldwork was completed in 2015, subsequent local and global developments confirm the continuing significance of many of the findings highlighted by our research. Our research highlighted the significance of ‘hope’ in sustaining the commercial market for reputed stem cell treatments. We used the concept of ‘political economy of hope’ to explore the dynamics of this market, including patient journeys. This was because we found the language of hope pervasive—in patient stories, in advertising and news reports—and recognised that hopes are socially created and sustained by many actors with often competing social, health, financial, personal and political interests. Hope remains a central feature of and driver in the current global industry that has nonetheless changed significantly since the beginning of our research. Business is booming not just in developing economies such as China and India but in countries presumed to have high regulatory and ethical

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standards governing health and medical care, such as the USA and Australia (Berger et al. 2016). Incidences of harm also continue to grow (Bauer et al. 2018). In response to these changing dynamics, there have been some regulatory developments in efforts to curb the growth of unscrupulous operators. Notably, Google (in September 2019) announced a ban on advertising of ‘unproven or experimental medical techniques’ including stem cell treatments following what they describe as a ‘rise in bad actors’. A single Florida clinic was also recently closed by the Federal Drugs Administration following a court case this year (2019) in the US, yet hundreds of clinics remain open for business. In Australia, the Therapeutic Goods Administration (TGA) have also recently announced new regulations which aim to curb misleading direct-to-consumer marketing and require use of cell and tissue products offered outside hospitals, including those that involve stem cells, to meet the TGA’s ‘requirements for safety, quality and effectiveness’, and stipulated criminal sanctions for those who fail to meet these requirements. Given the continuing strong appeal of ‘stem cell treatments’, however, and the resources required to effectively monitor providers and enforce regulations, questions remain about whether harmful practices will be effectively curtailed by these developments. While we believe our research has contributed much to our understanding of this field, there is much more work that needs to be done. We need to know more about the role digital media play in the creation and circulation of information and stories about treatments. Patients have increasingly relied on digital media, including to crowdsource for funds (Tanner et al. 2019), to lobby for research and to gain access to treatments—sometimes on grounds of ‘compassionate access’. They may combine different kinds of knowledge and create new knowledge using different media. Digital mediation is reshaping citizens’ identities and sense of agency, as well as their hopes and expectations of treatments. How does information flow online and offline—both between patients, and between providers and patients and other actors? Are some platforms

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(e.g. Facebook, WhatsApp, Reddit) used more than others for communication? To what extent and how do different media communications impact market transactions? Finally, we need to explore other areas that are difficult to research: the perspectives on providers and the operations of their clinics; and the contributions of scientists’ and clinicians’ views and practices. It is too easy to point to ‘regulatory gaps’ and ‘loopholes’ and failures to reign in ‘dodgy’ practitioners, and to overlook how different actors in the market, wherever they are positioned, may contribute to shaping views and actions.

 adine Wathen, Sally Wyatt and Roma Harris N (Eds.). (2008). Mediating Health Information. The Go-Betweens in a Changing Socio-Technical Landscape

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F rom: Sally Wyatt, Roma Harris and Nadine Wathen. The Go-Betweens: Health Technology and Info(r) mediation, pp. 1, 3–6 Welcome or not, most people in Western countries are unable to get through a day without receiving a dose of health information. It is available from, passed through or pushed at health help seekers by health care professionals, alternative health care practitioners, pharmaceutical companies, employers, co-workers, friends, family members, vendors of health products and through government-sponsored health promotion campaigns. It is delivered through a variety of media, including self-help books, magazines, leaflets, television and radio advertising and programming and, increasingly, the internet. … How are ordinary people taking up the challenge to locate, retrieve, receive, digest and cope with the mass of health information available? What are the roles of technologies and human helpers that mediate between health information sources and health ‘consumers’ or end-users? In this book we explore the largely unexplored ‘middle’ space of human and technical mediators in the health information process.

 ediation: Pipelines, Transforming Conduits or M Chinese Whispers? In this book we follow Latour (2005) in distinguishing between an intermediary and a mediator. He explains the distinction as follows: An intermediary, in my vocabulary, is what transports meaning or force without transformation: defining its inputs is enough to define its outputs. For all practical purposes, an intermediary can be taken not only as a black box, but also as a black box counting for one, even if it is internally made of many parts. Mediators, on the other hand, cannot be counted as just one; they might count for one, for nothing, for several, or for infinity. … Mediators transform, translate, distort, and modify the meaning of the elements they are supposed to carry. (Latour 2005: 39; emphasis in original)

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We are primarily interested in mediators and mediation because, as the chapters in this book demonstrate, health information is rarely, if ever, intermediated in a simple, straightforward way. The fantasy of some policy-­makers, played on by technology vendors, is that information can be sent easily from its source to its intended recipients, and that it will not be affected by the medium or by the context in which the recipients are situated, including factors such as their health situation, living arrangements and education. This is what Latour means by intermediation. … In this book, we explore the much more interesting, and real, situations in which information is produced, distributed, regulated and used. ‘Health information’ in its broadest sense is itself produced within local contexts by individuals and groups with a wide range of interests, such as scientists in research laboratories, health professionals in clinical settings, manufacturers of health and beauty products, peer support groups such as Alzheimer’s societies, organic produce growers or African politicians who claim that AIDS is a curable disease. The information produced by these different sources is transformed by others, ranging from professionals attached to the formal medical system (doctors, nurses, librarians, pharmacists) to those outside the system (health food store operators or shamanic elders in Aboriginal communities). As health help seekers, ordinary people, whether they are ‘health-concerned’ patients or providing care for others, attempt to make sense of this myriad of information in ways that will help them in their particular and local circumstances. … We use the term health ‘info(r)mediator’ to refer to people, as well as various configurations of people and technologies, that perform the mediating work involved in enabling health information seekers to locate, retrieve, understand, cope with and use the information for which they are looking. This is consistent with Latour’s use of mediation, as we share his emphasis on and interest in the transforming and distorting … power of mediators. His use of mediator is quite general, and by adding ‘info’ we signal our focus on the mediation of (health) information. For us, infomediation refers to the inevitable, if not always predictable, transformation that occurs as information is conveyed from one place, person

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or situation to another. Info(r)mediation, however, is used to draw attention to those situations in which the human mediators convey information in order to effect change in the behaviour or actions of those looking for information. … Thus, the ‘(r)’ draws attention to the way in which compliance or coercion is sometimes implied in the info(r)mediating process.

F rom: Flis Henwood, Roma Harris, Samantha Burdett and Audrey Marshall, Health Intermediaries? Positioning the Public Library in E-health Discourse, pp. 40–41, 45, 53 In this chapter, we draw on Foucault’s [1972] notion of discourse and his understandings of knowledge/power to reflect on the sociotechnical configurations which constitute e-health in a public library context. Our argument is that the particular social, cultural and organizational practices we observed can be understood as part of e-health discourse, which promotes the idea of the informed health care consumer, who, sometimes with the help of library staff, accesses and uses health information to empower him- or herself. However, while key actors (managers, staff and users) do at times embody these understandings, in their statements and their practices there is also some very clear resistance to this dominant discourse which, if explored and exploited, could result in the emergence of a more progressive model for library service development, one that can support the emergence of more active, critical and engaged citizen-users rather than neoliberal consumer-users. …

 ociotechnical Configurations of E-health S in the Public Library The city centre library in which the study took place opened in spring 2005, just a year before our research began. Several structural and organizational changes were implemented by the library service when the

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library opened. First, the library adopted an explicitly ‘self-service’ approach to service delivery, with self-service issue, renewal and return of books. Second, there would no longer be a separate reference section; instead, the reference collection was integrated into the main collection. Although there was still an enquiry desk, it covered all enquiries, was located on the first floor (and was not clearly signposted either on the ground floor or the first floor) and was always very busy. There were two staff on the enquiry desk at any one time (a professional librarian and a library assistant) and each had access to the library catalogues and the internet. Enquiry desk staff did not carry out what might be understood as a traditional ‘reference interview’, in health or other areas, as time spent with each user was limited to 10 minutes (with all other enquiries being categorized as ‘research’ and charged for or referred to another suitable information provider, as appropriate). The library’s IT centre was located in a separate room and most terminals had to be booked. (A few were available on a first-come, first-served basis, but time on these was limited to 15 minutes.) There were a few internet terminals located in the main library area, but these were also time-limited. Technical assistance in operating the equipment was available, but no specific help in information searching was available to those choosing to use the internet. …

Conclusion In our analysis of data collected in a study of health information seeking in a public library, we found both widespread take-up of, as well as some resistance to, the understandings, imperatives and subject positions/identities offered in e-health discourse. On the whole, library staff promoted the idea of the library as provider of consumer health information with a key role to play in the support for the newly responsible and informed health consumer. Similarly, many users were happy to identify with the informed health consumer identity readily available to them in e-health discourse. However, tensions and contradictions were found in the data which has enabled us to argue that there are signs of resistance to this discourse and the meanings and practices that it implies. This was

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particularly the case in relation to the very particular sociotechnical configuration found in the library we studied, where the self-service model of delivery was deemed less than satisfactory by many staff and by some users, who wanted or needed access to a human intermediary. Many members of staff felt that health enquires were fundamentally different from other enquiries, often requiring more time and sensitivity on the part of library staff. More importantly perhaps, although staff presented themselves as intermediaries (in the sense of neutral ‘go-betweens’ linking people with appropriate and relevant resources) … the data suggest that their role may be far from straightforward in this regard. As we discussed, library staff members’ response to the ‘dangers’ of the internet in the context of health information is either to encourage users to search alone or to access, or advise users to access, only a very limited number of government-­ sponsored or approved websites.

F rom: Elaine Gibson and Jan Sutherland. To Filter or Not to Filter: Legal and Ethical Aspects of Librarians’ Use of Internet Filtering Techniques, pp. 56, 60–61, 63–64, 75–76 From virtually anywhere that an electronic signal can be received, a world of information is at our fingertips and hours of research can be reduced to minutes just by keying a few well-chosen words into a web portal. It is difficult to control the quantity of the information received, and the quality can range from wholly accurate and reliable to grossly misleading and even dangerous. In our homes it is up to us to judge what is useful and safe and what is not. When public institutions like libraries provide patrons with internet access, it may behove them to exercise some control over what sites are accessible as the potential for harm exists—particularly for those searching for health information. Internet content filters are designed to control the information accessed by computer users. As such, filters mediate information through their effects on the ability of users to acquire information. Insofar as libraries choose to use filters or not, or to use them in some departments and not

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others, library administrators are implicated in this process of mediation, albeit tangentially, as their actions may restrict, transform or bias the information available to users. …

Internet Filtering Technologies Content filtering occurs when sites are blocked because they contain certain forbidden key words (breast, sex, gay) or suspect graphical data such as a large proportion of flesh-coloured images. Content filtering can also work in conjunction with a rating system known as Platform for Internet Content Selection (PICS). In this instance, webpage developers rate their system according to the PICS standard and insert this rating as metadata. Filters then block out pages rated as unsuitable. Exclusion lists work by blocking access to specific web addresses or to domain names. … Exclusion lists are generated either manually by humans designating sites as unacceptable or by automated computer searches which generate a list of inappropriate sites. Inclusion lists block all sites except those that are expressly permitted. … Inclusion lists are used infrequently as they are the most restrictive; they appear to be most often used in repressive political regimes and in the children’s section of some public libraries. … Filtering something as vast and dispersed as the internet cannot be accomplished with perfection. Two main difficulties with filtering technologies are over- and under-blocking. Under-blocking occurs when sites that ought to be blocked are not and inappropriate materials are easily accessed. Over-blocking occurs when legitimate sites are blocked because the filter erroneously classifies them as inappropriate.

Filtering and Health Information Over-blocking can interfere with health information seeking [because health information and pornography employ a similar vocabulary]. But it is also the case that there is a significant amount of pornographic,

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offensive and harmful materials on the internet. For people accessing information on their home computers, minimizing risk is their own responsibility, but in libraries, where computer access is supplied as a public good, those who deliver the service must try to balance allowing ‘good’ information in and screening out ‘bad’ information. Libraries have had to deal with the question of whether there should be filters placed on public access computer terminals to block access to pornographic and dangerous sites. …

Conclusion Two important conclusions emerge from this chapter. The first is that filters are an important, albeit often invisible, form of mediation. … It is clear that internet filters affect health-related searches on the internet. The hope is that as the technology improves, the proportion of good information that is screened out will be reduced. There are solid reasons, including legal requirements and social pressures, why librarians might want to use filters, especially in the children’s section. There are also solid reasons why libraries might want to forgo their use, given the mandate of libraries to serve the public. Decisions about the use of filters are not clear cut given the dangers inherent in an unregulated internet. The second conclusion concerns the role of regulation. Understanding the legal framework in which filters are regulated and used provides insight into the production and consumption of information. … The use of filters constrains the apparently boundless choices offered by the internet, so that information producers may not always be able reach their intended audiences. Consumers—in this case library users—are also affected not only by the filters themselves but also by the legal framework regulating their use. Within public libraries, a decision about the use of filters is not in itself sufficient. Where filters are utilized, they should only be part of the library’s internet strategy, which should also include the development of internet use policies and measures to increase computer literacy. Patrons will thus be assisted to access accurate, reliable and inoffensive information. An important element of computer literacy, for both

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library staff and library users, is an awareness of the possible presence of filters and what this may mean for the nature of the information that becomes visible during online searching. This is especially the case with respect to health information.

F rom: Adam Fiser and Robert Luke. Between the Clinic and the Community: Pathways for an Emerging E-health Policy in the Remote First Nations of Northwestern Ontario, pp. 128–130, 134–135, 139–143, 146–147 The Sioux Lookout Zone of Northwestern Ontario, Canada is home to 24 First Nations communities of Cree-, Oji-Cree- and Ojibway-speaking peoples. Their land is about as far from the urban landscape as one can get in Ontario, a swathe of boreal forest extending from the edge of the 50th parallel to the sub-arctic shores of Hudson Bay. The total population of less than 25,000 amounts to about 0.1 persons per square kilometre over a territorial expanse the size of France. Mobility to and from these communities is difficult and expensive, with light aircraft and watercraft the primary modes of transportation except between January and March, when the waterways freeze and become temporary highways for long-haul transport, snowmobiles and 4 × 4 vehicles. … Beyond the high cost of living in the Sioux Lookout Zone, the challenges in First Nations communities are many. More than half the people who live there are under the age of 20, and their elders, the traditional keepers of knowledge and community policy, have diminished to a small fraction of the population. … Among the most salient points in the contemporary configuration of this community structure is the status of remote First Nations health care and its delivery. Information and communications technologies (ICTs) have become increasingly integrated within Ontario’s health care system and provincial and federal bureaucrats have become enthusiastic believers in the possibility of enhanced efficiencies through e-health. As the broader

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health care system adapts to e-health and ICT-intensive initiatives such as electronic health records, patient-managed care and telemedicine, the ways in which communities operate in Northwestern Ontario will change. Since 1998, the First Nations of the Sioux Lookout Zone have worked hard, not only by preparing for the impact of new technologies, but by taking steps to shape the local systems through which e-health will operate. Their efforts to translate federal and provincial e-health policies into community policies provide the focal points for this chapter. …

 O [Keewaytinook Okimakanak Tribal Council] Telehealth/ K Telemedicine [T]he First Nations Inuit Health Branch (FNIHB) of Health Canada dedicates resources to cover the operational costs of telemedicine and other e-health-related network sessions in the 24 Zone communities … [The Ontario Telemedicine Network (OTN)] connects K-Net [First Nations wide-area network] to Ontario’s e-health backbone, enabling health clinics in the 24 Zone First Nations to communicate with and access physicians and specialists from five hospitals in Ontario and Manitoba (including a variety of clinical specialists from potentially 70 different specialties over the OTN). In terms of other network sessions shaping e-health policy, KO Telehealth/Telemedicine (KOTH/M) provides a variety of educational and information services in support of clinicians and community health workers based in the Sioux Lookout Zone. From FNIHB Health Canada’s policy perspective, KOTH/M’s mandate was to mediate consultations between patients and clinicians (i.e. doctors and specialists) in distant locations. This narrow view of e-health is commonly known as telemedicine, which is basically the use of ICTs to enable medical interventions at a distance. Telemedicine does not, for example, include the use of ICTs for public health education or staff peer support in its definition, nor does it include the management of patient information systems or the use of search engines to retrieve health information. These other ICT-based systems fall under the more general

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heading of e-health, which also includes systems of organizational change related to enabling the effective use of ICT infrastructure. …

A New (E-health) Mediator Enters the Zone Under the KOTH/M model, before prospective community telehealth coordinators are accepted, they must undergo a certification process developed and instituted by KO Telehealth. Through this process CTCs [community telehealth coordinators] learn a variety of tasks, including how to set up telemedicine equipment for clinical consults, how to guide consults, how to operate videoconferencing units for general meetings and how to promote KOTH/M to patients and the wider community. In this way the CTC role provides community members with opportunities to learn about and handle telemedicine and videoconferencing in order to help KOTH/M and its partners build e-health systems that community members will trust. At present, formal qualifications for the role are minimal. As with most community health worker roles, ‘learning by doing’ predominates and peer support is essential for effective job performance. … To be effective mediators the CTCs require opportunities to educate themselves regarding both the clinical and community-based health care systems. How they prefer to spend their work time appears to be skewed in favour of the community-based health care system. … As we understand their mediator role, CTCs normally participate in the set-up and take-down of clinical sessions. The intensity and extent of their participation may vary during actual diagnostic interventions at the patient end, and nurses are often present and may intervene. Education sessions, however, normally involve several CTCs for the full duration of a session, alongside a variety of community health workers and community health representatives (depending on session topics, personal preferences, and so on). In terms of time spent on the job, education sessions may have a greater influence on CTCs’ interpretation of their roles than clinical sessions, especially considering the importance of ‘learning by doing’ in the CTC job role. These are clearly the network sessions in which CTCs and community health workers have the greatest exposure

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to KOTH/M and the videoconferencing technology. The data suggest that KOTH/M’s pilot project, more than merely increasing efficiencies in the clinical system, reflects and reinforces the notion of two systems of health care. CTCs straddle both systems and perceive themselves as mediators, but appear to find their most natural fit in the community-­ based health care system. … We believe that if FNIHB Health Canada wants to reinforce local appreciation for the clinical aspects of e-health to, among other objectives, improve the uptake of telemedicine, its change management strategy should be holistic and include resources and systems that address the community health workers’ education and capacity needs. Community health care systems are strong cultural determinants of the First Nations’ entire health care experience. Encompassing personal health and community wellness, they frame patients’ perceptions of the quality of care. To be successfully integrated as a positive force in the First Nations’ health care experience, e-health tools such as telemedicine need to be translated in terms of community health and be confidently endorsed by community health workers if they are to be taken up and owned by the communities. …

Conclusion Our research in the Sioux Lookout Zone … indicates that First Nations health care para-professionals, community health workers, community health representatives and community telehealth coordinators straddle a dual system which contains clinical and community-based health care components. Though they act as mediators between the different components, they perceive themselves primarily as representatives of community-­ based health care, entrusted by the First Nations (and FNIHB Health Canada) to support patients undergoing clinical care, address deeper spiritual and emotional needs, and reinforce linkages between community well-being and personal health. Through the work of these para-­ professionals, health clinics in the First Nations are not simply nursing stations for visiting clinicians and points of clinical contact for patients. They are important places for community-based health care.

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The emergence of e-health policy through telemedicine and other ICTbased systems within KOTH/M simultaneously affirms and challenges the clinicians’ and para-professionals’ roles in the health clinics. As KOTH/M moves beyond its pilot phase, the prevailing sustainability model attributed to its future growth and operations stipulates a dominant role for telemedicine based on a narrow conception of e-health: the reduction of non-emergency, medical-related travel. We acknowledge that it is important to consider efficiency in remote health care contexts, but we are wary of sustainability models that focus too narrowly on the clinical aspects of First Nations health care. Such models risk alienating patients and paraprofessionals who measure the value of health care systems in terms of their impact on community well-being, as well as individual patient health. They may also risk overtaxing clinical staff if complementary support systems are not encouraged to develop in these communities. … Through e-health, both clinical professionals and community paraprofessionals will increasingly be called on to utilize ICTs in their work with patients in the remote First Nations. They will surely come to require more local support to shape and manage these ICTs and could therefore benefit from a professional e-health mediator. Ideally, such a mediator would help them choose and implement the right applications, whether videoconferencing, online information searches or other computer-­mediated activities; and help local stakeholders to integrate e-health with community policy.

 eflection by Nadine Wathen, Roma Harris R and Sally Wyatt It is an interesting time to reflect on why we decided that Mediating Health Information was an important topic for an edited collection. The work arose from the ‘Action 4 Health’ collaboration led by Ellen Balka at Simon Fraser University, Vancouver, Canada (one of the editors of Gender, Health and Information Technology in Context, also in this series, and discussed in Section 1, Innovation); of concern to us were the new public management discourses taking hold in most Western democracies, and the enthusiasm for information and communication technologies (ICTs) as ways to bridge funding gaps in core health services. Neoliberal

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narratives position(ed) ‘self-care’, supported by shiny ICT gadgets, as a panacea for both improving health outcomes and saving tax dollars. Essentially, we wanted to trouble the following: The fantasy of some policy-makers, played on by technology vendors, is that information can be sent easily from its source to its intended recipients, and that it will not be affected by the medium or by the context in which the recipients are situated, including factors such as their health situation, living arrangements and education. (Wyatt et al., Chap. 1, p. 3)… and bring in the reality experienced by oft-besieged health information seekers. Our focus became understanding the ‘middle space’ between health information and its producers, and health seekers and their needs. While ICTs were a key concern, other middle-space actors—human or otherwise, each exerting agency—were also of interest.

We turned to Bruno Latour, and his notion of mediators, framing our approach as follows: Info(r)mediation … is used to draw attention to those situations in which the human mediators convey information in order to effect change in the behaviour or actions of those looking for information. … Thus, the ‘(r)’ draws attention to the way in which compliance or coercion is sometimes implied in the info(r) mediating process. (Chap. 1, Wyatt et al., p. 6)

Contributors grappled with issues regarding info(r)mediation strategies ranging from paternalistic (e.g., policies implemented by benevolent administrators to protect naïve users) to pernicious (e.g., embedded filters removing offensive content that ‘over-block’ important health information) or even malicious (e.g., algorithms selecting health information to serve ends often antithetical to user needs). Thinking of the regulatory considerations we discussed more than a decade ago now seems quaint in today’s age of surveillance, micro-targeting and the ‘end of privacy’ (see van Dijck et al. 2018; Sharon and Lucivero 2019). Key themes pulled through the work included the positioning, and labelling, of those seeking health information. As described by Henwood and colleagues (Chap. 3), we wanted to encourage thinking of these

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people as ‘engaged citizen-users rather than neoliberal consumer-users’. The extent to which this reframing has been successful remains unclear. We also examined how we construct the info(r)mediators themselves, from ‘high(er) tech’ (e.g., search engines) to ‘high(er) touch’ (e.g., Indigenous health workers) and (ideal?) hybrid models where trained human mediators, such as librarians, can support health information seekers in finding and interpreting the best information among various on- and off-line sources. We posited an information seeking and provision spectrum ranging from ‘informing’ to ‘caring’. Given the austerity-­ driven turn away from, for example, librarians to self-serve computer kiosks, we are concerned that the ‘caring’ that often accompanies human-­ mediated technological interventions is being lost. Artificial intelligence (AI) applications to augment human mediators already exist, with the ‘promise’ of AI-enabled robots replacing many health care/information actors just around the corner. If those promises materialise and AI becomes able to mimic human caring, it really is a whole new world. Finally, a note on the theme of ‘transforming and distorting’ information through its various conduits is given. At the time, we were concerned with things like invisible Google algorithms and ‘for your own good’ filters making credible and useful information hard to find. However, these concepts now take on a more sinister meaning, with profit- and anti-­ science-­driven misinformation and ‘fake news’ leading to major concerns like vaccine denial and the return of diseases like measles. When children are dying, these are no longer theoretical concerns. So, despite various policy ‘fantasies’ and industry boosterism, health and health information inequities have not been magically resolved by technology. ‘Solutions’ have come and gone, with little of use embedded in systems, whether interoperable electronic medical records or user-­ focused health and wellness apps. People have not become, or at least they do not seem to act, better ‘informed’ and the ideal form and function of info(r)mediators remains elusive. Current crises, including falling life expectancies due to overdose epidemics, and ‘grey tsunamis’ as populations age, health care costs increase and tax bases shrink, may again focus policy attention on useful hybrid info(r)mediation models where ‘touch’ and ‘tech’ intersect to provide ‘care’.

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 ernike Pasveer, Oddgeir Synnes and Ingunn B Moser. (Eds.). (2020). Ways of Home Making in Care for Later Life

F rom: Bernike Pasveer, Oddgeir Synnes and Ingunn Moser. Doing Home with Care in Ageing Societies, pp. 1–16 Home as a Noun ‘Old age has its infirmities,’ or so the saying goes. This is a book about what happens to ‘home’ when its defaults—its unquestioned, standard settings—are being disrupted by infirmities: ageing, frailty, dementia and dying. Of course, whether and how ageing disrupts default ways of living, is not a universal given. This book takes issue with Western policies and desires in light of what is cast as the ‘problem’ of ageing societies, here defined as a twofold crisis: of a rapidly ageing population and of a resulting care deficit both quantitative and qualitative. Ageing thus seems to

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disrupt home as it exceeds its ‘normal’ capacities for caring, and it disrupts care as it exceeds available care provisions. We don’t think of homes as places without care until ill health enters. … ‘[H]ome’ is now increasingly being forwarded in policies, public discourse, academia and in the expressions of ageing people themselves as the place to grow old in and die. Home as a place of care connotates cost-­ effectiveness, the informalization of care and a plethora of normative ideals about ageing well despite and with its frailties: independence and autonomy, control, productivity, proximity and familiarity. … But home is promoted as the preferred place to be when growing old and frail, living with dementia and dying. Only in the case that home can’t provide anymore do care institutions come into view. However, these too must now aspire to be ‘homely’ and provide home with care to their residents. Yet a common and fundamental assumption within the ageing-in-­place discourse is that home is always somehow available as a singular, given location that naturally affords the inhabitant to live and age well (i.e., independently, healthily, productively etc.). Home seems to always be a noun. Of course, this home does not always actually exist. In the contexts of migration and transnational kinning as well as when home is lost due to dementia, home as a singular place is very literally not available (anymore). And home—even if singular and in place—does not in and of itself afford living well and being ‘at home,’ as Douglas (1991) has so forcefully shown. ‘Home starts with bringing some space under control,’ (289, emphasis ours) she writes, and its orderings may be blissful as well as with ‘laughably complex, tyrannical rules, unpredictably waived and unpredictably honored, and never quite amenable to rational justification’ (298). …

H  ome as a Verb This book argues for the need to understand home and how it intersects with care in later life as a making. We treat the intersections with care as moments or processes that call for articulations of what it takes to do home with care, care with home. We regard home as a verb

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(Blunt and Dowling 2006; Mallett 2004: 79). Home making always requires relations and arrangements between very different actors: older persons, care workers, family members, stairs, walkers, wheelchairs, spaces, policies and health care systems. Whether and how home emerges from and in these practices can never be taken for granted. Emphasizing the work that goes into home in care as making allows us to underline any eventual achievement of home with care as temporal, partial and unfinished. We hope to show how such a dynamic understanding of home brings to our attention the precariousness, the tensions and dilemmas and the possible uncanniness of home and home making in later-life care. But by looking at what appears as (im)possible in practice, we also hope to create leeway and alternatives for those involved in the dynamics of making home with care in later life. We think that such an understanding of the intersections of home and care is timely given the desires and policies for ageing in place, their problematic fixation on the placeness of home and care, and the often unachievable normatives of ageing. … This book moves forward with the idea of verb-ing home and, in focusing on home making in care for later life, we like to forward an understanding of home making as about things not given—as temporal and partial, not lasting and encompassing. As experimental, not fixed, as forever unfinished and thus open to new possibilities of making careful arrangements. With qualities that may, when opened up, bring forth helpful insights and inspirations for all who care.

F rom: Oddgeir Synnes and Arthur W. Frank. Home as Cultural Imaginary at the End of Life, pp. 19–20, 35 The dying patient spoke clearly when he answered the hospital ethicist’s question: ‘I want to go home.’ His medical team had decided that he could no longer benefit from treatment, but some members of his family wanted more treatment, so an ethics consultation led to the question of what he wanted. The problem posed by the patient’s response was not his

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mental competence; the problem was that, for him, as for most people, home has multiple meanings. Did home refer to the nursing home from which the patient had come to hospital? Or did he mean his former residence where he lived with his family from his second marriage before going to the nursing home? For the children from his first marriage home might mean their former family home. Or, depending on the man’s spiritual beliefs, home might refer to an afterlife, and he might be expressing a readiness to die. As a speech act, the statement ‘I want to go home’ is not so easy to interpret. Most people have multiple referents when they speak of home. We understand the word home as perhaps the primary instance of a class of words that we call cultural imaginaries. We adapt this idea from philosopher Charles Taylor’s (2004) work on what he calls ‘social imaginaries.’ Taylor’s premise, which we share, is that ‘modes of experience’ are available to people ‘from the society in which we are born’ (52). Personal experience is socially shaped and conditioned. Persons imagine based on social imaginaries and home is such an imagination. … In my work [Synnes offered creative writing and narrative storytelling sessions at nursing homes in western Norway for several years], I have been struck by how emotionally attached people were to their small stories of childhood homes. A telling example occurred at the first group session in the palliative unit at the nursing home. Staff asked if I wanted to go into the room of an elderly lady well into her 90s. The nurses thought that she might want to be part of the project. Entering the room, I saw a thin, frail, elderly woman lying in a hospital bed, barely breathing. I told her who I was and why I was there. The lady kindly rejected any telling; she was too sick and struggled with nausea. I asked if she minded if I sat down for a few minutes with her; she nodded affirmatively. After a while, and after exchanging some small talk, I noticed her dialect and asked where she came from. She named a small community on an island outside of the city, a place I knew and had visited. Hearing this, the woman immediately lit up and started telling of the farmhouse she grew up in and how she used to walk down to the small pier to greet the steamboat that came bringing mail, people and groceries. For a few minutes

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she talked of her childhood home and village, including details of her parents, the name of family members, the colour of the house, the animals, the barn and how this was such a special place. Then she got tired and said that she needed to rest. When asked if she would like me to come back next week and read what she had just told, she smiled and said yes, please. When I got up to leave, the woman grabbed my hands and, beaming, she whispered that this had been such a wonderful time. Before returning, I found out that the woman died a few days after our meeting. This narration and others of childhood homes may not seem very storylike if we are thinking in terms of a beginning, middle, and end or if we expect the narrative to involve some sort of ever-complicating events. Instead, these are meditations on relations, materials and connections from the narrators’ childhood home and setting. These stories mention the different people in the home: parents, grandparents and siblings. They speak of material aspects of home: how the house looked, the rooms, who stayed where. And in several instances we hear of the household economy: farming, contact with animals, the sharing of the work load. Some of the stories end with an evaluation: ‘this was the best place to grow up’, or ‘what a time to look back upon!’ For some of the narrators the tellings of home also become performances of a hope to revisit the place one final time ‘I have to get up there once more’; for others it involves a wistful experience of knowing they will not: ‘I will never be there again. But it would have been nice to see the place one last time and see if everything was the same.’

F rom: Christine Ceci, Ingunn Moser and Jeannette Pols. The Shifting Arrangements We Call Home, pp. 294, 300–302, 309–311 Articulation Empirically, this chapter is based on stories from ethnographic fieldwork in family care practices at home, particularly two cases of families caring for a family member with dementia: the Roberts family and the Cruz family. Theoretically, it draws on an approach in care research that investigates care as embedded in and resting upon a wide web of relations that

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entail much more than the dyadic relations between individual human caregivers and care recipients …. In the following, we present stories made from excerpts of fieldnotes, offer commentary and interpretations and develop our line of argument by working through the empirical materials. In this way, we aim to create analytical space for empirically unravelling and articulating how home with care emerges in and through shifting arrangements: through particular sets of relationships between people, things and institutions that are dynamic and changing. Our analytical strategy is to follow the arrangements on home making and maintaining as practices and processes in time rather than as individual actors or fixed objects. From there, we follow the simultaneous processes through which certain positions, bodies and objects and their identities and relations become defined, singled out and contested. First, we stay close to the house and observe the tasks our two families face there. Then, we move on to show what elements from outside the house order what becomes home and care regardless of internal forces.

Shifting Relations and Arrangements This story from fieldwork with the Roberts family demonstrates, firstly, that living with dementia implies profound changes in persons and their relations to others, arrangements, routines and activities. Secondly, it relates the extent of the work, struggles and tension entailed in adapting to the changes that at-home life with dementia brings. Thirdly, it shows the continuously shifting nature of any arrangements of home with care. When Ken complains that Marla’s current state is like ‘living with a two year old’ and that there is ‘no activity,’ this implies that the ordinary and pleasant activities of everyday life and of shared interests seem gradually to have become replaced by other everyday activities and relations reconfigured as work. It reflects that their relationship has indeed changed and is now very much focused on reasoning, cajoling, persuading, struggling and sometimes forcing Marla to participate in routine care as she is no longer concerned with the body. Much of Ken’s time is spent containing and managing Marla on one hand, protecting the physical space of

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home they created together from her fiddling, wandering and moving things where they should not be and, on the other hand, taking care of her bodily and personal care in order for her to appear as the well-groomed woman and wife she used to be. But Marla is not the only one who has changed. Ken, their relationship as spouses and their shared way of life have also changed. While Ken is working hard to maintain and protect their home and way of life as a married couple from Marla’s unruly body and expressions of dementia and therein to also create some particular qualities and ideals of home, he seems at the same time to be estranged. Estranged from her, his relationship with her, their shared experiences and activities and home. He is focused on maintaining a former standard of home so much so that he feels trapped and now only sees change, decline and loss. Still, even if they, for instance, have lost the practice of easy verbal exchanges as Marla’s ability to communicate has diminished, they are still known to each other in a highly familiar way. Ken has an intimate way of knowing Marla that seems to be about more than or other than the implementation of instrumental tasks of personal hygiene and appearance, even though it is these tasks that take up most of his day and become the focal point. While Marla is mostly treated as an object to be contained and managed, in a quite passive way she both resists and shapes their interactions. In a rare moment of lucid speech, after a struggle about an outdoor jacket on one of the trips to see a doctor where Chris accompanied them, Marla said, ‘Ken is always fussing.’ In another moment, while Ken was standing in the kitchen, Marla came up behind him, tapped him lightly on the back and then kissed his back before walking away again. Marla may seem to get to be at home through her wandering and fiddling with things. But this is a form of hominess that no longer fits with their old habits, routines and standards. For Ken, this disrupts home. For him, the situation is at the brink of being overwhelmed by change and where new roles and identities cannot provide a sense of home that is bearable for him. When Ken speaks of Marla, this mostly suggests that the situation has shifted into a quite new set of relationships of carer and cared for. This is reinforced by the fact that Ken, in his desperation to manage the

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situation and get more help, has taken up the role of contributing to the doctor’s and geriatrician’s painstaking documentation of the progression of dementia and the decline of Marla’s condition. In practice, however, the opposite is also the case, as when Ken writes letters to the doctors referencing ‘your patient, my wife,’ when he continues their old social habits of barbequing on Friday evenings and when their relationship as spouses and as a couple is maintained through a shared bed. What this clarifies is that, for some, making home and care does not necessarily imply that home is simultaneously maintained for the other actors involved such as partners, families or other caregivers. We also see that, although one result may be continuity, this continuity incorporates shifts and changes to different arrangements, relations and positions. Importantly, this story shows how this shifting of relations and arrangements rests upon and is distributed across a wide set of actors that include people, objects, normative expectations, practices and their material mediations. They consist of gates on stairs and respite care on Saturdays, of keeping the house tidy, managing the many hours of ‘being on duty,’ putting objects out of reach to prevent them being ‘fiddled about’ and contributing to the trajectory of dementia by producing documentation on the progression of Marla’s disease and condition. …

Discussion and Conclusion So what does this make of home? What home means in concrete situations is the result of the relationships that organize those situations: the condition of the members of the household that share daily life, the condition and organization of the material space/residence, the care available, the devices and techniques needed, the flexibility of its links, the prioritized norms and ideals one strives to achieve and so on. And where does it bring us to see home as the result of shifting arrangements that organize private and intimate relationships and ‘stuff’ in particular ways? Our stories show the work involved in keeping in synch with these shifts. At first, old family roles can be maintained but,

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paradoxically, this maintenance involves a lot of work from the members of the household. Family members slowly obtain new positions in the way home is arranged. … Our notion of shifting arrangements made the time dimension in how/ what is home clearer by showing the shifts people had to accommodate. In life with dementia, things are shifting, and the arrangement that fit yesterday no longer fits today. In the ageing-in-place policy, home becomes the house, and the house becomes a rather fixed and static place: the place where Alzheimer’s started and where you have to then remain living. … It also shifted the notion of home as a space, the space of the house. The arrangements and practices that make home and make one feel at home can be distributed across locations and brought along; it is possible to be at home outside of the home. But home could also be in different places, as arrangements that may or may not fit well but are one of the elements that constitute home. … So, even if home is not a place, the house and what it can and cannot accommodate is important in the arrangement. With the notion of home and home with care as shifting arrangements, it becomes clear that the task at hand will then be not to keep people living at home/in their houses for as long as possible. Rather, it shows that the challenge is to create and arrange for flexible arrangements that allow people to organize their intimate relationships in the best possible and most sustainable way for them.

F rom: Ken Worpole. A Home at the End-of-Life: Changing Definitions of ‘homeliness’ in the Hospice Movement and End-of-Life Care in the UK, pp. 135–136 This chapter addresses the idea of ‘homeliness’ in relation to the design of hospices and other places of palliative care, principally in the UK. This comes at a time when growing numbers of people are living longer lives, an increasing number who depend on institutional care, often in conditions that offer little or no emotional support or understanding as they approach death. In the UK, there has been increasing dissatisfaction with the quality of care—including the commonly accepted ideas of ‘homeliness’—in both public- and private-sector residential homes, as well as

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hospital geriatric wards, in many cases reaching the level of a national scandal (Demos 2014: 9). The fact that in the UK there has been an ‘All Party Parliamentary Group on Dying Well’ suggests that the concept of ‘a good death’ is becoming a new concern of public policy, as well as being increasingly central to medical and care-for-the-elderly ethics and practices. Hence, the UK has seen the growth of the hospice movement, with its key emphasis on innovative, noninstitutionalised architecture. In Modern Hospice Design (Worpole 2009), I argued that the independent and charitable sectors providing hospices and, more recently, the Maggie’s Cancer Care Centres have offered new ways of thinking about the design, programme and ethos of homeliness at the end-of-life, which mainstream care provision is now adopting. Nevertheless, hospice architecture itself has had to rapidly adapt to changes in the building programme, even in a relatively short amount of time. Beginning as an inpatient service for a small cohort of people at the very end-of-life, hospices are becoming hubs of extensive outreach programmes, often catering to hundreds of outpatients for whom the hospice has become a ‘second home’ or ‘community of peers.’ Likewise, the architecturally distinguished Maggie’s Cancer Care Centres provide drop-in centres catering to a wide range of informal users, where homeliness is created by subtle forms of space management and choreography in settings employing imaginative design and the use of quality materials. Meanwhile, tensions continue between the pressure to provide an increased (and individualised) medical programme within the hospice or whether to prioritise a (community-focused) social programme. The focus of this chapter is how to address the problem of the institutionalisation of end-of-life care—which affects both patients and staff— through the use of more imaginative architecture, particularly that which allows for greater connectivity to the wider world. This can be achieved through a more outward-facing design, but also through the programming of activities within residential boundaries and well beyond. The concept of the ‘home range’ is explored, which expands the idea of care well beyond the building to the neighbourhood and wider community and that has both spatial and temporal elements. Thus, this chapter helps

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to restore to prominence the idea that architecture is a problem-solving discipline, not only a technical and aesthetic approach to construction.

 eflection by Bernike Pasveer, Oddgeir Synnes R and Ingunn Moser Looking back at the history of a book that does not have one yet—Ways of Home Making in Care for Later Life is still in production as we write this—seems undoable. But the process through which this edited volume came into existence might merit some reflection. For this process seems to differ from how edited volumes tend to come into being, where a thematic panel at a conference or a workshop generates the idea to maybe turn the papers into a special issue or an edited volume. We worked in a different way, and it may be that it contributed to the process being relatively short and efficient, but also a pleasure to have been engaged in. Here is how we worked. The idea of the book was born in April 2017 when Bernike stayed for a month at VID Specialized University in Oslo to work on an article of her own, and be around Ingunn and Oddgeir for inspiration and pleasure. We thought of something we might work on together and that would combine our diverse research interests. The ‘something’ became an edited volume on the topic of ‘home’ as the blackboxed side of the ageing-­ in-­place paradigm. With a short outline, we checked with the editors of this series, who were very positive about the idea. Next we approached a number of potential authors (collected from our respective academic networks) with a full outline of the book, an invitation to contribute and a request for a synopsis for their chapter to the book. We received 14 positive responses of in total 17 authors. The next step was that we asked the authors—ourselves included—to write a full draft chapter to the book, and to make sure to have that with us in the summer of 2018, as we had secured a week-long ‘authors’ workshop’ at the Lorentz-NIAS Centre in Leiden, the Netherlands, in September 2018. During that week, all first and some second authors

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were present (with one participating through Skype). After an inspiring key-note by Jan Willem Duyvendak from NIAS, we went through an intensive peer feedback of all chapters as well as through possible modes of thematically (re-)ordering the book. This workshop—well cared and catered for by the Lorentz staff—proved to be crucial, not only because of the peer feedback but certainly also because it generated a feeling that this book was a collective enterprise and a sense of responsibility to make it work. After the workshop, all authors received instructions from the editors on how to revise their chapters given the feedback and the envisioned place of their chapter in the logic of the volume as a whole. By March 2019, all authors had handed in the final drafts of their chapters. In addition to the workshop, the editors had also been able to secure the possibility of a month-long sabbatical stay at the Fondation Brocher to edit all chapters and write the first, introductory chapter. Oddgeir and Bernike actually stayed the full month; Ingunn came over for a week. This month of work in such a secluded and blissful place—surrounded by mountains and with a splendid view onto the ever-changing Lac Léman (or Lake Geneva), well taken care of by Brocher staff and accompanied by a wonderful group of other scholars—proved highly productive. During another short stay of Bernike at VID, everything was finalised and on June 30, 2019, the precise date indicated in our contract with Palgrave Macmillan, we could upload the entire volume to the folder we shared with the publisher. Without the dedication of the authors, and the two periods in which we could work as a team (as authors during the workshop and as editors throughout but in particular at Brocher), and without the pleasant synergy within the editorial team, the book would not have been out, and certainly not within such a short time span. But we would also conjecture that starting with an outline of the book and then full draft chapters was a productive move.

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References Bauer, G., Elsallab, M., & Abou-El-Enein, M. (2018). Concise review: A comprehensive analysis of reported adverse events in patients receiving unproven stem cell-based interventions. Stem Cells Translational Medicine, 7(9), 676–685. Berger, I., et al. (2016). Global distribution of businesses marketing stem cell-­ based intervention. Cell Stem Cell, 19(2), 158–162. Blunt, A., & Dowling, R. (2006). Home. London: Routledge. Demos. (2014). The commission on residential care. London: Demos. Dijck, J. v., Poell, T., & de Waal, M. (2018). The platform society: Public values in a connective world. Oxford: Oxford University Press. Donaghey, K. (2013, October 12). Sunshine Coast mum flies to Beijing for unproven stem cell treatment for autistic daughter. The Courier Mail. Retrieved February 20, 2016, from http://www.couriermail.com.au/news/ queensland/sunshine-coast-mum-flies-to-beijing-for-unproven-stem-celltreatment-for-autistic-daughter/storyfnihsrf2-1226738607476. Douglas, M. (1991). The idea of a home: A kind of space. Social Research, 58(1), 287–307. Foucault, M. (1972). The archaeology of knowledge (Sheridan Smith, A., Trans.). London: Tavistock. Latour, B. (2005). Reassembling the social: An introduction to actor-network-­ theory. Oxford: Oxford University Press. Lau, D., Ogbogu, U., Taylor, B., Stafinski, T., et al. (2008). Stem cell clinics online: The direct-to-consumer portrayal of stem cell medicine. Cell Stem Cell, 3(6), 591–594. MacLennan, L. (2014, October 18). Overseas MS treatment sought by hundreds of Australians despite risks and cost. ABC News. Retrieved February 20, 2016, from http://www.abc.net.au/news/2014-10-18/australians-seek-mstreatment-overseas-despiterisks/5823790. Mallett, S. (2004). Understanding home: A critical review of the literature. The Sociological Review, 52(1), 62–89. Pasveer, B., Synnes, O., & Moser, I. (Eds.). (2020). Ways of home making in care for later life. Basingstoke: Palgrave Macmillan. Petersen, A., Munsie, M., Tanner, C., MacGregor, C., & Brophy, J. (2017). Stem cell tourism and political economy of hope. Basingstoke: Palgrave Macmillan. Petersen, A., & Seear, K. (2011). Technologies of hope: Techniques of the online advertising of stem cell treatments. New Genetics and Society, 30(4), 329–346.

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Petersen, A., Seear, K., & Munsie, M. (2014). Therapeutic journeys: The hopeful travails of stem cell tourists. Sociology of Health and Illness, 36(5), 670–685. Sharon, T., & Lucivero, F. (2019). Introduction to the Special Theme: The expansion of the health data ecosystem—Rethinking data ethics and governance. Big Data & Society, 6(2). https://doi.org/10.1177/2053951719852969. Tanner, C., Munsie, M., Sipp, D., Turner, L., & Wheatland, C. (2019). The politics of evidence in online illness narratives: An analysis of crowdfunding for purported stem cell treatments. Health, 23(4), 436–457. Taylor, C. (2004). Modern social imaginaries. Durham: Duke University Press. Wathen, C. N., Wyatt, S., & Harris, R. (Eds.). (2008). Mediating health information: The go-betweens in a changing socio-technical landscape. Basingstoke: Palgrave Macmillan. Worpole, K. (2009). Modern hospice design. Abingdon: Routledge.

Section 4: Knowledge Production Caragh Brosnan, Jenny-Ann Brodin Danell, Pia Vuolanto, Mike Michael, Marsha Rosengarten, Margaret Sleeboom-Faulkner, and Jessica Mesman

Introduction What counts as knowledge and expertise and how these are produced, afforded authority to underpin practice—in diverse health-related settings—is a theme explored in many of the books published in the HTS Series. In this section, we have selected four books which give particular attention to this, and which do so from a variety of analytical and empirical perspectives. Together, they help us to understand how knowledge and associated evidence claims are produced, how they gain value yet are often contested, and how they shape the framing of the meaning of (ill)health

C. Brosnan (*) University of Newcastle, Newcastle, NSW, Australia e-mail: [email protected] J.-A. Brodin Danell Department of Sociology, Umeå University, Umeå, Sweden P. Vuolanto Tampere University, Tampere, Finland © The Author(s) 2020 A. Webster, S. Wyatt (eds.), Health, Technology and Society, Health, Technology and Society, https://doi.org/10.1007/978-981-15-4354-8_5

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by diverse actors, and what is to count as its management and treatment. Typically, this will involve the deployment of biomedical techniques, devices, and interventions (such as clinical trials) that draw on and integrate forms of knowledge and understanding. Such technologies are however always open to change, disruption, and critique. Stabilising knowledge claims through, for example, standards and protocols attempts to iron out such tensions, but is never fully successful. These processes are embedded in a wider political frame which in turn shapes policy and practice at local, national, and international levels: if we compare how ‘health knowledges’ and their associated technologies fare in different countries—what they mean, how they are used, by whom, what authority they carry, and so on—we encounter a complex and changing landscape. The first book, edited by Caragh Brosnan et  al. (2018), guides us through the complex terrain known as ‘complementary and alternative medicine’ (CAM). Brosnan and her co-editors challenge the common assumption that CAM is outside of and critical of conventional biomedical orthodoxy and practice. They and their co-authors show how the area has engaged with and indeed been incorporated into aspects of biomedicine and its knowledge production, while at the same time being subject to powerful forms of professional and governmental control. Tensions between CAM practitioners—for example in the field of acupuncture—and biomedicine arise over what such integration means for

M. Michael Department of Sociology, Philosophy and Anthropology, University of Exeter, Exeter, UK M. Rosengarten Department of Sociology, Goldsmiths, University of London, London, UK M. Sleeboom-Faulkner Department of Anthropology, University of Sussex, Brighton, UK J. Mesman Department of Technology and Society Studies, Maastricht University, Maastricht, Netherlands e-mail: [email protected]

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the core health and treatment modalities found in CAM. Yet these are key to the forms of expertise and co-produced treatments (between practitioner and patient) that characterise CAM. Our second book by Mike Michael and Marsha Rosengarten (2013) examines processes of knowledge production in the very different domain of AIDS and HIV. The authors focus on the development and testing through a randomised control trial (RCT) of a drug to treat HIV. They show how the drug itself has to be understood not simply as a biochemical compound but as one that carries wider social, political, and cultural cargo. A central issue here is that the RCT that measured the drug’s safety and efficacy failed to understand the actual context of use for patients, key to its effectiveness on the ground, and so of central importance to its prophylactic or preventative value. The bioethical considerations that underpinned the RCT failed to consider this social context of use, and crucially the understanding, knowledge, and concerns of those taking the drug. What counted as knowledge remained in the preserve of those responsible for delivering the RCT. Our third book by Margaret Sleeboom-Faulkner (2014) takes us into the related but much broader area of biotechnology, especially in regard to genetic testing and biobanks. Again the question of bioethics and its oversight of new technologies is the focus, and with echoes of the previous book, concerns are raised about its inadequacies, notably failing to consider what Sleeboom-Faulkner calls the ‘life assemblages’—the diverse range of actors and communities—that together co-produce what a ‘life worth living’ actually means. The new technologies serve some but not all interests, and this is shown to vary in different national settings—here China, India, and Japan—where local political- and market-based processes shape the way biotechnology is applied and define what ‘life’ may be and what it is worth/and how worth living. Jessica Mesman, in Uncertainty in Medical Innovation. Experienced Pioneers in Neonatal Care (2008), examines how staff on a neonatal intensive care find their way in high-density zones of uncertainty. Mesman focuses on the in-between zone—on the hinge between the known and the unknown—and explains how various ways of ordering prevent the treatment process from stalling. Yet, they intervene differently in the constitution of knowledge and this may lead to frictions in the decision

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process regarding responsibility, the timing of when something has to be done, or when enough is really enough. Situating knowledge, it turns out, requires not only coordination at the level of the individual case (the construction of facts, the robustness of a moral turning point or the choice of a treatment trajectory), but also at the level of reasoning (repertoires), speaking (vocabularies) and acting (scripts). Mesman’s book should not be viewed as strictly an inductive effort, or as ‘just another case study’. Instead, it offers a new perspective on competences and the structure that comes with specific styles of ordering day-to-day practices. This analytical scope can be understood as an act of exnovation: that which is already present in practice is foregrounded. Exnovation of styles of ordering reveals how facts, values, and medical actions are interdependent and what actually takes place at their intersections. Together, these four books illustrate the dynamics of knowledge production, the contexts shaping them, and how a comparative and multidisciplinary perspective helps us to understand when and why forms of knowledge, evidence, and expertise begin to congeal yet are always open to critique.

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aragh Brosnan, Jenny-Ann Brodin Danell C and Pia Vuolanto. (Eds.) (2018). Complementary and  Alternative Medicine. Knowledge Production and Social Transformation From: Caragh Brosnan, Pia Vuolanto and  Jenny-Ann Brodin Danell. Introduction: Reconceptualising Complementary and  Alternative Medicine as  Knowledge Production and  Social Transformation, pp. 1–29 The purpose of this volume is to take sociological studies of complementary and alternative medicine (CAM) in a new direction. Our goal is to show that CAM not only reflects, but is shaped by, and implicated in, social transformations. We aim to shift the focus away from CAM as a stable entity that elicits perceptions and experiences, and towards an examination of the forms that CAM takes indifferent settings, how global social transformations elicit varieties of CAM, and how CAM knowledge and practices are co-produced in the context of social change. To achieve this, the volume draws strongly on Science and Technology Studies (STS)—an area that has influenced sociological and anthropological thinking in relation to other domains of health practice (Martin 2012; Webster 2002) but which is only beginning to inform studies of CAM. STS approaches are particularly attuned to studying knowledge-­ making practices and to unpicking controversies. The chapters in this volume demonstrate that the combination of a sociological focus on social transformations with an STS-informed perspective can offer new understandings of the material, social, and cultural dimensions of CAM …. The fact that CAM has rarely been a topic of STS inquiry probably reflects the historical construction of CAM as ‘non-science’ and its relatively recent move into the sites of scientific knowledge production that have been the predominant focus of STS. This development in itself raises interesting questions both for STS and CAM scholars about what counts as ‘science’ and how scientific research methods and practices long deemed

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unscientific interact. STS has had, at its heart, an interest in the methods and ‘machineries’ of scientific knowledge production (Knorr Cetina 1999: 2) and how these are shaped by or co-constructed through social factors … [that is] to understand CAM as constituted through, and implicated in, technologies, modes, and communities of knowledge production. To a large extent, it is CAM’s resistance to biomedical ways of knowing and its historical exclusion from biomedical sites of knowledge-making and knowledge transmission (e.g. hospitals and universities) that has defined it as CAM. Such epistemological boundaries have begun to erode with the rise of integrative medicine and the professionalisation of many CAM types, including their move into tertiary education settings. These developments have seen CAM increasingly evaluated against the evidence hierarchy of [evidence based medicine], and in research centres around the world, CAM therapies and technologies are now the subject of clinical and basic scientific research, with all the infrastructure, personnel, and funding that this implies …. What these developments highlight is that, while CAM can be understood as paradigmatic of challenges to the authority of bioscientific frameworks, it is also increasingly part of the apparatus of contemporary bioscientific research. It is transformed by—and intervenes in—dominant modes of knowledge production, as well as other political and cultural domains. These complex epistemological configurations are explored in a range of empirical contexts in this volume. Along with CAM’s multiplicity, together the chapters highlight the transnational character of contemporary CAM, including the movement of CAM technologies and knowledge from one setting to another, between institutions, and into dialogue with different regimes of evidence.

F rom: Nadine Ijaz and Heather Boon. Safety as ‘boundary object’: The Case of Acupuncture and Chinese Medicine Regulation in Ontario, Canada, pp. 193–216 In this chapter, we apply a theoretical concept from science and technology studies, that of the boundary object, to the field of professional regulation as it pertains to traditional, complementary and alternative medicine (TCAM).

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In their 1989 case study of the Berkeley Museum of Vertebrate Zoology, Star and Griesemer advanced [their] social worlds theory by introducing to it the boundary object concept. They characterised boundary objects, which may be ‘abstract or concrete,’ as having ‘different meanings in different social worlds,’ while preserving a structure ‘common enough to more than one world to make them recognisable, a means of translation … [for] developing and maintaining coherence across intersecting social worlds’ (Star and Griesemer 1989: 393). Examples of boundary objects in Star and Griesemer’s original study included ‘species and subspecies of mammals and birds,’ as well as ‘the habitats of collected animal species, ’which carried distinct meanings across the social worlds of (among others) the museum’s ‘research scientists, curators, amateur collectors, private sponsors and patrons’ (p. 392). … In this work, we … demonstrate how evidence-based medicine’s cardinal virtue of safety may act, somewhat problematically, as a central discursive boundary object in defining regulatory parameters for TCAM practices and practitioners. With reference to the case of acupuncture and Chinese medicine regulation in Ontario, Canada, and to the arena of intersecting social worlds at play in that process, we point to three areas in which safety has played a key discursive role as a regulatory boundary object: (a)in establishing the need for acupuncture’s regulation, (b) in formulating training standards across the professions and (c) in defining policy to address the distinct ethnolinguistic features of the Chinese medicine profession …. How to characterise acupuncture’s safety profile was central among the core questions the Council posed of stakeholders. Stakeholders represented a range of individuals, as well as representatives of multiple social worlds including medical doctors, Chinese medicine practitioners and naturopaths, as well as chiropractors, nurses and physio-therapists. What was shared across these worlds was a common interest in seeing acupuncture regulated in the province, discursively expressed as a characterisation of acupuncture as sufficiently unsafe to warrant statutory controls …. [In 2001] the Ontario Council concluded that acupuncture and Chinese medicine should be regulated in order to protect the public from potential harms. Similar stakeholders were involved in this second investigation and again used safety-based discourse to substantiate a commonly held view among the occupational groups involved that

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acupuncture should be regulated in the province. The specifics of the risk discourses deployed differed, however, across occupational groups, reflecting the ways in which safety as boundary object carried contrasting discursive subtexts across social worlds. Some, such as Ontario’s physiotherapists and podiatrists, bolstered their safety-based argumentation in support of acupuncture’s regulation by turf-related claims over the practice, as well as efficacy-based discourse geared to invalidating the epistemic claims of Chinese-medicine-based practitioners. Chinese medicine practitioners, by contrast, used safety discourse to argue that their government should limit the practice of acupuncture to those with some Chinese-medicine-based training. ‘The improper practice of acupuncture may cause side effects,’ they argued, alluding to argumentation that had been foregrounded in the Council’s [earlier] 1996 report, which strongly distinguished the practice of biomedical needling from traditional acupuncture …. Notably, Ontario’s eventual acupuncture regulations would closely reflect the exclusively biomedical epistemic position underpinning the 2001 report’s recommendations. In separating acupuncture from its traditional Chinese roots, these regulations’ conceptual underpinnings exemplify the cultural misappropriation of traditional knowledge. Such misappropriation, we find, was made possible through the state’s adoption of risk-based discourses by stakeholders from biomedically trained occupational social worlds …. As a regulatory boundary object, the concept of safety took several guises across distinct social worlds, playing multiple roles in the drama surrounding the regulation of acupuncture and Chinese medicine in the province. For instance, state actors’ discursive emphasis on patient safety masked issues not directly safety-related. This was evident between 1984 and 1996, when the Ontario government changed its official stance as to whether acupuncture was sufficiently risky to regulate, although it is clear that the practice itself (and its associated risks) would not have substantively changed over this period. The notion of safety was also deployed to construct regulatory boundaries surrounding acupuncture that would ultimately preserve biomedicine’s epistemic and positional authority in the province’s regulatory structures ….

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We do not contest that safety should be given careful consideration in the professional regulation of TCAM practitioners or practices. However, the safety concept is malleable, capable of supporting a range of epistemic stances and, in our study, shown to be unevenly applied in ways that mask a range of regulatory issues and power dynamics across the range of health professions. As such, we propose that those involved in crafting professional regulations for TCAM practitioners and practices make efforts to identify and directly address these other issues and dynamics, so that a slippery rhetoric of safety does not inappropriately dominate the policy process …. [T]his chapter’s distinct contribution lies in its demonstration of multiple means by which a discourse of safety may dominate a TCAM professional regulatory project in ways that ultimately reinforce biomedicine’s epistemic and institutional authority. As our analysis demonstrates, this type of reinforcement of dominant power dynamics may occur even as these same power relations are contested by the inclusion or entry of traditional medicine practices and professions into healthcare systems from which they would have previously been excluded. This type of hybrid phenomenon, characterised by multidirectional power relations amidst the blending of healthcare systems and approaches that were once considered distinct, is an area ripe for additional research.

F rom: Cathy Fournier and  Robin Oakley. Conversions and  Erasures: Colonial Ontologies inCanadian and  International Traditional, Complementary, and Alternative Medicine Integration Policies, pp. 217–245 Canada and other high-income countries are increasingly integrating traditional, complementary, and alternative medicine (TCAM) into their public healthcare structures in response to increased public use. We conducted a qualitative document analysis exploring the nature of TCAM’s integration into public healthcare in Canada and globally by analysing TCAM-related documents from the World Bank, the World Health Organization (WHO), and Health Canada (Canada’s national health

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department). … Examples of TCAM practices in Canada include massage, indigenous healing practices/medicines, Yoga, Ayurveda, traditional Chinese medicine, and herbal medicine …. The ‘integration’ of TCAM practices into biomedical settings has been articulated as part of an ingrained pattern of indigenous knowledge expropriation, assimilation, and in some cases, even conversion or erasure. … Integration is taking place within the context of an emerging disease paradigm. The emerging disease worldview is a perspective on international health that is concerned with the development of the global medical-industrial technological complex (e.g., increasing the global capitalist market by increasing the market for pharmaceuticals). …. The World Bank, WHO, and Health Canada are governing institutions that exercise power through policy recommendations and policy making. As illustrated …, central themes and keywords emerging from the World Bank, WHO, and Health Canada sample documents suggest a biomedicalisation of non-biomedically oriented health beliefs and practices, and the further entrenchment of biomedical hegemony, which may be further facilitated through the integration of TCAM in biomedical education. Analysing World Bank, WHO, and Health Canada TCAM-­ related documents for language, central themes, and keywords helped contextualise the nature of TCAM’s integration into public health systems and its existence in biomedical education. …. A key thematic continuity between the World Bank, WHO, and Health Canada is the focus on safety through surveillance to the exclusion of other important concerns. The materials we reviewed from Health Canada in particular repeatedly refer back to the importance of including TCAM in biomedical education so that doctors can oversee patient TCAM use. They also emphasise how doctors need to learn how to advise their patients on the safe and effective use of TCAM. In a preliminary examination of some TCAM-related curriculum documents for example, [one] website includes a ‘Quackwatch’ screening guide which divides up

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TCAM practitioner behaviour into ‘Red Flag’ and ‘Yellow Flag’ categories. These categories cite specific behaviours physicians should be on the lookout for so they can advise patients against these therapies. Neglected in these discussions are many possible behaviours and practices that may be ethically questionable for any health practitioner, such as accepting gifts from pharmaceutical companies, overprescribing medication, the many adverse medical events that occur each day in healthcare; financial benefit from industry (Barnes 2017), and ghost writing (Sismondo 2009). Instead, the focus is only on TCAM practitioners as potential charlatans. Physicians are portrayed as somehow above unethical behaviour, implying that public safety is ensured against charlatanism by modern science. Our analysis suggests that efforts to standardise, regulate, and biomedicalise TCAM, which may be further facilitated through its integration into biomedical education, are reflective of the pervasive nature of biomedical hegemony. While it has been argued that biomedical dominance is not forever assured (Moore and McLean 2010), we suggest that the easy adaptability of bio-medicine to market interests makes it hard to resist, and relatedly, knowledge that doesn’t conform or measure up to biomedical benchmarks is at risk of being reinterpreted and lost. In light of this, it is important to continue to investigate the ways that TCAM is ‘integrated’ into public healthcare, who decides what is included, what is left behind, and what is lost in this process. Similar to processes that occurred during the colonial era, the ‘integration’ of TCAM practices into biomedical settings, such as medical curricula, may be viewed as part of an entrenched pattern of indigenous knowledge and worldview expropriation, homogenisation, and in some cases even erasure. From this perspective, ‘integration’ may actually lead to the contortion of practices towards a logic that places profit and the expanding neoliberal market above people and health. Further, it circumscribes and constrains other ways of understanding health and healing from actually being ‘integrated’.

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F rom: Ana Ning. Epistemic Hybridity: TCM’s Knowledge Production in Canadian Contexts, pp. 247–272 Recent scholarly analyses of complementary and alternative medicine’s (CAM) global developments have interrogated taken-for-granted dichotomies between CAM and biomedicine as distinct health modalities, with separate ideological and pragmatic underpinnings. Rather than viewing CAM as a monolithic ‘Other’ versus a hegemonic biomedicine, many point to their significant overlap in the ways they legitimate, standardise, integrate, and globalise their knowledges and practices in diverse settings. …. Although ‘hybridity’ has been used in CAM analyses to critically examine the integration of CAM and biomedicine in different regions [Gale 2014], I will use epistemic hybridity as a heuristic tool to show how the knowledge production of a particular type of CAM—Traditional Chinese Medicine (TCM)—takes shape and shifts in very complex and sometimes contradictory ways within local contexts. …. Drawing upon ethnographic field research3 with TCM practitioners in British Columbia (BC) and Ontario, Canada, regarding constructions of TCM evidence of safety and effectiveness, I aim to demonstrate how TCM evidence is produced and applied in context, thus suggesting possible ways to address Gale’s (2014) ‘big question’—how and whether CAM therapies work. … In particular, I want to call attention to more encompassing types of evidence that TCM practitioners rely upon in TCM interventions that facilitate a complex synergy between patients, healers, and their shared healing experiences. These intersubjective experiences constitute sufficient ‘evidence’ for TCM practitioners to continue undertaking person-­ ally meaningful practices that are often discounted by biomedical practitioners due to limited ‘scientific’ bases. Here, I want to emphasise that to better understand TCM’s therapeutic effects, we must take into

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consideration broader factors beyond individual bodies’ functioning. As such, TCM practitioners’ reliance upon multiple evidence frameworks strictly mirrors neither a sense of historical continuity with ‘traditional’ Chinese medical knowledge nor concerted efforts to fit TCM within currently dominant bio-scientific lenses. Rather, by denoting incompatibilities and intersections between TCM and Western science in the production of therapeutic evidence, I am highlighting the coexistence of diverse ‘sciences’ that are equally valid, thus questioning the presumed naturalness and primacy of Western science as the most acceptable method of knowledge production. …. By declaring TCM’s reliance on experiential, ‘soft’ evidence as a reflection of its unique philosophy and practice, some TCM practitioners specifically highlighted the positive attributes of what biomedical practitioners discount as ‘non-scientific’ evidence. One of them—Joanne, trained in both TCM and biomedicine in China—uses primarily acupuncture in her Vancouver-based practice. Acupuncture is compatible with most of her Canadian patients’ preference to avoid potential hazardous interactions with biomedical interventions. It is generally believed to have no side effects if practised competently and is also one of the few TCM components that has successfully undergone RCTs for various conditions. …. TCM, like many other CAM treatments, does not consider a therapeutic effect such as successful conception to rest on a single remedy (e.g., herb) or technique (e.g., acupuncture) but in an energetic system that comprises the patient, the prescribed treatment, the healer, and the treatment setting (Barry 2006: 2647). By engaging with synergistic evidence, observing, and adjusting to the entire healing situation, the TCM practitioners in this study account for broader factors beyond the physical body (e.g., lifestyle, vital energies, diet, environment) to address their patients’ ailments. Since many also incorporate biomedical evidence bases into the irregular practices, epistemic hybridity unveils their reliance upon more encompassing types of evidence, hence, illustrating the production and co-constitution of multiple sciences to validate treatment outcomes.

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 eflection by Caragh Brosnan, Jenny-Ann Brodin R Danell and Pia Vuolanto This book was the first collaboration involving our team of editors. Sociologists working in three different and distant countries, we had each turned to the study of CAM in recent years, prompted by local controversies and debates around CAM’s knowledge production and academic or regulatory status. These knowledge contestations, involving biomedical sceptics, policy-makers, universities, and various professions, had parallels with each other and followed forms familiar from some STS studies of controversies. At the time, CAM had seldom been included in STS analyses, while sociological studies had focused more on CAM users and practitioners than knowledge production per se. Our symposium on ‘Science, sceptics and therapy cultures’ at the British Sociological Association Medical Sociology Group conference in 2015 and a stream we convened at 4S/EASST in 2016, ‘STS-CAM: Science and technology studies on complementary and alternative medicine’ (in which many of our book contributors took part), helped to bring together these domains and refine the book’s focus. Our open call for book chapter abstracts elicited submissions from thirteen countries in five continents, covering a multitude of empirical cases. This (pleasantly!) surprised us while confirming our suspicions that global transformations were occurring in CAM that were reshaping its relationship to science, biomedicine and the knowledge economy, and that were of interest to a range of social scientists. The themes of the book developed around the selected contributions. Along with knowledge production (‘Making CAM knowledge’), these include the drawing and shifting of boundaries between and within CAM and biomedicine (‘Defining CAM’), and the varied manifestations of CAM in different regulatory and political spaces, including its material forms (‘Doing CAM in different contexts’). The landscape of CAM is constantly evolving and even in the relatively short time since our volume was published there have been significant developments with implications for knowledge production. Changes in regulation of CAM tend to have an effect on the general acceptance and

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the teaching and research activities of CAM. Perhaps the most prominent development is the WHO’s inclusion of Traditional Chinese Medicine in the International Classification of Diseases (ICD-11) in 2019. This allows TCM diagnoses to be applied, counted, and researched in line with biomedical categories, potentially signifying increased legitimation— although Cathy Fournier and Robin Oakley’s chapter (below) alerts us to the inevitable exclusions and erasures that occur within such standardisation exercises. Whether and how TCM’s integration into global health knowledge systems benefits the multiple communities of Chinese medicine practitioners and users (described in Tereza Stöckelová and Jaroslav Klepal’s chapter in our book) will require empirical investigation. There are signs that CAM is establishing itself as a research domain. The number of CAM publications in medical and CAM journals has stabilised at about 4000–5000 per year (Danell et al. 2018). There are also a number of scientific journals targeted at CAM research, global and local conferences are being arranged, and there are several major interest organisations that support CAM research (e.g. in EFCAM and EUROCAM in Europe). The WHO promotes the establishment of dedicated CAM research centres. Simultaneously, recent closures of TCM degree courses in several British and Australian universities signal the ongoing negotiation of CAM’s place in arenas of knowledge production. STS studies of CAM are emerging but there is much more work to be done in this area. Ellen Stewart’s (2019) review of our volume notes that, in focussing on CAM as practice and knowledge, and in trying to treat human and non-human actors symmetrically, the collection omits consideration of the ethics of CAM. We would suggest that methods that follow the full range of CAM actors—including sought-after CAM therapies—can serve to bring ethical issues into view by unearthing otherwise hidden relationships. Because CAM’s very nature and boundaries are contested and shifting, so are the array of actors involved and the power dynamics at play. Nevertheless, there is certainly room to go further in examining the normative dimensions of CAM in future work, including the values that shape knowledge production.

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 ike Michael and Marsha Rosengarten. M (2013). Innovation and Biomedicine: Ethics, Evidence and Expectation in HIV

From: Introduction, pp. 1–13 It is a commonplace to worry about the pace of innovation in biomedicine. From the perspective of some actors, innovation moves too quickly, throwing up complex regulatory issues and ethical dilemmas that are sometimes barely tractable. For others, innovation cannot take place fast enough: in the here and now, there are lives to be saved and there is suffering to be eased. Often these two contrasting apprehensions toward biomedical innovation reside simultaneously in a single actor (whether that actor be individual or collective). This ambivalence reflects the

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contradictory character of much that passes for biomedical innovation. With the development and arrival of a new drug, technology, procedure or intervention, not only might lives be saved, but they can also be endangered at one and the same time. However, portraying the concerns associated with biomedical innovation in terms of such ambivalence misses the point on several levels. Or rather, it frames the issue in a very particular way that reflects, mediates and enacts a series of ontological, epistemological, political, social and ethical perspectives. By way of initial illustration, let us focus on the possible negative impacts of a new therapy. Immediately, we might note that it is not only the health of bare lives that is potentially placed at risk. This intervention can also negatively affect, for example, local and national communities, civil rights, economic opportunity, wider health system provision or particular types of gendered relations. To make this observation is to begin to shift our understanding of that intervention. Ontologically, it is not simply constituted of its material composition and technical properties (for example, such and such a pharmaceutical compound, such and such an effect on a disease entity or such and such side-effects on a human body) but emerges out of a nexus of complex multifarious and shifting relations that includes a range of material, individual, community, institutional, policy and political actors. Epistemologically, an intervention is not knowable simply through the assumptions that inform bioscientific and biomedical techniques (for example, the objectivity of randomized controlled trials) but through a model of knowing, or engagement, that aims to capture the situated-ness, relationality, emergence and performativity of a representation of a biomedical intervention. Such interventions are not politically and socially neutral, or even complicated in the sense that there are very many political and social factors to be taken into account in order to develop, deploy and assess an intervention. Rather, these social and political elements are complex in that they relate to each other recursively: the borders between social categories or political actors come in and out of focus in sometimes unusual and unexpected ways …. [T]he foregoing should have provided a preliminary sense of a series of interconnected relations—ontological, epistemological, material, social,

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political and ethical—through which we can approach biomedical innovation. … [This approach informs our analysis of ] biomedical innovation within the HIV field, and especially the randomized controlled trialling (from here on referred to as RCT or RCTs) of a pre-exposure prophylactic intervention, (PrEP), a pill taken every day that ostensibly decreases the risk of HIV infection) …. In July 2012, the United States Food and Drug Administration (FDA) approved the use of daily oral PrEP consisting of two antiretroviral drugs Tenofovir (TDF) and Emtricitabine (FTC). The two drugs were already approved for use in treating existing HIV infections but their officially approved use as a means of preventing infection confirmed that they could now become medically available for those of HIV negative status. That is, they could be legally prescribed for those not infected with HIV but for whom there is the possibility of sexual exposure to the virus. FDA approval followed a review of laboratory-based evidence and a series of RCTs, which we discuss throughout the book. United States approval is likely to pave the way for a number of other countries to consider the implementation of PrEP. However, the issues raised by PrEP implementation are complex and the response to these in many ways shows a field grappling with the use of costly and potentially toxic antiretroviral drugs for widespread prevention purposes. In this book, we review some of the history of PrEP, drawing on various articles and reports that reflect but also—as our analysis will consider—have participated in the emergence in PrEP. In many respects we believe that the understanding of PrEP by the HIV field—including its promise, challenges and, for some, its wrongheadedness (where it is considered as the wrong approach to prevention)—can be traced to the manner of its development. Although the first round of PrEP RCTs in the countries of Cambodia and Cameroon failed due to controversy about their ethics (and heated debate continues over the validity of a RCT with injecting drug users (IDUs) in Thailand that was set up at the same time), such controversy did not generate what we regard as any sort of radical rethinking. Specifically, the field did not draw on these cases to interrogate seriously the research technology of the RCT, the ethics of

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conducting RCTs in low and middle income countries or, crucially, standard distinctions between ‘behavioural’ and ‘biomedical’ intervention. Instead, a ‘coming together’ was engineered by the International AIDS Society (IAS) funded by the philanthropic organization Bill & Melinda Gates Foundation and, separately but with many of the same participants, by UNAIDS. This ‘coming together’ involved large scale consultations and some weighty reports that ultimately concluded with statements of commitment to greater community consultation and participation in the planning of trials. The reports, in particular, placed emphasis on the need to inform and provide follow-up care for trial participants (see Rosengarten and Michael 2009). Of course, we do not wish to imply any insincerity on the part of scientific stakeholders, that is, the trialists and their sponsors, or that the community stakeholders were in any way ineffectual in putting forward their concerns, or that community consultation and participation have no place. Nevertheless, we can suggest from a reading of such documents (as well as numerous other published materials that ensued in the wake of the early controversy) that little, if any, challenge was made to the technology of the RCT and the bioethics associated with it. In the absence of an appropriately interrogative engagement with RCTs and bioethics, one upshot has been that the field generally enacts PrEP as a singular chemoprophylaxis dependent on user adherence—a framing that comes up in almost all recent literature on PrEP. This seems to miss out not only on much of the complexity of PrEP and its testing and implementation, but also on the potential traction that PrEP might have with its various users. It thus seems to us even more imperative to revisit the work of the RCT and bioethics …. In succinct terms, a prevention pill acquires its capacity to be so only through use, which inevitably entails social relations and practices (which are also, of course, socio-material). Yet, as we shall see, the RCT is not designed to investigate this. Indeed, it seems designed to avoid inquiry into what makes an intervention effective by distinguishing what is ‘effective’ from what can be statistically demonstrated as ‘efficacious’. … Put simply, if prevention is to take place—in this instance through the uptake of PrEP—it must perform an alignment of sorts with the socio-material

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relations and dynamics that characterize those for whom it is intended. PrEP’s controversial status cannot be disentangled from the technology of the ‘efficacy-testing’ RCT and the legitimation of this by a particular version of bioethics. In sum, the technical and social warrants that are mobilized for RCTs in their current form (where only a delimited set of effects are of concern) exclude precisely those elements that characterize the everyday use of the candidate medical intervention—elements that variously flow into, but also from, the candidate intervention’s use …. Our engagement with ethics is through a consideration of the controversy that surrounded the first PrEP RCTs. Although the controversy resulted in the coming together of a diverse range of actors, recourse to bioethics by all functioned to legitimate the model of the RCT and, by doing so, delimit the experimental possibilities of other models of field-­ based research. Indeed, the manner in which the early controversy has been reported contrasts to an earlier pre-antiretroviral HIV drug period of the HIV epidemic. In the latter, HIV-affected lay members of the public have been shown to be positively central to the design of effective prevention strategies (Stengers 1997; Kippax and Race 2003). The account we present sets up the scene for subsequently tracing how bioethics effectively endorses a particular frame—encapsulated in the RCT—that diminishes the complexity of the phenomena that comprise HIV vulnerability and, we suggest, detracts from the importance of heterogeneity for possible prevention strategies …. Underpinning these [processes] is a universalized approach to the complexities of health and medicine that is encapsulated in the model of the RCT. It is an approach that elevates the ‘imperative’ to generalize, but without giving sufficient attention to the complex local contingencies that inevitably affect HIV transmission and prevention. So, while the RCT is celebrated for its apparent ability to exclude extraneous ‘social’ phenomena, everyday understandings and practices involved in the actual use of this biomedical intervention will fundamentally affect its capacity for prevention ….

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From p. 43 In a circular or co-constitutive logic, ethics seems to emerge alongside the RCT and is largely confined to a limited range of issues (for example, consent from the participants, provision of follow up care, prompt cessation of the RCT if results are very poor or very good). It is a range that at once reflects the standard design, and serves in the legitimation, of the RCT. The implication is that, because the RCT is ethically secured against broader context-related phenomena, a more complex and processual understanding of HIV vulnerability is occluded. Ethics, in this schema, remains an external ‘resource’ to the trial, an ‘add-on’ to, and a moderator of, what will take place—but, always as if on the outside of science. Despite many years of either unpromising results or indications of specifically harmful effects, and despite the ethically problematic undertaking of ‘offshore’ trials, it continues to be possible for the profoundly troubling conditions of life in these offshore locales to be erased from discussion of the RCT …. We are in awe of the complexity faced by trialists as they toil to find viable prophylactic interventions. But we also see promise in that complexity. The tendency amongst trialists has been to systematically simplify this complexity, and here bioethics has been a key helpmate, in pursuit of a ‘solution’ to the HIV epidemic. In comparison, our argument [is] that we need somehow to incorporate this complexity in its specificity across different cases and settings. By drawing creatively on this complexity we can begin to repose the problem of HIV and, in the process, allow more interesting questions to be asked and more tenable solutions to emerge.

From: Conclusion, pp. 159–171 [In this book] we have not been overly interested in whether PrEP RCTs have been successful in the endeavour to demonstrate PrEP efficacy or, indeed, whether the advocates and potential users of PrEP have deemed it a viable prevention option or not. Rather, our focus has been on the ways in which ‘success’ or ‘viable’ are themselves emergent categories— though, of course, ‘success’ in the present case, as can equally be said of

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‘viable,’ has taken on many guises that range from standard measures of efficacy through to the avoidance of police victimization by intravenous drug users. In other words, we have not been interested in ‘success’ as a distinct disjuncture, or a moment of discrete novelty. Instead, we have attended to the complex co-emergence of various parameters (which might be used to assess ‘success’ or ‘failure’ along various lines including—admixtures of—efficacy, politics, ethics, methodology) along with their ‘things’ (which might incorporate bodies, sexual relations, gendered relations of power, the ethics of offshore trials, the robustness of clinical data, the local institutional status of sex workers or intravenous drug users, and so on and so forth).

Reflection by Marsha Rosengarten and Mike Michael Since the publication of Innovation and Biomedicine: Ethics, Evidence and Expectation in HIV in 2013, which featured the development a daily oral pill to prevent HIV infection on exposure to the virus, frequently referred to as pre-exposure prophylaxis (PrEP), the technology itself has taken off. Now available in numerous countries either through ‘feasibility’ trials or having been made available by prescription, consistent with our argument, it continues to multiply novelties and thus create new possibles. For the natural sciences, the object PrEP conceived as if it is a distinct material entity, has provided new opportunities for variations of clinical trialing including ‘feasibility’ studies to establish patterns of usage and modifications to the product in the form of a topical prevention device. For the social sciences specifically focused on HIV, it has provided a new object with the potential to radically alter HIV risk. Here it is possible to see how a public health agenda has given currency to the problematic role of expectation and future-thinking raised in Innovation and Biomedicine. Indeed, much current debate on what PrEP will do is conceived on the basis that it can unfold in only two ways: it could either prevent or, paradoxically, increase new infections by undermining existing safe sex cultures and the normative use of condoms. This future thinking is premised on the idea that there is a linearity to the possibilities of innovation and invention: what happens in the present can be extrapolated into the

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future. Building on the argument of Innovation and Biomedicine, Rosengarten and Murphy (2019) have sought to find alternative ways of learning with PrEP as it departs from the prevalence of predictive modes of social research for policy making and detours through unexpected, emergent, and complex relations. Deploying the conventional method of interviewing, Rosengarten and Murphy explore how PrEP can be thought of as a speculative and pragmatic device. By listening to those engaged in using PrEP, Rosengarten and Murphy propose that PrEP warrants attention not for what it will do but, rather, as a participant in the cultivation of new modes of thinking and acting for unknown futures. This departure in focus from Innovation and Biomedicine joins a growing interest in Alfred North Whitehead’s speculative philosophy when addressing the practical and conceptual dimensions of research. This interest applies no less to the doing of social science research. On this score, Michael (e.g. 2017) has employed this speculative sensibility to think through how social scientists are themselves similarly engaged with unknown futures as they detour through unexpected, emergent, and complex relations. Returning to the method of the randomised control trial (RCT) covered at length in Innovation and Biomedicine, Savransky and Rosengarten (2016) take to task the premise that the RCT is able to establish, through probability estimates, ‘true causality’ based on the distinction between trial ‘efficacy’ and ‘real-life’ effectiveness. Indicative of the radical empiricism necessary to Whitehead’s speculative approach, these authors argue that causality cannot be separated from the situation in which it takes effect. In short, the achievement of ‘efficacy’ is, itself, a situated effect and thus the contrast between ‘efficacy’ and ‘effectiveness’ entails a false ontological distinction. On this basis, Savransky and Rosengarten propose that a ‘speculative’ orientation to the ontological commitments on which contemporary biomedical cultures rest can enable scholars to become open to new possibilities. In a further paper, Rosengarten and Savransky (2018), turn to the question of generalisation that is the premise of evidence-­ based medicine and consider what an attentiveness to Whitehead’s notion of abstraction suggests of the processes of knowledge production. Drawing on a recent shift to ‘adaptive trials’ in contrast to the conventional RCT when addressing the pressing demands of Ebola, these authors propose that the selective process of abstraction requires

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care. Michael (2019) likewise argues that ‘modes of care’ are central to the processes of social scientific abstraction in which generalisation across cases speculatively encompasses the emergent dimensions of those cases (or what he calls their ‘lineages of becoming’).

 argaret Sleeboom-Faulkner. (2014). Global M Morality and Life Science Practices in Asia

From: Introduction, pp. 1–3, 23 What is biotechnology about? Simply put, biotechnology puts knowledge of life, or life itself, to use in order to sustain, repair or enhance life. The United Nations Convention on Biological Diversity defines biotechnology as ‘Any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use’. Biotechnology harbours life-changing

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potential to cure the diseases of many patients, and promises evolutionary enhancement of the human species, to the delight of some (Harris 2011). However, advanced biotechnology, including genetic engineering, tissue engineering, genomics and stem cell research, is controversial, and not only for the hope it has sparked in—and the disappointment it has brought to—patients and their families. It is controversial also for its potential to radically change humankind and its environment on this globe (and beyond), for the financial and human resources it absorbs and for the uncertainty that surrounds it owing to its experimental nature. ‘Bioethical’ guidelines have been drafted to facilitate consensus about research conduct and to bolster its development, while trying to prevent and minimise the occurrence of ethical problems and allegations. In many ways, these guidelines are experimental, especially as they tend to vary internationally in their wording, spirit and application …. Like demography and epidemiology, bioethics addresses questions related to issues of life and death with moral and practical implications for the wider society, including the running of hospitals, life science research, the pharmaceutical industry, and policies on public health. While bioethics plays a key role in the regulation and justification of the life sciences, as implicated above, at the same time it is shaped and conditioned by what I introduce here as ‘life assemblages’. The concept of life assemblage as a heuristic methodological tool serves to define communities that share questions related to the definition of what is ‘a life worth living’. It also refers to the material, cultural and political conditions of communities that share notions and discourses about how to sustain a life worth living and about fundamental issues of whether and how biomedical science and technology should serve, maintain, repair, improve, enhance and extend life. A life assemblage develops under particular socio-economic conditions, shifting boundaries of knowledge, changing conceptualisations of the body, and forms of political organisation that underlie activities of assembling and reassembling life through technological interventions. A life assemblage shares questions about the biomedical intervention in the lives of citizens, the storage of human tissues and data on their lives, the kinds of human life given birth to, and notions of what is a normal or natural life, and what is not ….

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In life assemblages, rather than making decisions to find a cure for a particular disease, store blood for emergency situations or protect a community from a contagious disease, life science communities, including pharmaceutical industries, hospitals, charities, regulators and ‘bioethicists’, collectively engage in activities that focus on acquiring knowledge about life, repairing life, regenerating life, combining life and justifying life interventions on the basis of ethical principles, guidelines and decisions …. In a global context, however, bioethical capacity develops amidst the existence of diverging standards of wealth, diverging cultures and diverse political preferences. Bioethics, then, may be of diverging significance to patients and researchers, and play a different role in the implementation of research at different locations. This book aims to contribute insights into the different drivers of commercial and academic research institutions and forms of bioethical capacity building by state and non-­ governmental organisations, while exploring the ways in which moral discourses of development and economic growth are framed and, increasingly, reframed through government policies in Asian countries and the need for international collaboration. Bioethics as shaped in the context of a life assemblage is contested …. As internationally prevailing bioethics has been framed in the context of traditionally dominant life science and health institutions mostly located in the USA and Europe, the question arises of how biotechnologies in Asia develop in the sociocultural and political contexts of moral economies there. … The reason for studying Asian life assemblages lies in the need to take seriously the interaction of what is regarded as dominant ‘global’ moral economy in the life sciences with ‘local’ moral economies in Asia. The fact that we can think of bioethical guidelines in terms of the ‘global’ here is indicative of the marginal position of the bioethics of late-­ coming ‘local’ economies. What is needed, then, is to show how the multiplicity of bioethics in Asia appears to be ‘localised’ as a result of a process that is interpreted as the ‘globalisation’ of life science research and biotech applications in transnational settings. … The question here is whether ‘local’ versions of bioethics are just expressions of subjugation to ‘global’

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pressures or whether they are a product of creative agency and strategies of adaptation that actually help to mould what is often regarded as ‘global’, ‘Western’ or ‘first world’ ethics …. In brief, the chapters of this book explore social and political dimensions in developments of the life sciences and biotechnology that have been controversial in both Asia and the West. Rather than selecting and representing bioethical problems challenging Asian countries, this book explores the different dimensions of life assemblages—agency, power, the translation of bioethics, the embedding of bioethics, risk and public deliberation—through which bioethical ‘problems’ become manifest. In other words, the book asks questions about the ways newly introduced bioethics have played out in  local socio-political, legal and economic institutions underpinning life science research in Asia. Chapter 2 deploys discussions on eugenics and prenatal and premarital testing to ask how certain issues become ethical, and how ethicality is related to the state, the individual and other social units, such as the household, the family and the company; Chap. 3, on genetic testing and screening, asks whether the development of biotechnology inevitably leads to interventions based on rational decision-making and productive use in practice; Chap. 4, on the international pressure to regulate biobanking, asks questions about whose interests and wellbeing stores of data and samples serve, how their research relates to public needs and whether biobanks can survive the requirements of bioethics; Chap. 5 asks how biotechnology and life science become adopted as causes in politics, what kind of politics they serve and whose life science ethics comes to prevail; Chap. 6 asks when and how the public may have a say in what is bioethical and whether the standardisation of bioethics is conducive to civil society in Asia; Chap. 7 explores how the existing multiplicity of bioethics facilitates new research and therapy initiatives in stem cell science; and Chap. 8 integrates the various dimensions of life assemblages discussed in the chapters of this book around the question of public deliberation and life science policy-­ making …. …

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C  onclusion Life assemblages connect elements of life science and society that reflect different and broader ethical concerns compared with those salient in the political discourses around research ethics in the life sciences. Thus, it is possible that life assemblages contain practices that seem to be in conflict with the ideas advocated by formal bioethics institutions. As life sciences are ‘co-produced’ with society (Jasanoff 2005), formal bioethics institutions form just a fraction of the moral economies underlying life assemblages in practice. Chaps. 3–5 showed how bioethical practices in predictive and genetic testing technologies in practice affect ethical issues among the population in a wide range of fields. For genetic testing technologies generate new forms of ‘social justice’, as they serve some socio-­ economic groups better than others, and differently affect the availability of choices and ‘health needs’ of populations—in this case, China, Japan and India—whose life assemblages vary. Varying health needs and health provisions may be crucial to the justification of collective investments into life science ventures. Bioethical guidelines that are in place may be more efficacious when reflecting such justifications ….

From: Conclusion, pp. 186–188 The research into various dimensions of life assemblages as represented in the chapters of this book has resulted in a number of questions crucial to the co-production of the life sciences and society that takes place in multiple, diverging environments. It became clear that a central question to understanding bioethics in a particular territory is to observe how activities, connections, authorities, pressures and resources that make up life assemblages condition its development. This question required us to clarify how the various aspects of authority, power, governance and decision-­making constitute a life assemblage in practice. It appeared that the following aspects of life assemblages are crucial to the translation and embedding of bioethics in networks of power and at various levels of socio-political organisation: (a) Socio-political organisation, political decision-making (b) The receptiveness of the population to biotechnological innovation

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Pressure to apply ‘global’ bioethical standards The framing of bioethical problems The role of scientists and experts in public deliberation The moral positioning of bioethics.

Although bioethical guide-lines are justified as ways of dealing with the discrepancy between commercial, research and health aims of life science research, we have seen how bodies of bioethical guidelines are formed variously through locally-driven political, scientific and personal aims, through global pressures of collaboration and competition, and through the push and pull of markets. Capturing the real-world heterogeneity of the things, rules, drives and actors that shape bioethics and research regulation, life assemblages enable us to better understand and recognise relations between bioethical regulation and their local embedding: • the effects and interactions between centralised and more local forms of regulation, including state regulation of birth planning and scientific research, and its pragmatic adaptation by communities, local households and individuals; • the internationalisation of bioethical standards and bioethics discourses, and their effect on and interactions with local practices; • the relationship between national bioethical problematisations and representational ideologies as political constructs of local stakeholders; • the relationship between technological innovation and the intervention in reproductive practices of concrete communities (i.e. biopower); • the role of the public in life science policy-making and the concrete role the public plays in the lives of scientists and medical professionals; the ways in which transnational differences and similarities create possibilities for exchange and opportunities for investment, politics and health, and offer incentives to local life science initiatives. Recognising relations between bioethical regulation and their local embedding as life assemblages may considerably facilitate responsible innovation in a world of local and global inequalities.

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Reflection by Margaret Sleeboom-Faulkner Five years after the publication of Global Morality and Life Science Practices in Asia: Assemblages of Life, the relevance of the notion of life assemblage has not diminished. The need to understand local notions of what it is ‘to have a life worth living’ today is more important than ever, as we stand on the threshold of a new technological era. As a methodological tool, ‘life assemblage’ refers to communities that share questions of what is ‘a life worth living’ in relation to the economic, social, and political conditions and developments in that society. New possibilities in the life sciences have different consequences for communities of varying material, cultural, and political developments, and all struggle with changing ideas around the place of new biotechnologies in everyday conceptions of what is regarded as the natural life cycle (Strathern 1992) and meaningful life. The development and the potential application of new genome-editing technologies have the potential ‘to change human life as we know it’. In the view of some, such dramatic terminology may indicate gross exaggeration and science bashing. After all, we have had hysterical discussions about our first IVF Child, Louisa Brown in 1978, and we had great speculation about human cloning when Dolly the Sheep was born in 1996. In fact, IVF has helped to bring over 5 million children into the world and somatic cell nuclear transfer (SCNT), or ‘cloning’ has led to a greater understanding of molecular biology, genetics, and regenerative medicine, rather than to a world full of human clones. Yet, a closer look at life assemblages allows us to see what has changed for whom. Biotechnologies and regenerative medicine have meant very different things in countries around the world, depending on a wide range of conditions, including its wealth, its science policies, its healthcare system, its religious and cultural tradition and its political system. In some countries, the cost associated with IVF is forbidding to large parts of the population, while in others the affordability of IVF has meant birth for some, but disappointment for others. In countries that do not allow abortion, IVF has not been accessible, while in countries where it is accessible, it meant for many that procreation has been taken out of the hands of God and realm of nature. It meant that birth increasingly moved away from traditional and religious ideas around reproduction, such as

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gift, gratitude, family, nature, fortune, and blessing to the more ‘modern’, industrial notions of choice, means, rights, gametes, surrogates, and technology. And although many children have been born through IVF, scientists are aware that ideas around their health are still at an experimental stage (NICE 2013): further research on the first and next generations of IVF-born children may tell us more and with more evidence. Similarly, regenerative medicine has meant very different things to people in different parts of the world. Depending on regulation, infrastructure, and expertise available in their country, populations have had access to stem cell interventions of varying degrees of reliability. Although stem cell treatments for blood diseases, such as leukaemia, have become routine over the last decades, most stem cell interventions are experimental with only some products receiving market authorisation internationally. Until a few years ago, the notion of experimental treatment was usually associated with ‘snake-oil’ merchandise in ‘developing countries’. Over the past years, however, ‘experimental treatment’ has become normalised and has a positive ring to it for the hopeful, including in wealthy Western countries such as the US, Australia, and Japan (Sipp et al. 2017). Enormous investments by the governments and industry in wealthy and middleincome countries have led to an enormous growth of the field, and the promises of future therapeutic applications to severe and intractable conditions, continue the search for (hoped for) cheaper, one-stop applications. So much so, that in their ‘rush to clinical firsts’, some have started to downgrade their regulation, a move that was followed by competing countries (Sipp and Sleeboom-Faulkner 2019; Sleeboom-­Faulkner 2019). We see now that power over human reproduction and bodily regeneration has led to widely routinised IVF treatment, and its use as a platform for the application of other technologies, such as via Pre-implantation Genetic Diagnosis (PGD) and the development of new genomic therapies, and to the economic competition of experimental stem cell interventions and their regulation. The question arises how these developments will play out in the case of human germline intervention. Insight into their possible emergence in various life assemblages, and into their effects on others, will be crucial to the kinds of decisions we need to make regarding risks associated with human germline intervention, not just to the physical health of individual and human populations, but also to their sense of a life worth living.

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J essica Mesman. (2008). Uncertainty in Medical Innovation. Experienced Pioneers in Neonatal Care. Winner of Foundation for the Sociology of Health and Illness Book Prize 2009

F rom: Chapter 1, Neonatology: A Permanent Dynamic of Change, pp. 1–2, 4–7 Academic Medical Center: Bleeping monitors, toiling ventilators, and alarm signals all around. As the door swings open, an incubator rocks over the threshold, flanked by a nurse and a resident. In the incubator Tom is lying amidst lines and tubes, barely fifteen minutes old. He was born prematurely at twenty-five weeks’ gestation; his weight of 610 grams sharply contrasts with the average 3500 grams of full-term newborns. Skilled hands carefully take him out of the

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incubator and put him into his own bed: an incubator surrounded by an array of medical devices. His twin brother died right after the delivery.

Fed, warmed, and on a respirator: thus Tom’s life begins. Tiny and vulnerable, he is immediately taken to the intensive care unit of the hospital’s neonatology ward. The neonatology ward specializes in the care and treatment of newborns, also called neonates [a baby of no more than 28 days]. As a rule, children born after a term of less than 32 weeks or with a birth weight under 1000  grams are always admitted to this ward. […] A NICU leaves first-time visitors with an impression of controlled chaos—an amalgam of busy staff, noisy machinery, and a strange sense of order. Newborn babies are here because their lives are seriously at risk on account of complications linked to their delivery, congenital diseases, infections, or premature birth. Lined up, side-by-side, the incubators are connected to an array of state-of-the-art medical technologies with all sorts of tubes and cables: monitors that display flickering numbers and respirators that rhythmically do what they were designed to do until they suddenly generate a bubbling sound or piercing rattle. Most babies are sleeping all day and night, most with the help of sedatives. A single baby may be crying—without making a sound, on account of the respirator tube in the throat. The fragility of the children calls for their constant monitoring. After all, these are the children who do not always respond to medical interventions according to the descriptions found in handbooks, while factual data on their conditions are ambiguous or not available yet. This also explains the round-the-clock presence of nurses and physicians in a NICU. One sees them engrossed in their work of caring for their very young and fragile guests. Much of the medical work involved centres on generating and keeping track of patients’ vitals, recording new data, or checking and rechecking them. The calm, soft-spoken interactions of nurses and doctors rely on a vocabulary that seems specially invented for this space. Parents too have a prominent presence. Regardless of the time of day or night, some are found sitting for hours at the side of the incubator containing their newborn baby. Clearly, then, the lights in the NICU are never turned off. …

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This book provides insights into the concrete work setting of medical care practice, and into what actually happens at the interface of processes of diagnosing and prognostication, and of establishing facts and values. There is a need for this type of study because it is precisely the established routines and practices of actual medical intervention that are constantly destabilized in a health care system that is primarily marked by rapid change. The ensuing uncertainties have contributed to the emergence of a ‘grey area’, one where the established protocols and the conventional answers found in medical handbooks no longer apply. Yet, as before, many clinical conditions still require immediate medical attention and intervention. […] How do the staff members deal with the uncertainties that are intrinsic to being on a scientific-medical frontier? […] Aside from the ongoing need to develop pragmatic guidelines, the complex problems of our high-tech health care have to be addressed in other ways. It is argued that although various aspects of the contemporary neonatal practice have been studied thoroughly, there is still little insight into the hidden competence of the actors involved to cope with the complicated interplay of problems and dilemmas associated with the actual processes of managing day-to-day operations in the NICU. Mostly a NICU appears to be a smooth, well-ordered practice with professionals who know what they are doing and who treat and care for children in a routine manner. Yet appearances are deceptive: the order has to be made and adjusted constantly because in the treatment of gravely ill, unstable newborns the existing rules and routines will not always be effective for addressing new and unexpected situations. In a NICU, the normal everyday practice tends to be the outcome of a deliberate ordering process that leads a fragile existence. After all, there are the children who do not always respond to medical interventions as foreseen or for whom normal values are not even available yet. Furthermore, frequently decisions have to be taken within a very short time span and in the absence of—reliable—factual data. No wonder that occasionally intervention processes falter and, in the worst cases, end in a deadlock. To create, reproduce, and uphold the social-technical order in today’s medical practice calls for a substantial effort on the part of those involved. This effort is the object of analysis in

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this book. Its focus is on the interplay of control and contingency in critical care units like a NICU. Therefore, this book should not be viewed as strictly an inductive effort, or as just another case study. Instead, its analytical scope and effort can be understood as an act of exnovation. Exnovation refers to the attempt to foreground what is already present—though hidden—in specific practices, to render explicit what is implicit in them (de Wilde 2000). Where innovation can be defined as ‘to make something new’, exnovation pays attention to what is already in place and challenges the dominant trend to discard existing practices (p.  13). Importantly, ‘things or practices are not less valuable simply because they already exist’ (p. 13). A focus on exnovation allows us to bring to light implicit matters of actual practice and to develop a fresh perspective on the ingenuity of the professionals and the specific structure of their practices. Exnovation offers insights into their specific modes of ordering day-to-day practices (Law 1994). Exnovation, in other words, elucidates competencies of coordination and alignment of these modes of ordering of which those involved are not always aware.

F rom: Chapter 2, Newly Born and Indeterminate, pp. 36–38, 45 Styles of Reasoning By removing technology support, such as artificial ventilation, preterm infants die within minutes to hours. […] Although each month one member of the team of neonatologists is formally in charge, in Dutch hospitals these kinds of difficult decisions are taken collectively by the entire team. The medical staff of the Academic Medical Center NICU consists of neonatologists and if needed other medical specialists. In the staff meeting all data is re-ordered again. Various methods are used to do so. This ordering process can be described on the basis of the notion of ‘repertoire.’ A repertoire involves a particular style of reasoning; as such it functions as a guiding principle that orders our ideas about what the world is and how it works. This guiding aspect should not be viewed too strictly, though. Rather than exactly fixing what will be said

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or done, a repertoire determines what those involved view as relevant, which arguments or strategies, they feel, matter. It outlines what is central or peripheral in a particular situation of condition. It provides a frame for legitimizing decisions. 13.30 hours: The staff meeting begins. Its subject is the proposal to refrain from further treatment in the case of Esther. Seven staff members are ­present: the attending neonatologist, the resident on duty, two nurses who provide care to Esther, two other neonatologists, and a social worker. The resident opens the meeting with a report on the course of Esther’s condition since her birth and her current condition. She concludes her introduction with the question: ‘In light of the problems and taking into account the child’s immediate future and her very bad prognosis, what is our policy going to be?’ ‘What is “very bad”?’ the social worker wants to know from the resident. ‘A fourth-degree bleeding at both sides of the head makes her chance of survival very small and if she survives at all, what kind of life are we then talking about?’ ‘What do the parents think?’ one of the nurses asks. The resident: ‘If their child is going to be severely handicapped, they do not want us to keep going on.’ The social worker, who also talked to the parents, reports: ‘They do not regret their decision to have Esther treated, but they do have second thoughts if their child will be seriously handicapped. They told me: “It is something with which we want to burden neither the child nor ourselves.” In fact, based on the information they so far received they have already concluded for themselves that they have to reckon with their child’s passing. This is why at any rate they would like to have their child baptized. It might still be done today.’

In the first ten minutes of the meeting all staff members who in the past few days could constantly be found near Esther’s incubator articulated their concerns and points of view. Their stories suggest that they all use a repertoire in which the child’s specific situation is center stage. These speakers mainly rely on a situational repertoire. In this style of reasoning the uniqueness of a situation is foregrounded, situating the issue involved—the child in this case—in the here and now. Explicitly the

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child is associated with specific persons, places, and moments, and thus individualized. […] Next, the discussion takes a turn, when the two neonatologists who are not directly involved in Esther’s treatment join in and challenge all that has been said so far. One of the neonatologists: ‘Has an EEG been made as well?’ The resident: ‘No EEG was made. If you think it is useful for determining our course of action, we should have one made. But what are the criteria you use when the results come back?’ The neonatologist: ‘I believe that with a normal EEG you cannot make a life-ending decision.’ ‘Do you really think,’ the resident asks, ‘that with this cerebral condition there is a chance of getting a normal EEG? Don’t get me wrong, I only try to explore the boundaries of the new parameters on which to base our policy.’

Unlike the actors directly involved, these two neonatologists are not yet fully convinced of the hopelessness of Esther’s situation. They do not only present another opinion, however, but also introduce another style of reasoning: a case repertoire. In this logic the child is specifically considered in relation to other, similar cases. Thus, this repertoire reaches beyond the boundaries of the specific situation of the child at hand by inserting the outside world. The meeting no longer only addresses Esther, but also criteria for assessing an EEG result, parameters that help to determine the course of action, and anonymous children that are described as statistical units in the literature. The case repertoire allows one to highlight other aspects of a child’s identity, thus breaking the dichotomy between the general case and the specific child. Esther too is a case. …. An answer to the question ‘what to do?’ is closely intertwined with the question ‘what is the matter here?’ A reply to this question requires more than just a simple establishing of the facts. In a NICU facts are not so

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much givens, but they are moulded and fashioned on the basis of various materials, such as words, numbers, actions, and things. The staff is constantly geared toward collecting data to determine a child’s situation. Thus the child develops from a ‘case’ into a child with its own identity. Yet more is going on. In the effort needed to do away with the child’s unspecified identity, the NICU itself takes shape as a practice. In this process repertoires are deployed, brushed aside or combined. Their value or use is neither fixed, nor do they coincide with a specific discipline, a systematic treatment trajectory or a specific argument.

From: Chapter 4, Uncertain Trajectories, pp. 113–114 The NICU as a Quantitative Practice By constantly gathering numbers, calculating ratios and quantities, entering quantitative data on special forms and classifying them, and by interacting with each other in numeric language, the staff is able to monitor the condition of the child. Numbers, however, do not speak for themselves, nor can a large flow of quantitative data do away with each and every uncertainty: medical intervention trajectories in the NICU are always rife with risks and uncertainties. As tools, quantitative input and output are constructed in their actual application in practice. This contributes to a tension between contradictory numerical frameworks. On the one hand, numbers are considered as objective reflections of reality; on the other hand, they are constitutive elements of this same reality. In other words, numbers do not possess a solidity of their own, but become facts through processes of negotiation. Although claiming and seeming to rely on the exactness and objectivity of digital data, the staff engages in continuous negotiations about their meaning. A closer look at their daily activities reveals the contextual reframing of numbers. Knowledge derived from hard numbers cannot be applied irrespective of their context. There are always situation-specific activities and decisions. They are related to other numbers within particular contexts of practice and meaning. However, the existence and knowledge of such a framework is no guarantee that medical decisions and interventions will proceed smoothly. The distribution of numeric certainty and credibility

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appears not to be arbitrary but is rather affected by contextual constraints and possibilities. Again, there can be a mutual confirmation of numbers or continuing struggles for credibility. Analysis of this contingent interaction shows how the meaning of numbers in terms of true or false or certain or meaningless, is the outcome of a distribution of credibility within a network of quantitative data and other frames of knowledge. As such, the meaning of numbers is shaped by specific contexts.

F rom: Chapter 5, Beacons on the Horizon, pp. 124–125, 136–137 A Topography of Experience All actors in the NICU find themselves in a dynamic of experience and expectation that allows them to form and articulate a prognosis about a child. This not only applies to knowledge that is tied to education and position, but also to knowledge gained through all sorts of personal experiences involving the child and other NICU actors. In the specific ways in which nurses relate to a child—how they approach him, what they know about him, what they feel for him, how they speak for him—the subjective knowledge and experience emerge that are also used in prognoses. In other words, study of how those involved relate to Tom may concentrate on issues of role distribution and position, including the associated knowledge and prognosis, and on issues tied to the individual dimension of dealings and interactions with the child. Aside from professional knowledge, which generally emerges based on training, professional literature and deliberation, there is also knowledge and/or experience based on contact with the child and others involved. By focusing on this interactive dimension, room emerges in the analysis for the individuality of those involved as well as for other factors that play a role in the formulation of the prognosis, such as temporal aspects of specific situations and emotions like hope and frustration. The ways in which actors deal with children in the NICU can be conceptualized in terms of distance versus proximity, observing versus comparing, and hands-on versus hands-off. …

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Prognostic Markers Prognoses, then, are the outcome of multifaceted prognostic processes that reflect a certain amount of conflict and disparity between the experience and expectation of the actors involved. They all deploy experiences from the (recent) past to interpret both the developments that occur along the trajectory and—by extrapolation—the ones that are likely to occur in the near future. This gives rise to specific ‘horizons of expectation’, whereby the measure in which expectations are realized plays a palpable role as well (Koselleck 1985). In their formulation of new expectations, actors rely on subsequent knowledge. This may cause them to adjust their prognosis in a specific direction. It is in the reflection on the past that the future takes on a specific significance. Thus prognostic processes involve a linking of past and future in the present, resulting in a ‘current past’ and a ‘present future.’ In other words, a multi-layered understanding of such prognostic processes requires an exploration of the boundaries of the ‘space of experience’ of those involved and the way in which these boundaries shift. […] In a NICU various prognostic markers are used to determine a child’s prognosis. Their analysis may reveal the ways in which individual experience and the dynamic of the treatment trajectory (including the learning processes among those involved) influence the various prognostic processes. A number of reference points play a major role: other children that serve as an exemplary case, the level of technological support on which the child depends, the use of the NICU space or the specific pace and rhythm of the care and the treatment provided. They can be said to function as prognostic markers, on the basis of which those involved conceptualize the child’s position along the treatment trajectory.

From: Chapter 7, The End of the Journey, pp. 187–190 Opening up the In-between Zone By opening up the interface between diagnostic processes and processes of prognostication; the general and the particular; actors and technologies; formal protocols and the swirl of the treatment trajectory; public

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and local accountability; facts and values; expectation and experience, it becomes clear that good intentions and a gamut of data and guidelines can never fully preclude problems from occurring. In the treatment of children in the NICU there is always a marked tension between the familiar and the unusual, control and contingency, certainty and doubt, cohesion and conflict. In some cases the knowledge or technologies needed may simply not be available. But even if they are, it is not yet taken for granted which knowledge or experience matters or which technology is effective. Time and again, the value of the available knowledge has to be weighed, or it has to be decided which guidelines apply or which perspective is most valuable. These aspects are always, directly or indirectly, objects of negotiation. To keep complex treatment processes going more appears needed than merely the presence of knowledge, experience, and technology. Their application is not automatic but requires active involvement from doctors, nurses and parents. My analytical focus on the in-between zone—on the hinge between the known and the unknown, the risk and responsibility, and the collective and the individual—enables me to exnovate an available yet hidden form of competence that allows the staff to prevent the treatment process from stalling. One of the key insights of this book is the identification of the coordination between the individual, collective and systemic resources that are used to enhance the staff’s competence to produce workable knowledge and reliable performance while acting within a complex critical care unit such as a NICU. […] It turns out that in addition to the more tangible and concrete actions and interventions of the NICU staff members, more abstract processes are at work as well, and prominently so. Specifically, various styles of arranging and interpretation play a major role in decisions on treatment: repertoires guide processes of reasoning and legitimating, vocabularies suggest ways of speaking and interpreting, and scripts imply more or less explicit directions for action. Their application is not automatic but requires active involvement from doctors, nurses and parents. Exnovating the competence of staff members to select and combine the different styles of ordering provides insights into the way they actually deploy their knowledge, experience, and technology in the treatment trajectory. …

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The performative character of the various ways of ordering gives direction to how the treatment process takes shape. This may lead to frictions in the decision process regarding responsibility, the timing of when something has to be done, or when enough is really enough. To resolve such frictions, the actors look for a way out by combining vocabularies: they speak in terms of ‘compelling advice’; they in part move away from the script and add elements to a treatment guideline; they combine repertoires or merely opt for a confirmation of the radiological report. The various styles of reasoning, therefore, will rarely be encountered in their pure form. This is why the situating of knowledge and morality requires coordination not only at the level of the individual case (the construction of facts, the robustness of a moral turning point or the choice of a treatment trajectory), but also at the level of repertoires, vocabularies and scripts. Securing the treatment trajectory’s progress calls for coordination at the level of the individual case as well as at a meta-level. To foreground these acts of coordination offers not only a new perspective on the competence of the actors involved, but also on the ordering character of reasoning, speaking, and acting.

Reflection by Jessica Mesman Uncertainty in Medical Innovation aims to answer the question how healthcare staff succeed in acting promptly and adequately in situations of medical and ethical uncertainty. Diagnostic and prognostic facts are vital in their decision-making process, while at the same time these facts are hard to establish in a high-density zone of doubt, like an intensive care unit. In order to identify ways of knowledge production the book has its focus on the in-between zones, like for example the intersection of the general and the particular; protocols and the swirl of the treatment trajectory; facts and values; expectation and experience. This analytical emphasis on gradualisation (alignment, fine-tuning) rather than using a comparative/contrastive approach (e.g. the individual or the collective; certainty versus doubt) made me aware of the importance of implicit coordinative methods and strategies to order types of actions, styles of reasoning and forms of interaction. Whereas protocols and guidelines are

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petrified experiences that capture the anticipated, the coordinative competences of staff deal with what is left to practices in the situation at hand. My analysis exnovated the presence of the staff’s coordinative competences that helps them to navigate in an often, uncharted territory. Moreover, it also made me aware that the significance of such competences is highly underestimated. They are hardly ever discussed, let alone being included in medical curricula. As an act of signification in which staff build an understanding of an event, these coordinative competences are vital for achieving a reliable and professional outcome in any practice and therefore deserve attention. Moreover, I realised that insights in these unarticulated actions also provide opportunities for improvement. Whereas the responses by medical practitioners to my book had been very positive, it had not resulted in any practice improvement. Although it had never been my aim, it did frustrate me. From that moment onwards my exnovative quest became to foreground the ingenuity of practitioners in order to gain insights and to contribute to practice optimisation. During this time the issue of patient safety was high (and still is) on the agenda of healthcare. Aiming for practice improvement made patient safety an obvious choice. Not being trained as safety officer, my research question became again a positive one: ‘how to accomplish and preserve safety despite the complexities of everyday practice?’ It turned out that this positive approach made me an outsider in the world of patient safety for many years as at that time everyone else in this area (including its funding) had their focus on causes of errors and incidents. Based on my study in the neonatal intensive care unit I was aware how the ordinary is actually an extraordinary accomplishment. I therefore turned my analytical focus to the ‘mundane’ in order to excavate the hidden competences that contribute to patient safety. However, how to recognise and learn from practices that are used so often that they have become invisible or even forgotten. Fortunately, my book won the Sociology of Health and Illness Book of the Year Prize. This award generated publicity that reached as far as Australia. Based in Sydney, Rick Iedema, Katherine Carroll and colleagues studied the habitus of healthcare professionals with the help of video-reflexive ethnography (VRE). VRE is a collaborative method that involves filming daily practices and

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showing selected clips back to the participating professionals who— together with the researcher—conduct the analysis. The outcome of these reflexive meetings acts as a basis for academic output as well as practice improvement. The notion of ‘exnovation’ was a perfect fit with VRE as being a bottom-up approach, as it captures the idea of ‘innovation-from-­ within’. For me, on the other hand, VRE was the key I was looking for to open up mundane practices. Rick, Katherine, and I became friends for life and co-authors of several publications (e.g. Iedema et al. 2013). In our collaboration the video-reflexive method matured and diversified (Carroll and Mesman 2018). Over the years ‘exnovation’ has been further developed by the VRE-community and now acts as one of the four guiding principles of VRE (Iedema et al. 2019). That the VRE method provides an excellent infrastructure for practice optimisation is also recognised by several organisations in healthcare (like the Mayo Clinic and the International Red Cross), education, and infrastructure (railway). Several projects took off, are done or are still running (Mesman and Carroll forthcoming). In the meantime, the world changed. Academia adopted ‘societal relevancy’ as an important criterium for the evaluation of scholarly work. Now my work is evaluated from another perspective. The world of patient safety turned towards a positive approach. This too re-positioned my work and expertise. Many practitioners are fed up with innovations from outside and want to take control over their own work and its improvement. VRE offers them a tool to do so. Together with others I train them how to use the method and leave happily. Empowerment-in-action is what stays. It started with the book. Then, on the high wave of the FSHI Book prize, ‘exnovation’ started to travel to Australia, teamed up with the VRE method and continued its travel to the US, the UK and beyond. The book, the prize, Australia, societal impact, the positive approach in patient safety … too good to be true? Some people are just lucky, while others are persistent in their quest and wait patiently for the right moment! I might be both.

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References Barnes, B. (2017). Financial conflicts of interest in continuing medical education. JAMA, 317(17), 1741–1742. Barry C. A. (2006). The role of evidence in alternative medicine. Social Science and Medicine, 62(11), 2646–2657. Brosnan, C., Vuolanto, P., & Brodin-Danell, J.-A. (Eds.). (2018). Complementary and alternative medicine. Exploring health and technology through personal medical devices. Basingstoke: Palgrave Macmillan. Carroll, K., & Mesman, J. (2018). Multiple researcher roles in video-reflexive ethnography. Qualitative Health Research, 28(7), 1145–1156. Danell, J. A., Danell. R., & Vuolanto, P. (2018). Publication activity in complementary and alternative medicine revisited, 1966–2016. Presentation at 4S Conference, Sydney. Gale, N. (2014). The sociology of traditional, complementary and alternative medicine. Sociology Compass, 8(6), 805–882. Harris, J. (2011). Enhancing evolution. The ethical case for making better people. Princeton: Princeton University Press. Iedema, R., Carroll, K., Collier, A., Hor, S., Mesman, J., & Wyer, M. (2019). Video-reflexive ethnography in health research and healthcare improvement: Theory and application. Boca Raton, FL: CRC Press. Iedema, R., Mesman, J., & Carroll, K. (2013). Visualising health care practice improvement: Innovation from within. Boca Raton, FL: CRC Press. Jasanoff, S. (2005). Designs on nature: Science and democracy in Europe and the United States. Princeton: Princeton University Press. Kippax, S., & Race, K. (2003). Sustaining safe practice: Twenty years on. Social Science & Medicine, 57, 1–12. Knorr Cetina, K. (1999). Epistemic cultures: How the sciences make knowledge. Cambridge, Mass: Harvard University Press. Koselleck, R. (1985). Futures past. On the semantics of historical time. Cambridge, MA: The MIT Press. Law, J. (1994). Organizing modernity. Oxford: Blackwell. Martin, E. (2012). Grafting together medical anthropology, feminism and technoscience. In M. Inhorn & E. Wentzell (Eds.), Medical anthropology at the intersections: Histories, activisms and futures (pp. 23–40). Durham, NC: Duke University Press. Mesman, J. (2008). Uncertainty and medical innovation: Experienced pioneers in neonatal care. Basingstoke: Palgrave Macmillan.

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Mesman, J., & Carroll, K. (Forthcoming). The art of staying with making and doing: Exnovating video-reflexive ethnography. In G.  L. Downey & T. Zuiderent-Jerak (Eds.), Making and doing: Activating STS through knowledge expression and travel. Cambridge, MA: The MIT Press. Michael, M. (2019). Toward the abstractors: Modes of care and lineages of becoming. Distinktion, Journal of Social Theory, 20(3), 328–341. Michael, M., & Rosengarten, M. (2013). Innovation and biomedicine. Ethics, evidence and expectation in HIV. Basingstoke: Palgrave Macmillan. Moore, R., & McLean, S. (Eds.). (2010). Folk healing and health care practices in Britain and Ireland: Stethoscopes, wands and crystals. New York and Oxford: Berghahn Boo. NICE (National Institute for Health and Clinical Excellence). (2013). Fertility: Assessment and treatment for people with fertility problems. London: Royal College of Obstetricians and Gynaecologists. Retrieved December 20, 2019, from https://www.ncbi.nlm.nih.gov/books/NBK327768/. Rosengarten, M., & Michael, M. (2009). The performative function of expectations in translating treatment to prevention. The case of HIV Pre-exposure Prophylaxis or PrEP. Social Science & Medicine, 69(7), 1049–1055. Rosengarten, M., & Murphy, D. (2019). A wager on the future: A practicable response to HIV pre-exposure prophylaxis (PrEP) and the stubborn fact of process. Social Theory & Health.https://doi.org/10.1057/s41285-019-00115-y. Rosengarten, M., & Savransky, M. (2018). A careful biomedicine? Generalization and abstraction in RCTs. Critical Public Health, 1–11. https://doi.org/1 0.1080/09581596.2018.1431387. Savransky, M., & Rosengarten, M. (2016). What is nature capable of? Evidence, ontology and speculative medical humanities. Medical Humanities, 42, 166–173. https://doi.org/10.1136/medhum-2015-010858. Sipp, D. et al. (2017). Marketing of unproven stem cell-based interventions: A call to action, Science translational medicine 9(397). Sipp, D., & Sleeboom-Faulkner, M. (2019). Downgrading of regulation in regenerative medicine. Science, 365(6454), 644–646. Sismondo, S. (2009). Ghost Management: How Much of the Medical Literature Is Shaped Behind the Scenes by the Pharmaceutical Industry? PLOS Medicine. https://doi.org/10.1371/journal.pmed.0040286. Sleeboom-Faulkner, M. (2014). Global morality and life science practices in Asia. Assemblages of life. Basingstoke: Palgrave Macmillan. Sleeboom-Faulkner, M. (2019). Regulatory brokerage: Competitive advantage and regulation in the field of regenerative medicine. Social Studies of Science, 49, 355–380.

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Star, S., & Griesemer, J. (1989). Institutional ecology, ‘translations’ and boundary objects: Amateurs and professionals in Berkeley’s museum of vertebrate zoology, 1907–1939. Social Studies of Science, 19(3), 387–420. Stengers, I. (1997). Power and invention. Situating science (P.  Bains, Trans.). Minneapolis, MN: University of Minnesota Press. Stewart, E. (2019). Review of Brosnan, C., Vuolanto, P. and Brodin Danell, J.-A. (Eds.) ‘Complementary and alternative medicine: Knowledge production and social transformation’. Sociology of Health & Illness. Retrieved December 22, 2019, from https://onlinelibrary.wiley.com/doi/ full/10.1111/1467-9566.12886. Strathern, M. (1992). Reproducing the Future. Essays on anthropology, kinship and the new reproductive technologies. Manchester: Manchester University Press. Webster, A. (2002). Innovative health technologies and the social: Redefining health, medicine and the body. Current Sociology, 50(3), 443–457. Wilde, R. de (2000). Innovating innovation: A contribution to the philosophy of the future. Paper read at the POSTI Conference ‘Policy Agendas for Sustainable Technological Innovation’, 1–3 December. London.

Section 5: Regulation and Governance Alex Faulkner, Courtney Davis, John Abraham, Andrew Webster, Brian Salter, and Catherine Waldby

Introduction Health technologies—whether medical devices, drugs, or (the more recent) tissue-based therapeutics, such as stem cells—pose particular challenges in regard to their safety, efficacy, and long-term benefits and costs (and risks), both to patients and to the wider healthcare system. The HTS Series has examined these issues in many of the books published over the past decade and more but has especially done so in the four

A. Faulkner Centre for Global Health Policy, University of Sussex, Sussex, UK C. Davis • J. Abraham Department of Global Health and Social Medicine, King’s College London, London, UK e-mail: [email protected] A. Webster (*) Department of Sociology, University of York, York, UK e-mail: [email protected] © The Author(s) 2020 A. Webster, S. Wyatt (eds.), Health, Technology and Society, Health, Technology and Society, https://doi.org/10.1007/978-981-15-4354-8_6

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books chosen for this Theme section. The books offer a detailed exploration of the three forms of health technology noted above, how they are regulated and how this varies over time and across the regulatory environments found in different countries. These in turn reflect wider economic and political interests and forms of evidence and measurement (e.g. of the meaning of ‘safety’, or of therapeutic or commercial ‘value’). Governance points towards the ways in which such technologies and their producers are more, or less, accountable to those that use them, a process less to do with formal state regulation and more about process and practice within and between different social actors in scientific, clinical, and commercial domains. Our first book by Alex Faulkner (2009) discusses the world of medical devices, which includes the mundane as well as the more sophisticated— for example, everything from ‘the bandage to the bioreactor’ as he puts it—and in a field which though marked by high levels of innovation today, stretches back many years. Faulkner is especially interested in how devices are developed, regulated, and are accorded value (clinical and economic) and how regulation itself is of central import in determining this. He offers detailed accounts of the development of five devices to illustrate this process—hip prostheses, the prostate-specific antigen (PSA) test for prostate cancer, the infusion pump, coagulometers, and tissue—engineered products. In each case he explores the role of evidence for the device, how standards and the standardising process play a key role in defining the meaning and circulation of the devices across different markets and jurisdictions. But he also asks about what he calls their ‘usership’ in more mundane, everyday contexts for professionals and patients and how they thereby are given specific meaning and utility. He shows how as you move across these devices, some are more open to user

B. Salter Department of Political Economy, King’s College London, London, UK C. Waldby Australian National University, Canberra, ACT, Australia e-mail: [email protected]

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interpretability than others—the PSA test compared with the infusion pump, for example. In regard to how the state and its agencies at national and international (especially European) levels oversee these technologies he suggests we should think of this as a process of ‘governation’, the inventive practices of key stakeholders to shape and enable device production and use. The role of state agencies is central to our second book by Courtney Davis and John Abraham (2013). They offer an exceptionally detailed, forensic analysis of pharmaceutical drug regulation over the ‘neo-liberal era’ of the past 40 years, contrasting drug approval processes in the USA and EU.  They show how priority has been given to market approval rather than the clinical efficacy of new drugs. This has been associated with the push to accelerate access to new drugs, especially by patient activist groups, especially in the USA.  However, Davis and Abraham demonstrate very clearly that this was only partly to explain for new drugs approvals, and in fact more often than not drugs came to the market as a result of pressure for regulatory approval from the pharmaceutical industry itself. The ‘regulatory state’ which oversees and approves new medicinal products has been too quick to do so rather than determining their clinical value against existing (including non-drugs based) therapies, both key to an effective and resource efficient public health regime. The third book in the section examines the broad global ‘dynamics’ of regenerative medicine (RM), its boundaries and the ways in which these are permeable and unstable. Edited by Andrew Webster, The Global Dynamics of Regenerative Medicine (2013) ranges across a discussion of the field as a whole and how clinical and corporate as well as regulatory actors are co-producing the meaning and health and wealth values of the area. In addition, it examines diverse innovation pathways found across different countries and how these might be regulated, as well as asking whether the field as a whole is a new paradigm contrasting with the conventional medicinal and device models seen elsewhere in the healthcare system. The fourth book in this section is one that continues the discussion of the global aspects the stem cell field, focussing on human embryonic stem cells in particular. Gottweis et al. (2009) explore the strong relationship between emerging regulatory regimes and the global political economy of

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biomedicine as an area of innovation and biovalue creation (through, e.g., the patenting of tissue). They show how there are many tensions between and within countries in regard to perceptions of the status of embryonic stem cells, their bioethical oversight and their movement between states, made possible by international standards, licensing agreements, and biotechnological markets. But equally, they show how the emergence of a globalised bioethics has played a key role in enabling this market, acting to deflect criticism of the exploitation of biotissue. They argue that bioethics has helped science deal with challenges to stem cell research and application, by creating a ‘global infrastructure’—international bioethics networks and institutions that reassure and lubricate continued activity in the field. This globalising process only partially reduces tensions in the moral economy of stem cells research and application.

 lex Faulkner. (2009). Medical Technology A into Healthcare and Society

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From: Chapter 1, Introduction, pp. 1–12 Introduction Contemporary healthcare is characterised by what the UK government in the 1990s saw as a ‘tidal wave’ of innovation in health technology. Healthcare sciences and regulatory institutions for steering innovation have, over the last 20 years, been a notable social and political accompaniment to this tidal wave. … Contemporary technological healthcare is characterised by a multitude of medical devices, ranging from the bandage to the bioreactor, the thermometer to magnetic resonance imaging, from the cancer-screening test to the heart pacemaker and to human cell and tissue therapies. These technologies are hugely different from each other as artefacts, but the ways in which they are promoted and controlled in societies and economies have notable consistencies. Many, though not all, of the ubiquitous technologies of health care are medical devices. The terminology of ‘devices’ invokes attention to the institutionalised medical device industries and sectors, and medical device regulation and governance processes. Innovation of medical device technologies into the healthcare system is a process in which a variety of social, economic and medical interests and visions meet. The pursuit of medical innovation interests is typically conflictual, and often controversial. The ‘evidence-based’ movements in public policy and practice have grown over the last 20 years—methodologically and institutionally— nowhere more than in healthcare [sciences]. … An analysis of health-care innovation that conceptualises the dynamics of state and stake-holder actions to regulate and control innovation in the healthcare system must, therefore, accord the new healthcare sciences themselves a prime position. The agendas and knowledge products of the healthcare sciences have become closely tied to healthcare policymaking in a form of ‘regulatory science’ (Irwin et  al. 1997). Evidence-based health-care should thus be conceptualised as a phenomenon of political regulation and social legitimation as well as a scientific movement. …

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As will be demonstrated, the assessment of risks of technical performance, safety and efficacy of medical devices is a key part of the evolving regimes of evidence-related governance. This will be shown in, for example, case studies of hip prostheses, the PSA (prostate-specific antigen) test for prostate cancer and infusion pumps. … [I]t is one of the recurring themes of the case studies of medical devices in this book that the social and material boundary-definitions of technologies are constantly being redefined through society’s role in innovation of biomaterials, and combination and convergence between disparate technologies. …

G  overnance and Evidentiality The intervention of the state is required to deal with ‘market failure’ in provision of healthcare generally and medical technologies in particular. It is useful to distinguish between broadly collective—state—and broadly market-like forms of provision of technologies (Rose and Blume 2003). The case of technologies for medical application embraces both forms of provision. As Rose and Blume showed in the case of vaccination, different national states and healthcare systems may make available the same type of technology through different patterns of state/market arrangements. Thus in examining the transition of medical devices into healthcare systems, it is necessary to investigate the role of the state and the commercial marketplace in relation to sectors, zones and specific device technologies. Here, I briefly introduce some key concepts that are necessary to under-stand recent developments in the government activity associated with states, especially with the rise of ‘neoliberal governance’ across many societies globally. The most crucial concepts that I will consider here are those of the ‘regulatory state’, the ‘health care state’ and ‘governance’, distinct from and referring to a different formation of societal steerage than ‘government’. …

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The political economy of the European Union (EU) is important to the world of medical devices because of EU-wide regulatory regimes. … The jurisdiction of Europe is increasingly important as an arena for health policy and governance, more so in some aspects—such as public health and infectious disease—than others—such as medical care policy. Social theory and political science analysis point to the crucial part played by the harmonisation of standards within technological zones and political jurisdictions: the ‘EU’s governance blend … requires European domains to be constituted in order that they may be governed’ (Delanty and Rumford 2005: 146). The Europeanisation of health policy is advancing, marked by a tension between ‘deregulation and liberalisation’ and ‘re-­ regulation and harmonisation’ (Steffen et  al. 2005). ‘Europe’ can be regarded as a site of the construction and negotiation of zones in which scientific and technological knowledge and goods may circulate, and such zones themselves are sites of the active application of regulatory standards. Technical standardisation is a sine qua non of technological zones (Callon 2004). Thus in the case of medical devices and related technologies, the extent and nature of standardisation achieved through specific regulatory regimes is crucial to an understanding of both industrial economy and health protection through standards for the safety, quality and efficacy of devices entering the healthcare system. The rise of the regulatory state, in national and European modes, and the movement from government to governance in which networks and enrolment between state and experts are key features, characterise significant developments in the relations of science, civil society and politics. In this environment the credibility of knowledge, or evidence, has become paramount. The growth of evidentiality represented by the new healthcare sciences can be understood as providing tools by which the state, the healthcare professions and medical technology industries may seek the social legitimation of healthcare innovation and governance. The case studies in this book provide some evidence about the constitution of such government-related gatekeeping activities, and some indications of their success.

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From: Chapter 2, Approaching Technology, pp. 13–24 The Conundrum of Society/Technology The relationship between society and technology is by now the subject of a very substantial body of theoretical analysis and empirical research in the social sciences. In order for this book to delve into the world of medical devices and healthcare innovation, it will be useful first of all to take some bearings in the broad universe of society/technology studies. Here, therefore, I describe what I take to be some of the key insights from this field, in order to approach the world of medical devices armed with appropriate conceptual tools. It is important to highlight some of these society/technology concepts for the discussion of medical devices that I present here, because I aim to show how the patterns of social-­technological causation differ for different device technologies. My starting point is thus that there is unlikely to be a satisfactory one-size-fits-all society/ technology theory. My sense of the conundrum of society/technology causality is that while it is often the case that society/technology should be understood as denoting inextricably interlinked processes, it is nevertheless sometimes useful in analysing particular cases to treat the social and the technological ‘as if ’ they are separate spheres. Thus if one wishes to explain, for example, the rise to prominence of the technology of X-ray equipment, attention to various ‘social’ actors—industrial, medical, business, hospital and so on—will be appropriate. Equally, attention to various ‘technological’ processes and entities such as electromagnetic radiation, tungsten, electrons and photographic plates will be required. On the other hand, if the aim is to make theoretical generalisations about how the design of X-ray machines has come to be the way that itis, or about how they are used in everyday diagnostic practices, one might wish to say that we can understand them as a ‘sociotechnology’ or as constituting a set of ‘sociotechnical’ practices. …

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[A] technology-in-practice’ approach (Timmermans and Berg 2003) … makes the case, applied to society/technology studies of medicine, for focusing our attention on the more ‘invisible’ and mundane technologies. In healthcare, this approach should focus upon technologies such as ‘records, information systems, standards, small home-care technologies’ (op. cit., p.  108). The embedding of technology in ‘tools, practices, groups, professionals, and patients’ (p. 104) encapsulates a notion of the inextricability of society/technology relations. … Hence, here we are taken deep into what I will term the usership of technologies, the way in which they become embedded in everyday professional and patient practices, their social meanings and their implications for social organisation in the workplace and elsewhere. … [But we also need] to understand the powerful structuring forces that affect ‘the capacity of social groups to shape a technology’ (Klein and Kleinman 2002). …

F rom: Chapter 3, The World of Medical Devices, pp. 27–41 The world of medical devices is a complex, fragmented and paradoxical one. Its boundaries and contours are difficult to delineate, its societal participants not always obvious or easy to discern, its rules of engagement variable and contested, information about it relatively difficult to obtain, its technologies multiple and interdependent, its technology classifications labyrinthine and bureaucratic. … It is unlikely that many individuals live their lives without encountering one or other medical device. Some individuals will experience hundreds of them. They exist in massive numbers, shapes, sizes, materials and designs. Some single device types, heart pacemakers for example, may have hundreds of different models available to the end-user. Technological innovation is endemic, ranging from slight variants or modifications to

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existing devices, to some breakthrough technologies. Via biotechnology, more and more hybrid device technologies are being developed, as in the case of tissue engineering. The advanced healthcare systems are simply inconceivable without a myriad array of different device technologies. Yet many people will encounter medical devices without realising their connection with the processes of industrial capitalism, governmental policy, structures of healthcare delivery and consumption, scientific evaluation of safety and effectiveness, medicalisation and technological innovation. …

Deviceness and Device Classifications When is a medical device not a medical device? Classification is at the heart of human sense making and purposeful social action. As Mary Douglas and other anthropologists argued many decades ago, classification processes are central to processes of making and remaking social institutions and to the development of societal meanings and values. Typologies are useful to the social scientist attempting to make society intelligible, and they are useful to healthcare actors—the medical profession, industry and its promoters and regulatory policymakers. Their respective typologies of medical technology rarely coincide closely. The structuring work of classification is particularly striking in the socio-­ medical and industrial worlds of medicine and healthcare (Bowker and Star 1999). Classifications can usefully be seen as maps to the world of medical devices. Processes of classification of medical devices are part of society’s regulatory ordering of innovating technological zones. Society’s classifications of technology, as in other arenas, have important consequences for how risks and benefits are perceived, constructed and managed; what regulatory and evidential regimes are brought into play; what private or public resources might be deployed and what characteristics might be highlighted in the public sphere and thus give rise to public approval or concern. …

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In the case studies that follow, the different interrelationships of the socio-technological characteristics of particular devices that engender dynamics of innovation and diffusion will be analysed. Taking a commitment to the comparative method, I first outline the major dynamics of the innovation pathway of each device technology, paying particular attention to issues of material technology, scientific evidence, governance developments and the status of usership in relation to the technology. … More concretely, I describe the technological artefact itself; the stakeholders, including industry, regulatory agencies and users; ‘evidentiality’—the scientific, surveillance-related and other evidence constructed as salient to innovation and governance; and the governance process, including state and non-state actors, legislative and informal modes, national and EU-wide. Geographically, or geopolitically, the focus is on the United Kingdom1 and the EU because it is here that much of the formal device regulation is framed.

F rom: Chapter 9, Devising Healthcare and Society, pp. 190–209 Five Devices: Innovation-Governance Patterns Compared The five case studies provide contrasting and overlapping pictures (or, better, videos) of patterns of material technology, stakeholder interest, usership, evidentiality and governance involved in their innovation and diffusion in the healthcare system. … Clearly, a first conclusion to be drawn is that few of the innovation ‘pathways’ that technology producers or healthcare professionals or healthcare commissioners or patient groups might like to envisage are clear, straightforward or unobstructed. The respective patterns of powers of stakeholders and discourses in the material technology, usership, evidence and governance vary strikingly between devices. Many conflicting tensions between trends and stakeholders have been illustrated in each case. …

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Regulation, Governance and Governation The movement from government towards forms of governance associated with the neoliberal state and deregulation underlies much of the governance activity portrayed in this book. It is axiomatic that regulatory regime-building around technology constitutes a ‘fluid governance jigsaw’ (Brown et  al. 2006) and that technology governance is ‘forever breaking down and being reinvented to address societal changes’ (Fox et al. 2007). In my account of the technological zone of TE, I introduced the term‘ governation’ to indicate the constructive, inventive action of stakeholders in the European regulatory state in shaping the boundaries and rules of engagement for that piece of the evolving jigsaw puzzle of technological healthcare. The case studies in this book have illustrated the varying patchworks of regulatory activity in the distributed governance of the healthcare state. In this short section I interpret the actors and agencies of governation, further using some of the case study evidence. …

Discourses and Practices of Risk I have deliberately avoided discussing ‘risk’ as a primary concept in the case studies or introductory parts of this book. It is an over-used and overly broad term in sociological studies of medicine and health (where are the sociological analyses of benefit?), and it is easy for it to become enmeshed in grand theoretical analysis of the hypothesised ‘risk society’ and the like. However, of course, the hazards of healthcare and its technologies are important (to health, and politically and analytically), and the construction of hazards as risks in regulatory and health policy discourse is a crucial aspect of the governance of health technology innovation. As colleagues and I have discussed elsewhere, the societal framing of technology-related risks increasingly has become closely related to, but not necessarily matching or interlocked with, modes of governance in ‘risk regulation’ regimes (Faulkner et al. 2008).It is important to understand how risk is being discursively framed and constructed, and institutionalised and acted upon. In this book, a summary of the risk discourses

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across the five technologies shows evidence of risk defined in terms of many different dimensions: human physical safety, human or system error, scientific evidential uncertainty, citizen decision-making uncertainty, ‘technical’ performance (itself constituted in various dimensions), healthcare system cost, system-level clinical effectiveness, social values and ethics. Typically, several different framings of risk have been produced around the same device by different stakeholders and participants. It appears that this phenomenon is not a simple matter of different ‘types’ of technology evoking different types of socially shaped risk by some direct process of translation, though this is a factor: each device shows a variable pattern of social and technological ‘shaping’. Why, for example, has a discourse of ‘safety’ become dominant in the case of infusion pumps, but not in the case of artificial hips? Why has a discourse framed in the terminology of ‘risk’ itself—and risk management—become particularly prominent in the political governation of PSA testing? In the case of the infusion pump, contributing factors have been the link to the broader policy discourse of medication errors and the occasional exposure of news of fatalities in the public sphere. … In contrast, the risks of artificial hips were framed primarily in terms of a healthcare evaluation agenda of effectiveness and cost-effectiveness, constructed through application of the healthcare sciences to issues of a proliferation of ‘untested’ models. … In the case of the PSA test, the prevailing risk assessment and governation discourse has not been one of safety. My account of it showed that uppermost was a discourse of ‘risk’ of prostate cancer and of risk of knowledge or uncertainty for patients/ citizens associated with the imprecise quasi-diagnostic results produced by the technology. The case study showed the massive variation in men’s evaluations of the value and significance of the technology. Thus in this case the risk discourse was strongly associated with the broader discourse in population health policy about the benefits and disbenefits of disease screening programmes, a contested governance arena that also includes, for example, mammography. …

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[T]he sociality of medical device technology is variable between devices. Infusion pumps are highly ‘social’ but not in the sense that the PSA test is. In the PSA case the sociality of the technology lies in the simplicity of the material technology per se allied with the extreme uncertainty of its usership in the production and meaningful social interpretation of its ‘outputs’. In the case of infusion pumps, on the other hand, the sociality of the technology lies in the complex nexus of medico-social and medico-organisational relationships in which a functionally complex device is deployed, a sociality whose nature will change with the increasing incorporation of ICT features. … So some medical devices are ‘more social’ and ‘more interpretable’ than others. This final discussion has shown that for each device there is a different balance of forces between ‘social’ shaping and ‘technological’ shaping. … I have examined the dynamics of innovation and governation of selected device technologies and have analysed them in terms of the conundrum of society/technology. In the spirit of the ‘technology-in-­ practice’ approach (Timmermans and Berg 2003), I have looked at technologies that are not high profile in the public sphere. Focusing on such more or less unexceptional devices has enabled an analysis of the dynamic movements of innovation, governation and usership which interact with their artefactual technology in and around the constraints of the healthcare sector. The inescapable conclusion of this analysis is that generalisations about the relationship between medical technology and society must be very carefully scrutinised with empirical evidence, and that the dynamic relationship between the specifics of a medical device technology and the specifics of a social process takes distinctive forms.

Reflection by Alex Faulkner When I wrote Medical Technology into Healthcare and Society (MTHS) about a decade ago, one of my main aims was to contribute to remedying what was clearly an overemphasis, in social science studies of

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medicine and healthcare, on pharmaceuticals and their regulation. One notable exception had been the work of Professor Christa Altenstetter at City University New York (CUNY) though from more of a political science perspective. This relative neglect persists, though more scholarship on particular devices, or classes of devices, for example on screening or molecular diagnostic technologies or intensive care technologies has been produced—as evidenced by some of the monographs in the series of which the current volume provides an overview. A second aim was to develop a way of applying perspectives from the long standing sociology of scientific knowledge (SSK) and sociology of technology to the world of medical devices, arising from an innovative early article which started to explore SSK in the case of what I call in MTHS the healthcare sciences, in other words Health Technology Assessment (HTA) and Evidence-Based Medicine (EBM), movements then in their infancy (Faulkner 1997). It is fair to say that now, the field of Science and Technology Studies (STS) has a thriving focus in medical and healthcare sciences, technologies, and practices generally, though often not framed in the context of the medical devices industrial sector or the ever-evolving regulatory arena, responding not least to occasional safety scandals. There are striking developments in both the technologies and the governance of the medical device field that I would give more attention to, were I to re-write the book now. On the technology side, the boundaries between devices and other forms of medicine and technology continue to be blurred, for example with the further development of biotech medicine and cell therapy and the massive incorporation of digitalisation into devices. Of particular interest, and concern, is the incorporation of software and artificial intelligence (AI), which greatly complicates the regulatory challenge, not least because software alone can be classified as a medical device if it has a ‘medical function’. Digitalisation is also highlighted by the emergence of health ‘apps’ for self-tracking and the like, which themselves can impinge on multiple risk regulation regimes. On the governance side, we see the scientisation of the healthcare state exemplified by the rise of healthcare science and HTA in particular, institutionalised in the UK in the National Institute for Health and Care

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Excellence (NICE) whose scope and reach has become enormous, extending to some measures for new technology (medicine and as well as devices) mandatory for NHS adoption and a plethora of clinical guidelines based on extensive evidence reviews and consultation with stakeholders. It is notable that this embraces the ‘public and patient involvement’ agenda of NHS policy. On the theoretical side, I would remain committed to the insights and positions extracted in the volume above, including the need to study the specificity of particular devices in their sociotechnical networks. A notable development among less mundane, innovatory technologies is the emergence of what we might call ‘promissoriness’. The sociology of expectations (Borup et al. 2006) has shown that incumbent participants’ visions and expectations can have a generative and translational effect on the arc of technologies’ development and possible adoption into practice. Research which colleagues and I undertook on further cases of devices in the UK’s NHS produced the concept of ‘technology identity’ (Ulucanlar et al. 2013), which has been taken up by other scholars (Gardner 2017). Not only can we observe an important promissory aspect of technologies’ innovation pathways, but this promissoriness has found its way into the worlds of healthcare science and medical product regulation too. Thus, NICE can be seen to be extending its use of quantitative modelling around clinical uncertainty and cost implications of technologies (Woolacott et al. 2017), and regulatory regimes worldwide can be seen to have been evolving more flexible forms of regulation and alternative ‘gateways’ to adoption (Faulkner and Mahalatchimy 2018), for example the UK regulator MHRA’s ‘Promising Innovative Medicine’ designation, which is part of a European Union initiative on ‘early access to medicines’. Social scientists and healthcare evaluators should be alert to the realistic risks, opportunities, and the societal significance of this promissoriness.

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 ourtney Davis and John Abraham. (2013). C Unhealthy Pharmaceutical Regulation

F rom: Chapter 1, Putting Pharmaceutical Regulation to the Test: From Historical Description to a Social Science for Public Health, pp. 5–26 This book examines how innovative pharmaceuticals have been regulated in the US and the European Union (EU) since 1980—a period which we refer to as the ‘neo-liberal era’. Regarding the EU, our principal focus is on the period since 1995 because that is when a supranational EU regulatory agency and system became fully established with specific responsibilities for regulating innovative pharmaceuticals. Like many other writers, we refer to the post-1980 era in the US and western Europe as ‘neo-liberal’ because it was, and remains, a period in which the political project of minimizing state intervention, subjecting the state to

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competitive tests of ‘the market’, and elevating individual consumer choice above the state as a form of collective decision-making, all came to the fore. This has involved the ‘liberalization’ of markets, that is, relaxation of government regulations and controls believed to hamper business activity and the socio-economic signals of consumer demand (Fisher 2009). … In the pharmaceutical sector, a raft of pro-business deregulatory reforms ensued during the neo-liberal period (discussed in detail in Chap. 2). They included making the American and European government drug regulatory agencies largely and increasingly dependent on funds from the pharmaceutical industry; increasing the extent and flexibility of consultation between regulators and drug companies; reducing the amount and types of evidence that pharmaceutical firms had to collect to demonstrate the efficacy of particular categories of drugs in order to obtain marketing approval from regulators; and shortening the time taken by government regulatory agencies to grant marketing approval to drug companies for their products. Meanwhile, government regulation of pharmaceuticals maintained its legal responsibility and official democratic mandate to promote and protect public health. In that context, the crucial claim made by government and industry officials regarding the deregulatory reforms was that they would accelerate and increase pharmaceutical innovation, which was in the interests of patients and public health because they needed faster access to innovative drugs. Thus, one theory of pharmaceutical regulation since 1980, which we call ‘neo-liberal theory’, is that the pro-industry deregulatory reforms of that period were instigated by government in the interests of patients and public health. Implicit in the theory is the proposition that pharmaceutical innovations necessarily promise therapeutic advances for patients. In this book, we put that theory, among others, to the test by examining both the macro-politics of regulatory change and the micro-sociology of individual drug development and regulation. We present the first social science research to provide an analysis of both American and supranational EU pharmaceutical regulation of innovative prescription drugs. Given that the direction of

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drug regulation has significant implications for patients, public health and healthcare systems, it is important to understand its socio-political and technical dynamics in order to learn lessons from the past and reflect on possible future policy options. …

The Theoretical and Methodological Approach of This Book Following Abraham (1995, 2008), we take an empirical realist, interests-­ based approach. That is, we presuppose that within regulated capitalism, such as exists in the pharmaceutical sectors of Europe and the US, drug firms have objective commercial interests in maximization of profits for their shareholders and investors, while patients and the wider public have objective health interests in the maximization of the benefit–harm and benefit–risk ratios of pharmaceutical products. The pharmaceutical industry often argues that it is a highly profitable industry because it manufactures products that patients and healthcare systems need, with the implication that the commercial interests of drug companies and the health interests of patients and the public coincide. Sometimes those interests do converge, but as Abraham (2008) has pointed out, the very existence, and historical development, of government intervention to regulate the pharmaceutical industry logically implies that those interests can often diverge or conflict, and that consequently pharmaceutical manufacturers cannot be trusted to be the sole arbiters of whether their products are in the health interests of patients. If drug companies could be so trusted, then the existence of government regulation to check the safety and efficacy of pharmaceutical products would be unjustifiable. Thus, government drug regulatory agencies have been established ostensibly to regulate the pharmaceutical industry in the interests of patients and public health. Moreover, both the EU and US drug regulatory agencies accept that it is their legal responsibility to protect and promote public health. …

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Pharmaceutical Product Innovation and Regulation When a pharmaceutical firm or laboratory discovers a new compound with some therapeutic potential its novelty status is defined by its technical uniqueness from other molecules. The discovery of such technical novelty may also be regarded as a form of intellectual property, especially because work and resources have been involved in the discovery process. In western countries, drug companies typically make applications to patent their discoveries of new compounds. Patent offices provide authoritative determination and record of the technical unique-ness of the compound together with the party who made the discovery. The patent protects the intellectual property rights of the company/laboratory that made the discovery by preventing any other enterprise from copying the discovery for commercial purposes. Such protection is afforded by patent and intellectual property laws usually for 15–20 years from the date the patent is issued. The new, technically unique, drug compound is known as a ‘new molecular entity’ (NME)—the preferred term in North America. In Europe, NMEs are often known by the term, ‘new active substance’ (NAS). … In order to reach the market, the NME must gain regulatory approval from government agencies responsible for the markets in question. In this book, that means the EU and the US. When a new drug is granted permission on to the market by the regulatory agency in the US, it is referred to as a ‘new drug approval’, whereas in the EU, it is referred to as ‘marketing authorization’. … Evidently, pharmaceutical product innovation is, in effect, defined by technical and commercial (intellectual property and market) criteria, except for the requirements imposed by regulatory agencies to meet health-related criteria. Those health-related criteria, which exist in both EU and US pharmaceutical regulation, are drug quality, safety and

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efficacy. By ‘quality’ is meant the purity of the drug compound—that it is not adulterated with other ‘ingredients’, and that it meets very high standards of purity. … We presume that the meaning of drug ‘safety’ is self-evident in broad terms, while ‘efficacy’ relates to a drug’s effectiveness in treating the illness or condition for which it has been approved for use, or is hoped to be approved for use. Hence, in the context of pharmaceutical regulation, it is possible for a drug to be of very high quality, but to be unsafe or ineffective or both. This book is almost entirely concerned with drug efficacy and safety, primarily efficacy. … Thus, within the basic drug regulatory system that existed before and throughout the neo-liberal era in Europe and the US, a pharmaceutical product innovation was, and is, defined as an NME that has gained marketing approval by demonstrating that it is safe and effective. The basic system does not require new drugs to offer therapeutic advance for patients or public health by, for example, being more efficacious than drugs already on the market to treat the same condition. As the forgoing discussion reveals, the official accounting of innovation in the sector means that a new drug may be counted as an ‘innovation’, but offer no therapeutic advance. An ‘innovative drug’, in this official sense, might offer therapeutic advance or even be a major therapeutic breakthrough, but equally, it might be less effective than drugs already on the market. Logically, therefore, innovation does not necessarily imply therapeutic advance, and systematic analysis of the pharmaceutical sector must keep ‘product innovation’, on the one hand, and ‘therapeutic advance’, on the other, conceptually distinct. It is, then, a matter of empirical evidence whether an individual drug innovation also provides therapeutic advance.

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F rom: Chapter 2, The Political Economy of ‘Innovative’ Drug Regulation in the Neo-liberal Era, pp. 38–115  eo-liberal Reforms and Corporate Bias in European N Nation-States The UK election of Prime Minister Margaret Thatcher in 1979 and her New Right Conservative Party in three subsequent elections marked the beginning of the neo-liberal shift. The Thatcher Government was elected with a positive commitment to reduce state intervention in the economy; pharmaceutical regulation was to be no exception. At that time, drug regulation was conducted by a section within the UK government’s Department of Health called the Medicines Division, also known as the UK Licensing Authority. During the 1980s, the Association of the British Pharmaceutical Industry (ABPI) badgered the British Government to organize drug regulation more efficiently according to the industry’s desire for faster marketing approvals. The Thatcher Administration was already planning reform of the civil service as part of its neo-liberal agenda so it was sympathetic to the pharmaceutical industry’s claims that state regulation was insufficiently responsive to the needs of business and innovation because it did not approve new drugs on to the market fast enough (Abraham and Lewis 2000: 60–62). … [N]eo-liberal reforms went ahead. A new regulatory authority, known as the Medicines Control Agency (MCA), was established with a new director, who came from the pharmaceutical industry. … [U]nder the MCA, the entire running costs of UK drug regulation were to become dependent on fees paid by pharmaceutical firms. … On arrival, the new director of the MCA announced that the agency aimed to reduce the net processing times for new drugs by 24  percent within a year. Between 1989 and 1993, new drug processing times fell by more than half, from 154 working days to just 67, while the number of licences granted for new drugs increased from 57 in 1989 to 77 in 1993—results for which the pharmaceutical firms paid handsomely, making the MCA one of the

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richest regulatory agencies in Europe (Abraham and Lewis 2000: 65–66). Moreover, the agency increased its consultation with companies and integrated industry interests into its mission statement, which promoted the perspective that the interests of industry and public health coincided. … Notably, there is no evidence of patient activism or demands for any of these reforms at that time in the UK.  Rather, in 1991, the British Government invited the industry to join a board of experts to advise the Department of Health on the scope of the MCA’s targets and performance. Patient activism or even awareness about such matters were so absent that government ministers made little attempt even to present their reforms as if they were a response to patient demands (Abraham and Lewis 2000). These neo-liberal reforms in the UK were to be influential on other European countries and the framework for Europeanization of pharmaceutical regulation that ultimately informed the nature of the supra-­ national EU regulatory system established in 1995. For instance, soon after these UK reforms, one can observe similar developments in Sweden and Germany. In both countries, a shift to the political right was taking place, though we are not suggesting that the neo-liberalism of Germany, Sweden, and the UK were identical. Nevertheless, in the context of pharmaceutical regulation, the commonalities were unmistakeable and far outweighed subtle differences. …

The Drug Lag Mythology and Early Neo-liberal Shift in the US [In the US during] the 1960s through to the 1980s, the Food and Drug Administration (FDA) gained the reputation for having among the most stringent drug regulatory standards in the world, along with Norway. In particular, it prevented the sale of many unsafe or ineffective drugs in the US, including some drug disasters, which found their way on to markets

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in other countries (Abraham 1995; Abraham and Davis 2005, 2006, 2007). Unimpressed, throughout the 1970s and into the 1990s, the pharmaceutical industry and some researchers, such as the conservative economists from the industry-funded Tufts University Center for the Study of Drug Development (Tufts Centre), persistently accused the FDA of being unnecessarily cautious and bureaucratic about approving NASs. Such ‘over-regulation’, as they characterized it, resulted, they insisted, in important new drugs reaching markets and patients in the UK and other European countries while remaining under review in the US. The consequent ‘drug lag’, they argued, delayed American patients’ access to important medicines, negatively impacting on their health …. In 1981, the critics of the FDA’s supposed ‘over-cautious’ regulation from industry and conservative ‘think-tanks’, like the Tufts Centre and the American Enterprise Institute, were boosted by the election of Ronald Reagan as US President. A New Right Republican, he believed in minimal regulatory restrictions on business interests, and began what was to be a run of 12 years in the White House for the Republicans. Nonetheless, [some] theorists, contend that the FDA did not respond to pressure from these quarters, including the Reagan Administration, to accelerate new drug review and approvals until such reforms were also called for by AIDS activists in the late 1980s. For example, Edgar and Rothman (1990) assert that, before the mid-1980s, FDA’s ‘heavy-handed paternalism’ was ‘heavily biased in favour of caution’ about approving new drugs and denied patients the right to their own risk–benefit calculus about pharmaceuticals. AIDS patient activism, they argue, reversed this. … [However] while anti-regulation critics seeking less state intervention in the market complained that over-regulation at the FDA stifled pharmaceutical innovation and acted as an obstacle to patients’ access to medicines, it was in fact industry’s unwillingness to develop ‘unprofitable’ drugs that explained the lack of innovation for treatment of ‘rare’ diseases, rather than excessive regulation. …

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 e Neo-liberal Model of Resourcing Regulation Hits Th the FDA: The Prescription Drug Users Fee Act (PDUFA) As we have noted, prior to the AIDS crisis, and well before AIDS patient activists protested against the FDA in late 1988, the pharmaceutical industry and its neo-liberal allies in the Reagan Administration and the Senate sought reforms to reduce regulatory review times for all types of drug innovations, irrespective of whether they were to treat serious or life-threatening illnesses, or judged to promise therapeutic advance. It would be wrong to say that the AIDS crisis was a side show so far as that reform programme was concerned, because the challenge of AIDS treatment affected the shaping of some of those reforms, as we have seen. Nonetheless, the neo-liberal reform of pharmaceutical regulation more generally continued throughout the debate about accelerated access to, and approval for, new drugs to treat serious or life-threatening conditions. As FDA management attempted to decrease regulatory review times across the board, in response to the Reagan government’s demands, it did so in a context of severe cuts to its budget, which was provided and set by Congress. … The idea of charging the pharmaceutical industry fees for the FDA’s drug regulatory work had been suggested as a solution to the agency’s funding problems from the mid-1980s by both the Bush and Reagan Administrations but had never been authorized by Congress. In August 1992, the PMA indicated publicly that it would not oppose fee charges on condition that the fees, which became known as ‘user fees’, were wholly concentrated on new drug review and, that the FDA undertook to implement ‘specific improvements’ in the regulatory review process. Later that year, Congress enacted the 1992 Prescription Drug User Fee Act (PDUFA). …

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In return for user fees, the FDA agreed to meet increasingly demanding review performance goals regarding all innovative pharmaceuticals, irrespective of whether they offered therapeutic advance. For example, that by 1997 it would review 90 percent of applications for new products given a standard review classification within 12 months and 90 percent of those accorded priority review status within 6 months (FDA 1997). Such timeframes were goals rather than deadlines, however the particular character of the user fee legislation meant that FDA was under pressure to treat the timeframes as deadlines. PDUFA contained a ‘sunset’ provision whereby the user fee legislation had to be renegotiated every five years, allowing the pharmaceutical industry to refuse continued user fee funding if it felt that the FDA was not fulfilling its obligations under the legislation, or if industry and Congress could no longer agree on specific performance goals. … [This] allowed industry considerable de facto influence over FDA priorities and policies. … Although the neo-liberal reformers and those in the FDA management, who had resigned themselves to the ideology of their political masters, sought to represent the definition of FDA performance evaluation as speed of approval as good for patients and consumers, some patient/consumer organizations were not convinced. In evidence to FDA public meetings on PDUF … the US Center for Medical Consumers remarked poignantly: Speedier drug approval clearly benefits industry; in some cases it may benefit patients or specific populations, but in most cases there is no such evidence. It is, therefore, inappropriate for the agency to so narrowly define the objective of PDUFA. … Its self-evaluation and how it defines performance measures should focus on how well its activities improve the well-­ being of those who are sick and disabled.

…

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The responses of patient and consumer advocates to PDUFA provide further evidence that the AIDS drug scenario was an exception in a sea of regulatory reform designed to assist business and industry, with the interests of patients and public health a residual concern. …

The Creation of Supranational EU Pharmaceutical Regulation Meanwhile, the Europeanization of pharmaceutical regulation across western European nation-states was gathering pace like never before. The transnational research-based pharmaceutical industry saw advantages in the Europeanization project if it harmonized regulatory standards across Europe in ways conducive to greater market access for drug products. Reflecting those transnational priorities, in 1978, the industry established the European Federation of Pharmaceutical Industry Associations (EFPIA), which was a conglomerate of the national industry associations in Europe, and became the official representative of the European industry in negotiations with the European Commission and Parliament. … [I]n the late 1980s, the pharmaceutical industry set out its ‘blueprint for Europe’. The industry stressed that any new Europeanized system should enable companies to obtain a single, uniform marketing authorization quickly (within 210 days). While the industry wanted regulators to submit to stringent timeframes and guidelines, it also argued for the maintenance of three approval tracks (national, decentralized, and supranational-centralized) so that firms had maximum flexibility in deciding within which regulatory context to place their drug applications. Specifically, the industry proposed that there should be a centralized EU drug regulatory agency to handle biotechnologically-based drugs, while companies could retain the option of submitting non-­biotechnological, innovative pharmaceuticals to either a decentralized EU authority or national regulatory agencies within a mutual recognition procedure.

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Crucially, the industry recommended that if national regulatory agencies failed to mutually recognize each other’s assessments within a specified time, then the EU drug regulatory agency could impose a decision on the Member State. … Hence, marketing approval via the centralized procedure provided a company with an immediate, single European licence to sell its pharmaceutical product across the whole of the EU (bypassing entirely national regulatory agencies), just as an FDA approval enabled a firm to market its product across the US. …

Pharmaceutical Outcomes and the Neo-liberal Reforms Evidently, since the 1980s, the FDA and the EMEA have developed mechanisms for accelerating both regulatory review and development of innovative pharmaceuticals, including reductions in the amount of information regulators require from companies before clinical trials and/or marketing approval, and time management goals regarding formal meetings between regulators and firms encouraging regulators to provide companies with scientific advice about drug development. As we have seen those measures within the neo-liberal reform programme delivered much faster new drug review times in the EU and the US than previously. … Yet, despite decreasing regulatory review times, provisions aimed at shortening development times, and increasing harmonization of regulatory science requirements in the EU and US (Kaitin and Di Masi 2000), there has actually been a decline in pharmaceutical product innovation since and during those neo-liberal reforms … [and data from the FDA show that] the number of new drugs offering therapeutic advance has also been in decline since 1998.

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F rom: Chapter 7, Conclusions and Policy Implications, p. 275 The overwhelming lesson from our case studies is that the goal of public health benefit would have been better achieved by gathering and analyzing more and better data on drugs’ clinical efficacy and outcomes before marketing approval. Speed of approval is not the most important criterion of regulatory performance so far as health is concerned. Hence, in some respects the reforms needed to improve pharmaceutical regulation for health since 1980 should have gone in the opposite direction and encouraged different priorities to the priorities pursued under neo-liberal deregulation. For example, much progress could have been made towards strengthening the evidence base for new medicine shad regulators required new drugs to be tested against existing gold-standard therapies (where they exist), rather than merely placebo. Often gold-standard therapies would be medicines, but not necessarily so. For example, in the case of [irritable bowel syndrome], new drugs might also be systematically compared with dietary interventions. The problem, of course, during the neoliberal era is that far too frequently, before marketing approval, the efficacy of NMEs has not been systematically tested against other effective drugs, let alone gold-standard non-drug therapies. Where use of a placebo is ethical, three-arm trials (involving the experimental new drug, gold-standard therapy and placebo) provide the best evidence for patients, doctors and healthcare systems and encouraging this kind of clinical trial design should have been a priority of the regulatory reform agenda. It is a more challenging standard for industry, and more expensive since it would require larger clinical trials. Its neglect, relative to the enormous efforts marshalled to speed up marketing approval during the neo-liberal era, further highlights the extent to which the regulatory state in the EU and the US prioritized the commercial interests of industry over health interests.

Reflection by Courtney Davis and John Abraham In Unhealthy Pharmaceutical Regulation, we explored the introduction, implementation, and implications in the United States (US) and European Union (EU) of regulatory policies that aimed to accelerate

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innovative, new drugs onto the market by reducing regulatory review and drug development times. These included measures that lowered regulatory standards for drug testing and authorisation and increased levels of uncertainty around new drugs’ risks and benefits. Whilst proponents claimed these initiatives would facilitate medical innovation and speed patient access to ‘promising’ new therapies, we showed—through detailed case study analysis—that regulatory praxis did not necessarily lead to the prioritization, incentivisation or approval of therapeutically important drugs. On the contrary, in each of the cases examined, new regulatory tools were used to approve, and maintain on the market, drugs of unknown or doubtful therapeutic value to patients and public health. The trends we observed over the 20-year period between the late 1980s and 2010 have continued and intensified. Since 2013 additional legislative and regulatory tools to shorten product development times and speed market entry have emerged in North America, the EU, and the UK, and similar regulatory policies have been adopted over the last few years by governments in Australia, Japan, Argentina, Brazil, China, and India (see, e.g., Rosemann 2019; Webster 2019). As in North America and Europe, these initiatives increase uncertainty and risk for patients and clinicians by shifting parts of the drug development process to the post-approval period, when products are on the market and being used by patients. Whilst there is evidence to suggest that use of these ‘exceptional’ product development and review pathways has facilitated earlier patient access in the USA, it is not clear whether this is true in other national contexts. The proliferation of these policies and their diffusion across diverse national contexts over the past 30 years constitute a dominant trend in pharmaceutical governance. This process has involved the emergence of a new policy paradigm with significant implications for health systems and public health (Wieseler et al. 2019) yet aside from some notable exceptions (see, e.g., Herder 2019; Hoekman 2016; Hogarth 2015; Lexchin 2016; Nik-Khah 2014; Webster 2019; Rosemann 2019) there has been relatively little social scientific research on this topic. Studies to date have mainly focused on single geographic regions, disease areas, or health technologies. Only a small handful of studies have systematically compared the use of these pathways across different regulatory contexts or explored

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their relation to broader processes of change, convergence, and divergence in pharmaceutical policy and governance at national and international levels (as described, e.g., by Wiktorowicz et al. 2018). There is thus still much work to be done to investigate the drivers and implications— for healthcare systems, individual patients and public health—of this emerging regulatory paradigm, its global diffusion and local forms.

 ndrew Webster. (Ed.) (2013). The Global A Dynamics of Regenerative Medicine: A Social Science Critique

From: Andrew Webster. Introduction, pp. 1–17 The analysis of any field of inquiry depends on a clear understanding of where its boundaries lie and what thereby is to be the object of that analysis. However, many scientific fields today are characterised as having

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highly permeable boundaries, reflecting a number of processes at work— the moves towards transdisciplinarity, the creation of integrative technology platforms (as in the use of bioinformatics or genomics science in diverse domains) …. Contemporary developments in the biosciences associated with new biological possibilities—such as seen in synthetic biology, embryonic stem cell research, and gene therapy—also depend on the articulation and integration of different sciences and technologies, such as engineering, physics, and biology within synthetic biology. As a result, the epistemic and professional boundaries of these biosciences are similarly fluid, highly mobile, and yet to be stabilised. While the matter of disciplinary boundaries and their formation is of interest to those within the field of science and technology studies, what has been of especial interest is the ways in which these biosciences not only generate new biological but also social possibilities by disturbing our understanding of the boundaries between the body, nature, and identity (not least in the form of human/ animal hybrids), and how these create new ‘bio-objects’ that are contested, exploited, and require the search for new forms of state and societal regulation and governance (Vermeulen et  al. 2012). Indeed, these changes can be so fundamental as to require a radically new approach to the human ‘constitution’, in both its biological and socio-legal senses (Jasanoff 2011). As a field of inquiry, regenerative medicine has attracted major commercial, clinical, political, and popular interest as well as controversy, illustrated by the 2008–2009 debate in the United Kingdom over the licensing of research on so-called ‘admixed embryos’, the combination of human and animal cells. The contested nature of the area has attracted growing social science interest … and this bookbuilds on this body of work in an attempt to provide as broad-ranging an analysis of the current meaning and impact of regenerative medicine as possible, drawing on a number of different perspectives that provide acritical assessment of the science base and its geographical reach, the parallel hype and promise associated with the field, the uneven and often failed commercial exploitation we have seen, and the political, legal, and bioethical challenges that developments in the regenerative medicine field pose. It does

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this at a global level, including a detailed analysis of what we are seeing in the United States, Europe, China, and Australia …. Boundaries of a field are especially difficult to determine where afield is framed by its proponents as ‘revolutionary’, or as offering a new paradigm for theory and practice. … The two most notable developments in regenerative medicine that might be associated with this language of change were the identification and isolation of hESC, by Jamie Thomson in his lab at the University of Wisconsin–Madison in 1998, and the more recent (2007) creation, by Yamanaka at the University of Kyoto, of ‘induced pluripotent stem cells’ (iPS) that have the biological potential of embryonic cells without being derived from embryonic tissue as such but from reprogrammed ‘adult’ (mature, already differentiated) human cells such as skin cells. The long-term goal of regenerative medicine is to harness the regenerative potential of both hESC and iPS cell lines to restore functionality in the body. Both types of cell lines can, in theory, be used to generate primary tissues and organs through their controlled differentiation in the lab and subsequent transplantation into the human (or animal) body. For example, biomedical scientists are working on restoring heart function through the injection of a specific type of cell line— cardiomyocytes—that has been modified to act as heart muscle. Prior to this regenerative paradigm, the field was primarily associated with ‘tissue engineering’ which, with a focus more on replacement, can be traced back some 30 years, involving the use of cells and biomaterial compounds to rebuild damaged body tissue, through skin grafts or bone and cartilage repair, or the use of mature healthy cells trans-planted therapeutically to treat haematological (blood) disorders, such as bone marrow cells used to treat childhood leukaemia …. At present the clinical use of cell therapy techniques and products is in the domain of (non-iPS) ‘adult’ cell lines, using what are called ‘autologous’ (i.e., the patient’s own) cells. However, while there are some treatments on the market (such as cartilage repair), the cost of developing products, the cost of production, and the size of the markets are all factors, which mean that time to clinical use will take many years for most products currently in development.

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Boundary Closures and Openings The account of the field above provides a basic sketch of the bioscientific landscape upon which we can undertake a more sociological exploration of the social, economic, and cultural boundaries of regenerative medicine. In doing so we have to think how boundaries are drawn, contested, consolidated, and negotiated on this landscape through the play of diverse interests. In that sense, there is no natural, or inevitable, boundary to the field. The specific socio-technical landscape of regenerative medicine is populated by cell therapy labs, research networks, regulatory committees, patient advocacy groups, bioclinical collectives (Rabeharisoa and Bourret 2009), and a range of other heterogeneous elements. These must negotiate not only among themselves but with those actors/agencies found on a wider socio-technical terrain, such as the healthcare system, and the broader regulatory, ethical, and political institutions and cultures that are shaped by but yet constitutive of the field itself. The stabilisation and thereafter exploitation of any field requires action which in some way defines and marks off its boundary: the ‘closure’ here is not meant to suggest the closing off or the insulating/isolating of an area but rather establishing the terms on which it claims some degree of warrant, authority, and identity with which those outside the boundaries of the field can and do engage, perhaps better envisaged as a form of ‘enclosure’. This involves the policing and disciplining of those working within the field. But this is a process which, paradoxically, affords mobility, scale-up, and globalising effects that can ‘act at a distance’ (Latour 1987) …. There are a number of ways in which we can see this stabilisation and policing being undertaken by those within the scientific/corporate/regulatory nexus. Global stem cell research networks have been established by leading labs including those from Europe, the United States, Japan, and Australia as members of the International Stem Cell Initiative to police the production of stem cell lines via standard operating protocols and the identification of materials to reduce variability across labs, such as the move towards agreeing to a ‘defined media’ to help the reproducibility of cell batches, remove potential sources of contamination or confounding factors, and enable the comparability of results across labs in different

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countries. Not only scientists but companies too (those providing the media) have been involved in this process. A second way in which we have seen boundary closure at work is in regard to the move towards the automation of cell culture/management techniques through scientific equipment manufacturers involved in whole cell bioprocessing. Automation is, as Bartlett (2009) has eloquently suggested, ‘the material reification of rationalisation’ (p. 75) and in turn helps relieve the tedious work of manual handling of cell batches, their extraction, and the validation of results. It presupposes agreement over how variability in cell lines is to be understood and treated within automated systems, and presumes thereby that what is scaled up has a robust degree of consistency and uniformity. Regula-tors are very closely involved here since they require this degree of consistency and reproducibility in approving the move towards clinical trials …. The following chapters of the book, written from a variety of disciplinary perspectives within the social sciences, include contributions from international experts in science and technology studies, political science, law, and ethics. Our general integrative principle woven through the chapters is that, as a field in the making, regenerative medicine develops along different innovation paths or ‘journeys’ (Deuten and Rip 2000). These pathways are, for the most part, non-linear, messy, and complex, involving setbacks and detours. It is an especially complex field inasmuch as it combines ‘mature’ biomedical technologies and therapies (as in tissue engineering and cell therapy that goes back to the 1950s) with emergent and highly unstable science (as in embryonic stem cell research), and as such is characterised by boundary disputes/boundary work and by a regulatory environment which seeks to deploy traditional regulatory oversight of it while acknowledging the limitations of this (both aspects seen, for example, in clinical trial provisions and requirements).While such disjunctions figure within many advanced medical set-tings, the globalisation of regenerative medicine, as both promise and practice, has meant that these tensions are ratcheted up at the global level: the rapid growth of ‘stem cell tourism’ accompanied by moves to constrain this; the growth in China and India of unregulated treatment accompanied by global pressures and preparedness on China’s and India’s part to introduce new governance processes; the moves towards the international

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harmonisation of experimental standards in the field of embryonic stem cell research, and regulatory and licensing standards in advanced therapies, accompanied by prevailing localised lab practice sand national differences in reimbursement. Regenerative medicine, we argue, as all fields, is therefore co-constructed and co-evolves across these different fronts, and has a specific geography to it, and patterns of mobility across different boundaries (natural, jurisdictional, and geographical). The book examines the ways in which this creates divergences and convergences, multi-level forms of governance, commercial trajectories that move at different paces and with different ‘business models’, and the articulation between the demands of the bioeconomy and patenting on the one hand and the normative constraints of ethical and political cultures in regard to the use of oocytes and embryonic tissue for research on the other.

F rom: Michael Morrison, Stuart Hogarth, and Beth Kewell. Biocapital and Innovation Paths: The Exploitation of Regenerative Medicine, pp. 58–83 This chapter examines the dynamics of innovation in regenerative medicine (RM), focusing specifically on the contemporary activities of European-based RM firms. For the purposes of this chapter the term ‘innovation’ is taken to refer to the development and deployment of novel technologies. As Chaps. 1 and 2 have shown, ‘regenerative medicine’ is a heterogeneous domain incorporating a range of technologies. Different technological options within RM can be complementary or in competition with one another depending on how their deployment is envisaged. The heterogeneity of RM is not limited to specific material technologies, but also encompasses different models of how its products might be delivered in the clinic, how they might be reimbursed under different financial health care regimes, and different aims in terms of the diseases and patient populations particular RM technologies are best suited to address. There are thus different pathways which innovation are best suited to address. There are thus different pathways which innovation in RM can potentially follow ….

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Bioscience Innovation in Context In order to properly consider the commercial development of RM in Europe (and beyond) it is necessary to locate the activities of both individual firms and national RM industries in the wider context of the bioeconomy. Broadly, the bioeconomy is a particular life sciences-orientated formulation of ‘knowledge-based economy’, in which innovation is positioned as the source of raw value and the new knowledge it produces, when codified in the form of intellectual property rights (IPR), becomes the foundation for new rounds of economic activity and trade (Cooke 2001). In this model, small ‘start-up’ firms and companies ‘spun out’ from universities have been considered the best vehicles for the commercialisation of innovative technologies. Concomitantly, technoscientific research and development has become increasingly central to national and international economic operations and has been subject to increasingly strategic management and future-orientated regimes of planning (Borup et al. 2006; Kewell and Webster 2009). Leydesdorff and Etzkowitz (1996) theorised that innovation in a knowledge economy could be characterised as a ‘triple helix’ of links between the state, the academic sector and industry, where the state supports innovation through market-­ promoting reforms and (strategic) funding of science and technology R&D in the academic sector. Promising research from the academic sector is then patented and spun out into small biotech firms or licensed to entrepreneurs setting up their own companies. The subsequent development of research knowledge into products and services is then largely dependent on companies’ abilities to secure financial support from venture capital (VC) firms and other investors …. The bioeconomy extends this model into the realm of the life sciences and specifically biotechnological control and manipulation of (often living) organic biomaterial. Waldby and Mitchell (2006) describe the emergence of global ‘tissue economies’ of which the RM industry is partly based on the procurement and commodification of human tissues and body parts as the basis for novel medicinal and biotechnological products. Bioeconomic processes involve more than just collection and exchange of biomaterial; the technological manipulation of cells and

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tissues which is considered to transform them from ‘products of nature’ into patentable, fungible ‘bio-objects’ constitutes both recon-figuration and reproduction of the biological (Cooper 2008). Control of the regenerative capacities of living cells yields ‘biovalue’, a corporeal surplus which can become the object of speculative investment or ‘biocapital’ (Kent et  al. 2006; Rajan 2006; Waldby and Mitchell 2006). In essence, the generative potential of biological life becomes intertwined with that of capital ….

The Hidden Innovation System The triple helix/bioeconomy model, although dominant in biotech pol-­ icy circles, is not the only model of an innovation network. In a study of the UK science base carried out in the mid-1990s, Hicks and Katz (1996) observed a ‘hidden’ system of biomedical innovation based in hospitals and public laboratories and funded by research councils and charities, existing alongside the more visible university–state–industry network. Within the ‘triple helix’ model the health care system is often presented as a barrier to innovation, with sceptical clinicians and cost-conscious health care managers unwilling to embrace new technologies. However, the hidden innovation system presents an alternative account, which sees the health care system as an agent of, rather than an obstacle to, technological change. Focusing on the rapidly growing molecular diagnostics sector, Michael Hopkins (2006) has described the role of this hidden innovation system in developing clinical cytogenetic testing in the United Kingdom. Firms, while not excluded from this innovation system, are significantly more peripheral actors in these networks of technology development, relying instead on ‘public sector clinicians and scientists to establish and stabilize this market first’ (Hopkins 2006: 270) …. In the European context autologous stem cell therapies developed within academic and/or clinical settings present the best prospect for achieving clinical successes in the medium term. This may involve novel institutional and governance arrangements such as the formation of in  vitro fertilisation (IVF)-style clinics for autologous cell therapy or firm–hospital collaborations akin to the way commercial cord blood

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banks currently operate. Commercial development of allogeneic stem cell therapies for chronic illnesses will remain a longer-term prospect and may benefit from increasingly successful deployment of autologous therapies only indirectly as greater experience and know-how is built-up among a body of clinicians and researchers about how, for example, transplanted stem cells behave within the body and how they can best be tracked. However, as we go on to discuss in the next chapter, the regulatory warrant that experience and know-how can claim is no straightforward matter, and can vary considerably at the global level.

F rom: Christian Haddad, Haidan Chen and Herbert Gottweis. Unruly Objects: Novel Innovation Paths and Their Regulatory Challenge, pp. 88–117 Introduction During the last 15 years, stem cells have become sites of individual and collective human aspirations, where different scientific, medical, and economic visions and desires have been inscribed and contested, leading to multifold disputes and political controversies. Stem cells made headlines in the global mass media, and became a topic of electoral campaigns and heated parliamentary debates. They have brought stake-holders from different fields together into novel regulatory committees and expert bodies. In recent years, the focus of political and policy attention, professional and public concerns, as well as modes of expert deliberation shifted from basic biological research to efforts to apply these insights in clinical therapies, as stem cells moved into clinical research trials and experimental use (Webster et al. 2011). This push towards the clinic has not been a continuous or homogeneous process, but is characterised by striking frictions and heterogeneities in temporal and spatial terms, as well as with regard to practices. In 2010, a US biotech company, after years of preclinical development and intense relations with the competent regulatory authorities, announced the first embryonic stem cell therapy for initial human clinical trials (Roberts 2010), while in China, a network of stem cell labs, tissue banks, researchers, and affiliated clinics reported to have already

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treated several hundreds of patients with their own adult stem cells (Cyranoski 2009). In Germany, a prestigious team of scientists and clinicians have, fully supported by their peers and by state authorities, incrementally pursued the development of autologous stem cell treatments for a small range of cardiovascular diseases, whereas about 180 kms away, a clinical facility deemed ‘dubious’ has started to provide unproven and costly cell treatments for basically all kinds of paying patients in the same country (Mendick 2011). This clinic, operating in a legal grey zone, has already been shut down by regulators, as have been clinics in the United States, Mexico, the Netherlands, Bulgaria, and India. The international stem cell community, in unstable strategic alliances with national governments and protective regulatory agencies, has condemned this sort of experimentalism, and took action against ‘rogue clinics’, domestic and abroad. However, a great deal of suffering patients, rejecting such forms of protective paternalism, endorsed and actively engaged in new forms of medical experimentality (Chen and Gottweis 2011).The global landscape of stem cell therapy turns out, therefore, to be a messy and unruly field, marked by disparate medical, technical, legal configurations, as well as heterogeneous and conflicting ethical, political, and economic valuations …. In this chapter, we explore stem cell therapy as a site through which to understand the dynamics of contemporary social, technological, and economic transformations in the life sciences and accompanying regimes of biopower. Our aim is less to serve an ultimate picture or to systematically map the problems of the field and suggest definite answers and solutions, but rather to engage in a problematisation of governing under conditions of radical (epistemic and organisational) uncertainty and instability …. We hold that, on the one hand, increasing complexity and unruliness is thus an empirical and historical fact resulting from a variety of distinct but interrelated events and dynamics. In this sense, governing—in its broadest meaning—is always concerned with finding ways and mechanisms to order and disentangle social phenomena perceived as complex by rationalistic and administrative means. For instance, the concept of risk has helped to come to terms with growing uncertainty, making it calculable, predictable, and hence governable (cf. Dean 2010). On the other hand, we argue that concepts such as complexity may also be part

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of intellectual, organisational, and discursive strategies that help—by acknowledging and embracing complexity as an irreducible fact rather than a state to be overcome—making unclear and messy constellations manageable and governable in the first place …. Under these conditions of ‘endemic uncertainty’ (Bauman 2007), governing must be understood as the multiple attempts to order, control, and manage a messy, heterogeneous ensemble of objects—and is thus in itself an ensemble of messy, heterogeneous sets of practices that never arrives at full closure, complete control over its object, and ultimate ‘success’ regarding its objective. It is this aspect of the inevitable incompleteness of any attempts of governing that we will stress and develop in our analysis. Unruly forces in stem cell therapy Stem cell therapy, as a heterogeneous phenomenon and conflictual field of practice, is brought into being and shaped by a variety of diverse scientific, medical, commercial, and political pressures, demands, and imagination. … In this constellation, national regulatory science institutions are likely to struggle to provide and assemble the necessary knowledge and expertise demanded by advanced cell therapies. In Europe, such challenge crucially shaped the legal form of the new regulatory regime governing advanced therapies, which brought into being a newly established supranational scientific committee—assembling the scarce expertise to be found in the member states—in charge of advanced therapies. Governments, in the narrow sense of the executive branch, however, constitute only one powerful force within the contemporary network state which must be perceived less than a single actor, but a complex set of relations and connections that take shape and materialise in a variety of organisations, institutions, and agencies that are interlinked and operate in multidimensional networks, or assemblages …. Hence, stem cells appear as contested entities—what elsewhere has been called ‘bio-objects’ (Vermeulen et al. 2012)—at various sites within the rationalities of the state, its bureaucracies and affiliated, networked agencies. In these constellations, there emerge several conflicts out of the divergent prerogatives and rationalities embodied in the respective agencies. Thus in this specific constellation there exist science and technology policy, predominantly preoccupied with funding and stimulating basic and applied science and technology research, as well as what can be called

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protective governmental apparatuses, consisting of both public and private organisations, or rather hybrid forms thereof, preoccupied with the protection of citizens—patients, research participants, consumers—from bodily (and economic) harm caused by biomedical research and its products ….

Conclusion We conclude by reflecting on what could be learned from our exploration of stem cell therapies as fluid sites of regulatory science struggles. Hence, our research suggests that governing in such messy and unruly fields involves not only the calculated activity and the strategic establishment of regulatory knowledge and organisational regimes, but also a great deal of experimentation and improvisation. It is yet unclear if the fluidity and messiness that can be observed in contemporary con-stellations are just a difficult passage to new stabilities and certainties, or—to return to the quote of Zygmunt Bauman at the very beginning of our chapter—if uncertainty, and indeed fluidity and messiness are here to stay. Now, what are the theoretical and practical consequences that emerge from such conditions of endemic uncertainty? It seems that the dominant Western-­ style pharmaceutical model of drug development, which was based on the primacy of scientific fact finding and the production of stable scientific evidence, has thus been challenged and indeed destabilised. As many examples throughout this chapter suggest, the question whether stem cell therapies will work in practice has ceased to be centred on scientific evidence only. Rather, various, partially overlapping indications, such as clinical effectiveness, ethical acceptability, commercial viability, market acceptance, and so on, form part of unstable and cobbled innovating practices, rather than pre-established innovation models. We will need to further explore the meanings and the practical consequences of this emerging constellation that seems to challenge the idea that innovation can be rationally promoted and fostered by government agencies. Moreover, embracing radical endemic uncertainty and complexity will bring into focus the very political dimensions of governing science,

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technology, and innovation, as decisions need to be taken even if there might not be sufficient scientific evidence, clear legal frameworks, or stable social institutions in which these decisions can be grounded and justified

Reflection by Andrew Webster This book is the result of a major research project REMEDiE (Regenerative medicine in Europe) funded by the European Commission’s Framework Programme 7 during the period 2008–2011. The project brought together colleagues from a wide range of academic institutions across Europe, reflecting its disciplinary and geographical spread, including those from STS, bioethics, law, and political science/political economy. I had the privilege of both coordinating an excellent team of colleagues as well as editing the book itself. Many papers too were published during and after the project. The book itself captures the main issues of innovation, regulation, and the socio-legal and ethical matters of concern that regenerative medicine then, and still today, generates among a wide rand of social actors. The project and the book focused in particular on how the field is very different from conventional medicine, drugs, and devices, primarily because of its sourcing and handling of live tissue for the regeneration or replacement of damaged cells in the body. Since the book was published, all the authors have gone on to pursue new projects and publish important papers in this field (e.g., Hogarth 2017; Faulkner 2017). The field itself has moved on somewhat in terms of the count of mid-phase clinical trials (Phase 2/3) with the actual number of products now available increasing quite quickly. Many though are only within reach of patients because of the moves in regulatory spheres, in those countries with a strong stem cell platform of research and investment, towards adaptive, risk- (rather than principle-) based licensing, especially for rare diseases, where there is little alternative to treat. At the same time, we have seen the push towards regulatory approval for ‘advanced therapy medicinal products’ as part of this process, though again translating these to the hospital clinic requires new

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socio-technical, organisational, and governance capacities. Work that I was very happy to lead on following the REMEDiE project, the REGenableMED project funded by the ESRC in the UK, took up this issue and went on to develop the model of ‘institutional readiness’ (Webster and Gardner 2019) which is now being used in some UK advanced therapy treatment centres to help them determine whether and if not they have the capacities to take on the challenge posed by cell and gene therapies. New work led by REGenableMED colleague Michael Morrison is examining these therapies, alongside iPS cells and 3D bioprinting, and the different though at times overlapping ‘experimental spaces’ they occupy: again with Michael’s project (Biomodifying Technologies, also ESRC-funded [Morrison 2019]) there is a strong focus on governance and regulatory questions these novel fields of biomedical science pose. Moreover, following up on the challenges presented to pharmaceutical rationalities of making health, Haddad (Haddad 2019) has identified the emergence of a post-­pharmaceutical logic of “surplus vitality” at the heart of somatic stem cell therapies that consists in the extraction and ex-vivo accumulation of somatic stem cells—with profound implications also for the regulation and governance of biomedical innovations. His work has gone on to explore the innovation-driven approaches to global health security governance in the field of antimicrobial resistance. Chen has examined how the ethical, legal, and social implications of genetics and genomics are shaping today the governance of life sciences in China. The importance of these various studies is how, through a deep immersion in this field, social science and the humanities can not only unravel its various complications and bring these to front of stage but also how in doing so the audiences for this work can learn where challenges arise and how best to manage them. Much of this involves a shift away from the hype and promissory claims typically associated with new biosciences—and always difficult to dislodge—towards a more modest, less accelerated form of development that asks about the direction of travel being taken and what values inform it—how far, for example, do public health/public good priorities take centre stage (sadly not often enough).

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 erbert Gottweis, Brian Salter and Catherine H Waldby. (2009). The Global Politics of Human Embryonic Stem Cell Science. Regenerative Medicine in Transition

From: Introduction, pp. 1–21 In this book, we investigate these global relationships between the commercial and scientific trajectory of stem cell research; the contentious ethical status of embryos and stem cells; the cultural tensions they generate; the global biopolitical relations they have helped to create; and the complexities of regulation they present for national, regional and international governance bodies. In doing so, we hope to contribute to current debates and understandings of the social implications of stem cell research in particular and contemporary regenerative medicine policy and innovation more generally. By focusing on interactions between local, national,

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regional and global politics and governance, we will frame regulatory regimes within a network of global dynamics, rather than regard them as the products of discrete national histories and debates. We also hope to contribute to a better understanding of the interrelations between the multifarious social, economic, cultural and technological forces described by the term globalization in the arena of regenerative medicine, and more generally, the life sciences. Our book has a clear focus on stem cell research, but we also tell a story about regenerative medicine, a newly emerging field of medical research and application. Although stem cell research, particularly human Embryonic Stem Cell (hESC) research, has a number of highly specific characteristics, we believe that many of the insights we present here are shared by other areas in regenerative medicine. Regenerative medicine, the combined effort of medical and biotechnological approaches to develop smart scaffolds and molecules to direct tissue regeneration in patients and eventually to develop ‘custom-­ made’ tissue and organs, raises a highly specific set of shared political, ethical, regulatory and legal challenges, and a new global politics seems to be emerging in this field. In particular, we focus on the tight interrelationships among the shaping of new knowledge regimes in regenerative medicine, their financial backing by a variety of state and non-state actors, the often contentious status of the new knowledge regimes, attempts to stabilize and interconnect the various components of the new knowledge regimes through standardization and efforts to establish new appropriations regimes, typically through patenting. The combination of these different developments gives rise to new forms and mixes of private/ public governance in regenerative medicine on a global level. … [h]ESC technologies have proved to be controversial throughout the world. Although blood, organs and cellular material are historically donated by adult citizens who formally consent to give part of their bodies to another, embryonic material has a somewhat different status. Human blood or organs are ethically significant because they refer to or derive from a person whereas many people consider that embryos constitute persons. …

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[T]he various strategies to obtain hESCs and their application in medical research and therapy have turned immediately into a site of political controversy in Europe, the United States, Australia and other countries. Many issues and topics are raised in these debates, including the rights of embryos; the question of the potential risks for patients involved in these novel, experimental medical strategies; and the implications for women because of the possible increase in demand for ‘spare embryos’, oocytes and other reproductive tissues. With the emergence of hESC and cloning research, old lines of argument from former controversies about fetal research and abortion were reactivated. At the same time, new interpretations, facts and styles of controversy affected the construction of the meaning of hESC research. Even today when taking a cursory look at the stem cell/cloning debates in most industrialized countries, one might come to the conclusion that society and the state are faced with critical choices about the future of humankind. Because of the tensions involved within this highly emotional and conflict-filled debate among industry, state interests, consumer advocates and ethical opponents, medical research involving human embryos takes place in a heavily regulated and sometimes bitterly contested environment in many countries. Policies range from the complete prohibition of hESC research (as in Ireland, Austria, Lithuania, Poland and Slovakia) through an array of regulatory configurations that allow certain kinds of research to policies that permit the creation of embryos for research and for therapeutic cloning (as in Belgium, India, Israel, Sweden, China, Singapore, South Korea and the United Kingdom). Each set of regulations is the product of protracted negotiation, argument, stand-off and compromise. Each regulatory configuration reveals complex, often conflicting understandings of the status and meaning of prenatal life and the legitimacy of technical interventions into fundamental aspects of human reproduction and thus human origin. …

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This global scale and the contentious nature of stem cell research mean that new transnational and public/private forms of regulation are beginning to emerge in the stem cell arena. The various governance and deliberative organs of the European Union (EU) have acted as regional forums for debates and policymaking around stem cell technology the status of prenatal life, the rights and interests of patients and the imperatives of scientific development. The EU’s European Group on Ethics has proved to be a particularly important venue for deliberation over the biopolitics of stem cell technology, whereas the EU Framework Programme, which provides public research funding, has been the site of fierce lobbying, stalemate and compromise over stem cell research funding. … The extension of intellectual property (IP) rights to scientifically engineered living organisms has also been a crucial factor in fostering commercial investment in life sciences research. These developments have produced an explosion of innovation in the life sciences industries (pharmacology, agribusiness, medical biotechnology), organized around new sets of genetic and cellular techniques to manipulate life. To use Waldby’s (2002) term, biological life is being transformed into biovalue. … In this book we investigate the dynamic interactions between national regulatory formation and global biopolitics. We consider the underlying dynamics of discursive economies of hope, ageing populations as markets for regenerative medicine, the development of global technoscapes and high-technology knowledge economies, the process of biomedicalization, and shrinking public budgets for health care and social security. This situation places intense competitive pressure on states to fund and develop attractive climates for ESC science, which promises both to improve the health and productivity of ageing populations and to develop therapies for global health markets. We consider the development of internationally circulating arguments in favour of and in opposition to stem cell research and the various transnational bioethical spaces that have opened

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up to try and steer these arguments towards compromise and implementation. We consider the flow of embryonic materials from south to north and the ways these flows play into broader relations around global bio-­ politics. We investigate the place of transnational regulatory bodies such as the EU and the UN in organizing and modifying the international and national debates around stem cell science and ways in which national debates and policies influence each other. We identify the forces that have produced a degree of standardization in the stem cell debates and the forces of scientific, commercial and bioethical uncertainty and volatility that continue to fragment the field. We also show the emergence of new systems of knowledge appropriation through patenting and its effects on the shaping of global regenerative medicine. In carrying out this investigation, we hope to contribute to specific understandings of the global stem cell arena, but more broadly, to understandings of global regenerative medicine in the age of biotechnology.

F rom: Chapter 1, Globalization, Stem Cell Markets and National Interests, pp. 22–34 In this chapter we will investigate the role played by state institutions in the fostering of hESC research, and the life sciences more generally. Politicians and policymakers tend to foreground humanitarian rationales for supporting such research, pointing to the potential for real and significant clinical effects and applications for the ageing, the disabled and those waiting for organ and tissue transplants. Although such therapeutic aims are laudable, and dearly held by many clinicians, policymakers, patient support groups, patients and caregivers, they do not fully explain the active interest of the advanced industrial states in stem cell research. We must also consider the kind of economic productivity represented by stem cell research and the ways in which the reformulation of state-­ market-­civil society relations in the wake of post-Fordism and globalization gives nation states strong incentives to foster nodes of the global stem cell economy within their national borders. In what follows, we examine the kinds of pressures and constraints placed on contemporary nation states by the move to knowledge-based economies, the innovation

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and commercial structure of biotechnology R&D, the global marketization of health services and the ageing of populations. … This commercial exploitation of basic science underpins the OECD nations’ transition from industrial mass-manufacture economies to knowledge economies, dependent on a highly educated workforce; technical research and innovation; and extensive cooperation among university, industrial and government sectors to pursue promising research directions and strategic advantages (Etzkowitz 2003). In this context, state agencies increasingly play a coordinating role, for example, promoting and linking national and international research networks, and shaping research directions through public–private partnerships (Cooke 2002) … However, many lines of basic biology research fail to deliver usable applications or sustainable profitability. The dot.com boom and bust of the late 1990s reveals the risks and difficulties associated with developing new R&D-driven industries. This uncertainty is particularly marked in the biotechnology area, where high levels of expensive expertise are required and where development pipelines tend to belong and unpredictable. As we noted in the introduction, 20 years of genetically oriented biomedical research has failed to produce safe gene therapy applications, for example. … Despite these difficulties and setbacks, the OECD (2004, 2006) regards the biotechnology sector as relatively immature and open to much more innovation and industrial development. Biotechnology offers the best hope for a new long wave of economic growth, the OECD argues, because it has the capacity not only to develop new specific products and processes but also to change the material base of significant sectors of the economy. …

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Biotechnology research in general, and stem cell research in particular, involves a search for new biovaluable technologies (Waldby 2002)—optimum points of microbiological leverage and productivity—that could form the basis for a whole suite of clinical applications, in the same way that the microprocessor in information and communication technologies (ICTs) has formed the basis for a wholesale transformation in communication. … As a potential new core technology, stem cell R&D enjoys complex kinds of strategic and institutional support, in addition to straightforward research funding, as states attempt to secure competitive advantages in future commercial developments. … Success in hESC research would give the sponsoring state a leading edge in the fostering of a new industry with a huge potential global market—the market for regenerative therapies. It would attract significant investment from the pharmaceutical and medical device sectors, and be a source of national scientific prestige and economic dynamism. At the same time, it would contribute in a highly visible way to the welfare of the population, without a concomitant expansion in public service delivery. The reduction of disease burden in the elderly and disabled would help to contain health-care costs and extend active life. In the final analysis, public investment in hESC research is so attractive for states because it expresses both concern for the well-being of populations and the drive for global economic competitiveness, without any apparent contradiction between the two aims.

F rom: Chapter 2, Embryos, Oocytes, Cell Lines: HESC Science and the Human Tissue Market, pp. 35–55 In this chapter, we discuss the different global ‘tissue economies’ (Waldby and Mitchell 2006) that characterize the field of hESC research and consider their implications for the politics and regulation of the area. We

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examine the role of stem cell lines as commodities on a global biotechnology market, and the extent to which market forces propel their forms of circulation and research/therapeutic value. We also examine public-sector involvement in their circulation, particularly the role played by the various states in promoting, managing and restricting the global flow of hESC lines, paying particular attention to stem cell banks and registries and to import/export relations between consumer and producer stem cell nations. The tissue economy that precedes hESC lines is crucial for their existence; this is the sourcing of reproductive material, gametes (sperm and oocytes) and embryos themselves, and we focus on oocyte supply and demand in relation to the burgeoning stem cell nuclear transfer (SCNT) research area. A well-developed global market already exists for oocytes for reproductive purposes, a market that is open to worrying degrees of exploitation of poor women who may agree to super-ovulation and oocyte harvesting for a subsistence fee. The worldwide competition for supremacy in the stem cell field, coupled with the very large number of oocytes and embryos needed to strike a successful cell line, is bound to place even greater pressure on paid sources of reproductive material, with potentially serious risks to poor women dealing with unregulated fertility clinics.

HESC Lines and Biotechnology Markets Rapidly expanding global interest in the commercial possibilities of hESC lines creates huge demand for well-characterized, uncontaminated, and standardized hESC lines. About 200 hESC lines are estimated to be in existence worldwide (Biophoenix 2006), but the majority of them are poorly characterized. Several consortia have formed to try to agree on characterization standards and to gather information about phenotypic and gene expression profiles, microbiology assessment and genetic identity analysis ….

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The IP landscape is particularly important in determining global flows of knowledge and materials in the stem cell area. Researchers who have established IP in their stem cell lines have a strong commercial advantage because they can control the ways other researchers use their knowledge, and they can earn revenue through licensing and material transfer agreements. … The United States holds the majority of the world’s stem cell patents. Between 1980 and 2005, 2041 stem cell patent applications were filed in that country, with the vast majority filed after 2001. …

State and Public-Sector Management of hESC Circulation [h]ESC research has received considerable levels of public funding; in addition to financing, public-sector involvement often takes the form of encouraging international collaboration and knowledge exchange, particularly in the early stages of basic biology research. As Löfgren and Benner (2005) point out, despite the public sector’s involvement in biotechnology development and its broad partnership with industry, it is nevertheless concerned with foiling market tendencies towards the excessive privatization of research results. … Nationally based, publicly funded stem cell banks are emblematic of the tensions between liberal market forms of biotechnology innovation and the need for social governance. The UK Stem Cell Bank (UKSCB) has been set up to improve the flow of well-characterized and qualityassured hESC lines between research laboratories and to help create a research commons of hESC lines accessible to both private- and publicsector researchers. The bank will divert what might otherwise be strictly market forms of stem cell circulation into public-sector research institutions. …

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Oocyte Donation, Global Markets and the Politics of Cloning Most nations with hESC research programmes have some reasonably streamlined means of accessing ‘spare’ embryos directly within their national systems, or of importing existing hESC lines if embryos are not themselves available. … Laboratories in most of the countries that permit therapeutic cloning find oocytes to be a scarce resource. Oocytes are already in demand for assisted reproduction, and this demand has continued to expand as the use of IVF becomes more common. Almost all UK fertility clinics report a shortage of viable oocytes for women seeking donation (Echlin 2005). A demand for ‘research’ oocytes simply places greater pressure on an already short supply of oocytes and on female reproductive biology more generally. … Different jurisdictions have adopted different procurement policies to deal with the shortage of oocytes. Australia, Canada, Singapore and most of Western Europe have not altered their approach; they rely on gift systems to solicit oocytes—women must give oocytes as an act of generosity, without payment, although most regulatory systems allow the reimbursement of expenses.12In this regard oocytes are treated much like solid organs. The United Kingdom, with the second-largest hESC research programme in the world, has shifted its procurement policies beyond this strict gift system in a number of ways. It permits ‘egg sharing’ arrangements for women in IVF who agree to donate research oocytes; that is, they receive subsidized IVF treatment in exchange for research donation. … Two major dynamics shape the global circulation of stem cell biological material. One is the tension between proprietary innovation and public domain research. High-wall patents at the early stages of regenerative medicine innovation present barriers to public-sector researchers and to collaboration between private- and public-sector actors. Such barriers have a dampening effect on the early stage, basic biological research and

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large-scale collaborative effort necessary to translate biological theory into clinical and laboratory applications. Hence much state intervention, particularly around registries and stem cell banks, is designed to mitigate the effects of excessive privatization and premature commercialization. … The second key dynamic is between supply and demand for various biological materials, notably embryos and oocytes. Different national systems evince dramatically different abilities to ethically source these materials so that some can afford to export while some are forced to import. At present, the ethical sourcing of embryos is reasonably well embedded in the IVF clinics and regulatory systems of many stem cell research nations, whereas the ethical sourcing of oocytes is much more volatile, both because it is in the early stages of regulation and because of the existing unregulated global market for reproductive oocytes. … So, both key dynamics, public/private tensions and the political economy of supply and demand, demonstrate what is at stake in regulation of the biological material itself. Regulation shapes who donates or sells material, the conditions of its sourcing and its relative abundance or scarcity. It shapes who has access to research material, who can profit from it and the boundaries between private and public equity in research outcomes.

F rom: Chapter 6, Bioethics and the Global Moral Economy of HECS Science, pp. 127–147 [E]thical reasoning and the creation of national bioethics committees or boards have played an important part in dealing politically with the regulatory challenges of hESC research. For the most part, these bioethical actors have been supportive of hESC research, and they have also played a central role in separating reproductive from therapeutic cloning. Such separations have been essential for the further development of regulations concerning hESC research and cloning for medical purposes. …

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In this chapter we show how the political need to reconcile the promise of new health technologies with the cultural costs of scientific advance has been met by the evolution of bioethics as a political community, transnational network and bureaucratic device. Bioethics has become the political means for the creation of a global moral economy in which the trading and exchange of values is normalized and legitimated. This is a process that we can observe not only in the field of hESC research but also in many other areas of regenerative medicine, such as in tissue transplantation, or in others fields of biomedical research, such as in biobanking (Gottweis and Petersen 2008). Bioethics is the apparently neutral currency with which cultural values can be measured, positions priced and deals arranged. Without an active moral economy, the progress of the economy of hESC science and industry would be severely constrained. …

Bioethics and the Global Moral Economy In general, the political need for bioethics as the currency of a global moral economy arose because medical science was no longer able to research, develop and apply new health technologies while at the same time deal with cultural opposition and retain public trust in these technologies through the simple application of its scientific authority. Science could no longer legitimize science. It had always had ‘medical ethics’ as a legitimizing prop, but by the 1960s this had become, according to one observer, ‘a mixture of religion, whimsy, exhortation, legal precedents, various traditions, philosophies of life, miscellaneous moral rules, and epithets’ (Clouser 1993: S10): politically unhelpful if not positively dysfunctional. Given the social and economic importance of medical advances, their potential for cultural conflict and the inadequacies of medical ethics, a mechanism was required that could engage with the science, reassure the public and assume visible bureaucratic form if necessary. …

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The construction of bioethics took different paths [different] countries, each influenced by their national philosophical traditions and … by the continuing search for national identity. The moral and political concerns were also different. In the United Kingdom the driver was the need to safeguard a space for science, in the United States the minimization of the risk to patients and in Germany the protection of human dignity. Nonetheless despite the contrasting moral foci of the three countries, ‘bioethics was seen in all three countries as a device for bridging potentially troublesome divides: among disciplines, professions, and institutions; and increasingly also among science, state and society’ (Jasanoff 2005: 188). There was a common utilitarian emphasis on the identification of ethical procedures that could be used to address and perhaps resolve conflicting moral positions in ways that may be integrated with the policy process. … Inspired by an apparent sense of moral duty, the rise of bioethics as a political force in the global moral economy—particularly in areas of medical science that deal directly or indirectly with the human embryo, the human genome and human identity—has been swift. Its ascent has been marked by a global infrastructure: high profile ethical statements launched from the platform of established international bodies, an awareness of the need to translate these statements into legal/bureaucratic form, and the proliferation of horizontal and vertical networks linking international and national levels of ethical governance.

F rom: Chapter 8, Contested Governance: Uncertainty and Standardisation in Research and Planning, pp. 169–186 Many nations have moved, over time, towards the liberal end of the regulatory spectrum. While the previous two chapters focused on the global regularizing effects of bioethical governance, in this chapter we focus on another force for global convergence and governance—the demand for standardization. Standardization processes are essential for any scientific

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field to develop and are applicable to all stages of the knowledge-­ production process from the basic science to the market product. They are required for collaboration, for the performance of laboratory tasks, for the assessment of research results, for peer review, for the development of IP claims and for clinical applications. Standardization is necessary in all scientific fields and in the commercialization of scientific results, but in hESC research, the political volatility of the research and the divergence of national regulations introduce an extra dimension. Attempts to develop global technical standardization are entwined with global bioethical standardization. Scientific professional bodies are recognizing that international research collaboration will necessitate internationally agreed-upon bioethical standards if scientists are to comply with the national legislation that governs both their own and their partners’ research and gain access to international funding. …

Standardisation, Science and Global Governance Standardization is a central process of all scientific practice, and one of the major demarcators of scientific from non-scientific knowledge. Standardization is important in science because it creates the conditions for stable comparison and the interoperability of technical elements. Scientific discovery is impossible without agreed-upon measures, proto-­ cols, classificatory systems and technical benchmarks shared by laboratories working in the same research field (Timmermans and Berg 2003). Scientists require shared definitions and classificatory systems if they are to move from the particularity of their laboratory language and culture and work with other scientists in other sites. Standards bind com-­munities of practice together across space. Stable classification systems ensure that concepts and definitions are the same in every geographical location and cultural context, allowing predictable communication and shared understanding and practice (Timmermans et al. 1998). … Standards are not merely technical artefacts, however, and the process of agreeing standards is intertwined with broader issues of scientific

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governance and the negotiation of social relations. In many domains, standards touch on issues of public good (e.g., safety standards) and ethics. As we will discuss in detail, technical standards for stem cell line derivation are a complex example of this ethical aspect of standardization. Moreover, standards emerge from the political process generated by negotiation, debate and compromise between interested parties, including factions within scientific communities, state agencies, com-munity groups and market interests, and the outcome is not socially neutral (Bowker and Star 1999).

F rom: Conclusion. Towards the Global Politics of Stem Cell Research, pp. 187–194 Regenerative Medicine and Global Governance We have argued that today regenerative medicine with its focus on tissue regeneration has become a global theatre in which the biopolitical forces, technological vectors, corporate strategies and patterns of innovation clearly have transcended the confinements of the nation state and operate in the transnational arena. The dynamics of the development of regenerative medicine seem to be driven by a novel global, socioeconomic, political and scientific-technological constellation. As shown in Chaps. 1 and 2, and as also evident in the case of iPS cells, stem cell research and regenerative medicine more generally have turned rapidly from a basic science ‘breakthrough’ into a target for nations and corporations competing worldwide for influence, economic growth and health policy strategies, and for biological materials such as oocytes o rhESC lines. This newly emerging knowledge system has given rise to a new knowledge economy, and its vectors operate simultaneously on a national, a regional and a global level where researchers, policymakers, biological materials, stocks and interests circulate. Vast expectations, hopes and scenarios of transforming health care and whole economies seem to coexist with the basic nature of most of the current research in those fields of stem cell research that internationally receive not only most of the attention but also financial research support, such as in hESC and, most recently, iPS research.

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But these new biological strategies and technologies to ‘program and reprogram life’ have also opened up a new global space of uncertainty for governance. During the 1970s and 1980s, political discourse on genetic engineering and its applications focused on the risks associated with genetic engineering and the various strategies to control risk. Today political-­institutional strategies towards stem cell research and cloning are characterized by the extensive consideration of the ethical ambivalences of these lines of research and the exploration of their very meaning, applicability, impact and implications.

Reflection by Brian Salter and Catherine Waldby It can be said that all domains of politics are characterised by periods of continuity and contestation and the global politics of regenerative medicine is surely no exception to this axiom. Continuities there certainly are, sustaining the power alignments identified in our book (co-authored with our late colleague Professor Herbert Gottweis). But also new modes of contestation have emerged since its publication, challenging some of its assumptions and requiring reflection on their implications. At one level, transnational biomedical science, and regenerative medicine science in particular, have continued to assert their traditional hegemony of biomedical innovation, its close relationship with the research funding market, and politically sympathetic modes of consumer incorporation—all ably supported by the ideological role performed by bioethics as legitimating agency and institutional partner in key areas such as patenting (Salter et al. 2015; Salter and Salter 2013). New political forms of bioethical engagement such as anticipatory governance have sought to ensure that science retains the political initiative in the process of knowledge production through the creation of ethical space into which science can move (Harvey and Salter 2012; Salter and Harvey 2014). However, at another level, challenge to the dominant view of regenerative medicine innovation is very evident. Two main developments have contributed to the emergence of this political contest. First, consumer choice and consumer power are now an important feature of the global

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stem cell market with individuals prepared to access stem cell treatments provided outside the strict confines of science’s orthodox innovation governance. Since the mid-2000s, scientists, medical professionals, and regulators in Australia, Asia, Europe, and North America have been concerned about the provision and direct to consumer (DTC) marketing of stem cell-based interventions that have not been proved through clinical trial (SCBI) (Eliza 2009; Crozier and Thomsen 2010; Brown 2012). A notable feature of these interventions is that they are available not only in traditional medical tourism markets, for example Thailand, but also in high-income countries, including the United States, Japan, Germany, and Australia (Turner 2015; Berger et al. 2016). This reflects a growing division between the hospital and university-based regenerative medicine research sector, focused on Discovery science and establishing an evidence base, and an entrepreneurial sector focused on delivering treatments to patients who may feel that all their other options have run out. This ‘Right to Try’ movement now presents a complex challenge to national regulators like the US Food and Drug Administration and the Australian Therapeutic Goods Administration who grapple with the best way to regulate this newly emerged innovation sector (Begg et al. 2014). Second, facilitating the operation of this choice are the policies of Asian and Middle Eastern states reflecting their preparedness to explore more flexible and often more practice-based models of governance in stem cell innovation (Salter et  al. 2016). This potent combination of Western customers and ambitious states from the Global South poses an interesting political conundrum for the established transnational governance of regenerative medicine, predicated as this is on Western values and assumptions of innovation probity but aware also of the increasing scientific capacity of states such as China and India. The labelling by these networks of the increasingly diverse forms of biomedical innovation as ‘illicit’ fails to counter the dynamic of the market. At the same time, the efficacy of bioethics as a facilitator of a Western-oriented global moral economy has diminished in the face of resistance from local cultures and the rise of Asian bioethics.

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Index

A

Ageing and end of life care, 167–178 and dementia, 171–175 and the hospice, 175–177 AIDS/HIV, 183, 196–204 Alzheimer’s diagnosis, 20–22, 25–30 and cognitive screening tools, 22–25 and diagnostics, 25–28 Anthropotechnics, 108–110 Artificial intelligence, 67–68

Biotechnology, 204, 205, 210 Brain-machine interface, 114–116 C

Clinical gaze, 39 Complementary medicine, 182, 185–194 D

Digital divide, 68 B

Biobanks, 207 Bioethics, 198–200, 206–209, 283–286 Biomedical technologies, 4 and biomarkers, 21

E

e-health, 155–157, 161, 162, 164 End-of-life care, 176 Exnovation, 215

© The Author(s) 2020 A. Webster, S. Wyatt (eds.), Health, Technology and Society, Health, Technology and Society, https://doi.org/10.1007/978-981-15-4354-8

315

316 Index G

Genetics, 77–78 and diagnostics, 93–97, 103–105 and insurance, 97–99, 131 and risk, 100–102 and testing, 92–93 H

Health and the internet, 127–129, 157–160 Healthcare work, 49–51 Health-related policies, 122–126, 149, 160–164, 223, 224 Health technologies regimes of healthcare, 18 technogeographies of, 34 and telecare, 32–37 and value, 5 Home and care, 168 cultural imaginaries of, 169–171 and home-making, 169 Human embryonic stem cells, 231 Human enhancement, 78, 106–118 and animals, 118 and ethics, 107 and morality, 111–114

and diagnosis, 16, 28 and digital systems, 18, 36, 151 and ethics, 27, 107 hidden, 266–267 patient-centred, 17, 38–43, 120 responsible, 25, 26, 28–31 Institutional readiness, 272 Intensive care unit, 213–222 and competences, 181–224 and prognostics, 220 K

Knowledge production, 9 boundary objects, 186–189 dominant modes of, 186 knowledge-making, 185, 186 L

Life assemblages, 205, 206, 210 Locus of care, 6, 32–33, 135–178 M

Medical devices, 229, 230, 233–244 changing boundaries of, 243, 244 Medical imaging, 49–52

I

N

Information systems, 44–56 and gender, 44–56 and intermediaries, 153–166 Informed consent, 104 Innovation, 8, 15–68, 196, 197 and adoption, 17, 36, 39 and biocapital, 264–267 co-produced, 26

Neonatal care, 213–224 P

Paediatric neurology, 38–43 Patient empowerment, 122–126 Patient safety, 77, 80–82 and failsafe systems, 86, 87

 Index 

Personalised medical devices (PMDs), 18, 57, 67, 68 commercialisation of, 63–66 and diabetes, 58–60 and e-cigarettes, 61–63 Pharmaceutical regulation, 231 and EU regulation, 255 and governance, 258, 259 political economy of, 250–255 Place and space, 6 Precision medicine, 67 R

Randomised control trial, 203–204 Regenerative medicine, 211, 231, 260, 271–274 and biocapital, 264–267 and its boundaries, 259–264 Regulation and governance, 8, 9, 150, 151, 229–289 of medical devices, 239 of pharmaceuticals, 246–249 Responsibility, 75–131 and accountability, 84, 85 and genetics, 94–97 narratives of, 120 and risk, 96–98

317

Responsible research and innovation (RRI), 25–32 S

Sociotechnical assemblages, 42, 43 Standardisation, 286–287 Stem cell regulation, 229–289 globalisation of, 277–279 globals governance, 287–289 Stem cell tourism, 139–152 and the political economy of hope, 147, 150 Surveillance, 53–54, 131, 165 T

Technology identity, 244 Telecare/medicine, 32–37, 161–162 Tissue economies and markets, 277–279 V

Video-reflexive ethnography (VRE), 223 Visible and invisible work, 119–121