Big Data, Health Law, and Bioethics

doi:10.1017/9781108147972

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Edited by I. Glenn Cohen, Harvard Law School, Massachusetts, Holly Fernandez Lynch, Harvard Law School, Massachusetts, Effy Vayena, Swiss Federal University (ETH), Zürich, Urs Gasser, Berkman Klein Center for Internet and Society, Harvard University, Massachusetts

Publisher:: Cambridge University Press
Online publication date:: February 2018
Print publication year:: 2018
Online ISBN:: 9781108147972
DOI:: https://doi.org/10.1017/9781108147972

Subjects:: Medico-Legal, Bioethics and Health Law, Law, Medicine, Medical Law, Ethics and forensic Medicine

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When data from all aspects of our lives can be relevant to our health - from our habits at the grocery store and our Google searches to our FitBit data and our medical records - can we really differentiate between big data and health big data? Will health big data be used for good, such as to improve drug safety, or ill, as in insurance discrimination? Will it disrupt health care (and the health care system) as we know it? Will it be possible to protect our health privacy? What barriers will there be to collecting and utilizing health big data? What role should law play, and what ethical concerns may arise? This timely, groundbreaking volume explores these questions and more from a variety of perspectives, examining how law promotes or discourages the use of big data in the health care sphere, and also what we can learn from other sectors.

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Big Data, Health Law, and Bioethics

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Contents

Big Data, Health Law, and Bioethics
pp i-ii

Big Data, Health Law, and Bioethics - Title page
pp iii-iii

Copyright page
pp iv-iv

Dedication
pp v-vi

Contents
pp vii-x

Editors and Contributors
pp xi-xvi

Acknowledgments
pp xvii-xviii

Introduction
pp 1-14

Part I - Shifting Paradigms
pp 15-68

1 - Big Data and Individual Autonomy in a Crowd
pp 19-29

2 - Big Data’s Epistemology and Its Implications for Precision Medicine and Privacy
pp 30-41

3 - Correlation versus Causation in Health-Related Big Data Analysis
pp 42-55

4 - Big Data and Regulatory Arbitrage in Healthcare
pp 56-68

Part II - Overcoming the Downsides of Big Data
pp 69-124

5 - The Future of Pharmacovigilance
pp 73-84

6 - Big Data’s New Discrimination Threats
pp 85-97

7 - Who’s Left Out of Big Data?
pp 98-111

8 - Potential Roadblocks in Healthcare Big Data Collection
pp 112-124

Part III - The Internet of Things (IoT) and Health Big Data
pp 125-156

9 - Avoiding Overregulation in the Medical Internet of Things
pp 129-141

10 - Data Policy for Internet of Things Healthcare Devices
pp 142-156

Part IV - Protecting Health Privacy in the World of Big Data
pp 157-204

11 - Thought-Leader Perspectives on Risks in Precision Medicine Research
pp 161-174

12 - From Individual to Group Privacy in Biomedical Big Data
pp 175-192

13 - Big Data and Informed Consent
pp 193-204

Part V - Oversight of Big Data Health Research
pp 205-264

14 - Is There a Duty to Share Healthcare Data?
pp 209-222

15 - Societal Lapses in Protecting Individual Privacy, the Common Rule, and Big Data Health Research
pp 223-236

16 - The Common Rule and Research with Data, Big and Small
pp 237-250

17 - Big Data, HIPAA, and the Common Rule
pp 251-264

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Big Data, Health Law, and Bioethics

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