Big Data, Health Law, and Bioethics

This book explores the legal and ethical implications - both challenges and opportunities - of using big data in health care and research.

I. Glenn Cohen (Edited by), Holly Fernandez Lynch (Edited by), Effy Vayena (Edited by), Urs Gasser (Edited by)

9781107193659, Cambridge University Press

Hardback, published 15 March 2018

368 pages, 6 b/w illus. 2 tables
23.5 x 15.6 x 2.4 cm, 0.63 kg

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.

Introduction Effy Vayena, Urs Gasser, I. Glenn Cohen and Holly Fernandez Lynch
Part I. Shifting Paradigms: Big Data's Impact on Health Law and Bioethics: Introduction Urs Gasser
1. Big data and individual autonomy in a crowd Barbara J. Evans
2. Big data's epistemology and its implications for precision medicine and privacy Jeffrey M. Skopek
3. Correlation vs. causation in health-related big data analysis: the role of reason and regulation Tal Z. Zarsky
4. Big data and regulatory arbitrage in healthcare Nicolas P. Terry
Part II. Overcoming the Downsides of Big Data: Introduction I. Glenn Cohen
5. The future of pharmacovigilance: big data and the False Claims Act Efthimios Parasidis
6. Big data's new discrimination threats: amending the Americans with Disabilities Act to cover discrimination based on data-driven predictions of future disease Sharona Hoffman
7. Who's left out of big data? How big data collection, analysis, and use neglects populations most in need of medical and public health research and interventions Sarah E. Malanga, Jonathan D. Loe, Christopher T. Robertson and Kenneth S. Ramos
8. Potential roadblocks in health care big data collection: Gobeille v. Liberty Mutual, ERISA, and all-payer claims databases Carmel Shachar, Aaron S. Kesselheim, Gregory Curfman and Ameet Sarpatwari
Part III. The Internet of Things (IoT) and Health Big Data: Introduction Nathan Cortez
9. Avoiding over-regulation in the medical internet of Things Dov Greenbaum
10. Data policy for internet of things health care devices: aligning patient, industry, and privacy goals in the age of big data Marcus Comiter
Part IV. Protecting Health Privacy in the World of Big Data: Introduction Effy Vayena
11. Thought leader perspectives on risks in precision medicine research Laura M. Beskow, Catherine M. Hammack, Kathleen M. Brelsford and Kevin C. McKenna
12. From individual to group privacy in biomedical big data Brent Mittelstadt
13. Big data and informed consent: the case of estimated data Donna M. Gitter
Part V. Oversight of Big Data Health Research: Proposals for Improvement: Introduction Holly Fernandez Lynch
14. Is there a duty to share health care data? I. Glenn Cohen
15. Societal lapses in protecting individual privacy, the common rule, and big data health research Laura Odwazny
16. The common rule and research with data, big and small Liza Dawson
17. Big data, HIPAA and the common rule: time for big change? Margaret Foster Riley
Part VI. Big Data, FDA, and Liability Considerations: Introduction Jerry Avorn
18. Data sharing that enables post-approval drug and device research and protects patient privacy: best practice recommendations Ameet Sarpatwari, Bradley A. Malin, Aaron S. Kesselheim, Joshua J. Gagne, Sebastian Schneeweiss
19. Big data and human medical judgment: regulating next generation clinical decision support Jeffrey M. Senger and Patrick O'Leary
20. Medical malpractice and black-box medicine W. Nicholson Price II
Part VII. Calibrating Intellectual Property Rights for Health Big Data: Introduction Rachel E. Sachs
21. Big data and intellectual property rights in the health and life sciences Timo Minssen and Justin Pierce
22. The pathologies of data-generating patents Ted Sichelman and Brenda M. Simon
Epilogue: professional cooperation and rivalry in the future of data-driven healthcare Frank Pasquale.

Subject Areas: Medical & healthcare law [LNTM], Intellectual property law [LNR], Constitutional & administrative law [LND], E-commerce law [LNCB2], Law [L]