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

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.