Big Data, Health Law, and Bioethics

I. Glenn Cohen is one of the world's leading experts on the intersection of bioethics and the law, as well as health law. He also teaches civil procedure. He is the author of more than 80 articles in venues like the New England Journal of Medicine, JAMA, Nature, and the Harvard Law Review, and the author, editor, or co-editor of eight books. He has appeared on or been covered by PBS, NPR, ABC, CNN, MSNBC, Jones, the New York Times, the New Republic, the Boston Globe, among other media venues. He has been a Radcliffe Institute and Hastings Center Fellow. Holly Fernandez Lynch is an expert on issues at the intersection of law, bioethics, and health policy, in particular the regulation of research with human subjects and conflicts of conscience in health care. She published Conflicts of Conscience in Health Care: An Institutional Compromise (2008), and has released several co-edited volumes. In 2014, she was appointed as a member of the Secretary's Advisory Committee on Human Research Protections (SACHRP), US Department of Health and Human Services. She previously practiced FDA law, served as a bioethicist working with NIH's Division of AIDS, and staffed President Obama's Commission for the Study of Bioethical Issues. Effy Vayena, Ph.D., is an international expert on issues of ethics and policy in new health technologies. Her work has appeared in highly ranked journals such as the Lancet, PLoS Medicine and Proceedings of National Academies of Science. She has worked extensively in policy areas consulting for the World Health Organization and the Organization of Economic Co-operation and Development amongst others. She was elected member of the Swiss Academy of Medical Sciences and she chairs the Ethical, Legal and Societal Issues Advisory group of the newly established Swiss Personalised Health Network, a large scale, federally funded national program. Urs Gasser is the Executive Director of the Berkman Klein Center for Internet and Society at Harvard University and a Professor of Practice at Harvard Law School. He serves on the boards of the NEXA Center for Internet & Society at the University of Torino, the Research Center for Information Law at the University of St Gallen, and the International Advisory Board of the Alexander von Humboldt Institute for Internet and Society in Berlin. He is a Fellow at the Gruter Institute for Law and Behavioral Research. Dr Gasser has written and edited several books, and published over 100 journal articles.

• 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.

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