May 6, 2016
This conference aimed to: (1) identify the various ways in which law and ethics intersect with the use of big data in health care and health research, particularly in the United States; (2) understand the way U.S. law (and potentially other legal systems) currently promotes or stands as an obstacle to these potential uses; (3) determine what might be learned from the legal and ethical treatment of uses of big data in other sectors and countries; and (4) examine potential solutions (industry best practices, common law, legislative, executive, domestic and international) for better use of big data in health care and health research in the U.S.
Panel 6, Big Data and the FDA:
- W. Nicholson Price II, University of New Hampshire School of Law - Regulating Complex Algorithmic Medicine
- Jeffrey Senger, Sidley Austin LLP - Regulating Next Generation Clinical Decision Support: The Challenge of Ensuring Safety and Effectiveness at the Interface of Big Data and Human Medical Judgment
- Ameet Sarpatwari, Harvard Medical School and Brigham and Women's Hospital - Data Sharing that Enables Post-Approval Drug and Device Research and Protects Patient Privacy: Best Practice Recommendations
- Moderator: Jerry Avorn, Harvard Medical School and Brigham and Women's Hospital
The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School 2016 annual conference focused on “Big Data, Health Law, and Bioethics.” The conference was organized in collaboration with the Berkman Center for Internet & Society at Harvard University and the Health Ethics and Policy Lab, University of Zurich.
Learn more at petrieflom.law.harvard.edu/events/details/2016-annual-conference.