The Engelberg Center for Health Care Reform at Brookings hosted a small expert workshop to discuss legal issues in the development and implementation of FDA’s Sentinel Initiative for medical product safety surveillance.
The one-day workshop featured productive discussion and exchange of ideas with panelists representing government, academia, and the private sector on topics including:
- Protecting patient privacy in medical product safety surveillance;
- Appropriate human-subject protections for research use of Sentinel System data; and
- Addressing legal liability in medical product safety surveillance.
Professor and Chair, Department of Population Medicine - Harvard Pilgrim Health Care Institute
Johnson & Johnson and the Observational Medical Outcomes Partnership
Sentinel Initiative Scientific Lead, Office of Medical Policy, Center for Drug Evaluation and Research
Health Law & Policy Institute and Center for Biotechnology & Law, University of Houston
Office for Human Research Protections, HHS
University of Miami Bioethics Program
National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention
Office of the Center Director, Center for Biologics Evaluation and Research, Food and Drug Administration
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