Past Event
Legal Issues in Active Medical Product Surveillance
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.
Agenda
Welcome, Introduction, and Meeting Objectives
Mark B. McClellan
Former Brookings Expert
Director, Margolis Center for Health Policy - Duke University
The Sentinel Initiative
Rachel Behrman
Director, Office of Medical Policy, Center for Drug Evaluation and Research
Panel 1: Scientific and Data Needs for Active Medical Product Surveillance in the Near and Longer Terms
Richard Platt
Professor and Chair, Department of Population Medicine - Harvard Pilgrim Health Care Institute
Paul Stang
Johnson & Johnson and the Observational Medical Outcomes Partnership
Judy Racoosin
Sentinel Initiative Scientific Lead, Office of Medical Policy, Center for Drug Evaluation and Research
Panel 2: Protecting Patient Privacy in Medical Product Safety Surveillance
Kristen B. Rosati
Coppersmith Schermer & Brockelman PLC
Deven McGraw
Director, Health Privacy Project
Joy Pritts
Office of the National Coordinator for Health Information Technology, HHS
Donald O. Beers
Office of Chief Counsel
Panel 3: Appropriate Human-Subject Protections for Research Use of Sentinel System Data
Barbara Evans
Health Law & Policy Institute and Center for Biotechnology & Law, University of Houston
Jerry Menikoff
Office for Human Research Protections, HHS
Kenneth W. Goodman
University of Miami Bioethics Program
Laura Youngblood
National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention
Kate Cook
Office of the Center Director, Center for Biologics Evaluation and Research, Food and Drug Administration
Panel 4: Addressing Legal Liability in Medical Product Safety Surveillance
Kristen B. Rosati
Coppersmith Schermer & Brockelman PLC
Stanley B. Watson
Kaiser Foundation Research Institute
Heidi Garwood
Humana
Dan Troy
Senior Vice President and General Counsel
Recap and Closing Remarks
Mark B. McClellan
Former Brookings Expert
Director, Margolis Center for Health Policy - Duke University
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