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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.


Welcome, Introduction, and Meeting Objectives

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


Joy Pritts

Office of the National Coordinator for Health Information Technology, HHS

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


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


Dan Troy

Senior Vice President and General Counsel

Recap and Closing Remarks

More Information


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