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

The Sentinel Initiative

D

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

P

Richard Platt

Professor and Chair, Department of Population Medicine - Harvard Pilgrim Health Care Institute

J

Paul Stang

Johnson & Johnson and the Observational Medical Outcomes Partnership

S

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

O

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

H

Barbara Evans

Health Law & Policy Institute and Center for Biotechnology & Law, University of Houston

N

Laura Youngblood

National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention

O

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

S

Dan Troy

Senior Vice President and General Counsel

Recap and Closing Remarks

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