Who Is Involved

The FDA leads the Sentinel System and Sentinel Initiative. In this capacity, the FDA:

  • Maintains decision-making authority and handles administering the Sentinel System contract
  • Establishes strategic priorities
  • Issues project requests
  • Reviews all work products

Sentinel generates evidence by partnering with various organizations such as: 

  • Academic medical centers
  • Healthcare systems
  • Health insurance companies

The Harvard Pilgrim Health Care Institute leads the Sentinel System Coordinating Center. They partner with a broad range of Data and Academic Partners to answer FDA’s questions. Together, these Collaborating Institutions provide healthcare data and scientific, technical, and organizational expertise.

Below is a complete list of Collaborating Institutions.

  1. Aetna, a CVS Health company*
  2. Blue Cross Blue Shield of Massachusetts*
  3. Booz Allen Hamilton
  4. Brigham and Women's Hospital: Division of Pharmacoepidemiology & Pharmacoeconomics in the Department of Medicine
  5. Duke University School of Medicine: Department of Population Health Sciences (Medicare Fee-for-Service data)*
  6. Harvard T.H. Chan School of Public Health
  7. HCA Healthcare*
  8. HealthCore, Inc (Anthem, Inc data)*
  9. Health Care Systems Research Network
  10. Humana, Inc.*
  11. IBM Watson Health
  12. Kaiser Permanente Center for Effectiveness and Safety Research
  13. Optum (OptumInsight Life Sciences Inc. and Optum Labs®)*
  14. PCORnet
  15. Rutgers University: Center for Health Services Research on Pharmacotherapy, Chronic Disease Management and Outcomes at the Institute for Health, Health Care Policy and Aging Research
  16. RTI International
  17. TriNetX
  18. University of Alabama at Birmingham: Center for Outcomes and Effectiveness Research and Education
  19. University of Florida College of Pharmacy: Department of Pharmaceutical Outcomes & Policy
  20. University of Iowa: Department of Epidemiology in the College of Public Health
  21. University of North Carolina Gillings School of Global Public Health: Center for Pharmacoepidemiology
  22. University of Pennsylvania School of Medicine: Center for Clinical Epidemiology and Biostatistics and Department of Biostatistics and Epidemiology
  23. Vanderbilt University Medical Center, Department of Health Policy (Tennesee Medicaid data)*
  24. Veradigm

* Indicates Collaborating Institutions that are also Data Partners

 

Reagan-Udall Foundation for the Food and Drug Administration logo

The Reagan-Udall Foundation for the FDA is an independent 501(c)(3) nonprofit. Congress created this nonprofit to advance regulatory science.

Innovation in Medical Evidence Development and Surveillance (IMEDS)

The Reagan-Udall Foundation has a private-public partnership called IMEDS. IMEDS gives private-sector entities access to a system based on the Sentinel Initiative. This system offers industry, academia, and researchers data that can help:

  • Check safety signals
  • Put in place post-market studies
  • Assess the impact of risk management actions

This is possible through select Data Partners and the Harvard Pilgrim Health Care Institute. Together, these two groups function as the Analytic Center. They help with the analyses of medical product safety evaluations.

 

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