Who Is Involved

Sentinel generates evidence by partnering with various organizations such as: 

• Academic medical centers
• Healthcare systems
• Health insurance companies

The following Data Partners have data in the Sentinel Common Data Model:

1. Aetna, a CVS Health company 
2. Carelon Research/Elevance Health
3. Duke University School of Medicine: Department of Population Health Sciences (Medicare Fee-for-Service and Medicaid data)
4. HealthPartners Institute
5. Humana, Inc.
6. Kaiser Permanente Colorado Institute for Health Research
7. Kaiser Permanente Hawai'i, Center for Integrated Health Care Research
8. Kaiser Foundation Health Plan of the Mid-Atlantic States, Inc.
9. Kaiser Permanente Northwest Center for Health Research
10. Kaiser Permanente Washington Health Research Institute
11. Marshfield Clinic Research Institute
12. Optum
13. Vanderbilt University Medical Center, Department of Health Policy (Tennessee Medicaid data)

Contributions from Sentinel Data Partners are coordinated through the Sentinel Operations Center (SOC). In this model:

1. FDA submits a study design to SOC
2. SOC distributes analytic code to applicable Sentinel Data Partners to run on their source data
3. Sentinel Data Partners return de-identified data to SOC
4. SOC aggregates data from Sentinel Data Partners, and delivers final results to FDA

Learn more about how Sentinel gets its data.
 

The Harvard Pilgrim Health Care Institute leads the Sentinel Operations 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. Brigham and Women's Hospital: Division of Pharmacoepidemiology & Pharmacoeconomics in the Department of Medicine
3. Carelon Research/Elevance Health*
4. Duke University School of Medicine: Department of Population Health Sciences (Medicare Fee-for-Service and Medicaid data)*
5. Harvard T.H. Chan School of Public Health
6. HCA Healthcare
7. Health Care Systems Research Network
   • Harvard Pilgrim Health Care Institute
   • HealthPartners Institute*
   • Marshfield Clinic Research Institute*
   • Meyers Health Care Institute, a joint endeavor of UMass Chan Medical School, Reliant Medical Group, and Fallon Health
8. Humana, Inc.*
9. Kaiser Permanente Center for Effectiveness and Safety Research
   • Kaiser Permanente Colorado Institute for Health Research*
   • Kaiser Permanente Hawai'i, Center for Integrated Health Care Research*
   • Kaiser Foundation Health Plan of the Mid-Atlantic States, Inc.*
   • Kaiser Permanente Northwest Center for Health Research*
   • Kaiser Permanente Washington Health Research Institute*
10. Merative 
11. Optum (OptumInsight Life Sciences Inc. and Optum Labs®)*
12. TriNetX
13. University of Florida College of Pharmacy: Department of Pharmaceutical Outcomes & Policy
14. University of North Carolina Gillings School of Global Public Health: Center for Pharmacoepidemiology
15. University of Pennsylvania School of Medicine: Center for Clinical Epidemiology and Biostatistics and Department of Biostatistics and Epidemiology
16. Vanderbilt University Medical Center, Department of Health Policy (Tennesee Medicaid data)*

* Indicates Collaborating Institutions that are also Data Partners

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.