The U.S. Food and Drug Administration (FDA) leads the Sentinel Initiative. The main goal is to improve how FDA evaluates the safety and performance of medical products.
The FDA uses Sentinel data to evaluate the safety of medical products. They also use Sentinel data to learn more about potential side effects.
Sentinel uses a distributed data approach. In this approach, data remain with the data owner, i.e., an insurance company. Also, data owners remove patient identifiers to protect privacy.
Sentinel data come from existing sources. These include insurance claims, electronic health records, and patient reports.
Data from the health systems, insurance companies, or medical records can be used without personal information being shared to learn more about medical products.
The Duke-Margolis Center for Health Policy hosted the 15th Annual Sentinel Initiative Public Workshop under a cooperative agreement with the Food and Drug Administration on November 8, 2023. Participants heard from Sentinel Initiative leadership on a range of key issues, including recent studies and applications of Sentinel to protect and promote public health during the COVID-19 pandemic.
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Sentinel has various methods and tools to support the evaluation of medical products. U.S. Food and Drug Administration (FDA) scientists use Sentinel data to complement their data and information.
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