FDA Sentinel Initiative
FDA (US Food and Drug Administration)
The FDA Sentinel Initiative is a distributed system for evaluating the safety and performance of medical products using real-world data from insurance claims, electronic health records, and patient reports covering approximately 138.7 million members. Data remain with their sources (insurance companies, EHR systems, etc.) and are analyzed through a decentralized model that preserves privacy and data security.
Category
Research database
Access
By application
Cost
Free for FDA-approved research
Region
US — United States
Size
138.7 million members
Data types
insurance claims, electronic health records, patient reports