News release: “The Food and Drug Administration (FDA) has unveiled plans for the Sentinel Initiative, a strategy to create and implement a national, integrated, electronic system for monitoring medical product safety. The resulting “Sentinel System” will strengthen FDA’s ability to track how drugs and medical products perform once they go on the market. Ultimately, this system will help monitor medical products throughout their entire life cycle and thus better ensure the protection and promotion of public health.

The Sentinel System will:

• enable FDA to have access to a variety of electronic data sources to identify possible adverse events once a drug or medical product has been approved for use, while protecting patient privacy
• use tools and processes that ensure the protection of personal and proprietary information
• support research and epidemiology studies, as well as FDA’s existing risk identification and analysis processes.”

The Initiative is described in an FDA report titled, The Sentinel Initiative – A National Strategy for Monitoring Medical Product Safety.