U.S. Food and Drug Administration

FDA's Sentinel Initiative

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On May 22, 2008, FDA launched the Sentinel Initiative with the ultimate goal of creating and implementing the Sentinel System--a national, integrated, electronic system for monitoring medical product safety.

The Sentinel System will enable FDA to query multiple, existing data sources, such as electronic health record systems and medical claims databases, for information about medical products. The system will enable FDA to query data sources at remote locations, consistent with strong privacy and security safeguards.  Data sources will continue to be maintained by their owners.

This historic new system will strengthen FDA's ability to monitor the performance of a product throughout its entire life cycle, thus enhancing the protection and promotion of public health. Such a system could also ultimately facilitate data mining and other research-related activities.

As envisioned, the Sentinel System can be achieved with minimal transfer of data, using tools and processes that will ensure the protection of patient information.

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