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Introduction
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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