FDA's Sentinel Initiative

The project report associated with the contract entitled, "Evaluation of State Privacy Regulations in Relation to the Sentinel Initiative" is available for viewing and comment in the docket. This project's scope of work involved conducting a legal evaluation of state statues, regulations and practices in each of the 50 states in order to determine whether data sources may participate in the Sentinel Initiative and the conditions on that participation. It is noted that Federal regulations, including the HIPAA Privacy Rule constitutes a minimum for privacy protection, so states may enact more rigorous privacy protection if desired. This project encompassed a thorough evaluation of state statues and regulations to determine whether those state laws impose any additional restrictions on the use or disclosure of health information beyond the federal law requirements discussed in the legal analysis already received by the Agency, and if so, to set out what those additional restrictions entail.


FDA's Sentinel Initiative

Transforming how we monitor the safety
of FDA-regulated products2

A national electronic system that will transform FDA’s ability to track the safety of drugs, biologics, medical devices--and ultimately all FDA-regulated products once they reach the market--is now on the horizon. Launched in May 2008 by FDA, the Sentinel Initiative aims to develop and implement a proactive system that will complement existing systems that the Agency has in place to track reports of adverse events linked to the use of its regulated products.

Monitoring the safety of its regulated products is a major part of FDA’s mission to protect public health. The Sentinel System would enable FDA to actively query diverse automated healthcare data holders—like electronic health record systems, administrative and insurance claims databases, and registries—to evaluate possible medical product safety issues quickly and securely.

Sentinel will be developed and implemented in stages. As the system is envisioned, data would continue to be managed by its owners and questions would be sent to the participating data holders. Within pre-established privacy and security safeguards, these data holders would evaluate their information and send summary results to FDA. It is also anticipated that Sentinel will facilitate the development of active surveillance methodologies related to signal detection, strengthening, and validation.

-Related Links
Critical Path Initiative3

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FDA's Sentinel Initiative