A national electronic system that will transform FDA’s ability to track the safety of drugs, biologics, and medical devices 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 enables 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 being developed, data will 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.