Last May, FDA launched the Sentinel Initiative to create and implement the Sentinel System. The purpose and goal for the Sentinel System is to be a national, integrated, electronic system used to monitor 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 also enable FDA to query data sources at remote locations with data sources to continue to be maintained by their owners. FDA will be able to monitor the performance of a product throughout its entire life cycle, and the system could ultimately facilitate data mining and other research related activities.
On September 19, 2008, FDA awarded contracts to further the development of the Sentinel System:
- Pragmatic Data LLC in Indianapolis received $98,000 to identify and evaluate population-based data sources to study the safety of blood and tissue products
- Harvard Pilgrim Health Care, Inc in Wellesley Massachusetts received $98,344 to define and evaluate possible database models
- Booz Allen Hamilton Inc. in Rockville Maryland received $98,532 to evaluate potential data sources and/or data environments
- Outcome Sciences, Inc. in Cambridge Massachusetts received $99,564 to evaluate potential data sources for a National Network of Orthopedic Device Implant Registries
- Group Health Cooperative Center for Health Studies in Seattle Washington received $98,000 to identify, describe, and evaluate existing signal detection methods
- IMS Government Solutions, Inc. in Falls Church Virginia received $92,020 to examine two recent medical product launches each in at least two different types of healthcare databases to assess the timeliness of the products