The Sentinel Initiative
Fact Sheet
- Sentinel Initiative is a long-term effort by the U.S. Food and Drug Administration (FDA) to create a national electronic system for monitoring medical product safety. It will strengthen FDA's ability to track how drugs and other medical products perform once they go on the market and, ultimately, facilitate the development of tools to strengthen the agency’s ability to communicate safety information to the public.
- The Sentinel Initiative will include the development of a new electronic system, called the Sentinel System, that will enable FDA to gather information about medical products by posing targeted queries (consistent with all applicable privacy and security safeguards) of electronic health records, patient registry data, insurance claims data, and other large healthcare information databases.
- The Sentinel System will be created through public-private partnerships. It will capitalize on existing large electronic claims and medical records data sources maintained by private and government entities that agree to participate in this nationwide effort.
- The Sentinel System will enable FDA to analyze significantly more information than it can today by tapping into vast databases of health information and using new techniques to detect early signs of emerging safety problems. The system will augment FDA’s primarily passive surveillance systems and allow FDA to actively gather information about the performance of medical products after those products are approved and used in the health care system.
- The vision, goals, challenges, and proposed methodologies of the overall initiative are described in an FDA white paper titled, “The Sentinel Initiative—A National Strategy for Monitoring Medical Product Safety.” The report is available at http://www.fda.gov/oc/initiatives/advance/reports/report0508.html
- A new CMS regulation makes it possible for federal agencies, states, and academic researchers to use claims data from the Medicare prescription drug program -- subject to protections for beneficiary privacy and commercially sensitive data -- for public health and safety research, quality initiatives, care coordination, and other research and analysis. This data source could contribute, as one of the many sources of public and private data, to augment current surveillance methods with the creation of the Sentinel System.
- The Sentinel System is an important example of how electronic health records and other electronic health information, such as the Medicare data, can help move the nation toward a system that delivers safer and better quality healthcare. President Bush has stated a goal of most Americans having access to an interoperable electronic health record by 2014.
- Creating a surveillance system such as the Sentinel System was one of the recommendations made by the Institute of Medicine in a 2006 report on ways to improve the safe use of drugs. The Food and Drug Administration Amendments Act of 2007 (FDAAA) includes provisions that call for the development of such a system. As planned, the Sentinel System will fulfill some requirements of FDAAA while also meeting additional FDA needs.