The U.S. Food and Drug Administration has awarded a contract to Harvard Pilgrim Health Care Inc. of Wellesley, MA, to develop a pilot of the FDA's Sentinel System. The project will use automated health care data in order to evaluate medical product safety.

The Sentinel Initiative is a national electronic system that the FDA says will transform the agency's ability to track the safety of drugs, biologics, and medical devices. The system will enhance other existing systems the FDA has to track reports of adverse events in regulated products. Specifically, the Sentinel System would enable FDA to search and query diverse automated health care data holders, such as electronic health record systems, administrative and insurance claims databases, and registries to swiftly evaluate possible medical product safety issues. This helps overcome a gap of incomplete or untimely information from reports filed by hospitals, industry and health care professionals.

The one-year contract with Harvard Pilgrim includes four renewable years for a total of $72 million. Harvard Pilgrim will establish a coordinating center that will operate as a scaled down version of the Sentinel System. The center will identify appropriate databases, develop methodologies for obtaining real-time data, and ensure data quality. Personal information will remain protected as only summary results will be sent to the coordinating center.

Richard Platt, MD, Chairman of Population Medicine Harvard Medical School and Harvard Pilgrim Health Care Institute commented to DOTmed about the award: "This project will help the FDA better understand how to use routinely collected health care data to improve the safety of medical products."

"The award of this contract to Harvard Pilgrim to develop a medical product safety monitoring system is an important step forward for FDA's drug and medical device safety efforts," said FDA Commissioner Margaret A. Hamburg, M.D., in a press release on the FDA's website.

Read more details:

The FDA announcement: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm196968.htm

More on the Sentinel Initiative: http://www.fda.gov/Safety/FDAsSentinelInitiative/default.htm

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