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FDA Awards Contract to Harvard Pilgrim to Develop Pilot for Safety Monitoring System
Date:1/8/2010

SILVER SPRING, Md., Jan. 8 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration has awarded a contract to Harvard Pilgrim Health Care Inc. to develop a pilot of the FDA's Sentinel System, which will use automated health care data to evaluate medical product safety.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)

Reports filed by hospitals, health care professionals, and industry account for much of the information that the FDA relies on regarding medical product safety. For a variety of reasons, these reports may be incomplete or not filed in a timely manner.

The Sentinel System, once operational, will bolster the FDA's efforts in monitoring product safety. Sentinel will provide FDA with the ability to analyze information collected during the course of routine health care, such as data from electronic health record systems, administrative and insurance claims databases and medical registries.

The one-year contract with Harvard Pilgrim, based in Wellesley, Mass., includes four renewable years for a total of $72 million. Under the terms of the contract, Harvard Pilgrim will establish a coordinating center that will operate as a scaled down version of the Sentinel System. This center, or "mini-Sentinel," will identify appropriate databases, develop a scientific framework for obtaining real-time data, and ensure data quality. To protect personal information, only summary results will be sent to the coordinating center. The data itself will remain within its database.

"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
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SOURCE U.S. Food and Drug Administration
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