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Harvard Pilgrim to Develop FDA Pilot for Safety Monitoring System

Sentinel System will bolster the FDA’s efforts in monitoring product safety.

FDA
Tue, 01/12/2010 - 13:19
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(FDA: Washington) -- The U.S. Food and Drug Administration (FDA) 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.

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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.

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