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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.

Published: Tuesday, January 12, 2010 - 14:19

(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.

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, Massachusetts, 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 safety efforts,” says FDA commissioner, Margaret A. Hamburg.

The Sentinel System fulfills some requirements of the FDA Amendments Act of 2007 (FDAAA) which include provisions calling for the development of such a system.

The Harvard Pilgrim contract is one of the many activities contributing to building the Sentinel System. The FDA already has awarded 10 small contracts addressing scientific operations, data and infrastructure, privacy, and stakeholder engagement. In addition, the FDA has awarded a cooperative agreement with the Brookings Institution to convene meetings and workshops on active medical product surveillance issues.

“The FDA has been doing the groundwork for a nationwide Sentinel System,” says Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “Once operational, the Sentinel System will help us find answers to important drug safety questions, leading to stronger safeguards for public health, while still protecting the privacy and security of individual health information.”

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The U.S. Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable, and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.