Harvard Pilgrim to Develop Safety Monitoring System for FDA

The Food and Drug Administration has awarded a contract to Harvard Pilgrim Health Care Inc. to develop a pilot of the agency'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 information that 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 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 safety efforts," said FDA Commissioner Margaret A. Hamburg, M.D.

The Sentinel System fulfills some requirements of the Food and Drug Administration Amendments Act of 2007, 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. FDA already has awarded 10 small contracts addressing scientific operations, data and infrastructure, privacy, and stakeholder engagement. In addition, FDA has awarded a cooperative agreement with the Brookings Institution to convene meetings and workshops on active medical product surveillance issues. The workshop on the Sentinel Initiative is scheduled for Jan. 11, 2010, in Washington, D.C.

"The FDA has been doing the groundwork for a nationwide Sentinel System," said Janet Woodcock, M.D., director of 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."

In addition to public meetings, FDA has opened a docket for public comment and developed a listserv for those who want to stay apprised of Sentinel developments. For more information, go to www.fda.gov/Safety/FDAsSentinelInitiative/default.htm.

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