Health insurer Harvard Pilgrim Health Care Inc. will develop a pilot of the Food and Drug Administration's Sentinel System to better monitor the safety of regulated medical products. The one-year contract with four renewable years is worth a total of $72 million.
Under the Sentinel System, the FDA wants to create a national, integrated electronic system that will enable the agency to access and query multiple existing data systems for de-identified product safety information. These existing data systems could include electronic health records, registries and medical claims databases, among other sources. The goal is to improve the monitoring of medical products after they have received FDA approval.
Wellesley, Mass.-based Harvard Pilgrim will create a coordinating center that will operate as a scaled-down version of the Sentinel System, according to the FDA. The center will identify appropriate databases, develop a framework for obtaining real-time surveillance data and ensure data quality. Only summary results will be sent to the coordinating center; originating data will remain within the database of its organization.
The Food and Drug Administration Amendments Act of 2007 authorized creation of the Sentinel System. The FDA previously has awarded 10 small contracts addressing scientific operational, data infrastructure, privacy and stakeholder engagement issues. The agency also contracted with the Brookings Institution in Washington to convene meetings and workshops on medical product surveillance issues.
More information is available at fda.gov/Safety/FDAsSentinelInitiative/default.htm.
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