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.
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