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FDA Harnesses Power of Claims, EHR Data for Monitoring Drug Safety
Health Data Management

A pilot program for the Food and Drug Administration’s Sentinel active surveillance system, dubbed Mini-Sentinel, is leveraging electronic healthcare data — principally claims data but also including data from EHRs — to monitor the safety of FDA-regulated medical products. According to Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, the Mini-Sentinel system can survey more than 350 million person years of observation, 4 billion pharmaceutical dispensings, and 4.1 billion patient encounters.