The Food and Drug Administration’s Sentinel initiative for monitoring the safety of FDA-regulated drugs and other medical products is one of the largest uses of big data in healthcare, according to the regulatory agency’s outgoing commissioner Margaret Hamburg, M.D.
The active surveillance system, which recently transitioned from a five-year pilot program to a full-scale system, has established secure access to the healthcare data of more than 170 million patients across the country, including claims data and electronic health records. FDA is currently querying large, diverse health care data for product safety through Sentinel and exploring opportunities to expand the use of real-world observational data to optimize the performance of medical products.
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