image: Andrew Harnik/AP

FDA looks to leverage EHR data to better evaluate medical products

July 11, 2018

The Food and Drug Administration wants to take advantage of the real-world data available from electronic health records to more fully evaluate medical products in the post-market setting, according to FDA Commissioner Scott Gottlieb, MD.

The agency is seeking $100 million in its Fiscal Year 2019 budget request to build a system that would include electronic records from about 10 million individuals, supplementing the FDA’s active post-market monitoring systems—the National Evaluation System for health Technology (NEST) for medical devices and Sentinel system for drugs and biologics—which depend largely on the secondary use of claims data.

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