“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…”
“At the same time, he notes that real-world data comes from sources other than EHRs, including…” Read the full article here.
Source: FDA looks to leverage EHR data to better evaluate medical products – By Greg Slabodkin, July 11, 2018. HealthData Management.