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FDA’s $100M Proposal Could Set E-Health Data Standards

May 4, 2018, 8:16 PM

The FDA’s push to use real-time data for evaluating drugs and devices could bring about more useful electronic medical records that improve patient care, current and former commissioners said May 4.

The Food and Drug Administration is asking Congress for $100 million in its 2019 budget to build a database of 10 million individual electronic health records across a range of health-care settings that could help guide how it evaluates medical products.

The agency has a unique opportunity to develop a repository that establishes standards for these electronic health records (EHRs), FDA Commissioner Scott Gottlieb said. A lack of EHR ...