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Gottlieb: Tighter scrutiny of EHRs needed amid reports of patient harm

FDA Commissioner Scott Gottlieb has called for stricter scrutiny of EHR systems in light of reports of patient deaths, injuries and close calls related to the conversion from paper to electronic records. The 21st Century Cures Act prevents the FDA from overseeing EHRs as medical devices, and Gottlieb said companies have avoided adding functionality that could improve the systems because of concern the changes would bring them under FDA oversight.

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