The Senate health committee on Wednesday approved a bill that would exempt low-risk medical software and mobile apps from regulation by the Food and Drug Administration, so as not to stifle innovation by developers.
In a March 9 executive mark-up session, the committee passed by voice vote the bipartisan Medical Electronic Data Technology Enhancement for Consumers’ Health (MEDTECH) Act introduced by Sens. Michael Bennet (D-Colo.) and Orrin Hatch (R-Utah), designed to limit and clarify the FDA’s role regarding the regulation of administrative and financial software, wellness and lifestyle products, certain aspects of electronic health records, and clinical decision support software.
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