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Senate Tweaks Bill To Let FDA Step In If Health Software Poses Serious Risk

The Senate health committee cleared a bill Wednesday (March 9) that removes certain health-related software, including electronic patient records and clinical decision software, from FDA's authority, but an amendment added to the legislation would allow the agency to step in if software poses serious adverse health consequences. Health IT Now praised the legislation, and the general counsel for the CDS Coalition said the bill's movement is a huge step forward in narrowing the gray area around FDA's authority. The bill's...

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