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June 28, 2018

Statement Type Regulatory Comment
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AMIA responded to an FDA request for input with a preliminary review of relevant research into the specific benefits and risks to health associated with software functions that the 21st Century Cures Act excluded from the definition of medical device. While some health IT applications to healthcare delivery have unambiguously improved patient safety and saved lives, the evidence gathered also suggests that software design, implementation decisions, user training, and maintenance processes can all have a material impact on the safety of health IT.