Devices

American Hospital Association AI Policy Ideas

David McFarland

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The American Hospital Association (AHA) says it generally supports artificial intelligence (AI) policy frameworks that balance flexibility to drive market-based innovations with appropriate safeguards to protect privacy and patient safety. The association stated its position in response to an FDA request for comment on the measurement and evaluation of AI-enabled medical devices.

The AHA says that as FDA considers future policy approaches to measuring and evaluating AI-enabled medical device performance, it should:

  • pursue risk-based post-deployment measurement and evaluation standards for AI-enabled medical device vendors and developers;
  • synchronize measurement and evaluation activities with existing frameworks; and
  • align incentives and address infrastructure barriers to measurement and evaluation.

AHA provided specific recommendations on those three themes, given AI growth and use in hospitals and health systems.

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