AHA responds to FDA request for information on AI-enabled medical devices

The AHA provided recommendations to the Food and Drug Administration Dec. 1 in response to a request for information on the measurement and evaluation of artificial intelligence-enabled medical devices. The AHA encouraged the agency to pursue risk-based post-deployment measurement and evaluation standards for device vendors and developers, synchronize measurement and evaluation activities with existing frameworks, and align incentives and address infrastructure barriers to measurement and evaluation. “AI-enabled medical devices offer tremendous promise for improved patient outcomes and quality of life,” the AHA wrote. “At the same time, they also pose novel challenges — including model bias, hallucinations and model drift — that are not yet fully accounted for in existing medical device frameworks... In general, the AHA supports AI policy frameworks that balance flexibility to drive market-based innovations with appropriate safeguards to protect privacy and patient safety.”