Artificial intelligence (AI) in health care is rapidly advancing beyond traditional applications. Autonomous AI agents are gaining significant attention for their potential to fundamentally transform medicine. However, researchers at the Else Kröner Fresenius Center (EKFZ) for Digital Health at TUD Dresden University of Technology highlight a growing mismatch between the capabilities of autonomous AI agents and existing medical device regulatory frameworks in the US and Europe.
Autonomous AI agents outpace medical device regulations, study finds
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