<p>➀ Autonomous AI agents in healthcare are advancing beyond traditional applications, but existing regulatory frameworks in the US and Europe are insufficient for their complexity and adaptability;</p><p>➁ Researchers propose adaptive regulatory pathways, including enforcement discretion policies, voluntary alternative approval pathways, and long-term solutions akin to medical professional qualification, to ensure safety and innovation;</p><p>➂ Collaboration among regulators, healthcare providers, and developers is critical to achieving safe and effective implementation of autonomous AI agents in clinical settings.</p>