STAT (4/23, Aguilar, Subscription Publication) reports that the American Medical Association is urging “lawmakers to pursue safeguards around the use of chatbots in mental health care.” The AMA “urges Congress to direct the Food and Drug Administration to clarify its stance on what kinds of health AIs count as general wellness products versus medical devices.” More specifically, the “AMA wants to close the loophole that allows companies to dodge regulators by claiming their product is not intended for medical uses.” In a series of letters to federal lawmakers, AMA CEO John Whyte, MD, MPH, wrote “Determinations of regulatory status should be based on the function of the technology and should not be solely based on marketing claims. … Simple disclaimers included by chatbots should not be considered sufficient to escape regulatory review.”
Becker’s Hospital Review (4/22, Bruce) reported, “The AMA’s recommendations include requiring chatbots to clearly disclose that users are interacting with AI, prohibiting them from presenting themselves as licensed clinicians, banning them from diagnosing or treating mental health conditions without regulatory due diligence, clarifying when AI solutions qualify as medical devices, and mandating strict data protection standards.” Dr. Whyte said, “AI-enabled tools may help expand access to mental health resources and support innovation in health care delivery, but they lack consistent safeguards against serious risks, including emotional dependency, misinformation, and inadequate crisis response. … With thoughtful oversight and accountability, policymakers can support innovation and ensure technologies prioritize patient safety, strengthen public trust, and responsibly complement – not replace – clinical care.”
Related Links:
— “AMA calls for regulatory crackdown on chatbots, wellness AI,”Mario Aguilar, STAT, April 23, 2026