18 V.S.A. § 9764(a)-(b)
Plain Language
Mental health chatbot suppliers may claim an affirmative defense against professional regulation enforcement actions if they have created, maintained, and implemented a comprehensive written policy covering 15 enumerated requirements, maintained documentation of the chatbot's development and implementation (including foundation models, training tools, privacy compliance, data practices, and safety efforts), filed the policy with the Attorney General, and complied with it at the time of the alleged violation. The required policy is extensive — it must cover clinical professional involvement, best-practices monitoring, pre- and post-deployment testing benchmarked against human therapy safety, adverse outcome identification, user harm reporting mechanisms, real-time acute harm protocols, regular safety audits, user disclosure of AI nature and limitations, prioritization of user safety over engagement, anti-discrimination measures, and HIPAA-equivalent privacy compliance. While structured as an affirmative defense rather than a mandatory obligation, as a practical matter any supplier seeking regulatory protection will need to comply with all requirements.
Statutory Text
(a) It is an affirmative defense to liability in an action for unlawful or unprofessional conduct brought against a supplier by the Office of Professional Regulation or the Board of Medical Practice if the supplier demonstrates that the supplier meets all of the following conditions: (1) the supplier created, maintained, and implemented a policy that meets the requirements of subsection (b) of this section; (2) the supplier maintains documentation regarding the development and implementation of the mental health chatbot that describes: (A) foundation models used in development; (B) training tools used; (C) compliance with federal health privacy regulations; (D) user data collection and sharing practices; and (E) ongoing efforts to ensure accuracy, reliability, fairness, and safety; (3) the supplier filed the policy with the Office of the Attorney General; and (4) the supplier complied with all requirements of the filed policy at the time of the alleged violation. (b) A policy described in subdivision (a)(1) of this section shall meet all of the following requirements: (1) be in writing; (2) clearly state: (A) the intended purposes of the mental health chatbot; and (B) the abilities and limitations of the mental health chatbot; (3) describe the procedures by which the supplier: (A) ensures that qualified mental health providers licensed in Vermont or in one or more other states, or both, are involved in the development and review process; (B) ensures that the mental health chatbot is developed and monitored in a manner consistent with clinical best practices; (C) conducts testing prior to making the mental health chatbot publicly available and regularly thereafter to ensure that the output of the mental health chatbot poses no greater risk to a user than that posed to an individual in psychotherapy with a licensed mental health provider; (D) identifies reasonably foreseeable adverse outcomes to and potentially harmful interactions with users that could result from using the mental health chatbot; (E) provides a mechanism for a user to report any potentially harmful interactions from use of the mental health chatbot; (F) implements protocols to assess and respond to risk of harm to users or other individuals; (G) details actions taken to prevent or mitigate any such adverse outcomes or potentially harmful interactions; (H) implements protocols to respond in real time to acute risk of physical harm; (I) reasonably ensures regular, objective reviews of safety, accuracy, and efficacy, which may include internal or external audits; (J) provides users any necessary instructions on the safe use of the mental health chatbot; (K) ensures users understand that they are interacting with artificial intelligence; (L) ensures users understand the intended purpose, capabilities, and limitations of the mental health chatbot; (M) prioritizes user mental health and safety over engagement metrics or profit; (N) implements measures to prevent discriminatory treatment of users; and (O) ensures compliance with the security and privacy protections of 45 C.F.R. Part 160 and 45 C.F.R. Part 164, Subparts A, C, and E, as if the supplier were a covered entity, and applicable consumer protection requirements, including sections 9761-9763 of this subchapter.