18 V.S.A. § 9764(a)-(b)
Plain Language
Suppliers of mental health chatbots may assert an affirmative defense to professional conduct enforcement actions if they can demonstrate they: (1) created, maintained, and implemented a comprehensive written policy covering the chatbot's intended purposes, abilities, limitations, safety procedures (including licensed provider involvement in development, clinical best-practice compliance, pre- and post-deployment testing, adverse outcome identification, user harm reporting mechanisms, real-time crisis response protocols, regular safety audits, nondiscrimination measures, and HIPAA-equivalent compliance); (2) maintained documentation of foundation models used, training tools, privacy compliance, data practices, and ongoing accuracy/safety efforts; (3) filed the policy with the Attorney General; and (4) complied with the filed policy at the time of the alleged violation. This is structured as a safe harbor rather than an affirmative obligation — but practically, any supplier that wants access to the defense must build and maintain this comprehensive governance program.
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.