AI Therapy under the EU AI Act

AI Act · 3 weeks ago · 28 ● 74 sources

The EU AI Act regulates AI systems used for therapy or emotional support through both system-level and model-level obligations, including potential bans for systems that exploit vulnerable users' vulnerabilities to cause harm. AI systems marketed for mental health purposes may be classified as high-risk medical devices requiring third-party conformity assessments, risk management systems, and technical documentation, with enforcement beginning August 2, 2026. Providers must ensure transparency by disclosing AI interaction to users, with heightened care for vulnerable groups like children and elderly people who may not realize they're communicating with an AI rather than a human professional.