2026 AI for Mental Health (AI4MH) Symposium: Policy & Ethics — Governing AI in Mental Health
Zero AI-driven mental health apps have been FDA-cleared because the regulatory framework predates generative AI.
“the number of AI-driven apps that have been cleared by the FDA for mental health purposes is zero”
At Stanford HAI's AI4MH Symposium, law professor Michelle Mello explained that the FDA's 1970s-era medical-device framework exempts 'wellness' apps from review, leaving virtually all mental health apps—and every AI-driven one—uncleared. This matters because generative AI companion chatbots now occupy a regulatory gap that assumed wellness tools were low-risk, an assumption that no longer holds.