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flag APA, CHI, and Spring Health urge FDA to regulate AI in mental health devices for safety and privacy.

flag On October 25, 2025, the American Psychiatric Association, the Connected Health Initiative, and Spring Health urged the FDA to establish stronger regulations for generative AI in mental health devices. flag They called for clear oversight to ensure safety, efficacy, transparency, and patient privacy, citing risks like bias, data misuse, and unreliable AI decisions. flag The groups emphasized the need for adaptable, ongoing monitoring and accountability as AI tools become more common in mental health care. flag Their comments are part of growing pressure on the FDA to develop modern, flexible guidelines for AI-driven health technologies.

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