ICT&health November 15, 2025
The US Food and Drug Administration (FDA) Digital Health Advisory Committee recently convened to examine a fast-evolving frontier in care: generative AI–enabled digital mental health devices. During the virtual meeting, chaired by Ami Bhatt, MD, experts discussed clinician needs, regulatory evolution, and the responsible integration of AI within mental health care.
The committee acknowledged the significant promise of generative AI tools for supporting patients with psychiatric conditions. At the same time, members emphasized that human susceptibility to AI-generated outputs, the challenges of monitoring risks such as suicidal ideation, and the potential impact of long-term AI engagement must not be underestimated. The FDA noted that generative AI and large language models (LLMs) continue to show vulnerabilities precisely in areas where human...
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