Dear colleagues,
On November 6, 2025, the FDA Digital Health Advisory Committee will meet to discuss and make recommendations on the topic of generative AI-enabled digital mental health medical devices.
The Committee will address:
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Benefits and risks of these new digital mental health devices
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Risk mitigation strategies
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Premarket evidence requirements
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Post-market monitoring considerations
📍 Format: Virtual, open to the public (no registration required)
🎥 A webcast link will be made available by FDA at least two business days before the meeting.
🔗 Additional details are available on the FDA Digital Health Advisory Committee webpage.
This meeting is highly relevant for various SIGs working at the intersection of RWE, digital health and AI-enabled technologies, particularly as FDA is also seeking public comment on methodologies for measuring and evaluating AI-enabled medical device performance in real-world settings.
Thank you!
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John Diaz-Decaro
Chair- ISPE Digital Technology and Artificial Intelligence SIG
Sr. Director, Epidemiology Latent Viruses (EBV)
ModernaTX, Inc.
Cambridge, MA
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