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FDA to Hold Advisory Committee Meeting on AI-Driven Mental Health Devices

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FDA plans advisory committee meeting on AI mental health devices

Mario Aguilar reports on the ongoing transformation in healthcare driven by technology, including artificial intelligence (AI), virtual reality, wearable devices, telehealth, and digital therapeutics. His insights examine the implications of these innovations on healthcare practices, alongside the associated business and policy challenges. Notably, the FDA is convening experts to address regulatory challenges related to AI-driven mental health products. This meeting, set for Nov. 6, will focus on the risks associated with generative AI in digital mental health devices, emphasizing the need for evolving regulatory frameworks to adapt to these complexities. As companies increasingly release AI-powered chatbots for mental health support, the FDA is poised to intensify its scrutiny of these technologies to ensure safety and efficacy. For ongoing analysis of healthcare technology, readers are encouraged to subscribe to the STAT Health Tech newsletter. Connect with Mario Aguilar on Signal at mariojoze.13 for more insights.

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