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The Mind, the Machine, and the Model Drift: FDA’s Emerging Oversight of Generative AI Mental-Health Devices
The FDA’s Digital Health Advisory Committee (DHAC) met on November 6, 2025 to explore how generative AI-enabled digital mental health medical devices should be regulated—a first-of-its-kind review in a rapidly expanding market projected to hit $11 billion in 2025….
By: Venable LLP