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FDA Advisory Committee Signals New Regulatory Expectations for Generative AI in Digital Mental Health: What Innovators Need to Know Now
On November 6, 2025, the FDA’s Digital Health Advisory Committee delivered a clear message to the generative AI DMH sector: expect greater structure and tighter oversight. This article breaks down the 6 key themes—including the need for a new risk taxonomy, model drift management, and clinician-supervised use—and provides 5 immediate actions developers, deployers, and investors must prioritize to navigate the evolving regulatory landscape.
Cracking the Code on AI Compliance: A Competitive Edge for Digital Health Innovators
Learn how to turn AI compliance into a strategic advantage. This webinar breaks down evolving regulations and what digital health innovators need to stay ahead.
Healthcare AI at a Crossroads: How OSTP and FDA’s New Calls for Comment Could Shape Regulation
Federal agencies are reshaping how AI is regulated in healthcare. The White House OSTP and FDA are seeking stakeholder input on the impact of legacy regulations and real-world AI oversight. Learn what these calls for comment mean for innovators, investors, and providers—and how your input can shape the future of healthcare AI.
FDA Cracks Down on Wearable Devices: Lessons from WHOOP and Dexcom Enforcement Actions
Recent FDA actions against WHOOP and Dexcom reveal how wearables and SaMD are being regulated more aggressively. Here’s what digital health founders must know.