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FDA Relaxes Clinical Decision Support and General Wellness Guidance: What It Means for Generative AI and Consumer Wearables
In January 2026, FDA issued major updates to its Clinical Decision Support and General Wellness guidance, signaling a more innovation-friendly approach to generative AI, clinical copilots, and consumer wearables. This post explains what changed, which AI tools can now remain outside FDA regulation, and how digital health companies can design for compliance while accelerating time to market.
Digital Mental Health Technology - The Quick Breakdown
In this rapid-fire breakdown, Nixon Law Group Senior Counsel Reema Taneja and Digital Health Expert Michael Schellhous cut through the noise to explain the critical shifts in Digital Mental Health Treatment (DMHT) codes.
They cover what the DMHT codes actually reimburse, how they fundamentally differ from Remote Patient Monitoring (RPM) and Remote Therapeutic Monitoring (RTM), and the strict FDA/CMS requirements your device must meet. They unpack the major hurdles—from the lack of a national payment amount (MAC contractor pricing) to provider uptake challenges—and advise founders on how to position their companies for success despite these limitations.
This video is an essential resource for founders looking to understand the pathway to reimbursement and influence the future of digital mental healthcare policy.
FDA Launches TEMPO: What Digital Health Innovators Need to Know Now
FDA’s new TEMPO pilot creates a flexible, real-world evidence pathway for digital health, SaMD, DTx, wearables, and AI-enabled devices—aligned with CMS’s ACCESS model. Learn how innovators can use enforcement discretion to deploy faster, collect RWD/RWE, and strengthen future FDA submissions.
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.