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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.
How States Are Enforcing New AI Laws in Healthcare—and Why It Matters
States are rapidly passing new laws to regulate Artificial Intelligence (AI) in healthcare, covering everything from mental health chatbots to AI-generated patient communications. The enforcement landscape is fragmented: some states rely on high administrative fines (up to $\$15,000$ per day), others empower Medical Boards, and some even grant a private right of action for consumers. For national digital health solutions, this patchwork of risk requires immediate mapping and proactive AI governance.
California Cracks Down on MSOs and Private Equity Influence: What Digital Health Companies Must Know
California has escalated its oversight of Management Services Organizations (MSOs) and private investment in healthcare. With the signing of SB-351 and AB-1415, the state reinforces the Corporate Practice of Medicine (CPOM) by banning interference with clinical judgment and introducing mandatory transaction and data reporting to the Office of Health Care Affordability (OHCA). Digital health enterprises using the MSO-PC model must reassess their structures, workflows, and governance to ensure compliance and avoid penalties.
CMS Finalizes 2026 Remote Monitoring Reimbursement Updates: What Changed for RPM and RTM
CMS Finalizes Major 2026 RPM/RTM Rule: New Short-Duration Codes & OPPS Valuation Shift. The CY 2026 Medicare Physician Fee Schedule (MPFS) introduces unprecedented flexibility for digital health companies by finalizing new CPT codes for 2–15 day RPM/RTM monitoring (e.g., CPT 99445, 98984–98986) and 10-minute treatment management codes (e.g., 99470, 98979). Crucially, CMS is adopting Outpatient Prospective Payment System (OPPS) data for device supply code valuation, setting a precedent for valuing SaaS infrastructure costs. Learn how these changes—including the "sometimes therapy" designation for RTM—will reshape hybrid virtual care models, episodic monitoring, and reimbursement strategy going forward.
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.
Government Shutdown Looms: How the Medicare Telehealth Cliff Impacts Providers and Patients Starting October 1
Unless Congress acts by midnight, Medicare’s temporary telehealth flexibilities will expire on September 30, 2025. Starting October 1, many non-behavioral telehealth services face new limits, while behavioral health coverage and Medicare Advantage plans remain more flexible. Here’s what patients and providers need to know now.
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.
OIG’s 2025 Report on Remote Patient Monitoring: Growth, Compliance Red Flags, and Medicare Billing Clarifications
The Office of Inspector General (OIG) has released August 2025 Data Snapshot on Remote Patient Monitoring (RPM) in Medicare. The findings highlight both the explosive growth of RPM adoption and the compliance red flags that providers, digital health vendors, and investors need to proactively address.
Telehealth Compliance Alert: Oregon CPOM Changes and Federal OIG Insights
Learn how Oregon’s new CPOM law and a recent OIG opinion impact MSO-PC models, and how telemedicine providers can stay compliant and scale responsibly.
CMS Proposes Expanded Coverage for Digital Mental Health Devices—And Seeks Input on Broader Digital Therapeutics Use Cases
CMS proposes expanded reimbursement for digital mental health devices and seeks public input on broader digital therapeutics coverage. Comments due Sept. 12.
Remote Monitoring in the 2026 MPFS: New Codes, Old Concerns, and a Call to Action for Stakeholders
The 2026 Medicare Physician Fee Schedule proposes key changes to remote monitoring reimbursement—including new codes and a shift in data requirements. Learn what’s at stake and why stakeholders should act before the September 12, 2025 comment deadline.
Reshaping Food as Medicine: New Insights from Federal and State Policymakers
Explore how the 2026 Medicare Physician Fee Schedule and the Big Beautiful Bill are shaping the future of Food as Medicine (FaM). Learn about proposed changes to MNT reimbursement, new federal and state laws, and key compliance issues for FaM and virtual food care innovators.
CMS Proposes 2026 Changes to RPM, APCM, DMHT, and More: What Digital Health Companies Need to Know
CMS’ 2026 MPFS rule proposes major changes to RPM, APCM, and DMHT codes. See how digital health innovators can prepare and weigh in on key policies.
Digital Health Stakeholders: Weigh In on CMS 2026 Chronic Disease and Virtual Care RFIs
CMS is exploring major shifts in Medicare reimbursement policy for virtual care and chronic disease management. This article breaks down the 2026 RFIs and what policymakers, providers, and digital health innovators need to know before the September 12, 2025 comment deadline.
