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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.
Inside the Deal: Healthcare VCs to Watch with Parth Desai – Investing in the Future of Health Tech
We’re joined by Parth Desai, Principal at Flare Capital Partners, one of the largest venture firms dedicated exclusively to healthcare technology. Parth blends a clinical and policy background with deep operational insight from inside major health systems.
In this conversation, he shares how Flare identifies venture-backable startups, evaluates AI and digital health opportunities beyond the hype, and leverages dissent within the firm to make sharper investment decisions.
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.
Inside the Deal: Healthcare VCs to Watch with Stasia Obremskey – Impact Capital for Women’s Health
We’re joined by Stasia Obremskey, Managing Partner at Foreground Capital, a fund built to close the equity gap in women’s health. Stasia blends a finance-first background with a deep commitment to public health and impact.
In this powerful conversation, she shares how founders can navigate policy risk, build Medicaid-aligned business models, and evaluate investor fit with the same rigor as raising capital.
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.
Inside the Deal: Healthcare VCs to Watch with Sal DeTrane – Smart Capital, Real Impact
We’re joined by Sal DeTrane, a seasoned operator and Managing Director of Empactful Capital. With decades of experience on both sides of the table, Sal brings a rare mix of business strategy, empathy, and capital discipline to digital health investing.
In this candid conversation, Sal unpacks the advantages of micro funds, why “EQ” should be part of your cap table, and how the right capital at the right time can be the difference between dilution and durability.
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.
Inside the Deal: Healthcare VCs to Watch with Anne DeGheest - How to Build HealthTech That Lasts
We’re joined by Anne DeGheest, a true pioneer in the HealthTech space. As founder of HealthTech Capital and a mentor to countless startups, Anne brings decades of experience from all sides of the table: operator, investor, and advisor.
With 8 IPOs under her belt and over 10 million lives impacted, Anne shares how to build companies that last—and why market understanding, stakeholder alignment, and flexibility are more important than pitch decks or patents.
Inside the Deal: Healthcare VCs to Watch with Kristi Ebong - Digital Health Innovation, Fundraising, and Founder Discipline
We’re kicking things off with the incomparable Kristi Ebong, Partner at HealthX Ventures.
Kristi brings a rare 360° perspective to digital health. With experience as an operator, investor, and ecosystem builder, she understands what it really takes to scale in healthcare. From launching the Cedars-Sinai Accelerator to supporting early-stage founders at Define Ventures and now HealthX, Kristi has been at the forefront of turning vision into impact.
In our conversation, Kristi pulls back the curtain on the realities of building in health tech, and she doesn’t hold back! She explains why constant fundraising is a distraction, how a casual chat with a founder led to backing a behavioral health company that grew to $10M ARR, and why now is the time for more healthcare innovation.
Her advice is sharp, encouraging, and exactly what founders navigating this space need to hear.
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.