Resources
for You and Your Team
OIG Advisory Opinion 26-10: What Digital Health Companies Should Know Before Paying Clinician Royalties
Can digital health companies pay physicians and other clinicians royalties tied to platform revenue, product sales, or adoption? In OIG Advisory Opinion 26-10, the Office of Inspector General rejected a proposed clinician royalty arrangement despite fair market value safeguards, finding that physician influence over product utilization created Anti-Kickback Statute concerns. This article explains the OIG's reasoning, key compliance lessons, and what digital health, clinical AI, RPM, RTM, telehealth, and health tech companies should know before structuring clinician compensation arrangements.
OIG Audit Alert: What are the Key Medicare Compliance Risks in Virtual Check-Ins and E-Visits?
The OIG’s April 2026 audit report signals heightened Medicare enforcement for virtual check-ins and e-visits. Digital health providers face increasing scrutiny over timing violations, duplicative billing, Modifier 25 misuse, and improper reimbursement for communication technology-based services (CTBS). This article breaks down the OIG’s findings, CMS’s response, and the key compliance steps digital health companies should take now to reduce audit risk and prepare for stricter claims oversight.
Does Every Digital Health Company Need a Health Tech Lawyer?
Can AI or a general business attorney handle legal and regulatory issues for your digital health company? In this article, Carrie Nixon explains why health tech startups, telehealth companies, and digital health platforms face unique risks involving HIPAA, Corporate Practice of Medicine (CPOM), Stark Law, Anti-Kickback Statute compliance, healthcare data privacy, reimbursement structures, and AI governance. Learn where AI tools can help health tech founders—and where experienced healthcare legal counsel is essential.
The 2026 Guide to Healthcare Generative AI Regulations: Frameworks and Compliance for Leaders
Healthcare generative AI has entered a new regulatory era in 2026. This guide breaks down the core framework leaders need to understand—from FDA medical device rules and HIPAA obligations to FTC enforcement and fast-evolving state laws. Learn how key design choices—such as generative vs rules-based AI, chatbots vs autonomous agents, and clinical vs administrative use—directly shape compliance requirements, risk exposure, and go-to-market strategy.
Legal as a Go-To-Market Strategy for Healthcare AI Companies
In 2026, leading Healthcare AI companies are transforming legal and regulatory strategy into a powerful go-to-market lever. From state-level regulatory sandboxes to evolving FDA Clinical Decision Support (CDS) guidance and CMMI reimbursement models, this post explores how companies can accelerate market entry, generate real-world evidence, and build a durable competitive moat.
How to Avoid Corporate Practice of Medicine (CPOM) Violations: Lessons from the NaphCare Investigation
Is your MSO-PC model truly compliant? The March 2026 NaphCare investigation by the New York OAG resulted in $875,000 in penalties, highlighting the dangers of "nominal" professional corporations and clinical interference.
Key Takeaways for Digital Health:
Clinical Autonomy: Why the PC must control all workflows.
Operational Separation: Avoiding the "Alabama Trap" of shared leadership.
NY CPOM Strictness: Why template-based compliance fails in New York.
Read our full analysis of the NaphCare case to protect your telehealth enterprise from regulatory scrutiny.
What is the CMS ASPIRE Model? A 10-Year Value-Based Care Roadmap for Digital Health
The CMS ASPIRE Model (Accelerating State Pediatric Innovation Readiness and Effectiveness) is a landmark 10-year initiative launched in 2026 to transform pediatric care for Medicaid and CHIP beneficiaries. By moving from Fee-For-Service to a Value-Based Care (VBC) framework, ASPIRE incentivizes "whole-person" health for youth up to age 21. For digital health innovators, the model creates a critical demand for interoperable care management, AI-driven risk stratification, and unified care plans that bridge clinical, school, and home environments.
OIG Work Plan Targets Chronic Care Management: What Care Management Companies and Investors Need to Know
The OIG’s 2026 Work Plan includes a major audit of Medicare Chronic Care Management (CCM) services, focusing on eligibility, documentation, and vendor oversight. With rising Part B payments, regulators are targeting compliance risks tied to “multiple chronic conditions” requirements. This article outlines key audit triggers, common red flags, and how care management companies and investors can proactively strengthen compliance ahead of federal scrutiny.
Is the ACCESS Model the Secret to Tech-Driven Care Management Maintenance?
The Centers for Medicare & Medicaid Services ACCESS Model may seem like a reimbursement downgrade from traditional Virtual Care Management—but it could be the missing link in tech-enabled chronic care maintenance. Instead of rewarding episodic, labor-intensive interventions, ACCESS supports continuous, AI-enhanced oversight that keeps stabilized patients engaged and reduces readmission risk. Here’s why this shift could redefine scalability in value-based care.
Women’s Health & FemTech in 2026: 5 Compliance Pillars for Founders
In 2026, compliance is a competitive advantage in women’s health and FemTech. This article breaks down five critical pillars founders must address—from reproductive data privacy and FDA regulation to AI governance, corporate practice of medicine, and intellectual property strategy—to build trust, attract investment, and scale responsibly.
National Privacy Day: A Data Privacy Check-In for Digital Health and Wellness Companies
Is your digital health privacy strategy keeping pace with your technology? On National Privacy Day, we explore why privacy is a core business driver for telehealth, AI, and RPM innovators. From navigating the intersection of HIPAA and state consumer health laws to managing AI data governance and FDA cybersecurity, discover the five critical questions every healthcare leader must answer to ensure compliance, investor confidence, and long-term scalability.
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.
CMS Announces MAHA ELEVATE Model: A New Opportunity to Shape Reimbursement for Lifestyle, Functional, and Whole-Person Care Services
CMS’s new MAHA ELEVATE Model offers $100M in funding to evaluate evidence-based lifestyle, functional, and whole-person care interventions not currently covered by Medicare. Launching in 2026, this initiative creates a pathway for healthcare innovators, digital health companies, and care organizations to influence future Medicare coverage and reimbursement for chronic disease prevention and management.
The 2026 MPFS Final Rule: A Pivot Point for Digital Health in RHCs and FQHCs
The CMS CY 2026 MPFS Final Rule ends simplified G-code billing (G0071, G0512) for safety net providers. FQHCs and RHCs must shift to granular CPT/HCPCS coding for virtual check-ins, Chronic Care Management (CCM), and Behavioral Health Integration (BHI). This structural change is a major product roadmap update for digital health vendors serving the rural and community health market. Learn the 4 key billing changes to maintain revenue for your RHC/FQHC partners.
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.