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.
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.
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.