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National Privacy Day: A Data Privacy Check-In for Digital Health and Wellness Companies
Articles Cyndi Baily, Olivia Goldner, and Michael Schellhous Articles Cyndi Baily, Olivia Goldner, and Michael Schellhous

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.

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FDA Advisory Committee Signals New Regulatory Expectations for Generative AI in Digital Mental Health: What Innovators Need to Know Now
Articles Michael Schellhous and Sam Pinson Articles Michael Schellhous and Sam Pinson

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.

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How States Are Enforcing New AI Laws in Healthcare—and Why It Matters
Articles Sam Pinson Articles Sam Pinson

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.

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