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Implementing a Privacy Program that Scales: Essential HIPAA Practices for Digital Health Companies
Articles Carrie Nixon and Olivia Goldner Articles Carrie Nixon and Olivia Goldner

Implementing a Privacy Program that Scales: Essential HIPAA Practices for Digital Health Companies

HIPAA compliance is more than encryption and security controls—it requires a scalable privacy program that matures as your digital health company grows. Learn how Privacy Risk Assessments, BAAs, staff training, and patient-rights workflows create a competitive advantage in today’s health tech landscape.

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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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