Resources
for You and Your Team
New CMS & FDA Innovation Models: What ACCESS, TEMPO, and MAHA ELEVATE Mean for Digital Health Innovators
CMS and FDA introduced ACCESS, TEMPO, and MAHA ELEVATE, three major innovation models that signal a shift in how federal agencies are thinking about digital health, care management, and reimbursement. In this webinar, Nixon Law Group’s attorneys break down what each model does, what types of entities can participate, and where we see concrete opportunities for digital health companies to engage.
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.
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.
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.
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.
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.
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.
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.