Digital Health Stakeholders: Weigh In on CMS 2026 Chronic Disease and Virtual Care RFIs

The 2026 Medicare Physician Fee Schedule (MPFS) Proposed Rule includes several important Requests for Information (RFIs) that could significantly shape the future of digital health, chronic disease prevention, and virtual care. These RFIs offer digital health companies, providers, and other stakeholders a critical opportunity to weigh in on CMS’s thinking around new payment pathways, services, and innovations. We strongly encourage stakeholders to submit comments, and the Nixon Law Group team is here to help.

FDA’s New Playbook for AI in Medical Devices: What Developers Need to Know

AI is reshaping healthcare—but for innovators building AI/ML-enabled software as a medical device (SaMD), staying compliant with FDA regulations is just as critical as building great tech. The FDA’s evolving Total Product Lifecycle (TPLC) approach, new transparency principles, and guidance on Predetermined Change Control Plans (PCCPs) are reshaping the path to market.

Operating at Scale: Legal Considerations for Growth-Stage Health AI Companies

Scaling a healthcare AI company? Learn the top legal strategies for growth-stage digital health companies—from FDA SaMD analysis and HIPAA compliance to state AI laws and AI governance.

Navigating the Future of AI in Healthcare: 3 State Law Trends to Watch

Explore how state laws are shaping the future of AI in healthcare, focusing on transparency, consumer rights, and algorithmic fairness. As regulations evolve, healthcare AI innovators must adapt to ensure compliance and equitable outcomes in a multijurisdictional landscape.

AI in Healthcare 2025: Navigating New Frontiers in Innovation and Regulation

Discover how AI is transforming healthcare in 2025, driving advancements in clinical care and value-based models while navigating a rapidly evolving regulatory landscape.

Trends and Opportunities for Digital Health Innovators in 2025

Discover the top trends and opportunities for digital health innovators in 2025, from AI adoption and value-based care to regulatory shifts and cybersecurity challenges. These insights from Nixon Law Group will help you navigate the year ahead.

Point Solution Fatigue, Meet M&A: How Strategic Transactions Can Transform Digital Health

Explore how strategic mergers and acquisitions (M&A) can reduce or even eliminate point solution fatigue by creating more comprehensive and integrated platforms that will improve patient care and reduce administrative burden.

Colorado’s New AI Law Sets “National Standard” for Healthcare AI: 5 Things Developers and Deployers Need to Know, Now

Last Friday, Colorado’s governor signed into law the Colorado AI Act (“CAIA”). For digital health companies building with artificial intelligence, CAIA sets the first comprehensive national benchmark for minimum rights and protections for users of healthcare AI, effective February 1, 2026.

ATA Nexus 2024: 4 Game-Changing Takeaways for Healthcare Innovators

The ATA Nexus 2024 Conference, one of the largest gatherings of virtual healthcare experts and thought leaders, just took place in Phoenix last week. If you weren’t able to attend…what did you miss?

How do Healthcare AI Developers (and Buyers) Stay Ahead of the Regulatory Curve?

No centralized framework for the regulation of artificial intelligence in the United States currently exists. That said, the flurry of regulatory policymaking and legislation, congressional hearings and inquiries, and industry stakeholder organization around the development and deployment of healthcare AI portends major developments in the coming years. Experienced entrepreneurs and executives know that the ability to peer into the future can pay dividends, and we agree.