Resources
for You and Your Team
Legal as a Go-To-Market Strategy for Healthcare AI Companies
In 2026, leading Healthcare AI companies are transforming legal and regulatory strategy into a powerful go-to-market lever. From state-level regulatory sandboxes to evolving FDA Clinical Decision Support (CDS) guidance and CMMI reimbursement models, this post explores how companies can accelerate market entry, generate real-world evidence, and build a durable competitive moat.
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.
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.