Expert guidance. Proven pathways for digital health innovation.

Regulatory Strategy for AI-Enabled Devices

Portfolio Strategy & Innovation Roadmapping

Clinical Evidence & Study Design

Clinical Due Diligence & Risk Assessment

Reimbursement, Coding & Coverage Strategy

AI/ML Product Development & Technical Guidance

Explore how FHA supports innovation

Learn More

Explore Recent Articles

2

vecteezy_businessman-holding-global-internet-connection-technology_7252575.jpg

The FHA Vision

We bridge clinical relevance with regulatory rigor, guiding innovation from algorithm to approval. Founded by Dr. Frank and a cross-disciplinary team, FHA unites leaders in regulatory science, clinical research, and AI diagnostics.

Explore