CMS rulemaking, FDA pathways, WHO guidance, and the legislation deciding what gets built and paid for.
The new office gives the agency a dedicated home for artificial intelligence, interoperability, and digital health policy across Medicare and Medicaid — a consolidation the industry has requested for years.
The joint FDA-CMS pilot ties regulatory evaluation to real-world outcomes and Medicare coverage — and Dexcom's AI-driven Glucose Health Program is the template case.
The proposed rule adds five telehealth codes, overhauls remote monitoring billing, and floats a 'Software as a Medical Service' category — the most consequential digital health rulemaking of the year.
H.R. 9431 would prohibit healthcare facilities from charging separate facility fees for telehealth — fees that can add up to $1,000 in out-of-pocket costs for a visit that never used a facility.
The discussion paper examines AI's role across all three stages of health policy-making and prescribes impact assessments, living evidence workflows, and human accountability — extending WHO's AI governance beyond the clinic.