crazyaiml FDA Has No Framework for Agentic Clinical AI. ARPA-H Is About to Create One.
ARPA-H is selecting teams this month to build the first FDA-authorized agentic clinical AI — a system that writes prescriptions, adjusts medications, and acts as a 24/7 cardiovascular care member. FDA has no published guidance for agentic AI validation, no clearance precedent, and no framework that covers autonomous clinical agents.