Healthcare AI is now a regulated product category — and the data layer hasn't caught up.
The FDA has authorised more than 1,000 AI / ML-enabled medical devices, the EU AI Act has classified clinical AI as high-risk, and frontier model providers are racing to ship medical assistants. Yet most of the data those systems learn from is still labelled by generalist crowd workers grading fluency, not clinical safety. SORAMEDAI exists to be the physician-only layer that fits between a model and a regulator.