AI in healthcare isn’t starting from a regulatory vacuum. It’s starting from an environment that already treats digital tools as safety‑critical: medical device rules, clinical trial regulations, GxP controls, HIPAA and GDPR, and payer oversight all assume that failing systems can directly harm patients or distort evidence. That makes healthcare one of the few sectors where AI is being plugged into dense, pre‑existing regulatory schemas rather than waiting for AI‑specific laws to catch up.
