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Aerial view of three distinct currents flowing side by side without merging, symbolizing separate regulatory tracks that have not yet converged.

The Convergence Gap in AI Life Sciences Regulation

Regulators describe AI, digital health, and clinical trial law as converging, but FDA, UK, and Chinese actions show the frameworks are still moving on separate, misaligned tracks.

A single strand of DNA reflected through a fractured mirror into three diverging paths of light, symbolizing regulatory divergence.

AI Governance's Real Fault Line Is Classification, Not Geography

Divergence in AI rules across the US, EU, and China is driven less by geography than by conflicting definitions of what counts as a regulated AI function.

Illustration of patient health data flowing from a regulated zone into an unregulated open space.

When Health Data Leaves the Regulated Perimeter

FDA's wellness classification determines more than marketing claims. It decides whether patient data uploaded to AI tools carries any regulatory protection at all.