AI adoption in healthcare regulation is accelerating, with the EU AI Act and U.S.–EU collaboration setting new compliance standards. QARA teams must adapt by strengthening education, addressing data bias, and ensuring transparency in AI-enabled devices. Regulators like the MHRA are already exploring AI for reviewing technical submissions, while diversity gaps in datasets highlight risks for underserved populations. SMEs and large corporates differ in uptake—smaller firms use AI to offset regulatory costs, while larger ones embed it globally. Future QARA practice demands clean datasets, standardized algorithms, and patient safety as the guiding priority.

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