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More information11th September 2026
Summary: The National Commission into the Regulation of AI in Healthcare has published recommendations for a future framework designed to enable safe innovation while protecting patients and maintaining public trust. The Commission argues that traditional one-off, pre-market assessment is not sufficient for AI technologies that can evolve and perform differently in real-world settings. Its recommendations centre on three areas: proportionate lifecycle regulation, including risk-based oversight, real-world evidence and regulatory sandboxes; system-wide responsibility, with clearer accountability, governance and AI literacy across healthcare organisations; and greater trust and transparency for patients, professionals and innovators. The report also emphasises health equity, human oversight and continuous monitoring throughout the lifecycle of AI-enabled products. A cross-government response to the recommendations will follow.