Clinical Safety ToolkitStaffordshire Training Hub

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    What's changing

    National changes that affect this toolkit, newest first.

    Date Change What it means for practices
    Jul 2026 MHRA and NHS England publish guidance on when AI scribes count as medical devices Ask suppliers about their product’s device status. Explainer
    Mar 2026 NHS England publishes a template DPIA for AI scribes Use it as the starting point for AI scribe data protection work
    Jan 2026 NHS England lists 19 suppliers on its self-certified AI scribe registry (HTN) Being listed isn’t an approval; you still do your own checks. Explainer
    Nov 2025 National safety investigator finds electronic record systems still contribute to missed and delayed care (HSSIB) Set-up, defaults and training matter as much as the product
    Oct 2025 A national study finds 70% of digital tools in NHS trusts and ICBs have no documented clinical safety assurance (JMIR) Expect more scrutiny of safety paperwork, including from CQC. Why it matters
    Oct 2025 National study finds most NHS digital tools lack evidence of safety compliance (JMIR) Expect more scrutiny of safety paperwork
    Ongoing NHS England is reviewing DCB0129 and DCB0160 The process may change; this toolkit will be updated

    Sources on this page last checked 3 November 2026.