NHS England has warned that it may be unable to lawfully deploy AI features on the NHS App from next year, due to incoming medical device regulation changes.
A new entry on NHSE’s operational risk register, published last week, flags the risk of an “innovation freeze” in which the organisation cannot place new and updated software and AI medical devices into clinical use in a lawful manner from spring 2027.
The freeze could delay key commitments in the 10-Year Health Plan, including plans for AI-led triage on the NHS App – central to the government’s ambition to give every patient a “doctor in your pocket”.
It comes as draft amendments to UK Medical Device Regulations are due to be laid before Parliament, before being implemented in 2027.
NHSE said that, as a developer of its own digital tools, it must meet the new conformity assessment and classification requirements as they come into force.
It confirmed that services currently in use, including in the NHS App, remain compliant under current legislation.
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Source: HSJ, 10 June 2026
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