UK healthcare AI reforms leave liability unresolved

The UK government accepted all 44 recommendations from the National Commission into the Regulation of AI in Healthcare on 6 October, backing greater scrutiny after tools are approved. The response leaves unresolved who is legally responsible when medical AI fails, particularly when software updates or changes in patient populations affect performance.

NHS Resolution says negligence claims are more likely to target the NHS organisation providing care than the developer. Clinicians retain a duty of care, while manufacturers may be responsible for faulty products. Courts have yet to establish what reasonable care means when AI is involved. Medical Protection warns that clinicians could become a “liability sink” for failures they cannot control. Hospitals are advised to retain supplier contracts, software-version records and notes showing whether staff followed AI advice.

Medical-device monitoring rules in Great Britain were strengthened in June 2025. The Medicines and Healthcare products Regulatory Agency plans draft guidance by December 2026 on predetermined change control plans, setting boundaries for software updates and requiring developers to manage risks. A 2026 study of four deployed clinical AI systems found performance changed over time even without deliberate updates, highlighting the need for continuing checks.

The government’s implementation roadmap is expected in spring 2027. Stronger monitoring and audit trails may help explain failures, but patients seeking compensation could still face disputes over whether hospitals or software makers should pay.