NHS Classifies AI Clinical Tools as Medical Devices, Spurs Debate
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Contributed by: Bill Russell
Summary
The NHS has classified AI tools for clinical summarization as Class 1 medical devices, requiring self-declaration, which shifts liability for non-compliance to the deploying organizations or individuals. This regulatory change is viewed as a major development that could impede innovation in European healthcare, particularly impacting those rapidly adopting tools like ChatGPT in clinical settings. While the NHS is promoting compliant systems through a national RFP rather than outright banning AI scribes, the move has sparked debate over the balance between regulation and innovation, with concerns about hindering development versus the necessity of ensuring patient safety. This classification may also prompt similar regulatory actions in other regions, including the EU and the US.
