Five AI technologies have been selected by the Medicines and Healthcare products Regulatory Agency (MHRA) for its AI Airlock pilot scheme for medical devices.
The scheme is aimed at building understanding on how to regulate AI devices in a way that makes it possible to get them to the NHS and patients as quickly and safely as possible.
It works as a regulatory sandbox in which manufacturers can explore under MHRA supervision how best to collect evidence that could later be used to support the approval of their product.
One of the pilots involves using AI to support patients at risk of chronic obstructive pulmonary disease (COPD). Lenus Health has developed the Lenus Stratify device, which uses AI to analyse health data and predict serious outcomes, helping to alert care teams to intervene earlier and adjust treatment plans.
A second, led by Philips, uses large language models (LLMs) to improve the efficiency and accuracy of radiology reporting. The AI summarises the ‘impression’ section of a radiology report to highlight the information that is most important for the referring physician.
Third is a pilot on the use of AI performance monitoring platforms in hospitals. Newton’s Tree has developed a platform that includes a federated AI monitoring service to identify issues such as drift – in which an AI’s performance declines – making it possible to resolve them early. This is aimed at ensuring that patients receive safer, more consistent and higher quality AI powered care.
Efficient cancer care
The fourth pilot involves the use of OncoFlow AI to improve the efficient of cancer care by helping healthcare professionals to create personalised management plans for patients. It has the potential to reduce the waiting times for appointments and will initially focus on breast cancer patients.
Finally is a scheme using LLMs to support clinical decision making. It involves the SmartGuideline AI powered device, which helps clinicians run smart searches on national guidelines with normal questions and drawing on a verified knowledge base and specially trained LLM.
The MHRA emphasised that being selected for AI Airlock does not constitute regulatory approval and that findings from the pilots will be revealed next year. These are likely to influence how it works with approved bodies in the future.
The scheme is being led by the MHRA in partnership with the NHS AI Lab and Team AB, a consortium of approach bodies, along with subject matter experts, the Information Commissioner’s Office and other regulators.
Increasing accuracy
Laura Squire, medtech regulatory reform lead and chief officer at the MHRA, said: “New AI medical devices have the potential to increase the accuracy of healthcare decisions, save time and improve efficiency, leading to better outcomes for the NHS and patients across all healthcare settings.
“But we need to be confident that AI powered medical devices introduced into the NHS are safe and stay safe, and perform as intended through their lifetime of use.
“By examining the technologies announced today in a safe setting, in partnership with technology specialists, developers and the NHS, we can test and improve the rules for AI powered medical devices, helping get products like these to the hospitals and patients who need them sooner.”
