MHRA Pilots Five AI Techs to Revamp Regulations

Five innovative technologies have been selected by the Medicines and Healthcare products Regulatory Agency (MHRA) for the AI Airlock, a pilot scheme to better understand how we can regulate artificial intelligence (AI) powered medical devices in a way that that enables getting these types of products to the NHS and patients who need them as quickly and safely as possible.

These novel medical devices have the potential to significantly improve the diagnosis and care of patients. Those selected for the pilot include medical devices for cancer and chronic respiratory disease patients as well as those requiring radiology diagnostic services

Before any medical product can reach patients, there must be evidence to show that it is safe and that it works when used for its intended purpose outside of a study setting. New AI technology makes it challenging to generate this evidence for a number of reasons, including the fact that the medical device changes as it learns.

AI Airlock is a regulatory "sandbox", a type of study where manufacturers can explore how best to collect evidence that could later be used to support the approval of their product. This is done under MHRA supervision in a virtual or simulated setting. Doing so will help the manufacturer and the MHRA better understand the challenges of regulating AI in medical devices, leading to a more bespoke and enabling regulatory framework, a clearer route to market for industry and, most importantly, paving the way for quicker NHS and patient access to potentially transformative AI technologies.

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."

Karin Smyth, Minister of State for Health (Secondary Care)said:

"As part of our 10 Year Health Plan, we're shifting NHS care from analogue to digital and this project will help bring the most promising technology to patients.

"AI has the power to revolutionise care by supporting doctors to diagnose diseases, automating time-consuming admin tasks and reducing hospital admissions by predicting future ill health allowing targeted, preventative action."

Science Minister, Lord Vallance said:

"AI Airlock is a great example of government working with businesses to enable them to turn ideas into products that improve lives. This shows how good regulation can facilitate emerging technologies for the benefit of the UK and our economy."

Following an industry-wide call for applications earlier this autumn, eligible candidates were required to demonstrate that their AI-powered medical device has the potential to deliver benefits to patients and therefore the NHS, is a novel or innovative application, and can present a regulatory challenge that is ready to be tested in the Airlock pilot programme.

Being selected for AI Airlock does not constitute a regulatory approval. The findings from the pilot, due to be announced in 2025, will inform future AI Airlock projects and influence future UK AI Medical Device guidance. For example, the findings are likely to influence how we work with UK Approved Bodies on UKCA marking and improve the framework of support for manufacturers developing these types of products.

The MHRA's announcement follows a recent report by Lord Darzi that highlights the critical state of the health service in England and the transformational impact that the AI revolution could have on the long-term future of the NHS. The MHRA's AI Airlock addresses the Darzi report's call for regulatory frameworks that enable the development and implementation of innovative AI medical devices to ensure they are safe and perform as intended. It forms part of the UK regulator's overhaul of the medical device regulations.

The five selected technologies

Using AI to target at risk patients with COPD

Chronic Obstructive Pulmonary Disease a lung disease affecting millions of people in the UK, in which airways become narrow and damaged. This causes breathing difficulties that tend to worsen over time and that lead to a high number of unscheduled hospital admissions. Lenus Stratify® is a medical device, developed by Lenus Health, that uses AI to analyse health data and predict serious outcomes from COPD, such as the risk of hospital admission. These predictions could allow multi-disciplinary care teams to intervene earlier, adjust treatment plans and significantly reduce the multiple hospital admissions that are unpleasant for patients and costly for the NHS.

Using Large Language Models to improve the efficiency and accuracy of radiology reporting

Philips aims to improve the workflow for radiologists by integrating AI into their existing systems. Typically, when radiologists review patient results, they write a summary called the "Impression", which is a section of the radiology report that includes only information that the radiologist deems most important for the referring physician. By automatically summarising this section using AI, Philips aims to make radiology reporting more efficient and accurate: reducing administrative loads, errors, omissions, and miscommunications, to ultimately benefit patients and public health.

Using AI performance monitoring platforms in hospitals

AI learns by analysing large amounts of data. However, real life continually changes, and no dataset can capture every possible situation. This means that over time the AI's performance may decline. It may decline because new types of patients are seen, or new medical scanners are used, or something else in the environment has changed. This is called drift and presents a significant barrier to AI safety, and therefore its uptake. FAMOS (Federated AI Monitoring Service) is part of an AI platform developed by Newton's Tree, that helps hospitals, AI developers and regulators monitor AI performance in real time. This proactive approach identifies and allows issues like drift to be resolved early, preventing potential risks and ensuring AI applications remain reliable. For patients, this means safer, more consistent, and higher-quality care powered by AI.

Using AI to improve the efficiency of cancer care

OncoFlow uses AI to help healthcare professionals involved in cancer care create personalised management plans for cancer patients. This has the potential to reduce waiting times for cancer appointments, leading to earlier treatment which in turn significantly increases the chances of survival. Initially, OncoFlow will focus on breast cancer patients due to the high number of cases and waiting times. However, the platform can be adapted for other types of cancer in the future.

Using AI to facilitate clinician decision-making

Large language models (LLMs) are a type of AI designed to generate normal language. However, it is often unclear what data was used to teach the AI and what information the AI used in its answer. This can lead to biased or inaccurate information being produced. SmartGuideline is an AI-powered medical device that allows clinicians to smart-search national guidelines with normal questions. It does this using a verified knowledge base (NICE guidelines) with a specially trained LLM. This helps doctors give patients the safest and most reliable treatments by using the most accurate and up-to-date information

This collaborative project is led by the MHRA, in partnership with the NHS AI Lab and Team AB, the consortium of UK Approved Bodies. Also involved are subject matter experts across the healthcare sector, government and academia, the Information Commissioner's Office and other regulators.

Notes

• The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
• The MHRA is an executive agency of the Department of Health and Social Care.