Five innovative technologies have been selected by the Medicines and Healthcare products Regulatory Agency (MHRA) for the AI airlock, a pilot project scheme better understand how we can regulate medical devices powered by artificial intelligence (AI) in a way that helps get these types of products to the NHS and the patients who need them as quickly and safely as possible.
These new medical devices have the potential to significantly improve diagnosis and patient care. Those selected for the pilot include medical devices intended for patients with cancer and chronic respiratory diseases as well as those requiring radiological diagnostic services.
Before a medical product can reach patients, there must be evidence that it is safe and works when used for its intended purpose outside of a study. New AI technologies make it difficult to produce this evidence for a number of reasons, including the fact that the medical device evolves as it learns.
AI Airlock is a regulatory “sandbox,” a type of study in which manufacturers can explore how best to collect evidence that could then be used to support approval of their product. This is done under the supervision of the MHRA in a virtual or simulated setting. This will help the manufacturer and the MHRA better understand the challenges of regulating AI in medical devices, leading to a more tailored and enabling regulatory framework, a clearer route to market for the industry and, most importantly, paving the way for faster delivery of the NHS and patients. access to potentially transformative AI technologies.
Laura Squire, Head of MedTech Regulatory Reform and Chief Executive of 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 in all health care facilities.
“But we need to be sure that AI-based medical devices introduced into the NHS are safe, that they remain safe, and that they perform as intended throughout their lifespan.
“By reviewing the technologies announced today in a safe environment, in partnership with technology specialists, developers and the NHS, we can test and improve the rules around AI-based medical devices, helping to deliver products like these to hospitals and patients who need them. earlier. »
Karin Smyth, Minister of State for Health (Secondary Care), said:
“As part of our 10-year health plan, we are moving NHS care from analogue to digital and this project will help bring the most promising technology to patients.
“AI has the power to revolutionize care by helping doctors diagnose diseases, automating time-consuming administrative tasks and reducing hospitalizations by predicting future health problems, enabling targeted preventative action. »
Science Minister Lord Vallance said:
“AI Airlock is a great example of government and business working together to turn ideas into products that improve lives. This shows how good regulation can facilitate emerging technologies to the benefit of the UK and our economy.
Following a industry-wide call for applications Earlier this autumn, eligible applicants had to demonstrate that their AI-powered medical device has the potential to bring benefits to patients and therefore the NHS, that it is a new or innovative application and that it it may present a regulatory challenge ripe for testing in the Airlock pilot program.
Being selected for AI Airlock does not constitute regulatory approval. The results of the pilot project, which are expected to be announced in 2025, will inform future AI Airlock projects and influence future UK guidance on AI medical devices. For example, the results are likely to influence the way we work with Approved organizations in the UK on UKCA marking and improve the support framework for manufacturers developing this type of product.
The MHRA’s announcement follows a recent report by Lord Darzi which 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 AI Airlock responds to the Darzi Report’s call for regulatory frameworks to enable the development and implementation of innovative AI-powered medical devices to ensure they are safe and work as intended. This is part of the UK regulator’s overhaul of medical device regulations.
The five technologies selected
Using AI to target at-risk COPD patients
Chronic obstructive pulmonary disease is a lung disease affecting millions of people in the UK, in which the airways become narrow and damaged. This causes breathing difficulties that tend to worsen over time and lead to a high number of unplanned hospitalizations. Lenus Stratify® is a medical device developed by Lenus Health, which uses AI to analyze health data and predict serious consequences of COPD, such as the risk of hospitalization. These predictions could enable multidisciplinary care teams to intervene earlier, adjust treatment plans and significantly reduce multiple hospitalizations 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 radiologists’ workflow by integrating AI into their existing systems. Typically, when radiologists review patient results, they write a summary called an “impression,” which is a section of the radiology report that includes only the information that the radiologist believes is most important to the treating physician. By automatically summarizing this section using AI, Philips aims to make radiology reporting more efficient and accurate: reducing administrative burdens, errors, omissions and miscommunications, ultimately benefiting patients and public health.
Use AI performance monitoring platforms in hospitals
AI learns by analyzing large amounts of data. However, real life is continually changing and no dataset can capture every possible situation. This means that over time, AI performance may decrease. It may decrease because new types of patients are seen, or new medical scanners are used, or because something else in the environment has changed. This is called drift and is a significant barrier to AI security, and therefore adoption. FAMOS (Federated AI Monitoring Service) is part of an AI platform developed by Newton’s Tree, which helps hospitals, AI developers and regulators monitor AI performance in real time. This proactive approach quickly identifies and resolves issues such as drift, avoiding potential risks and ensuring the reliability of AI applications. 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 personalized care plans for cancer patients. This could potentially reduce waiting times for cancer appointments, leading to earlier treatment, which would significantly increase the chances of survival. Initially, OncoFlow will focus on breast cancer patients due to high caseloads and wait times. However, the platform may be adapted to other types of cancer in the future.
Using AI to aid clinician decision-making
Large language models (LLM) 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 response. This can lead to the production of biased or inaccurate information. SmartGuideline is an AI-powered medical device that allows clinicians to intelligently search national guidelines with standard questions. It does this using a verified knowledge base (NICE guidelines) with a specially trained LLM. This helps doctors provide patients with the safest and most reliable treatments 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 from the health sector, government and academia, the Information Commissioner’s Office and other regulators.
Notes to editors
- The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK, ensuring that they work and are sufficiently safe. All of our work relies on sound, fact-based judgments to ensure that the benefits justify any risks.
- The MHRA is an executive agency of the Department of Health and Social Care.
- For media inquiries please contact the Press Center on 020 3080 7651 or newscentre@mhra.gov.uk
