The Medicines and Healthcare products Regulatory Agency (MHRA) has announced the selection of five healthcare technologies for its ‘AI Airlock’ scheme.
AI Airlock aims to refine the process of regulating AI-driven medical devices and help fast-track their safe introduction to the UK’s National Health Service (NHS) and patients in need.
The technologies chosen for this scheme include solutions targeting cancer and chronic respiratory diseases, as well as advancements in radiology diagnostics. These AI systems promise to revolutionise the accuracy and efficiency of healthcare, potentially driving better diagnostic tools and patient care.
The AI Airlock, as described by the MHRA, is a “sandbox” environment—an experimental framework designed to help manufacturers determine how best to collect real-world evidence to support the regulatory approval of their devices.
Unlike traditional medical devices, AI models continue to evolve through learning, making the establishment of safety and efficacy evidence more complex. The Airlock enables this exploration within a monitored virtual setting, giving developers insight into the practical challenges of regulation while supporting the NHS’s broader adoption of transformative AI technologies.
Safely enabling AI healthcare innovation
Laura Squire, the lead figure in MedTech regulatory reform 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, stay safe, and perform as intended through their lifetime of use.”
Squire emphasised that the AI Airlock pilot allows collaboration “in partnership with technology specialists, developers and the NHS,” facilitating the exploration of best practices and accelerating safe patient access to innovative solutions.
Government representatives have praised the initiative for its forward-thinking framework.
Karin Smyth, Minister of State for Health, commented: “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.”
Science Minister Lord Vallance lauded the AI Airlock pilot as “a great example of government working with businesses to enable them to turn ideas into products that improve lives.” He added, “This shows how good regulation can facilitate emerging technologies for the benefit of the UK and our economy.”
Selected technologies
The deployment of AI-powered medical devices requires meeting stringent criteria to ensure innovation, patient benefits, and regulatory challenge readiness. The five technologies selected for this inaugural pilot offer vital insights into healthcare’s future:
- Lenus Stratify
Patients with Chronic Obstructive Pulmonary Disease (COPD) are among those who stand to benefit significantly from AI innovation. Lenus Stratify, developed by Lenus Health, analyses patient data to predict severe lung disease outcomes, reducing unscheduled hospital admissions. The system empowers care providers to adopt earlier interventions, affording patients an improved quality of life while alleviating NHS resource strain.
- Philips Radiology Reporting Enhancer
Philips has integrated AI into existing radiology workflows to enhance the efficiency and accuracy of critical radiology reports. This system uses AI to prepare the “Impression” section of reports, summarising essential diagnostic information for healthcare providers. By automating this process, Philips aims to minimise workload struggles, human errors, and miscommunication, creating a more seamless diagnostic experience.
- Federated AI Monitoring Service (FAMOS)
One recurring AI challenge is the concept of “drift,” when changing real-world conditions impair system performance over time. Newton’s Tree has developed FAMOS to monitor AI models in real time, flagging degradation and enabling rapid corrections. Hospitals, regulators, and software developers can use this tool to ensure algorithms remain high-performing, adapting to evolving circumstances while prioritising patient safety.
- OncoFlow Personalised Cancer Management
Targeting the pressing healthcare challenge of reducing waiting times for cancer treatment, OncoFlow speeds up clinical workflows through its intelligent care pathway platform. Initially applied to breast cancer protocols, the system later aims to expand across other oncology domains. With quicker access to tailored therapies, patients gain increased survival rates amidst mounting NHS pressures.
- SmartGuideline
Developed to simplify complex clinical decision-making processes, SmartGuideline uses large-language AI trained on official NICE medical guidelines. This technology allows clinicians to ask routine questions and receive verified, precise answers, eliminating the ambiguity associated with current AI language models. By integrating this tool, patients benefit from more accurate treatments grounded in up-to-date medical knowledge.
Broader implications
The influence of the AI Airlock extends beyond its current applications. The MHRA expects pilot findings, due in 2025, to inform future medical device regulations and create a clearer path for manufacturers developing AI-enabled technologies.
The evidence derived will contribute to shaping post-Brexit UKCA marking processes, helping manufacturers achieve compliance with higher levels of transparency. By improving regulatory frameworks, the UK could position itself as a global hub for med-tech innovation while ensuring faster access to life-saving tools.
The urgency of these developments was underscored earlier this year in Lord Darzi’s review of health and care. The report outlined the “critical state” of the NHS, offering AI interventions as a promising pathway to sustainability. The work on AI Airlock by the MHRA addresses one of the report’s major recommendations for enabling regulatory solutions and “unlocking the AI revolution” for healthcare advancements.
While being selected into the AI Airlock pilot does not indicate regulatory approval, the technologies chosen represent a potential leap forward in applying AI to some of healthcare’s most pressing challenges. The coming years will test the potential of these solutions under regulatory scrutiny.
If successful, the initiative from the MHRA could redefine how pioneering technologies like AI are adopted in healthcare, balancing the need for speed, safety, and efficiency. With the NHS under immense pressure from growing demand, AI’s ability to augment clinicians, predict illnesses, and streamline workflows may well be the game-changer the system urgently needs.
(Photo by National Cancer Institute)
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By AI News, December 4, 2024.
