The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has chosen five groundbreaking technologies for its AI Airlock pilot, aimed at reshaping how AI-powered medical devices are regulated. This initiative is designed to facilitate the swift and safe introduction of these devices to the NHS, benefiting patients who need them.
These innovative devices promise major advancements in patient diagnosis and care, focusing on areas such as cancer treatment, chronic respiratory conditions, and radiology diagnostics.
Before medical products can be provided to patients, they must be proven safe and effective in real-world applications. With AI technologies, this validation becomes challenging since these devices continuously evolve by learning from data.
The AI Airlock serves as a regulatory “sandbox,” offering manufacturers the opportunity to gather evidence supporting their products’ approval while working under MHRA guidance. This exploratory approach aims to strengthen AI regulation, ensuring faster NHS adoption of transformative AI solutions.
Laura Squire, head of MedTech Regulatory Reform at the MHRA, stressed the transformative potential of AI devices in improving healthcare efficiency and outcomes across different NHS settings, emphasizing the need for safe and reliable AI integration.
Karin Smyth, Minister of State for Health, highlighted the project’s importance in transitioning NHS care to digital, aiming to revolutionize diagnostics and allow preventative healthcare interventions.
Science Minister Lord Vallance praised AI Airlock as a model for productive government-business collaboration, paving the way for beneficial technological advancements.
Following a competitive selection process, applicants demonstrated their devices’ potential benefits, innovation, and regulatory challenges, qualifying them to join the Airlock pilot. Being part of this pilot, however, is not equivalent to receiving regulatory approval. The results, expected by 2025, will contribute to UK AI Medical Device guidelines and enhance support for manufacturers.
The initiative echoes Lord Darzi’s call for adaptive regulatory frameworks to support AI advancements, as articulated in his recent report on the NHS’s future. The MHRA’s AI Airlock seeks to address these recommendations as part of an overarching reform of medical device regulations.
Selected technologies include:
1. **AI for COPD Risk Assessment** – Lenus Health’s device predicts COPD outcomes, enabling early intervention and reducing hospital admissions.
2. **AI-Enhanced Radiology Workflow** – Philips uses AI to streamline radiology reporting, improving accuracy and efficiency.
3. **AI Monitoring for Hospitals** – Newton’s Tree developed FAMOS, tracking AI performance to preemptively address issues like data drift.
4. **AI in Cancer Care** – OncoFlow personalizes treatment plans for cancer patients, aiming to decrease appointment delays and improve survival rates.
5. **AI for Clinical Decision-making** – SmartGuideline leverages verified large language models to provide clinicians with up-to-date guidelines.
This project is a collaborative effort led by the MHRA, involving NHS AI Lab, UK Approved Bodies, healthcare experts, government officials, academia, and other regulators, including the Information Commissioner’s Office.
The MHRA, operating under the Department of Health and Social Care, is dedicated to ensuring medical products in the UK are safe and effective, grounded in solid, evidence-based evaluations.