Editorial | Open Access | Published 7th January 2025
GUEST EDITORIAL: MHRA AI technologies pilot
Author: Malcolm Holmes
PHSS PHSS Honorary member, Regulation SME.
Big Data, Artificial Intelligence (AI), Machine Learning (ML). Part of a new and expanding set of Terms and Acronyms which increasingly are impinging on and affecting our daily lives both at home and at work. The benefits and the risks are far-reaching. The industry is busy working out how best to use these technologies to speed up and enhance their developments, processes and products, with, of course, an ever-present focus on patient safety as well as productivity. How refreshing it is to see our industry regulators embracing and encouraging such change so early in its development, using a patient and quality risk Management-focused approach.
The UK MHRA's pilot Sandbox is one of the first examples of this. The Term makes us think perhaps of the gold miner's separation table or prospecting pan where lots of material (in this case, techniques and ideas) are sifted through to pick out the gold dust.
Summary of AI Use in Healthcare with MHRA’s Involvement
The Medicines and Healthcare products Regulatory Agency (MHRA) has launched the AI Airlock pilot scheme, a forward-thinking initiative aimed at testing and refining regulatory approaches for artificial intelligence (AI)-powered medical devices. This scheme is crucial for ensuring that AI technologies can reach NHS patients safely, efficiently, and effectively while addressing the unique challenges of AI regulation.
Impact on Key Stakeholders:
Patients:
The selected AI devices offer transformative potential in diagnosing and treating critical conditions. For example:
COPD Management: Lenus Stratify® predicts hospital admissions, enabling earlier intervention and improving patient outcomes.
Cancer Care: OncoFlow reduces delays in cancer treatment, enhancing survival rates.
Decision Support: SmartGuideline ensure clinicians access verified, up-to-date guidelines, providing safer, more accurate treatments.
Practitioners:
Tools like Philips' radiology AI streamline workflows by generating accurate and efficient summaries, reducing administrative burdens. Similarly, SmartGuideline enhances decision-making with verified knowledge bases, improving diagnostic accuracy and patient care.
Regulators (MHRA):
The AI Airlock serves as a "sandbox" where developers and regulators collaborate to address the challenges of AI technology, such as adaptive learning ("drift") and evidence generation. This initiative also lays the groundwork for a more adaptable and effective regulatory framework tailored to AI technologies.
Industry:
AI Airlock helps manufacturers navigate the regulatory landscape by testing evidence-collection methods under MHRA supervision. This initiative clarifies market pathways, accelerates approval processes, and supports innovation.
Broader Significance:
The MHRA’s leadership in this domain aligns with the UK's broader goals to transition NHS care from analogue to digital, as outlined in its 10-Year Health Plan. The pilot’s findings will influence future UK AI Medical Device guidance, streamline the approval process, and support the development of AI technologies that align with the NHS’s needs.
This initiative underscores the MHRA’s commitment to fostering safe innovation, bridging gaps in AI regulation, and empowering healthcare transformation through collaboration with the NHS, industry experts, and academia.
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