MHRA announces ‘regulatory sandbox for AI developers’ will officially launch April 2024

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced that it is progressing with a new “regulatory sandbox”, AI-Airlock, a partnership between government, regulators and industry “which will see advanced AI technology used in NHS settings safely ahead of regulatory approval”, in order to allow NHS patients to benefit early from emerging technologies.

AI-Airlock is to open for products in April 2024, with the ‘sandbox’ approach aiming to support safe development and deployment of software along with a collaborative space in which learnings can be shared to promote a wider understanding of challenges and potential solutions.

MHRA specifies that the AI technology will be used with “strict safety controls” and will follow “a robust process, so manufacturers of software and AI medical devices understand and deliver what is required to ensure the real-world visibility of these devices”.

It is hoped that the partnership will support innovators to work within the current regulatory system and identify where more evidence is required for their products to build a safety and efficacy assessment.

MHRA’s head of software and AI, Dr Paul Campbell, comments: “We need to ensure that AI is safe and properly regulated, but in a way that doesn’t stifle innovation and access to the latest of medical technologies to improve patient care.” Noting that the deployment of AI and machine learning enabled med-tech devices is “challenging, given the level of complexity of these products”, he adds: “By moving beyond conventional product concepts and associated regulations, sandboxes like the AI-Airlock offer a unique and safe learning space for manufacturers to work with regulators and other parties to explore new, cutting-edge solutions to help resolve these challenges.

“The new AI-Airlock scheme run by the MHRA will give us answers about how best to provide safe and effective products, such as AI-driven medical devices, to the NHS and patients.”

Earlier in the year, we covered the announcement from UK Research and Innovation (UKRI) that it will be investing £54 million to develop artificial intelligence technologies in the UK, along with investing £7 million to “establish the Innovation and Research Caucus (IRC) as a world leading centre of excellence in research and innovation funding”.

We previously welcomed Dr Hatim Abdulhussein, national clinical lead for AI and digital media workforce at NHS England, for a discussion on how AI can be used to improve equity in healthcare along with the landscape and opportunities within the NHS regarding AI.

HTN’s special report into AI in healthcare explored news and research on the topic; read more here.