The U.K.’s Medicines & Healthcare products Regulatory Agency’s ‘sandbox’, AI Airlock, will be used to create simulated environments to address regulatory challenges associated with AI as a Medical Device (AIaMD). In collaboration with the UK National Health Service (NHS), AI Lab and the Department of Health and Social Care, it will initially support 4-6 projects to enhance understanding and ensure safe deployment with the aim to influence future guidelines and improving patient safety while fostering innovation in AI-based healthcare solutions.

The following article originally appeared in Pharmabiz.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has launched AI Airlock, its new regulatory sandbox for AI as a Medical Device (AIaMD).

Last month, the MHRA set out its strategic approach to AI in response to a white paper published in 2023 by Government. This pilot project is a key part of that approach. It will help the Agency to identify and address the challenges for regulating standalone AI medical devices (AIaMD), initially seeking out and supporting 4-6 virtual or real-world projects through simulation. This will allow us to test a range of regulatory issues for these devices when they are used for direct clinical purposes within the NHS.

The regulatory sandbox model is a recognised mechanism to help address novel regulatory challenges across sectors. The AI Airlock is a world-leading version in healthcare, designed to assist in safe development and deployment of AIaMDs, and this project will follow that robust process so manufacturers can deliver what is required to ensure the real-world viability of these devices.

The MHRA’s regulatory AI Airlock takes into account evidence-based work produced by other bodies with a similar focus and we will work collaboratively with the NHS AI Lab and the Department of Health and Social Care (DHSC). AIaMD products are deployed via NHS infrastructure, making the Devolved Nations crucial to regulatory discussions around deployment and post-market surveillance.

The findings from this partnership between government, regulators and industry will inform future AI Airlock projects and influence future UK and international AIaMD guidance, including how we work with UK Approved Bodies on UKCA marking and with trusted regulatory partners on international recognition of medical devices.

Dr Paul Campbell, MHRA Head of Software and AI, said: “We are currently seeing a marked increase in innovative AIaMD products entering the UK market that have the potential to revolutionise the healthcare landscape and provide improved ways to address patient and public needs.

“As a regulator, we must balance appropriate oversight to protect patient safety with the agility needed to respond to the particular challenges presented by these products to ensure we continue to be an enabler for innovation.

“The launch of the AI Airlock will enhance our collective understanding and accelerate solutions to novel regulatory challenges, ultimately improving the experience of patients."

This fact-finding approach is key to safeguarding patients as we learn about the full potential of this technology. Where AI Airlock can enhance the relationship between developers and manufacturers with the MHRA as a regulatory body, in the future, it may also serve to support confidence in patient engagement and the safe use of AIaMD products.

MHRA’s regulatory sandbox is an expanding offering in the healthcare technology space, and investment in innovative solutions is underway to position the NHS as an industry leader by 2030.

Further information about how the sandbox will enable NHS patients to benefit earlier from emerging technologies without implications for safety and post market surveillance is available from the MHRA. Visit the AI Airlock webpage for latest updates on the project.

MHRA’s vision for a developing regulatory framework for AI and software as a medical device, can be found on our guidance page.

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All its work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.

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