UK’s MHRA Launches AI Airlock to Regulate AI as Medical Device

The AI Airlock will function as a regulatory sandbox, allowing the MHRA to evaluate and address the unique challenges posed by AIaMDs.

The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) has unveiled its latest initiative, the AI Airlock, a regulatory sandbox designed for Artificial Intelligence as a Medical Device (AIaMD).

This strategic move comes in response to a white paper published by the government in 2023 outlining the MHRA's approach to AI.

The AI Airlock serves as a pivotal component of this strategy, aiming to identify and tackle the regulatory challenges associated with standalone AI medical devices.

Last month, the MHRA outlined its strategic approach to AI, aligning with the government's vision for the sector. This pilot project, the AI Airlock, represents a significant step towards implementing this approach.

By facilitating the development and deployment of AIaMDs, the MHRA aims to ensure patient safety while fostering innovation in healthcare.

How Does AI Airlock Work?

The AI Airlock will function as a regulatory sandbox, allowing the MHRA to evaluate and address the unique challenges posed by AIaMDs.

Initially, the project will support 4-6 virtual or real-world projects, providing a platform to simulate the use of these devices in clinical settings within the NHS.

Through this process, the MHRA aims to test various regulatory issues and refine its oversight mechanisms.

The MHRA's regulatory sandbox model is informed by evidence-based research and collaborative partnerships with key stakeholders.

The agency will work closely with the NHS AI Lab and the Department of Health and Social Care (DHSC) to ensure the seamless integration of AIaMDs into healthcare infrastructure.

Additionally, collaboration with Devolved Nations will be instrumental in addressing deployment and post-market surveillance challenges.

Sharing thoughts, 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 has the potential to revolutionize the healthcare landscape and provide improved ways to address patient and public needs.

He added that as regulators, 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," he said.

By facilitating collaboration between developers, manufacturers, and regulatory bodies, the AI Airlock seeks to promote patient engagement and ensure the safe use of AIaMD products.

Expansion of Regulatory Sandbox

The MHRA's regulatory sandbox represents a significant investment in healthcare technology. By providing a platform for innovation, the agency aims to position the NHS as a global leader in healthcare technology by 2030.

The MHRA's overarching goal is to safeguard patients by ensuring that all medicines and medical devices meet stringent safety standards. The agency's work is guided by robust and evidence-based assessments, ensuring that the benefits of these products outweigh any potential risks.