MHRA launches AI Airlock initiative to address challenges of regulating standalone AI medical devices
The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a pilot project to assess the challenges of regulating standalone artificial intelligence medical devices (AIaMDs).
This “AI Airlock” initiative is part of the MHRA’s strategic approach to AI outlined last month in response to a government white paper.
The project will initially involve 4-6 virtual or real-world AIaMD simulations to test various regulatory issues when these devices are used for direct clinical purposes within the National Health Service (NHS). As Dr Paul Campbell, MHRA Head of Software and AI, noted: “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.”
Regulatory sandbox model
The regulatory sandbox model, utilized across sectors, allows safe testing of novel technologies. The AI Airlock is an advanced healthcare version facilitating the secure development and deployment of AIaMDs.
“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,” Dr Campbell explained.
The MHRA is collaborating with the NHS AI Lab, Department of Health and Social Care, devolved nations, and industry partners. Findings will inform future AI Airlock projects, UK and international AIaMD guidance, work with UK Approved Bodies on UKCA marking, and cooperation with trusted regulators internationally.
Novel regulatory challenges
Dr Campbell said: “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.”
- Visit the AI Airlock webpage for latest updates on the project.
- The MHRA’s vision for a developing regulatory framework for AI and software as a medical device, can be found on their guidance page
