The UK Medicines and Healthcare products Regulatory Agency (MHRA) on 30 April 2024 set out its strategic approach to artificial intelligence (AI). In particular, the MHRA welcomed the publication of the UK Government’s white paper ‘A pro-innovation approach to AI regulation’, published in 2023, and has taken significant steps in the past 12 months to adopt its recommendations in the work they do based on five key strategic principles.
These principles encompass safety, security and robustness; appropriate transparency and explainability; fairness, accountability and governance; and contestability and redress.
As part of their AI strategy, the MHRA announced the launch of the AI Airlock project. This regulatory sandbox is designed to tackle the challenges of AI as a Medical Device (AIaMD), ensuring the safe and efficient integration of AI technologies into healthcare.
What is AI Airlock?
AI Airlock is a collaborative initiative that leverages real-world products to address regulatory challenges associated with AIaMD. By uniting MHRA, Approved Bodies, NHS, and other key partners, the project offers innovative solutions to streamline regulatory compliance.
Key Collaborations
• Team AB: Works to standardise the interpretation of medical device regulations.
• The NHS: Partners with the Department of Health and Social Care (DHSC) and the NHS AI Lab to tap into healthcare system expertise, aiding discussions on deployment and post-market surveillance.
Project Goals
AI Airlock aims to identify and address regulatory hurdles, providing product reports and findings to support future funding and assessment. This collaboration offers manufacturers insights and guidance for their regulatory journey.
How to Get Involved
The pilot project will focus on a small number of products, across a range of medical device regulatory issues, with different sections of healthcare or clinical disciplines and levels of product regulatory maturity. Examples of such regulatory challenges could include, amongst others, understanding the safety, validation and design implications of:
• Detecting and reporting product performance errors (including drift) and failure modes in post market surveillance data.
• Increased automation and decision-making responsibilities within clinical workflow and producing pre-market evidence of safety.
• Breaking down the complexities of generative AI based medical devices.
AI Airlock will open for applications after the project webinar on 5 June 2024.
The full announcement can be found here.
For further information please feel free to contact Julia Gillert, Jaspreet Takhar or Elina Angeloudi from our London office.
