The UK today (24th June) became the first country in the world to join a new global network of health regulators focusing on the safe and effective use of artificial intelligence (AI) in healthcare.
The move places the Medicine and Healthcare Products Regulatory Agency (MHRA) at the heart of a global effort to securely and quickly obtain AI tools from clinics.
By participating as a “pioneer” nation founded in the Healthai Global Regulatory Network, MHRA will work with regulators around the world to share early safety warnings, monitor the actual performance of AI tools, and form international standards together. Other countries are expected to participate in the coming months.
MHRA utilizes key work from home to help shape the network from scratch. This includes AI Airlock, a global leading example of AI medical device regulatory sandboxes. This allows businesses to test new tools with regulators before wider NHS rollouts. Early examples include AI models that help GPS find lung condition faster, and AI that supports more personalized cancer care.
MHRA has updated its guidance, launched reforms to medical device safety regulations, and continues to adapt to rapidly developing fields such as adaptive and generator AI. The MHRA is also working with researchers, the National Institutes of Health (NICE), and the NHS to strengthen real-world evidence on how these tools actually work.
The signing ceremony to mark UK membership took place today in Westminster with Minister of Science, Minister of Balance, MHRA CEO Lawrence Talon, and Healthy CEO Dr. Ricardo Baptista Leitt.
Wes Streeting, a health and social care secretary, said:
“We are pleased to see the UK being invited to pioneer Healthai's global regulatory network.
“This perception underscores our commitment to being at the forefront of responsible AI innovation in healthcare. As we implement our 10-year health plan, cutting-edge technology is critical to transforming patient care and NHS efficiency.
“Working with international partners through this network will leverage the incredible possibilities of AI while maintaining the highest standards of safety and ethics.”
Science and Technology Secretary Peter Kyle said:
“The UK is leading the way in ensuring that AI delivers real benefits, from better care for patients to new opportunities for growth.”
“By forming global standards and breaking down unnecessary regulatory barriers at home, we are helping innovators get reliable tools quickly to the NHS, improving patient care while increasing the economy to help plan for change.”
Lawrence Talon, CEO of MHRA, said:
“AI has a huge promise to speed up diagnosis, reduce NHS wait times and save lives. But only if people can trust it to work and be safe. That's why we are proud to shape the way this powerful technology is used safely here and around the world. That's what we're proud to say.”
Healthai CEO Dr. Ricardo Baptista Leite – Health's global body of responsible AI said:
“We are proud of this groundbreaking collaboration with the UK government and MHRA. The UK has long been a pioneer at the intersection of artificial intelligence and health. As the first of the 10 pioneers of a healthy global regulatory network, we are honored to welcome you to provide regulations and schedules to promote global collaboration and shared learning. Our impartial, AI-powered health systems that promote peers, global advancements, ultimately contribute to improving quality of life and the well-being of all.”
Notes for the editor
- The Healthai Global Regulatory Network is a new international platform that brings together health regulators to enhance AI surveillance in healthcare. It aims to build trust, improve safety and accelerate responsible innovation through shared learning, collaborative standards and early warning of emerging risks. Members also have access to the global directory of registered AI health tools to support transparency and collaboration.
Ten “pioneering countries” from diverse regions have been invited from the start to form a global regulatory network. Each will work with HealthAI to develop a stronger regulatory framework, support local innovation, and ensure that AI technology meets the high standards of safety, effectiveness and equity.
For more information about Healthai, please visit the www.healthai.agency website. - AI Airlock is the world's first regulated sandbox for AI medical devices led by MHRA. Applications for the second round of the program are open from June 23rd to July 14th, 2025. The pilot phase supported four groundbreaking technologies and tested performance in real-world settings under regulatory oversight. For more information, see AI Airlock:Aiamd -gov.uk's Regulation Sandbox.
- Software and Artificial Intelligence (AI) as Medical Devices – Gov.uk
- MHRA Real World Evidence Scientific Dialogue Program – gov.uk
- The Medicines and Healthcare Products Regulation Authority (MHRA) is responsible for adjusting all UK medicines and medical devices by ensuring that all UK medicines and medical devices are functional and acceptable safe. All of our work is supported by robust and factual judgments to ensure that profits justify risk.
- The MHRA is the executive body of the Ministry of Health and Social Care.
- For media inquiries, please contact newscentre@mhra.gov.uk or call 020 3080 7651.
