Creating a new NHS England: Health Education England, NHS Digital and NHS England have merged. Learn more.
The AI and digital regulations service
Formerly known as the multi-agency advisory service (MAAS), this is a cross-regulatory advisory service supporting developers and adopters of AI and digital technologies. The service provides guidance across the regulatory, evaluation and data governance pathways. This will bring benefits to the entire health and social care landscape through safer and more effective use of technology.
"The most informative all-in-one platform, walking developers from idea conception to realisation.”
User feedback on the AI and Digital Regulations Service
A robust, efficient regulatory and access system is key to ensuring that the UK remains a world leader in the development and adoption of safe and effective digital technologies including AI. Transparent and clear arrangements for regulation and access are central to patient safety. They also ensure that health and social care professionals are confident in using these new technologies.
Advances in the field of AI are happening fast. Navigating the regulatory and access pathway can be complex and the landscape is changing rapidly.
The NHS AI Lab has therefore funded the creation of the AI and Digital Regulations Service to guide those interested in developing or adopting AI technologies effectively through this complex landscape.
About the service
The AI and Digital Regulations Service is a multi-agency collaboration between 4 organisations. They are involved in regulating and evaluating health and social care technologies and ensuring they deliver value for money:
- The National Institute for Health and Care Excellence, who evaluate the clinical and cost effectiveness of health technologies and produce evidence-based guidance and advice for health, public health and social care.
- The Medicines and Healthcare products Regulatory Agency, who regulate medicines and medical devices, including software as a medical device.
- The Health Research Authority, who protect the rights of patients, including by regulating the use of data collected within health and social care for research and product development.
- The Care Quality Commission, who monitor, inspect and regulate services to make sure they meet fundamental standards of quality and safety and publish findings.
Progress so far
Following extensive user research, the four partner organisations have launched the section of the website aimed at developers. Access the site to find guidance on understanding regulations of AI and digital technology in health and social care. .
They are currently testing the section of the website aimed at adopters. If you’d like to access the adopter content, please register for user research.
What the service offers
The online service maps out the regulatory and health technology assessment pathway for AI and digital technologies. Service users have described the format as ‘friendly’ and ‘easy-to-use’. This helps developers and adopters understand and navigate the pathway more effectively. The service provides guidance on each stage of the pathway. All content is continually refreshed, keeping it up-to-date and aligned with new developments.
The online service offers advice from the project partners on queries and challenges in the regulatory and evaluation pathway via the website’s contact us form. The site also provides access to existing support services where users can receive more bespoke advice. This includes transactional services, such as NICE Scientific Advice, and free services, such as the NHS Innovation Service.
The AI and Digital Regulations Service directly supports the government’s Life Sciences Vision which seeks to improve clarity on the authorisation and approval pathway for digital health technologies.
If you have an interest in this project and would like to receive updates on its continuous development, please complete our short online form.
If you have any queries, you can email the project team at AI.firstname.lastname@example.org.
You can also join our Future NHS community by becoming a member of the AI Virtual Hub.