The multi-agency advisory service (MAAS)
Developing a world-first cross regulatory advisory service for developers and adopters of AI and digital technologies. The service will support regulatory alignment across the product life cycle. This will bring benefits to the entire health and social care landscape through safer and more effective use of technology.
The MAAS programme will be, to our knowledge, the world’s first cross-regulatory advisory service for developers and adopters of AI and other digital technologies in health and social care.
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. Regulation provides a clear set of rules around the evidence and safety standards that innovators need to meet when developing technologies like AI.
Advances in the field of AI are happening fast. Currently, navigating the regulatory and access pathway can be complex and the landscape is changing rapidly. With the collaboration of the 4 MAAS partners, we can guide those interested in developing or adopting AI technologies effectively.
The NHS AI Lab has funded the creation of the MAAS to address these challenges.
MAAS is a 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 (NICE), 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 (MHRA), who regulate medicines and medical devices, including software as a medical device.
- The Health Research Authority (HRA), 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 (CQC), who monitor, inspect and regulate services to make sure they meet fundamental standards of quality and safety and publish findings.
Progress so far
The 4 partner organisations developed and tested the pathway for the developer’s informational platform during 2022. They launched an early version of the site in August 2022, which showcased content for developers. Future users are invited to test this service and provide their feedback by signing up to user research.
The partner organisations are now creating an informational platform for adopters. We expect the site to be updated with this content in early 2023.
What the service will do
The online service will map out the regulatory and health technology assessment pathway for AI and digital technologies. This will help developers and adopters understand and navigate the pathway more effectively. The service will provide guidance on each stage of the pathway, keeping it up-to-date and aligned with new developments.
The online service will also provide access to existing support services where users can receive more bespoke advice. This will include transactional services, such as NICE Scientific Advice, and free services, such as the HRA Integrated Research Application System and the NHS Innovation Service. MAAS will directly support the government’s Life Sciences Vision which seeks to improve clarity on the authorisation and approval pathway for digital health technologies.
To create a service that enables the development and widespread adoption of safe, innovative, and value-adding technologies.
These in turn will optimise care and improve outcomes across the system.
The goals for the service are:
- Increased clarity – through cross-regulatory policy development, provide advice that is clear, specific and meaningful to developers and adopters of AI and digital technologies.
- Improved navigation – one access point for advice from relevant regulators across the system which will foster timely access to new and promising technologies.
- Increased compliance – demystify regulatory requirements and clearly signpost to necessary approvals and best practice guidance that highlight system-wide benefits.
- Increased trust – ensure trust in both the service and technologies it regulates. The MAAS will be transparent and regulate in line with ethical, legal and best practice principles. The partners will continually evaluate the service, share our learning and ensure the service is accessible to all who need it.
If you have an interest in this project and would like to participate in its ongoing development, please complete our short online form to register for user research and regular updates.
If you have any queries, you can email the project team at AI.email@example.com.
You can also join our Future NHS community by becoming a member of the AI Virtual Hub.