The multi-agency advice service (MAAS)
Giving innovators and health and care providers a one stop shop for support, information and guidance on the regulation and evaluation of AI technologies
Indra Joshi, Johan Ordish, Felix Greaves, Meindert Boysen, Juliet Tizzard, Sarah Bickerstaffe announce the new multi-agency advice service, MAAS.
The MAAS programme will be, to our knowledge, the world’s first cross-regulatory advisory service for developers and adopters of AI and other data-driven technologies in healthcare.
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 data-driven technologies like artificial intelligence (AI). Transparent and clear arrangements for regulation and access are central to upholding patient safety. They also ensure that health and 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. By collaborating, we can guide those interested in developing or adopting AI technology properly. The NHS AI Lab has funded the creation of the multi agency advisory service (MAAS) to address these challenges.
MAAS is a collaboration between the 4 organisations involved in regulating these technologies and ensuring they deliver value for money:
- The National Institute for Health and Care Excellence (NICE), who produce evidence-based guidance and advice for health, public health and social care practitioners.
- 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), which protects the rights of patients, including by regulating the use of data collected within health and 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.
What the service will do
It will be a single platform for advice and guidance, working for innovators and adopters to help them understand what must be done and when it must be done. The advisory service will clearly delineate ‘must do’ requirements and strongly advise to follow the ‘should do’. It will also clarify jurisdictions to which the advice applies, noting that some requirements may differ across the four nations of the UK.
It is essential that the regulatory system is responsive to new types of technology so that we can ensure safe and value-adding technologies are deployed faster and with minimal effort..
MAAS will enable this by streamlining the regulatory and health technology assessment (HTA) pathway and provide advice all in one place, whilst joining up with other systems of support, such as the NHS Innovation Service and services provided by the partner organisations. In doing so, MAAS also will deliver on the government’s Life Sciences Vision which seeks to create clarity on the authorisation and approvals pathway for digital health technologies.
Our vision is that this robust and newly streamlined regulatory pathway will lead to safer and more effective development and adoption of data-driven technologies, such as AI, which improve the quality of care and the outcomes for those in receipt of that care. By bringing together the four partners to think through the overall regulatory and access pathway, the MAAS will ensure there is a feedback loop to help to test, adjust and improve.
The MAAS partners have conducted the following activities to date:
- User research, conducted with more than 35 users to understand concretely what problems the service should tackle.
- Pathway analysis to identify any gaps, overlaps or areas for improvement in the regulatory landscape and tackle them.
- Engaged an independent evaluation partner to assess and provide feedback throughout the programme in order to maximise the likelihood of successful design and execution.
- Commenced design and iterative testing of different service prototypes with users, known as the alpha research stage, with a digital agency.
The alpha stage of the project, which will be completed by autumn 2021, will result in a plan to build the advisory service platform based on user needs, including refining the name and branding. We expect to go live with the first iteration of the service in summer 2022.
Following the pathway analysis, the MAAS will continue to undertake cross-regulatory policy work on thorniest issues, such as safe and effective deployment in real-world settings, to develop the pathway and ensure that opportunities for streamlining are exploited.
The service, once complete, will provide advice, most likely through an online platform, by creating educational materials, outreach and engagement activities as well as one-to-one support.
In the coming months, we will be publishing a series of updates on the detailed findings from our discovery phase, some top tips from the regulators involved, and a look “behind the scenes” at how we are improving the way we work together.
If you are interested in participating in user research or learning more about the MAAS, please feel free to sign up for further updates by emailing: email@example.com