Artificial Intelligence Regulatory Framework

AI Regulatory Framework

When considering the use of AI in service provision, it is important to consider the applicability to the problem you are trying to solve. Providers should be able to explain why they are choosing AI and how this will clearly address identified unmet need, as described in A Buyer’s Guide to AI in Health and Care (NHSX) Sep 2020

For further information on AI deployment in the UK, please see the AI Regulatory Framework information below and associated resources.

MHRA 

The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood components for transfusion in the UK. The Medicines and Healthcare products Regulatory Agency (MHRA) is updating regulations applying to software and artificial intelligence (AI) as a medical device.

Below are some of the relevant MHRA resources on AI:

• Managing medical devices: Guidance for healthcare and social services organisations on managing medical devices in practice 
• Medical devices: how to comply with the legal requirements
• Medical device stand-alone software including apps
• Transforming the regulation of software and artificial intelligence as a medical device
• Regulating medical devices in the UK
• Medical devices: conformity assessment and the UKCA mark
• Medical devices: the regulations and how we enforce them

HRA

The Health Research Authority (HRA) protects and promotes the interests of patients and the public in health research. HRA is an executive non-departmental public body, sponsored by the Department of Health and Social Care. The HRA are working to embrace the opportunities which technology creates for the organisation, as well as to consider how they may need to operate in the future so that digital products can be efficiently, ethically assessed and trailed in the NHS.

Please refer to the below for useful links in relation to consent and ethical guidance:

• Informing participants and seeking consent
• Do I need Medical Research Council Research Ethics Committee Review
• The Research Ethics Service have created a Defining Research table to help you decide if your study is researched

ICO

The ICO is the UK’s independent body who promote openness of official information and protection of private information, and their role is to uphold the information rights in the public interest.

Please refer to the link below which clarifies how data is defined by UK GDPR:

• What is personal data?

CQC

The Care Quality Commission (CQC) regulates all health and social care services in England. The commission ensures the quality and safety of care in hospitals, dentists, ambulances, and care homes, and the care given in people’s own homes.

The Care Quality Commission has published the findings of a pilot that looked at the use of machine learning applications in diagnostic services.

• Using Machine Learning in Diagnostic Services – A report with recommendations from CQC’s regulatory sandbox

NICE

The National Institute for Health and Care Excellence (NICE) provides national guidance and advice to improve health and social care. As digital health technologies develop at an increasing pace, NICE have worked with partners to develop standards that ensure new technologies are clinically effective and offer economic value.

• Evidence standards framework for digital health technologies

NHS Digital

NHS Digital uses information and technology to improve health and care. NHS Digital have produced a Data and Technology Standards Framework, which describes their newexpectations around the use of data, interoperability, and design standards within the NHS.

• AI Knowledge Repository