Working together to improve the AI regulation system

Doing AI right means putting a set of rules around it that will make sure it is done safely, in a way that respects patients’ privacy and retains the confidence of citizens and staff.

To address this I convened the CEOs and heads of all the 12 regulators and organisations involved to a round table event last year, which brought together the key players to agree roles and ensure a joined up approach.

It included MHRA, NICE, CQC, the Information Commissioner, the National Data Guardian, the Health Research Authority, the Centre for Data Ethics and Innovation, NHSD, NHSR, the Better Regulation Executive and the MRC.

We need to get this right, so we build the trust of both the public and professions in the use of AI in health and care

This group met again on 28 January 2021, to update on the huge amount of work that has already been done. Serious, collaborative progress is being made in shaping a new regulatory framework for medical devices in the UK:

Information:

The MHRA has been leading work on developing foundational regulations for AI, with support from NHSX and other arms length bodies. The Medicines and Medical Devices Act is a key part of this as it will grant the powers to update the current UK’s regulatory framework for medical devices to ensure that it reflects the needs of new technologies. There is now a once in a generation opportunity to transform the regulation of ‘software as a medical device’, solving many of the internationally recognised problems ahead of other international markets.

NICE is setting up and launching a new Office for Digital Health in March 2021 as part of their 5 year strategy, and working closely with NHSX on how an updated Digital Technology Assessment Criteria might be adopted considering clinical, organisational, or financial risk to health care systems.

NICE is working with the MHRA to set up a comprehensive data and analytics methods and standards programme which will ultimately give professionals and patients confidence that these new technologies are clinically and cost effective.

Together we are starting to plan a multi agency advice service. This will, when fully established, aim to give innovators and health care providers developing AI technologies a one stop shop for support, information and guidance on regulation and evaluation.

The NHS AI Lab will continue to support and fund this work, with regulation as one of its core programmes.

We need to get this right, so we build the trust of both the public and professions in the use of AI in health and care. With that trust and the right regulations and safeguards, we can deploy AI across the NHS with confidence, and create a positive context for innovation.

List of attendees at the meeting on the 28 January

Attendees at the meeting on the 28 January included representatives from MHRA, NICE, CQC, the Information Commissioner, the National Data Guardian, the Health Research Authority, the Centre for Data Ethics and Innovation, NHSD, NHSR, the Better Regulation Executive and the MRC.

From NHSX: Matthew Gould - CEO (Chair); Simon Madden - Director of Policy and Strategy, and Dr Indra Joshi - Director of AI; Naomi Radcliffe - Deputy Director of Tech Policy; Peter Williams - Head of AI Regulations and Policy; Rhod Joyce - Deputy Director of Innovation Development; Sarah Knight - AI Policy; Lauren Harkins - Seniors Partnerships Manager.

Ian Trenholm, CEO CQC; Fiona Watt - CEO, Medical Research Council; Felix Greaves - Director of Science, Evidence and Analytics, NICE and Rebecca Threlfall - Chief of Staff, NICE; Gillian Leng - CEO National Institute for Health and Care Excellence; Dame Fiona Caldicott - National Data Guardian; Gareth James - NHSD Sponsorship Lead; Simon McDougal - Deputy Commissioner Regulatory Innovation and Technology, ICO.; Helen Vernon - CEO, NHS Resolution and Niamh Mckenna - CIO, NHS Resolution; Teresa Allen - CEO HRA; Joanne Bailey - Office of the National Data Guardian.

From MHRA: Graeme Tunbridge - Director of Devices; Johan Ordish - Deputy Director SaMD and June Raine - CEO, MHRA.

From NHS Digital: Jackie Gray - Executive Director of Privacy, Transparency and Ethics and James Hawkins - Director of Assurance and Risk Management.

From DHSC: Sean Mosby - Senior Policy Advisor, MDR,; Alison Stradling - Head of Medical Devices Regulation, Medicines and Pharmacy Directorate.