Regulating the AI ecosystem - Multi-agency advisory service

Regulating the AI ecosystem - Multi-agency advisory service
NHSX

• The NHSX AI Lab will fund programmes to enable a world leading, safe and ethically robust ecosystem for the development and deployment of AI technologies. 
• One of the first programmes is a Multi-agency advisory service which aims to give innovators and health and care providers developing AI technologies a one stop shop for support, information and guidance on regulation and evaluation. Bodies participating in the project are the National Institute of Health Excellence (NICE), Care Quality Commission (CQC), Medicines and Healthcare Products Regulatory Agency (MHRA) and the Health Research Authority (HRA). 
• Other programmes support streamlining the process for technological review, work to scale the development of synthetic datasets, and post market surveillance.

Health information technology and digital innovation for national learning health and care systems

Health information technology and digital innovation for national learning health and care systems
The Lancet Digital Health June 2021 v3(6) p e383-e396 

• A discussion of the opportunities around the use of digital health technology to support policy and planning, public health, and personalisation of care. Innovations include integrating electronic health records across health and care providers, investing in health data science research, generating real-world data, developing artificial intelligence and robotics, and facilitating public–private partnerships. To address the ethical issues there is a need to develop regulatory frameworks for the development, management, and procurement of artificial intelligence and health information technology systems, create public–private partnerships, and ethically and safely apply artificial intelligence in the National Health Service.

AI and healthcare

AI and healthcare
UK Parliamentary Office of Science and Technology Briefing 18 January 2021

• There are various applications of AI in healthcare, such as helping clinicians to make decisions, monitoring patient health, and automating routine administrative tasks. This POSTnote gives an overview of these uses, and their potential impacts on the cost and quality of healthcare, and on the workforce. It summarises the challenges to wider adoption of AI in healthcare, including those relating to safety, privacy, data-sharing, trust, accountability and health inequalities. It also outlines some of the regulations relevant to AI, and how these may change. As healthcare is a devolved issue, policies on healthcare AI differ across the UK. This POSTnote focusses on regulations and policies relevant to England.

CQC regulation and quality of health and care services

CQC regulation and quality of health and care services, September 2020

• Three pieces of research have been carried out to look into areas where CQC’s regulation has contributed to improving the quality of health and care services, and how it can be improved.
• CQC’s impact on the quality of care
• Rapid literature review on effective regulation: Implications for the Care Quality Commission
• Evaluation of the healthcare services well-led framework

Machine learning AI in medical devices

Machine learning AI in medical devices: Adapting regulatory frameworks and standards to ensure safety and performance [requires basic contact details for access]
BSI, AAMI, 5 May 2020

• This second paper builds on the initial work set out in the first white paper. It examines how AI is different from conventional medical device software, explores the implications of these differences, and discusses the controls that may be necessary to ensure AI in healthcare is safe and effective. The paper also provides some recommendations for evolving standards and guidance for medical AI technologies in the future.

ICO - How we will regulate during coronavirus

How we will regulate during coronavirus

ICO 15 April 2020.

• The ICO has set out the regulatory approach during the coronavirus pandemic. Includes Engagement with the public and organisations, Regulatory Action Policy and FOI.

Artificial Intelligence: How to get it right

Artificial Intelligence: How to get it right
NHSX October 2019

• Subtitled "Putting policy into practice for safe data-driven innovation in health and care", this report gives a considered and cohesive overview of the current state of play of data-driven technologies within the health and care system. It discusses a governance framework (including Code of Conduct for Data-Driven Health and Care Technology in particular Algorithmic Explainability, Evidence for Effectiveness and Commercial Strategy), the regulation journey, Data agreements, adoption and spread and the NHS AI lab.
• Figure 2: Proportion of products likely or very likely to be ready for at scale deployment in 1,3 or 5 years from the UK State of the Nation Report
• Figure 3: Areas of greatest development in AI/data-driven technologies
• Figure 4: Consideration of ethical issues associated with algorithms during the development process
• Figure 6: current regulator journey map for data driven technologies in health and care
• Appendix: Case Studies

Assurance over regulations for digital tools

Letter from Jeremy Hunt (Secretary of State for Health) to Sarah Wollaston (Chair Health Select Committee)
3 July 2018

• A letter regarding concerns raised about Babylon Health app (GP at Hand) provides an outline of the programme of work (led by DHSC and NHS England) to manage the regulatory environment for technological innovations in health and social care. 
• These include
• A code of conduct for more “intelligent” platforms including a range of standards for innovators
• Testing potential scenaros are being tested by cross-government legal teams to assess the current regulatory system and possible risk based “fixes”.
• NHS England has developed a series of Digital Assessment Questions to support the “NHS Approved tick” on the NHS Apps library.
• PHE and NHS England are working with NICE on a method of classifying digital health tools based on an assessment of risk of harm.

The changing nature of regulation in the NHS - a survey

The changing nature of regulation in the NHS
NHS Providers 9 April 2018

• This report is based on responses from 86 NHS trusts on experiences of regulation in 2017/18 and their views on the future of regulation. 
• The survey finds that trusts are concerned that the regulatory framework is not keeping pace with developments taking place on the ground. 
• Trusts highlighted that the oversight of sustainability and transformation partnerships (STPs) and integrated care systems (ICSs) risks becoming an extra layer of performance management. 
• Respondents also questioned whether STPs and ICSs can take on oversight and assurance roles for local systems without a statutory footing.