UK Government

On April 30, 2024, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) outlined its strategic approach (“Approach”) to artificial intelligence (“AI”).  The Approach is a response to the UK Government’s white paper: a pro-innovation approach to AI regulation and subsequent Secretary of State letter of 1 February 2024, and is the culmination of 12 months’ work by the MHRA to ensure the risks of AI are appropriately balanced with the potential transformative impact of AI in healthcare.

AI in Healthcare

AI has the potential to revolutionize the healthcare sector and improve health outcomes at every stage of healthcare provision – from preventative care through to diagnosis and treatment.  AI can help in research and development by strengthening outcomes of clinical trials, as well as being used to improve the clinical care of patients by personalizing care, improving diagnosis and treatment, enhancing the delivery of care and health system efficiency, and supplementing healthcare professionals’ knowledge, skills and competencies. Continue Reading MHRA Outlines New Strategic Approach to Artificial Intelligence

Last week, Jeremy Hunt, Chancellor of the Exchequer, published his Spring Budget for the UK.  It identified life sciences and digital technologies as “high growth sectors,” which the UK Government wishes to prioritize.  Among other things, the Budget outlined the Government’s plans to simplify medicines and technology approvals, plus changes to the regulation

The UK has reaffirmed its commitment to leading the way in regulatory innovation in software as a medical device (“SaMD”) and artificial intelligence as a medical device (“AIaMD”).  On 17 October 2022, the UK Medicines & Healthcare products Regulatory Agency (“MHRA”) published its Guidance on “Software and AI as a Medical Device Change Programme

On February 9, 2021, the UK Government’s Department for Health and Social Care (“DHSC”) announced a review into the efficient and safe use of health data for research and analysis for the benefit of patients in the health sector (“Review”). The DHSC encourages stakeholder feedback in the context of the Review, and will be of particular interest to organisations that have, or seek to have, access to NHS patient data for research purposes.
Continue Reading UK Government Announces Review Into Use Of Health Data For Research And Analysis

On January 6, 2021, the UK’s AI Council (an independent government advisory body) published its AI Roadmap (“Roadmap”). In addition to calling for a  Public Interest Data Bill to ‘protect against automation and collective harms’, the Roadmap acknowledges the need to counteract public suspicion of AI and makes 16 recommendations, based on three main pillars, to guide the UK Government’s AI strategy.
Continue Reading AI Update: The Future of AI Policy in the UK

On 18 January 2021, the UK Parliamentary Office of Science and Technology (“POST”)* published its AI and Healthcare Research Briefing about the use of artificial intelligence (“AI”) in the UK healthcare system (the “Briefing”).  The Briefing considers the potential impacts of AI on the cost and quality of healthcare, and the challenges posed by the wider adoption of AI, including safety, privacy and health inequalities.

The Briefing summarises the different possible applications of AI in healthcare settings, which raises unique considerations for healthcare providers.  It notes that AI, developed through machine learning algorithms, is not yet widely used within the NHS, but some AI products are at various stages of trial and evaluation.  The areas of healthcare identified by the Briefing as having the potential for AI to be incorporated include (among others): interpretation of medical imaging, planning patients’ treatment, and patient-facing applications such as voice assistants, smartphone apps and wearable devices.Continue Reading AI Update: UK Parliament Research Briefing on AI in the UK Healthcare System

On February 10, 2020, the UK Government’s Committee on Standards in Public Life* (the “Committee”) published its Report on Artificial Intelligence and Public Standards (the “Report”). The Report examines potential opportunities and hurdles in the deployment of AI in the public sector, including how such deployment may implicate the “Seven Principles of Public Life” applicable to holders of public office, also known as the “Nolan Principles” (available here). It also sets out practical recommendations for use of AI in public services, which will be of interest to companies supplying AI technologies to the public sector (including the UK National Health Service (“NHS”)), or offering public services directly to UK citizens on behalf of the UK Government. The Report elaborates on the UK Government’s June 2019 Guide to using AI in the public sector (see our previous blog here).
Continue Reading UK Government’s Advisory Committee Publishes Report on Public Sector Use of AI