On 29 July 2026, the UK’s Medicines and Healthcare products Regulatory Agency (“MHRA”) (the regulatory authority with responsibility for enforcing UK medical device rules) published new guidance on ambient voice technology-enabled products (“AVTs,” also known as ambient scribing tools) (“AVT Guidance”). The AVT Guidance is intended to clarify (and essentially
Continue Reading New UK Guidance Clarifies Medical Device Status of AI ScribesOn August 23, 2021 the UK Government published its report entitled “Harnessing technology for the long-term sustainability of the UK’s healthcare system” (the “Report”). The Report calls for system-wide adoption of technology in the UK health system to enable transformative change that will benefit the health and wellbeing of the UK and promote economic growth. However, the Report cautions that technology alone cannot overcome the inequalities that lead to disparities in health outcomes and that digital tools for health should be accessible to all, or risk exacerbating health inequalities as a result of a “digital divide”. The Report notes how the COVID-19 pandemic has both exposed the limitations of the current system and highlighted the capability of the UK National Health Service (“NHS”) for responding with flexibility and agility. The Report also makes several recommendations to the UK Government, including to set up “Demonstrators” to test the system-wide application of healthcare technologies.
The Report arrives ahead of the expected publication of the UK Government’s review into the use of health data for research and analysis (see our earlier blog here), and outlines the opportunities presented by technology in the context of public healthcare systems.Continue Reading UK Government Publishes Report on Harnessing Technology For Benefit of the UK Healthcare System
On January 6, 2021 the UK’s Department of Health and Social Care (“DHSC”) published “A Guide to Good Practice for Digital and Data-Driven Health Technologies” (the “Guidance”). The Guidance updates the DHSC’s “Code of Conduct for Data-Driven Health and Care Technologies” (the “Code”) (for further information on the Code see our earlier blog, here).
As with the Code, the Guidance is a valuable resource to help parties understand what the National Health Service (“NHS”) looks for when acquiring digital and data-driven technologies for use in health and care.Continue Reading UK’s Department of Health and Social Care Publishes Updated Guidance on Good Practice for Digital and Data-Driven Health Technologies
NHSX recently published “A Buyer’s Checklist for AI in Health and Care” (Guidance) that sets out 10 key questions which will be of use to parties deploying AI solutions or conducting data driven projects (in a health and care setting or otherwise). For example, the Guidance
Continue Reading NHSX Publishes “Buyer’s Checklist” for AI Solutions
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
On February 27, 2020 NHSX, the technology and digital unit of the NHS, published its draft Digital Health Technology Standard (the “Standard”) for consultation to stakeholders in the digital health space (the “Consultation”). The Consultation is open until 22 April, 2020 (and is available here).
The Standard, which is based on existing industry and health standards, is intended to streamline how digital health technologies are reviewed and commissioned by the NHS and social care.Continue Reading NHSX Consults on Draft Digital Health Technology Standard
The Institute of Global Health Innovation at Imperial College London has published a report called “NHS data: Maximising its impact on the health and wealth of the United Kingdom” (the “Report”).[1] The Report begins from the premise that the knowledge gleaned from the combination of patient health data and “big data” technologies has incredible potential for “transformative …impact” on patient health, scientific advancement and the UK’s economy. However, the Report argues that the current efforts of scientists, medical professionals and the UK government to develop the UK’s capacities are not sufficiently coordinated to maximise that potential. To address this, the Report presents a single, high-level, strategic framework for the collection, governance and use of patient health data in the NHS.
Continue Reading New Report Recommends Putting Public Engagement at the Heart of NHS Health Data Strategy
On 17 October, the UK Government’s Department of Health and Social Care (DHSC) published a policy paper entitled “The future of healthcare: our vision for digital, data and technology in health and care” (the Policy Paper). The Policy Paper outlines the DHSC’s vision to use
Continue Reading UK Government publishes new policy paper outlining vision for digitizing health care and becoming a global leader in healthtech
On 5 September, in response to the opportunities presented by data-driven innovations, apps, clinician decision support tools, electronic health care records and advances in technology such as artificial intelligence, the UK Government published a draft “Initial code of conduct for data-driven health and care technology” (Code) for consultation. The Code is designed to be supplementary to the Data Ethics Framework, published by the Department for Digital, Culture, Media and Sport on 30 August, which guides appropriate data use in the public sector. The Code demonstrates a willingness of the UK Government to support data sharing to take advantage of new technologies to improve outcomes for patients and accelerate medical breakthroughs, while balancing key privacy principles enshrined in the GDPR and emerging issues such as the validation and monitoring of algorithm-based technologies. For parties considering data-driven digital health projects, the Code provides a framework to help conceptualise a commercial strategy before engaging with legal teams.
The Code contains:
each of which are listed further below.
While the full text of the Code will be of interest to all those operating in the digital health space, the following points are of particular note:
The Code provides sets out a number of factors consider before engaging with legal teams to help define a commercial strategy for data-driven digital health project. These factors include: considering the scope of the project, term, value, compliance obligations and responsibilities, IP, liability and risk allocation, transparency, management of potential bias in algorithms, the ability of the NHS to add value, and defining the respective roles of the parties (which will require thinking beyond traditional research collaboration models).
Considering how value is created and realised is a key aspect of any data-driven digital health project, the Code identifies a number of potential options: simple royalties, reduced payments for commercial products, equity shares in business, improved datasets – but there is also no simple of single answer. Members of Covington’s digital health group have advised on numerous data-driven collaborations in the healthcare sector. Covington recently advised UK healthcare technology company Sensyne Health plc on pioneering strategic research and data processing agreements with three NHS Trust partners. Financial returns generated by Sensyne Health are shared with its NHS Trust partners via equity ownership in Sensyne Health and a share of royalties (further details are available here).
The UK Government also intends to conduct a formal review of the regulatory framework and assessing the commercial models used in technology partnerships in order to address issues such as bias, transparency, liability and accountability.
The UK Government is currently consulting on the Code (a questionnaire on the Code is available here) and intends to publish a final version of the Code in December.Continue Reading UK Government publishes “Initial code of conduct for data-driven health and care technology” for consultation
On 1 May, 2018 the Centre for Policy Studies (the “CPS”) published its latest paper on the UK’s National Health Service (the “NHS”) entitled “Powerful Patients, Paperless Systems: How New Technology Can Renew The NHS” (the “Paper”). The Paper advocates a “digital first NHS” that adopts a paperless system and enables patients to take full advantage of the continuing digitisation and integration of technology, often referred to as the Fourth Industrial Revolution (“4IR”).
To facilitate this change the Paper outlines three key targets that should be set by the Department of Health and Social Care, to be achieved by 2028: