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On 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 highlights:

  • key data-related considerations, such

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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).
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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 technology across the health and…

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:

  • a set of ten principles for safe and effective digital innovations; and
  • five commitments from Government to ensure the health and care system is ready and able to adopt new technologies at scale,

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 UK Government recognises the “immense promise” that data sharing has for improving the NHS and social care system as well as for developing new treatments and medical breakthroughs;
  • the UK Government is committed to the safe use of data to improve outcomes of patients;
  • the Code intends to provide the basis for the health and care system and suppliers of digital technology to enter into commercial terms in which the benefits of the partnerships between technology companies and health and care providers are shared fairly (see further below); and
  • given the need of artificial intelligence for large datasets to function, two key challenges arise: (i) these datasets must be defined and structured in accordance with interoperable standards, and (ii) from an ethical and legal standpoint, people must be able to trust that data is used appropriately, safely and securely as the benefits of data sharing rely upon public confidence in the appropriate and effective use of data.

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:

  1. Move the NHS to a “digital first” platform and to aim to ensure that all interactions within the health service are digitally driven.
  2. Build an ecosystem of apps and innovation within and around the NHS, to improve patient service and control.
  3. Ensure that the savings made from automation and innovation are put back into frontline services and that budgets for staff R&D and technology training rise in line with overall NHS spending.

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Continue Reading Summary of the CPS Paper on the Integration of Technology in the UK’s National Health Service

On August 30, the UK government published a report by Professor Sir John Bell of Oxford University providing a number of recommendations to government to ensure the long term success of the life sciences sector in the UK (Life Sciences Industry Strategy).  This blog post summarises the key recommendations and observations made from…