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

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.


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

The UK Government has opened a consultation, running until September 7, 2016, regarding how UK National Health Service (NHS) patient data should be safeguarded, and how it could be used for purposes other than direct care (e.g. scientific research).

The consultation comes after two parallel-track reviews of information governance and data security arrangements in the NHS found a number of shortcomings, described below.  The  Care Quality Commission (CQC) and the National Data Guardian (NDG, led by Dame Fiona Caldicott) made a range of recommendations, including new security standards, stronger inspection and enforcement around security lapses and re-identification of anonymized patient data, and an eight-point process around assuming and respecting patient consent decisions.

Following the public consultation, the new security standards could eventually be required and audited by government inspectors from the CQC, and imposed under revised standard NHS England contract terms.  CQC inspectors could potentially act on tip-offs from NHS Digital (formerly known as the NHS Health and Social Care Information Centre, ‘HSCIC’).  Those tip-offs could be based on low scores obtained by organizations in their annual NHS Information Governance Toolkit (IGT) self-assessments.  The IGT, which the reviewers said should be redesigned, applies both to NHS bodies and their commercial vendors.

The new consent model, meanwhile, could provide more streamlined, system-wide consents for use of patient data for purposes including quality assurance and research.

The CQC and the NDG’s findings and twenty-four recommendations were jointly presented in a covering letter to the UK government, available here, and fuller reports, available here and here (CQC and NDG, respectively).  This post provides a brief summary of their main findings and recommendations.  For the consultation questions themselves, see here.
Continue Reading UK Government Considering New Patient Data Security and Research Consent Standards, Sanctions