Guidance

Creating the right framework to realise the benefits for patients and the NHS where data underpins innovation

Published 15 July 2019

1. Purpose

The purpose of this document is to provide an update on the development of government policy to:

• establish guiding principles and a framework to help the NHS realise benefits for patients and the public where the NHS shares data with researchers
• establish a National Centre of Expertise to provide specialist advice and guidance to the NHS on agreements for use of data

2. Introduction

Our shared goal, working with partners across the healthcare system and working hand-in-hand with NHS England and NHS Improvement, is to improve outcomes for patients, make the NHS more efficient and cost effective, and contribute to making the UK home to the latest data-driven scientific advances in healthcare.

Our starting point is that the government wants NHS partnerships to flourish within the strictest parameters of transparency and accountability. We recognise that each partnership will be different, and that there is no ‘one-size-fits-all’ solution.

Some datasets may increasingly be made openly available to enable innovators to develop solutions to some of our greatest healthcare and technology challenges, but we also anticipate that NHS organisations will enter increasing numbers of arrangements for better use of data, where it is right that NHS patients benefit directly from the innovations enabled using NHS data.

Better use of data between the NHS and partners has the potential to improve diagnosis, treatment, experience of care, efficiency of the system and overall outcomes for the people at the heart of the NHS, public health and the wider healthcare system.

It must be done so in a way which is safe, ethical, evidenced and transparent. People need to know that data about them is being used to develop and test these healthcare solutions, and that their privacy and rights are safeguarded. For this reason, and to enable partnerships between the NHS and partners to thrive, we have developed 5 guiding principles.

The first draft of these principles was published in December 2018 to test with partners whether they form the right basis for a more detailed national policy framework. Since then, we have undertaken a period of engagement with the NHS, medical research charities, public and patient engagement advocates, healthcare professionals, researchers, regulators and industry experts. This version of the principles reflects that engagement.

In line with the code of conduct for data-driven health and care technology, and the data ethics framework, these revised principles address a number of emerging ethical challenges associated with the use of data in developing and testing data-driven innovations in the NHS.

We therefore expect the principles to reflect ongoing collaboration and alignment between the Centre for Data Ethics and Innovation and the Code of Conduct. As detailed in the ‘Next steps’ section below, we are fully committed to substantive engagement with patients, the public, clinicians and other representatives from across all sectors of the healthcare community and we expect to further update the principles in light of this as part of a detailed policy framework to be published later this year.

3. Guiding principles

Principle 1

Any use of NHS data, including operational data, not available in the public domain must have an explicit aim to improve the health, welfare and/or care of patients in the NHS, or the operation of the NHS. This may include the discovery of new treatments, diagnostics, and other scientific breakthroughs, as well as additional wider benefits.

Where possible, the terms of any arrangements should include quantifiable and explicit benefits for patients which will be realised as part of the arrangement.

Principle 2

NHS data is an important resource and NHS organisations entering into arrangements involving their data, individually or as a consortium, should ensure they agree fair terms for their organisation and for the NHS as a whole. In particular, the boards of NHS organisations should consider themselves ultimately responsible for ensuring that any arrangements entered into by their organisation are fair, including recognising and safeguarding the value of the data that is shared and the resources which are generated as a result of the arrangement.

Principle 3

Any arrangements agreed by NHS organisations should not undermine, inhibit or impact the ability of the NHS, at national level, to maximise the value or use of NHS data. NHS organisations should not enter into exclusive arrangements for raw data held by the NHS, nor include conditions limiting any benefits from being applied at a national level, nor undermine the wider NHS digital architecture, including the free flow of data within health and care, open standards and interoperability.

Principle 4

Any arrangements agreed by NHS organisations should be transparent and clearly communicated in order to support public trust and confidence in the NHS and wider government data policies.

Principle 5

Any arrangements agreed by NHS organisations should fully adhere to all applicable national level legal, regulatory, privacy and security obligations, including in respect of the National Data Guardian’s Data Security Standards, the General Data Protection Regulation (GDPR) and the Common Law Duty of Confidentiality.

4. Scope and application of the principles

Although subject to further development, this refined version of the principles should now be factored into decisions taken by the NHS and partners when entering into data agreements.

NHS organisations should note that agreements should not be entered into which grant one organisation sole (exclusive) right of access to or use of raw NHS data, either patient or operational data. The principles are intended to cover agreements involving data entered into by all NHS organisations, at the primary (GPs), secondary and tertiary care levels, including relevant data from organisations contracted and funded to deliver NHS services.

The principles are designed to apply to agreements which include a commercial partner or where the outputs could be commercialised, regardless of the type of organisation the NHS is partnering with.

5. Centre of expertise

Alongside the draft principles published last year, we also committed to develop the concept of a National Centre of Expertise (the ‘Centre’), which would oversee the policy framework, provide specialist commercial and legal advice to NHS organisations entering data agreements, develop standard contracts and guidance, and ensure that the advantages of scale in the NHS can deliver benefits for patients and the NHS.

The Centre will sit in NHSX and its core functions will include:

• providing hands-on commercial and legal expertise to NHS organisations – for potential agreements involving one or many NHS organisations (eg for cross-trust data agreements or those involving national datasets). This could include providing support to negotiate and execute agreements, and assessing and building capability within NHS organisations where useful. The Centre will develop and provide tailored legal advice on relevant issues (eg intellectual property, state aid).
• providing tools and products including good practise guidance and examples, standard contracts, and methods for assessing the value of different partnership models to the NHS.
• signposting NHS organisations to relevant expert sources of guidance and support on matters of ethics and public engagement, both within the NHS and beyond.
• engagement and understanding the landscape – building relationships and credibility with the research and industry community, regulators, and with NHS organisations and patient organisations, including developing insight into demand for different datasets and identifying and communicating opportunities for agreements that support data-driven research and innovation.
• developing benchmarks and scenarios to provide NHS organisations with reference points on what ‘good’ looks like in agreements involving their data, taking into account demand for data, market conditions and the international context, and setting clear and robust standards on transparency and reporting to underpin and support public trust.

We will explore what additional functions, or nuancing of these functions, would be useful ahead of publishing the full policy framework document later this year.

We will coordinate with other government departments and associated organisations to ensure that the role and scope of the Centre is complementary to their work.

We will begin the process of recruitment for the Head of the Centre and other key personnel over the coming months, to enable the Centre to commence operations as soon as possible this year.

6. Next steps and further commitments

We are committed to ongoing engagement with representatives from across all sectors of the healthcare community. Facilitating meaningful public and patient engagement is critical. In support of our commitment to thoroughly test the framework, Understanding Patient Data (UPD) and NHS England are commissioning an independent programme of deliberative engagement over the coming months.

This deliberative engagement will test the principles and key underlying concepts outlined in this document in detail with patients and members of the public. It will report its findings from this work, which, alongside other engagement activities, will inform the next phase of work in developing the full policy framework.

In addition to the deliberative engagement we will run a further period of engagement with wider stakeholders to test the revised principles. We are keen to hear views on the issues raised in this document and welcome feedback. Views and comments should be sent to feedback@dhsc.gov.uk.

We will ensure that, as this policy framework develops, it aligns with other related government policies, including the code of conduct for data-driven health and care technologies, the data ethics framework, the HMT knowledge assets review and the National Data Strategy.

We plan to publish the next iteration of the principles in a policy framework later this year. The framework will be used as a basis to develop detailed operational guidance for NHS organisations. This will include working with regulators, for example to ensure that trusts’ board governance, oversight and accountability arrangements are calibrated to embed the principles.