Executive summary
This paper is for the Board’s information only to provide an overview of the GPES Data for Consented Research Directions 2026 (Directions) issued to NHS England in February 2026 by the Secretary of State for Health and Social Care (SoS). The Directions have been issued under section 254(1), 260(2)(d), 261(2)(e) and 304(9), (10) and (12) of the Health and Social Care Act 2012[1] (the 2012 Act) and sections 13ZC and 272(7) and (8) of the National Health Service Act 2006 (the 2006 Act).
The purpose of the Directions (Purpose) is to is to enable NHS England to establish a service to enable certain information it already collects from General Practice (GP) health records to be shared with specific research studies approved to access that information (Approved Research Studies). They will only be able to access this data for their participants where either:
a. explicit consent has been provided by or on behalf of the participant to their data being shared with that study for health research; or
b. it is lawful under the Mental Capacity Act 2005 (2005 Act) for the research study to carry out the research on, or in relation to a participant who lacks capacity.
[1] 2012 c.7 (the 2012 Act). Relevant amendments were made by the Health and Social Care Information Centre (Transfer of Functions, Abolition and Transitional Provisions) Regulations 2023 (S.I. 2023/98).
Action required
The Board is asked to note the new Directions and the information provided in this Paper regarding their purpose, effect, and requirements.
Background
1. Under section 254 of the 2012 Act, the SoS may direct NHS England to establish and operate a system for the collection or analysis of information. These are functions exercisable in relation to the development or operation of information systems in connection with the provision of health services or of adult social care in England. Under section 13ZC of the 2006 Act, the SoS may give NHS England directions as to the exercise of any of its functions. The Directions are issued by the SoS to NHS England under these provisions and are functions which were transferred to NHS England from NHS Digital under the Health and Social Care Information Centre (Transfer of Functions, Abolition and Transitional Provisions) Regulations 2023.
Purpose of the Direction
2. The purpose of the Directions is to enable NHS England to establish and operate a new information system to use coded data from GP health records that it has already collected under existing directions [2] for COVID 19 purposes, and which can currently only be shared for COVID-19 research. The new Directions will require NHS England to share the data for wider non-COVID-19 health research, subject to certain conditions being met that are laid out in the new Directions.
[2] Covid-19 Public Health Directions 2020 (as amended)
3. The Directions will enable NHS England to operate a service (the Service) to share this data with specific research studies approved to access their participant data by the Department of Health and Social Care (DHSC) and NHS England (Approved Research Studies), for certain patients where:
a. explicit consent has been provided by or on behalf of the patient to their data being shared with that Approved Research Study for health research; or
b. it is lawful under the 2005 Act for the Approved Research Study to carry out the research on, or in relation to a patient who lacks capacity.
4. For a research study to be approved to access their participant data under these Directions, they are required to meet certain defined and published criteria (Access Criteria) including the criteria set out in the Directions Requirements Specification published with the Directions and other access criteria published by NHS England from time to time on its website. This includes a requirement to only make the data onwardly available to third party researchers through a Secure Data Environment.
5. To be approved, a research study will need to demonstrate to NHS England’s reasonable satisfaction that they also meet the requirement to hold explicit consent or lawful authority for participants under the 2005 Act. To support this, NHS England will carry out an audit of consenting processes and will review and assure the participant consents and consent materials used by a research study, supported with advice from its Advisory Group for Data. Approved Research Studies will be approved by DHSC and NHS England in line with the process set out in the Directions Requirements Specification and details of Approved Research Studies will be published by NHS England on its website.
6. There are three research studies who are in the process of seeking approval to become Approved Research Studies and access data through the new Service: UK Biobank (UKBB), Our Future Health (OFH) and Genomics England Limited (GEL). In 2025, NHS England undertook audits of their consenting processes, which it considered were satisfactory, and the Advisory Group for Data reviewed their consents and consent materials and concluded they were appropriate. A group called the Consent Review Assurance Group comprising of the National Data Guardian and representatives from the Confidentiality Advisory Group, the Health Research Authority, the British Medical Association and the Royal College of General Practitioners was also set up in 2025 to review the outcomes from the audits and the consent reviews, and were also satisfied with the arrangements and the assurance that had been undertaken by NHS England.
7. Before any data is shared by NHS England, the three research studies will need to complete their work to meet the NHS England and DHSC Access Criteria. Once approved, each Approved Research Study will need to enter into a legally binding Data Sharing Agreement (DSA) with NHS England and meet certain conditions. Details about the data shared under the DSAs will be published in the NHS England Data Use Register on its website: Data Uses Registers – NHS England Digital
Effect and Requirements of the Direction
8. From 10 February 2026, NHS England has a legal duty to comply with the Directions, which will require it to establish and operate such systems for the collection and analysis of information as are necessary to meet the above Purpose of the Directions.
9. These functions are to be exercised in accordance with the Requirements Specification attached to the Directions (as they may be updated from time to time). Also in accordance with the service levels, support and monitoring requirements, and the reporting and governance requirements notified by the SoS in writing to NHS England. The exercise by NHS England of the functions set out in the Directions is also subject to the statutory guidance issued by the SoS to NHS England under section 274A of the 2012 Act: NHS England’s protection of patient data, 23 May 2023 which is guidance that NHS England has a duty to have regard to when discharging its functions under these Directions.
10. A new Data Provision Notice (DPN) was issued to GP Practices on 11 February 2026 to require them under section 259 of the 2012 Act to provide NHS England with the data which is already collected for COVID-19 purposes, for this new purpose. No new data collection is however required so GP Practices will not be required to take any action in response to the DPN. The effect of the Directions will be to avoid burden on GP Practices who would otherwise need to respond to individual requests from Approved Research Studies to share data with them.
11. Providing the GP data already held by NHS England about participants in these studies will increase the benefits that they, and the researchers accessing the data through them, can deliver for health and social care. The GP record is the only place where some diagnoses or risk factors are recorded. In other cases, it can complement other sources of healthcare data to give a more complete picture and avoid biases in research.
Publication
12. NHS England is directed not to publish any data obtained by virtue of these Directions.
Approval of acceptance of Directions and publication
13. The interim National Director of Clinical Transformation and the National Medical Director approved acceptance of the Directions on behalf of the Accounting Officer as set out in the NHS England Scheme of Delegation in 2025. The Directions have now been issued and are published on the NHS England Digital website: GPES Data for Consented Research Directions 2026 – NHS England Digital