Executive summary and action required
This paper is for the Board’s information only to provide an overview of the DigiTrials Recruitment Service Directions 2026 (Directions) issued to NHS England in March 2026 by the Secretary of State for Health and Social Care (SoS). These Directions have been issued under section 254 of the Health and Social Care Act 2012 (2012 Act) and section 13ZC and 272(7) and (8) of the National Health Service Act 2006 (the 2006 Act).
The purpose of the Directions is to enable NHS England to enhance its support for health and life sciences research by moving from a pilot to full service delivery, implementing and operating the NHS DigiTrials Recruitment Service.
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 and/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.
Purpose of the directions
2. Following the success of a four year pilot of the Service under the Pilot NHS DigiTrials Directions, the decision was made to transition this service into business as usual under the new Directions. The purpose of the Directions (the Purpose) is to enable NHS England to enhance its support for health and life sciences research by implementing and operating the Service, which will:
- Aim to enhance the efficiency and effectiveness of clinical trial recruitment across the UK by identifying appropriate cohorts to be invited to take part in research, using data which has already been collected by NHS England;
- Collect, analyse and link data required to support requesting organisations in the use of the Service; and
- Enable the use of data obtained as part of delivering the Service, including through analysis and linkage of data, to support service delivery management, monitoring and improvement.
3. Developed in collaboration with researchers and grounded in strong public and patient engagement, the Service will use patient data to identify potential participants who meet clinical study criterion and will be able to handle the entire recruitment, identifying and proactively contacting eligible individuals through letters, emails, and SMS. The Service compliments existing recruitment methods by offering a streamlined, data-driven approach that reduces the time, effort, and cost associated with participant recruitment.
4. The Service directly supports the ambitions of the government’s 10‑Year Health Plan, which places a national focus on accelerating clinical trials, improving digital access to research opportunities, and enabling faster delivery of cutting‑edge treatments
Effect and requirements of the direction
5. From the 24 March 2026, when the Directions were issued, NHS England has a legal duty to comply with the Directions, which require it:
- to establish and operate such systems for the collection and analysis of information set out in the published Requirements Specification to the Directions; and
- to analyse the information obtained as may be required by the SoS or as NHS England considers necessary to achieve the Purpose of the Directions. Analysis includes:
- analysis by reference or linkage to any other information described in the Requirements Specification;
- analysis for data quality purposes, including undertaking comparison and consistency analysis of the same or similar information obtained by complying with other directions;
- any other analysis as NHS England considers appropriate to maintain data quality, accuracy and consistency in relation to the information.
6. These functions are to be exercised in accordance with the Requirements Specification and 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.
7. From 24 March 2026, under the Directions, the Pilot NHS Digit rials Directions have been revoked.
Approval of acceptance of directions and publication
8. The National Medical Director as Caldicott Guardian and the Director of Privacy and Information Governance approved acceptance of the Directions on behalf of the Accounting Officer as set out in the NHS England Scheme of Delegation.
9. The Directions and the Requirements Specification have been published on the NHS England website, the link to which is in the Annex to this Paper.