NHS England » Summary of Outcomes and Registries Directions 2024 issued to NHS England by the Secretary of State for Health and Social Care in March 2024

Organisation objective

Governance
Statutory item

Executive summary

This paper provides an overview of the Outcomes and Registries Directions 2024 (Directions) issued to NHS England in March 2024 by the Secretary of State for Health and Social Care. 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 (purpose) is to require NHS England to establish and operate an information system to collect and analyse information for the purposes of improving clinical safety and patient outcomes, reducing variation in clinical practice and to support the NHS and Government response to the recommendations of the Independent Medicines and Medical Devices Safety Review (July 2020) and the Paterson Inquiry report (February 2020).

Information may be collected from relevant health and social care bodies and other organisations, including private healthcare providers in England. The Directions will replace the previous Surgical Devices and Implants Directions 2020, which have been revoked by these Directions.

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 Secretary of State (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 have been 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 NHS England Outcomes and Registries Programme was established in 2022 to develop a single, unified registry solution – the Outcome Registries Platform. The platform consolidates existing implantable device-level registries and implements new outcome registry* data collections to address data and vigilance gaps, enabling the prevention of patient safety issues and adverse outcomes. The programme builds upon an improved model for patient engagement and involvement, and maximises governance, clinical leadership, and specialty-specific data roadmaps to deliver patient-centred change.

*Outcome registries are organised systems that use observational methods to collect routine, uniform data on specified outcomes in a population defined by a particular disease, condition, or exposure.

3. The Outcomes and Registries Programme will collect data and use it for the primary purpose of improving patient safety. Patient identifiable data collected from health care providers will be used where it is necessary to provide direct patient care or to support public functions related to patient safety and the improvement of patient outcomes. These include:

a. access to submitted data for clinical data validation, practice review and appraisal

b. patient-event linkage across settings and providers for continuity of care

c. recall/alert flagging and feedback to providers

d. clinical direct care feedback

e. patient feedback and GP continuity of care.

4. The purpose of the Directions includes setting up new registries and consolidating a range of existing outcome registries, patient reported outcome datasets and audits over time. The Directions therefore operate as framework directions. This means that they establish a broad purpose for which data is to be collected and analysed and provide for separate requirements specifications to be put in place under this Direction over time. The requirements specifications contain the detail of individual collections and registries that NHS England will be directed to collect and analyse. Each of the separate requirements specifications will be published alongside the Directions. There are 2 initial requirements specifications published with the Directions for:

a. The National Major Trauma Registry. This is an established national clinical audit for trauma care previously operated by a University under Regulation 5 of the Health Services (Control of Patient Information ) Regulations 2022, responsibility for which has now been transferred to NHS England under this Direction. The data set supports 218 trauma receiving trusts by providing each trauma unit with case mix adjusted outcome analysis, performance of key process measures and comparisons of trauma care. Trauma is defined as serious injuries that could result in death or a life-changing disability.

b. The Medical Devices and Outcomes Registry. This was an existing NHS England collection under the Surgical Devices and Implants Directions 2020 (now revoked by this Direction), and continues that previous collection. The data collected relates to high risk medical devices and procedures and was established in response to the Independent Medicines and Medical Devices Safety Review: First Do No Harm, also known as the Cumberlege Report (July 2020).

Effect and requirements of the Direction

5. From 14 March 2024, the date of signature of the Directions, 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 as set out in, and in accordance with the accompanying 2 requirements specifications. This includes linkage to other data lawfully held by NHS England as described in the requirements specifications and such other analysis as the Secretary of State may require or as NHS England determines is necessary, to achieve the purpose.

6. These functions are to be exercised in accordance with the requirements specifications. Also in accordance with the service levels, support and monitoring requirements, and the reporting and governance requirements notified by the Secretary of State 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 Secretary of State to NHS England under section 274A of the 2012 Act: NHS England’s protection of patient data, 23 May 2023. This is guidance that NHS England has a duty to have regard to when discharging its functions under these Directions.

Approval of acceptance of Directions and publication

7. The National Director of Transformation (interim) and National Medical Director approved acceptance of the Directions on behalf of the Accounting Officer as set out in the NHS England Scheme of Delegation. The Directions have been published on the NHS England website.

Annex 1

Outcomes and Registries Directions 2024

Publication reference: Public Board paper (BM/24/25(Pu)

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