National Imaging Registry (NIR) Governance

Governance for the National Imaging Registry is in place to make sure the service is safe, secure, lawful and clinically appropriate to use.

Overview

Governance for the National Imaging Registry (NIR) is in place to make sure the service is safe, secure, lawful and clinically appropriate to use.

NIR does not remove or replace the data controller responsibilities of participating healthcare organisations. Each organisation remains responsible for the patient information it makes available, retrieves, stores or uses through NIR, and for ensuring this is managed in line with its local information governance, data protection and clinical safety arrangements. The NIR data sharing agreement that all NIR users must sign up to clearly sets out roles and responsibilities.

Suppliers or health IT vendors supporting the connection to NIR must continue to meet their responsibilities as data processors, or in any other role agreed through local contracts and governance arrangements. This includes maintaining appropriate security controls, supporting safe integration, protecting patient data, managing incidents appropriately, and ensuring their products and services continue to operate safely and effectively. The NIR connection agreement that all suppliers must sign up to clearly sets out roles and responsibilities.

Therefore, NIR governance operates at two levels:

Governance of the NIR product
NHS England in its system delivery function assures the NIR product through national product governance, including the DCB0129 clinical safety approval process, information governance review, data protection, cyber security, service management and technical assurance.
Governance of organisations and suppliers connecting to NIR
Assurance is sought by NHSE as part of the onboarding governance process for the NIR. Healthcare organisations and suppliers connecting to NIR must have appropriate local governance in place before live access is enabled.

Together, these controls provide assurance that NIR can support the secure sharing of diagnostic imaging information for direct patient care.

Keeping patient data secure

NIR is one of the services established under the Secretary of State’s Digital Interoperability Platform (DIP) Directions 2019. These directions gave NHS England the authority to develop and operate the IT applications, infrastructure and systems required to deliver direct care platforms to enable systems to query and retrieve patient information for agreed direct care purpose.

The legal framework for sharing personal confidential data in health and care includes the NHS Act 2006, the Health and Social Care Act 2012, the Data Protection Act 2018, UK GDPR and the Human Rights Act. The law allows personal data to be shared between those providing direct care and also supports patient rights to confidentiality and opt-out.

NIR does not replace local systems or create a new shared care record. It provides a secure way for authorised systems to access imaging information from participating organisations and their clinical teams, where there is a valid care reason to do so.

These controls help make sure patient imaging and report information is shared safely, appropriately and only with the people who need it to support care.

Clinical safety

NIR follows national NHS clinical safety standards.

The NIR API is assured by NHS England under DCB0129, which applies to the manufacture, design and development of health IT systems. This includes the NIR clinical safety case, hazard management and the controls required for the NIR product.

Suppliers connecting to the NIR must also complete their DCB0129 prior to connection, to ensure their product is clinically safe and meets the standards for a clinical IT system.

Healthcare organisations deploying and using NIR locally are responsible for their DCB0160. This standard applies to the local deployment and use of health IT systems in a care setting. Local organisations must make sure NIR is implemented safely within their own workflows, governance arrangements and operating model.

What NHS England is responsible for

NHS England is responsible for the national clinical safety assurance of the NIR API product. This includes:

maintaining the NIR DCB0129 clinical safety case
managing the national NIR hazard log
identifying and managing product-level clinical risks
providing clinical safety documentation to support local deployment
maintaining service-level controls, including incident and escalation processes
assuring changes to the NIR product through appropriate clinical safety governance

Documentation evidencing this activity is provided below and should be used to assist in completing local clinical safety documentation.

NIR DCB0129 documentation

The NIR Hazard Log sets out the hazards identified for the NIR and provides supporting information for organisations completing their own local hazard management process.

It includes:

DCB0129 hazards identified and managed by NHS England for the NIR product
DCB0160 considerations for participating organisations to review, assess and manage as part of their local deployment and use of NIR

Organisations and suppliers should use this hazard log to support their local clinical safety assessment, update their own hazard log where relevant, and confirm that appropriate controls are in place before using NIR.

The NIR Clinical Safety Case Report provides the clinical safety case for the National Imaging Registry under DCB0129.

It describes how NHS England has assessed and managed clinical safety risks for the NIR product, including the hazards, mitigations and controls identified through the national clinical safety process.

Participating healthcare organisations should use this report to support their local DCB0160 assessment and confirm that NIR is deployed safely within their own clinical workflows.

Suppliers should use the report to understand the clinical safety assurance completed by NHS England for the NIR product and how this may affect their own system, integration and onboarding activity.

The Clinical Risk Management Plan sets out the clinical risk management process for NIR, including how clinical risks are identified, assessed, controlled and communicated throughout the product lifecycle. It also explains how the DCB0129 is applied to support safe development, assurance and ongoing management of the service.

Participating healthcare organisations should use this plan to support their local DCB0160 assurance. This includes reviewing the relevant hazards and controls, and considering how they apply to local workflows.

Suppliers should use this document to understand the national DCB0129 clinical risk management approach for the NIR product, including the identified product-level hazards, controls and safety requirements that may affect their integration.

NIR Hazard Log

xlsx 120 KB

NIR Clinical Safety Case Report

docx 1 MB

NIR DCB0129 Clinical Risk Management Plan

docx 506 KB

NIR DCB0160 Clinical safety templates

NIR Clinical Safety Guidance explains why organisations are required to complete a clinical safety assessment for NIR, how this supports the NIR programme and NHS statutory clinical safety requirements.

The NIR Clinical Safety Case Report template provides a tailored NIR specific template to support clinical safety case reporting for NIR deployment. Healthcare organisations can use this to understand the expected structure and evidence required for local deployment assurance.

NIR Clinical Safety Guidance DCB0160

docx 646 KB

NIR CSCR DCB0160 Template

docx 636 KB

Deployment responsibilities

NHS England provides national clinical safety assurance for the NIR product under DCB0129.

In turn, suppliers and participating healthcare organisations must use this national assurance to support their own NIR deployment activity.

This means suppliers and organisations should review the relevant NIR safety information and consider how it applies to their local organisations and companies.

This includes making sure that:

users are appropriately trained
role-based access control is mapped to local clinical roles
standard operating procedures are in place
local workflows have been validated
business continuity and fallback arrangements are understood
partial, failed or unavailable results are handled safely
metadata and patient identification processes are checked
incidents and clinical safety concerns can be reported and escalated
supplier integrations have been tested and shown to behave safely

Supplier deployment responsibilities

Suppliers connecting to NIR must support safe local deployment by ensuring their integration is correctly configured, tested and clinically assured before go-live.

This includes confirming that patient identification, metadata mapping, image and report retrieval, error handling, access controls and audit logging work as expected.

Suppliers must be able to demonstrate that their connection to NIR is clinically safe and that their product continues to meet expected standards for a clinical IT system under DCB0129.

Suppliers must also support participating organisations with the information they need for local clinical safety, information governance, SOPs, training and go-live readiness.

Core responsibilities include:

interoperability and configuration
degraded modes and fallback behaviour
providing training materials
clinical safety hazards and mitigations
incident and escalation processes
changes that may affect the NIR integration
local clinical safety sign-off by the company’s Clinical Safety Officer

Technical Conformance

Technical Conformance is an important part of safe NIR deployment. It provides assurance that the supplier product and its NIR integration have been tested against the required technical behaviours before use in a live clinical environment.

This assurance supports the supplier’s DCB0129 clinical safety assessment and provides healthcare organisations with evidence to support their local DCB0160 deployment assurance and commissioning of the supplier for integration testing.

If a subsequent product change materially affects the NIR integration or the product’s clinical risk profile, the existing Technical Conformance assurance may no longer remain valid and Technical Conformance may need to be repeated.

Updates to the product after technical conformance

Managing significant product updates is an important part of maintaining safe NIR deployment. Changes to a supplier product can affect how the NIR connection behaves, introduce new clinical risks or alter existing risk controls. Identifying these changes early ensures that suppliers and healthcare organisations can review the relevant DCB0129 and local deployment safety documentation, confirm that existing assurance remains valid, and complete further Technical Conformance where the release or modification is significant, before the updated product is used in live service.

Significant product update guidance

For NIR, a significant product update is a release or modification that could reasonably be expected to affect the product’s NIR connection and/or safety profile and, as a result, requires the supplier to review and update the DCB0129 clinical safety documentation issued to customers.

For the purposes of this guidance:

Release has the meaning defined in DCB0129: a specific configuration of a Health IT System delivered to a Health Organisation by the Manufacturer following the introduction of new or modified functionality.
Modification is not separately defined in the DCB0129 glossary. For the purposes of this guidance, it refers to a change or update to a deployed Health IT System to which the DCB0129 clinical risk management process must be applied. DCB0129 requires that this process is proportionate to the scale and extent of the change and any new clinical risks introduced.

A significant product update affecting the NIR Service may include changes that:

alter the product’s clinical scope or intended use
introduce new or modified functionality
affect existing hazards or risk controls
introduce new clinical risks
otherwise change the clinical risk profile of the product.

Where a release or modification results in an updated Clinical Safety Case Report and associated DCB0129 safety documentation being issued to customers, the updated product version must be treated as a significant change for NIR, and may require Technical Conformance to be completed again.

A change to a product version number, including under a MAJOR.MINOR.PATCH versioning structure, does not on its own constitute a significant change. The trigger for repeating NIR Technical Conformance is whether the release or modification materially affects the product or configuration that previously completed NIR Technical Conformance. Where that change alters the clinical risk profile and requires the supplier to reissue updated DCB0129 safety documentation to customers, Technical Conformance must be completed again.

This reflects DCB0129 requirements that the clinical risk management process is applied to modifications and updates, and that a Clinical Safety Case Report must be issued where a release or modification changes the functionality and/or clinical risk profile of the Health IT System.

For further guidance, contact [email protected]

Trust deployment responsibilities

Participating healthcare organisations using NIR must complete local deployment assurance before the service is used in a live care setting.

Imaging Networks and collaboratives may coordinate IG, clinical safety and deployment assurance activity on behalf of participating organisations where agreed locally. However, responsibility remains with the participating data controllers.

This includes confirming that NIR is safely embedded into local clinical workflows, governance arrangements and operational processes, and that a local DCB0160 clinical safety assessment is in place.

Healthcare organisations remain responsible for how NIR is deployed and used within their clinical environment, including ensuring staff understand when and how to use the service, and what to do if information is incomplete, unavailable or does not match the patient context.

Core responsibilities include establishing:

how NIR is deployed and used locally
local workflows and standard operating procedures
execution of staff training and adoption
role-based access control
operational governance
local incident management
local clinical safety sign-off by the organisation’s Clinical Safety Officer

NIR’s national DCB0129 assurance provides a baseline for the product, but it does not replace the need for local DCB0160 assurance. A DCB0160 template which includes key NIR clinical safety information is provided, and should be further tailored to the healthcare context.

Historic Imaging Data Availability

To support a consistent national approach and maximise the clinical value of the National Imaging Registry (NIR), organisations and suppliers connecting to NIR are expected to make available all eligible imaging studies and associated reports, to further enhance patient care and clinical decision-making. Where this is not technically or operationally feasible, organisations must make all imaging acquired on or after 1 January 2023 available.

Establishing a common national minimal baseline helps ensure a predictable user experience, supports important clinical follow-up pathways, and enables clinicians to access relevant imaging history regardless of where the imaging was originally performed.

Essential deployment documents

The NIR duplicate imaging policy supports local deployment assurance by helping healthcare organisations determine how externally sourced imaging will be handled once retrieved through NIR and used within local systems. Organisations should confirm how this imaging will be identified, presented and managed within local workflows, including ensuring it is distinguishable from locally created studies and is not re-shared to NIR as though it were new. The policy supports safe deployment by reducing the risk of duplicate imaging causing clinical confusion, unnecessary storage growth or onward sharing loops.

The NIR Functional Capabilities can be used with suppliers to develop local test scripts based on the behaviours and limitations relevant to the organisation’s systems and workflows.

The Go/No-Go template provides the final readiness checkpoint before live service, confirming that local assurance, testing and operational arrangements are complete and recording the agreed go-live date.

NIR Duplicate Imaging Policy

pdf 116 KB

Go/No Go go-live template

docx 45 KB

ARTICLE

National Imaging Registry (NIR) Functional Capabilities

An overview of how the National Imaging Registry (NIR) enables clinicians to discover and retrieve imaging‑related records across organisations, now and in the future.

Information governance

NIR’s information governance approach is designed to support lawful, secure and appropriate sharing of diagnostic imaging information for direct patient care.

Further information on NHS England’s approach to information governance is available on the NHS England Information Governance page.

Audit

NIR activity is auditable through PARS, which records when patient imaging information is queried or retrieved, who requested access, and whether the request succeeded or failed allowing authorised teams to monitor appropriate use and investigate access queries.

Data Sharing Arrangement

The Data Sharing Arrangement (DSA) or Agreement, sets out the legal, governance and operational rules for sharing diagnostic imaging information through NIR.

It confirms that NIR may only be used for direct patient care. It must not be used for secondary purposes such as planning, research or other non-direct care activity.

Data security

NIR is designed to support secure access to diagnostic imaging information.

Before connecting to NIR, organisations and suppliers must provide assurance that they meet relevant information governance, cyber security and data protection requirements, including:

Data Security and Protection Toolkit (DSPT) standard of met or exceeded
Local healthcare organisation Data Protection Impact Assessment (DPIA)
Acceptable Use Policy, set out within the Data Sharing Agreement (DSA)
NHS England Supplier Connection Agreement (applicable to suppliers and IT healthcare vendors)

The NIR product-level DPIA is not published externally because it contains information about NIR architecture and security controls which could increase cyber security risk if disclosed.

To support local governance, NIR will provide DPIA template material for onboarding organisations to use as part of their local assessment and approval processes.

Information governance safeguards

The Data sharing agreement

The Data Sharing Arrangement / Agreement (DSA) sets out the legal, governance and operational rules for sharing diagnostic imaging information through NIR.

It applies to participating healthcare providers and consumers and must be agreed before live access is enabled.

The Data Sharing Arrangement confirms:

the purpose of sharing through NIR
the responsibilities of participating organisations
the direct care basis for using the service
the requirement for appropriate information governance controls
the requirement for transparency information and privacy notices
expectations for role-based access control
audit and monitoring requirements
incident and breach management responsibilities
how patient rights are upheld

Providers and Consumers act as independent Data Controllers, and the DSA applies to both public and private healthcare organisations using NIR. The Data Sharing Arrangement document must be signed by a suitably qualified person within the organisation, such as the SIRO, Caldicott Guardian, CIO, CEO or other suitably qualified person.

NHS England connection agreement

The NHS England supplier Connection Agreement sets out the requirements suppliers must meet when connecting to NIR. This includes complying with data protection law, maintaining appropriate security measures, notifying NHS England of any actual or potential security issues, and ensuring their integration does not compromise NHS England systems, services or security.

Suppliers must sign the Connection Agreement once they have successfully completed technical conformance testing. This is required before they can progress to being commissioned by a healthcare organisation for integration testing and a live NIR connection.

appropriate privacy and transparency information for customers
the ability to support role-based access controls
system specific NIR training materials
support audit and monitoring
an acceptable Data Security and Protection Toolkit (DSPT) status
local clinical safety governance

IG documentation

Below you'll find copies of the DSA and links to the Privacy Notice and NIR Onboarding.

Data sharing arrangement (PDF)

pdf 294 KB

Data sharing arrangement (editable word document)

docx 117 KB

ARTICLE

National Imaging Registry (NIR) Privacy Notice

As part of onboarding, you'll need to update your organisation’s privacy notice to explain how patient information is used and shared through NIR to support direct care, aligned to the NIR Privacy Notice.

ARTICLE

Onboarding to the National Imaging Registry (NIR)

The digital onboarding journey for the National Imaging Registry (NIR).

Data security

NIR is designed to support secure access to diagnostic imaging information.

Before connecting to NIR, organisations and suppliers must be able to show that they can meet the relevant security and data protection requirements.

This includes:

maintaining appropriate cyber security controls
protecting access credentials, certificates and connection keys
using secure network configurations
maintaining appropriate access controls
ensuring staff are trained in the handling of patient information
reporting actual or suspected security issues
managing incidents in line with NHS England requirements
maintaining compliance with the DSPT where applicable

Data Security Protection Toolkit (DSPT)

Suppliers and participating healthcare organisations connected NIR must have an in-year acceptable Data Security and Protection Toolkit (DSPT) standard.

The DSPT provides assurance that an organisation has the right cyber security, data protection and information governance controls in place. This includes how the organisation protects systems, manages access, trains staff, handles incidents and keeps patient information secure.

An organisation may not be able to onboard to NIR if it does not meet the required DSPT standard. Continued compliance is also checked after onboarding.

You must have an active ODS Code to be able to complete and be assessed under DSPT.

ARTICLE

DSPT organisation search

You can check your current DSPT status here

ARTICLE

ODS code look-up

You require an ODS code to complete the DSPT. You can look-up your current ODS code here.

ARTICLE

Request an ODS code

If your company or health organisation does not have an ODS code, you can request one here.

Patient Audit Record Service (PARS)

The Patient Audit Record Service (PARS) is a national reporting service that shows how patient data has been accessed using modern FHIR-based audit standards. PARS is a product within NHSE that records audit events for NIR activity. It helps show when patient imaging information has been queried or retrieved, which organisation or system requested access, and whether the request was successful or failed.

Why this matters

PARS supports information governance by helping authorised teams review how patient information has been accessed through NIR. This helps healthcare organisations monitor appropriate use, investigate access queries, and provide assurance that diagnostic imaging information is being accessed safely and for legitimate direct care purposes.

PARS can capture key audit details such as:

the type of activity, such as a query, export or image retrieval

the time the activity took place

the patient identifier, such as NHS number

the requesting organisation, practitioner or system

transaction and endpoint details

relevant imaging or document identifiers

whether the activity succeeded, failed or partially succeeded

For NIR, this means audit events can be recorded for activities such as checking whether imaging information is available, retrieving reports, or retrieving imaging studies.

How to access PARS

Access to PARS reporting is managed through the existing Spine Reporting Service (SRS) interface.

ARTICLE

How to make a Subject Access Request (SAR)

Information on making a subject access request.

Data Protection Impact Assessment (DPIA)

A DPIA helps organisations identify and reduce data protection risks before using or sharing personal data. For NIR, this is important because participating organisations will be using identifiable health and care information, including diagnostic imaging information, to support direct patient care.

NHS England has completed a DPIA for the NIR product and national service. This supports the information governance and data protection assurance for the platform.

The national NIR DPIA cannot be published or shared as it contains sensitive information about the NIR product.

The NIR DPIA describes:

what diagnostic imaging information is being shared
why the sharing is necessary for direct care
who the information may be shared with
the lawful basis for processing
how patients are informed
how access is controlled
how data security risks are managed
how any residual risks are reviewed and approved

To support participating organisations, NHS England provides a template NIR DPIA for local use. This will help organisations complete their own DPIA by setting out the key areas they need to consider.

However, each healthcare organisation remains responsible for completing and approving its own DPIA before connecting to NIR, based on its local systems, suppliers, workflows and governance arrangements.

What the local NIR DPIA should cover

The healthcare organisation completing the DPIA is responsible for understanding how NIR will work with its own supplier system and the local care environment.

This means the DPIA should not only describe the national NIR service. It should also explain how the organisation’s PACS, RIS, imaging viewer, shared care record or other connected system will query, retrieve, display, store or audit information through NIR.

Healthcare organisations should work with their supplier to confirm the local data flow, including:

which systems connect to NIR
what information is queried, retrieved or made available
how user access and role-based controls are managed
how audit logs are captured and accessed
how errors, incomplete results or system outages are handled
what business continuity arrangements apply

The template DPIA will provide a structure and suggested wording, but each organisation must review and adapt it, so it accurately reflects its own supplier system, local workflows, information governance arrangements and deployment model.

Key DPIA sections

Why NIR is being used?
Explain the purpose of using NIR, including how it supports direct patient care, joined-up working, access to imaging information, safer decision-making and reduced delays in care.

What data will be used or shared
Set out the types of data involved. This is likely to include patient identifiers such as name, date of birth, NHS number and imaging-related information. Organisations should also confirm that health information is special category data and explain why identifiable data is needed rather than anonymous data.

Where data will flow
Describe how imaging information and associated reports may be queried, retrieved or made available through NIR. The DPIA should explain the local systems involved, such as PACS, RIS, imaging viewers, repositories or gateways, and how these connect with NIR.

Lawful basis and confidentiality
Confirm the lawful basis for processing under UK GDPR, the special category condition for health and care data, and the common law position for sharing information for direct care. Suggested areas include for public task, health or social care purposes, and implied consent for direct care, but organisations must review and confirm their own position locally.

How data is kept secure
Explain the security controls in place, including encryption, authentication, role-based access control, security policies, business continuity arrangements, audit and local controls within imaging and clinical systems.

Retention and records management
Describe how long data will be kept, where it will be stored, and how it will be managed in line with local clinical record and records management requirements.

Patient rights and transparency
Explain how patients will be informed, including updates to local privacy notices. The DPIA should also describe how subject access requests, rectification requests, objections and other rights will be handled where they apply.

Organisations involved
List the organisations involved, including controllers, processors, sub-processors and any other relevant organisations. This should include the participating healthcare organisation, relevant suppliers and any intermediary or shared care record services involved in the local model.

Risks and mitigations
Identify local data protection risks and the controls that reduce them. This may include risks around unauthorised access, patient awareness, metadata accuracy, patient matching, incomplete results, system availability, audit access, duplicate results and undocumented data flows.

Review and sign-off
Confirm the local review and approval route. This may include the SIRO, Caldicott Guardian, Data Protection Officer, Information Governance Lead, Information Asset Owner, IT lead or other appropriate approvers, depending on local governance.

High-level data flow to discuss with your supplier

This is a high-level guide to help organisations work through their local DPIA with their imaging supplier. At a high level, your data flow would include:

An authorised clinician uses a local clinical system, imaging viewer, PACS, RIS or connected application to search for relevant imaging information.
The local system sends a secure query through the supplier integration to NIR.
NIR helps identify whether imaging information or reports are available from participating organisations.
Where information is available and there is a valid direct care purpose, the requesting system retrieves the relevant imaging information or report from the source organisation.
The clinician views the information in the local system to support care.
Access is logged and audit information is available through local audit arrangements and NHS England audit service, PARS.

Organisations should work with their supplier to confirm the actual local flow, including which systems are involved, where information is temporarily or permanently stored, how access is controlled, how errors are displayed, how audit logs are captured, and how business continuity works if NIR or the local imaging system is unavailable.

Ongoing assurance

Governance does not stop once a healthcare organisation or supplier has connected to NIR.

NHS England may request evidence of continued compliance. Suppliers and organisations must also notify NHS England of relevant changes, incidents, security issues or clinical safety concerns via the National IT Service Desk.

Where requirements are not met, NHS England may require remediation, suspend access, restrict access, prevent onboarding of further organisations, or terminate access where necessary.

This ongoing assurance helps make sure NIR remains safe, secure and appropriate as the service evolves.

Offboarding responsibilities

Healthcare organisations remain responsible for the patient information they make available, retrieve, store or use through NIR.

If an organisation stops using NIR, or if a supplier connection is removed, the organisation must make sure that any offboarding activity is managed safely and in line with local information governance, records management and clinical safety processes.

This includes confirming:

who needs to be notified before access is removed
when NIR access should be disabled
whether any local system changes are required
how audit information will be retained or accessed if needed
how any temporary data is removed or managed
whether local records, ROPA, DPIA, privacy notices or information asset records need to be updated
how business continuity or alternative image-sharing arrangements will work after offboarding

NIR does not remove the organisation’s responsibilities as a Data Controller. Each participating organisation remains responsible for the personal data it holds, makes available or retrieves through NIR, including how that information is used in the local care setting and how it is managed after use.

Suppliers must also meet the offboarding obligations set out in their Connection Agreement. This includes supporting organisations to confirm what happens during offboarding, including access removal, certificate or key management, audit log access, deletion of temporary data, and any changes to local system configuration.

Contact us

For further information about information governance or clinical safety for NIR, contact the NIR Delivery Team at:

[email protected]

Further information

National Imaging Registry (NIR)

The National Imaging Registry (NIR) allows for the sharing of imaging data across clinical organisations.

National Imaging Registry API

Use this API to access patient imaging records across NHS and private healthcare networks. The National Imaging Registry (NIR) API allows authorised systems to view a patient’s imaging history, including examinations, diagnostic reports, and imaging studies.

Last edited: 11 August 2026 12:31 pm