Background

This Roadmap item builds upon the recent roadmap item RM264 Childhood Immunisation GPIT Uplift and will follow the recently published RM282 Adult Vaccine Expansion Immunisation Uplift and targets the flow of vaccination event data to support Neonatal, Infant and Toddler vaccination.

NHS England and the Vaccination Digital Services (VDS) currently supports the recording and sending of specified vaccination data to Supplier Solutions via a DPS MESH Mailbox, and the receiving of specified vaccination data from Supplier Solutions to either the same DPS MESH Mailbox or the IMMS-API MESH Mailbox.

NHS England and VDS will now also support receiving of specified vaccination data from Supplier Solutions via the Immunisation FHIR API.

The Immunisation FHIR API Solution is a disease type agnostic system that is being extended to support further vaccinations that are provided across health and care settings. The API has been developed to support Suppliers to continue to use their existing Solution and technology to transfer data in a scalable, disease type agnostic manner or integrate directly with the Immunisation FHIR API Solution.

The lawful basis to support the flowing of the vaccination data included in this Roadmap Item will be documented in the relevant NHS England Data Protection Impact Assessment (DPIA) and will be IG assured before data flows begin.

This Roadmap Item will introduce the flow of vaccination event data to support Neonatal, Infant and Toddler vaccinations:

• The sending of vaccination event data from Core Clinical Solution to the Authority via one or more of the following integration mechanisms:

  • Immunisation MESH Mailbox & CSV-Imms V5.1

  • Direct integration with the Immunisation FHIR API

• For Core Clinical Solution to send vaccination event data for the following vaccine types to the Authority:

  • BCG

  • Hep B

  • Hib/MenC

  • MenB

  • Rotavirus

  • 4 in 1

  • 6 in 1

• For Core Clinical Solution to receive and process vaccination event data for the following vaccine types from the Authority:

  • BCG

  • Hep B

  • Hib/MenC

  • MenB

  • Rotavirus

  • 4 in 1

  • 6 in 1

In addition to the changes above which will be represented in the summary of change, NHS England and VDS would like to rationalise the use of SNOMED codes for the following vaccine types:

• Flu

• MMR

• RSV

• HPV

• MenACWY

• 3 in 1

• BCG 

• Hep B

• Hib/MenC

• MenB 

• Rotavirus

• 4 in 1

• 6 in 1

Please see the below attachment.

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The following diagrams illustrate the requested change for this Roadmap Item.

Figure 1: shows the AS-IS vaccination data flows between Core Clinical Solution Suppliers and the Authority following the Adult Vaccination Expansion uplift and the TO-BE vaccination data flows for Neonatal, Infant and Toddler Expansion. Note that the pink arrows indicate the requested change.

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Figure 2: shows the TO-BE vaccination data flows between Core Clinical Solution Suppliers and the Authority, including the integration via MESH and the MESH mailboxes. Note that the pink arrows indicate the requested change.

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Figure 3: shows the TO-BE vaccination data flows between Core Clinical Solution Suppliers and the Authority, including integration via the Immunisation FHIR API. Note that the pink arrows indicate the requested change.

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Outline Plan

Supplier Solutions must be fully compliant with this change by the Effective Date. For NHS assurance, the VDS team expects this to take a minimum of four weeks.

Supplier Solutions must be fully rolled out by 30th April 2026.

Summary of Change

Full Specification

• Vaccination Extract Standard

• Digital Medicines and Pharmacy FHIR Payload Standard

Assurance Approach

Pre-Go-Live Assurance in Test Environment

Neonatal, Infant and Toddler Immunisations data inbound into the Core Clinical Solution from VDS

Assurance by the NHSE Vaccinations Digital Services (VDS) Team will be in line with the already established assurance process which was followed by the Supplier for the previous data flows e.g. RM264 Childhood Immunisation GPIT uplift, a brief summary of the approach as below:

The assurance by the NHSE VDS Team of the ingestion of the Digital Medicines and Pharmacy FHIR Payload messages containing Neonatal, Infant and Toddler data is to ensure that the data (add/replace) is processed correctly by the Core Clinical Solution without any data loss, data corruption and is displayed correctly to the system End Users and also that the Core Clinical Solution can handle the expected volumes of data. The assurance will also ensure the end to end integration including the upload of the data onto Summary Care Record (SCR). The assurance will be done using the VDS team provisioned test scenarios for the identified risks along with supporting test data. The VDS team will have regular engagement sessions with the Core Clinical Solution Suppliers and provide the line of support to facilitate any clarifications, requests etc.

In addition to the above, the Core Clinical Solution Suppliers need to complete a Digital Services for Integrated Care (DSIC) Standards Assurance risk log submission for the end to end risks. This is supported by the required risks mitigation test evidence and self-certification statements (where applicable). These evidence that the Neonatal, Infant and Toddler immunisation data will be available through the national interoperability standards such as IM1, GP Connect, GP2GP for consumption by the relevant recipient / consuming healthcare systems including Patient Facing Services applications as well as being made available in GP Practice migrations through their Practice data migration extracts. Through this risk log, the Core Clinical Solution Supplier would also need to confirm that impact assessment and regression testing has been done to confirm no adverse impact on compliance of any existing Capabilities, Overarching Standards and Non-Overarching Standards.

Neonatal, Infant and Toddler Immunisations data outbound from the Core Clinical Solution to VDS

Assurance will be in line with the assurance done for the previous data flows e.g. RM264 Childhood Immunisation GPIT uplift if using the NHSE Daily Vaccination Events (In-Bound) Extract.

If integrating using the Immunisation FHIR API, technical Assurance for Immunisation FHIR API will be driven through the established Digital Onboarding Service approach. The Immunisation FHIR API will be available to test in the INT path to live test environment to support testing the Immunisation FHIR API endpoints.

Additional clinical assurance will be required to mitigate any clinical risks associated with the implementation and clinical safety assurance process will have to be followed in addition to the above assurance for the clinical safety report and clinical hazard logs as per the DCB0129 standard.

Immunisations data SNOMED Code Rationalisation

The assurance by the NHSE VDS Team of the recommended SNOMED codes to be used going forward, is to ensure that the data (added into the system) is processed correctly by the Core Clinical Solution.

Clinical Safety assurance

Suppliers will be required to submit a Clinical Safety Case Report and Hazard Log which has been signed off by the Supplier’s Clinical Safety Officer (CSO) in accordance with the NHS England Clinical Safety Group (CSG) requirements and in compliance to the Clinical Safety Standard. The NHS England VDS Clinicians and the CSG Assurance Leads will review the evidence provided.

Go-Live Assurance in Production Environment

Smoke Tests will be expected to be done in the production environment for the pre-implementation phase. For the post-implementation phase, validation checks of live data flowing and acknowledgements will be done.