ISO/TS 5384:2024

This document specifies an immunization categorial structure and data elements for use as the basis for an immunization registry and in digital health solutions that require interaction with the immunization registry and other systems in the management of immunization information. The data set includes data element descriptions, requirements, considerations for implementation and conformance with the following use cases:
—     populate an immunization registry;
—     record and/or share a current immunization event;
—     record and/or share a historic immunization event;
—     create and/or share an immunization history;
—     create an immunization reminder;
—     create anonymized immunization reports;
—     schedule a new immunization event.
This document has adopted data element names from relevant ISO standards and leverages and elaborates on the immunization data element descriptions and constraints provided in HL7 specifications. The structure of the data element definition provides:
—     business rules and requirements (e.g. rationale for including the data element and how the data element supports the use case);
—     the meaning of absent data and how it can be addressed;
—     how to represent the data if more information is required to clarify data type use and will include value set considerations.
The use case and related data elements out of scope for this document include adverse event following an immunization.