ISO/TS 5384:2024
(Main)Health informatics — Categorial structure and data elements for the identification and exchange of immunization data
Health informatics — Categorial structure and data elements for the identification and exchange of immunization data
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.
Informatique de santé — Structure catégorielle et éléments de données pour l'identification et l'échange des données d'immunisation
General Information
Standards Content (Sample)
Technical
Specification
ISO/TS 5384
First edition
Health informatics — Categorial
2024-09
structure and data elements for
the identification and exchange of
immunization data
Informatique de santé — Structure catégorielle et éléments
de données pour l'identification et l'échange des données
d'immunisation
Reference number
© ISO 2024
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ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
3.1 General terms .2
3.2 Terms related to subject of care data elements .3
3.3 Terms related to immunization event data elements .3
3.4 Terms related to the location, organization and provider data elements .5
3.5 Terms related to the immunization forecast data elements .6
4 Use cases . 7
5 Definition of the immunization data elements . 7
5.1 General .7
5.2 Data elements .8
5.2.1 Subject of care data elements.8
5.2.2 Immunization event data elements .8
5.2.3 Location, organization and provider data elements . .16
5.2.4 Immunization forecast data elements .17
6 Data elements by use case .18
Bibliography .22
iii
Foreword
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This document was prepared by Technical Committee ISO/TC 125, Health informatics.
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iv
Introduction
Public health stakeholders working with immunization information do not have a structured view of their
data that is aligned with technical stakeholders who are very familiar with Health Level Seven (HL7) and
other message standards. This document can enable effective and efficient interaction between public health
and technical stakeholders in the planning of digital health solutions with immunization data by enabling a
common understanding of the data elements required and how they can be used.
The data represented in interoperability standards such as HL7 Fast Healthcare Interoperability Resources
(FHIR) does not cover all frequently encountered immunization management use cases. This includes the
data elements required for an immunization registry and the level of data element definition detail to enable
consistent understanding and application. There is a business need for alignment across various other
existing standards such as International Patient Summary and Identification of Medicinal Products (IDMP).
There is also a need to align with emerging standards regarding the document and sharing of sex and gender
and the considerable amount of effort across all standards development organizations and the World Health
Organization in developing data standards to address the COVID-19 pandemic challenges.
The purpose of this document is to address the challenges with sharing health care information with
incompatible data structures and improve interactions and understanding of the data between technical
and business stakeholders. By defining a set of data elements to be used within an immunization registry
and other systems, recording and sharing immunization data with specific use cases implementation effort
will be enhanced.
This document can be used to harmonize the data used in interoperability standards such as Integrating the
Health Care Enterprise (IHE), HL7 FHIR and Clinical Knowledge Management Structures and other related
initiatives (such as the WHO COVID-19 vaccine certificate) by providing detailed descriptions of the data
elements and considerations for how to apply the data elements within digital health solutions including
consumer apps.
This document can also aid low and middle-income countries in the development of an immunization
registry by providing the core structures and data needed to record and monitor a population.
This document is particularly suitable for business and technical resources planning immunization digital
health solutions and immunization registries.
This document can be helpful to a broad range of stakeholders such as:
— public health immunization and communicable disease stakeholders;
— government including public health agencies responsible for public health, emergency preparedness and
response, and infectious disease control and prevention;
— software developers;
— vendors providing electronic medical record, pharmacy, immunization registry systems, knowledge
base vendors and consumer app providers;
— educators and educational organizations to educate the health informatics and healthcare communities
on the requirements for immunization terminology implementation;
— clinicians working with immunization data.
v
Technical Specification ISO/TS 5384:2024(en)
Health informatics — Categorial structure and data elements
for the identification and exchange of immunization data
1 Scope
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.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1 General terms
3.1.1
data element
basic unit of identifiable and definable data
[SOURCE: ISO 2146:2010, 3.4]
3.1.2
immunization registry
confidential, population-based, information system that records and manages all immunization doses
administered by participating providers to persons residing within a given geopolitical area
3.1.3
active immunizing agent
complex biologic product designed to induce a protective immune response effectively and safely
3.1.4
passive immunizing agent
preparation containing pre-formed antibodies derived from humans or animals or produced by recombinant
DNA technology
Note 1 to entry: Administration of passive immunizing agents can prevent certain infections or reduce the severity of
illness caused by the infectious agent.
3.1.5
cold chain break
breach or failure in following a set of rules and procedures that ensure the proper storage and distribution
of an immunizing agent
3.1.6
combined vaccine
vaccine that is designed to protect against two or more diseases or against one disease caused by different
strains or serotypes of the same organism
Note 1 to entry: Combined vaccines contain two or more antigens that are either combined by the manufacturer
[7]
(3.3.10) or mixed immediately before administration .
3.1.7
vaccine certificate
receipt provided by a health care authority that identifies the immunization information to enable proof of
vaccination
3.1.8
immunization protocol
policy and/or schedule developed by government jurisdiction or their expert immunization advisory
committees, based on jurisdiction-specific needs, other immunization recommendations, program resource
availability and constraints, and identified
...
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