ISO 13606-1:2019
Health informatics — Electronic health record communication — Part 1: Reference model
Health informatics — Electronic health record communication — Part 1: Reference model
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 78
- Дата публикации:
- 7 июня 2019 г.
- Издание:
- ISO IS 13606 edition 2 version 1
- ICS:
- 35.240.80
This document specifies a means for communicating part or all of the electronic health record (EHR) of one or more identified subjects of care between EHR systems, or between EHR systems and a centralised EHR data repository. It can also be used for EHR communication between an EHR system or repository and clinical applications or middleware components (such as decision support components), or personal health applications and devices, that need to access or provide EHR data, or as the representation of EHR data within a distributed (federated) record system. This document will predominantly be used to support the direct care given to identifiable individuals or self-care by individuals themselves, or to support population monitoring systems such as disease registries and public health surveillance. Uses of health records for other purposes such as teaching, clinical audit, administration and reporting, service management, research and epidemiology, which often require anonymization or aggregation of individual records, are not the focus of this document but such secondary uses might also find the document useful. This Part 1 of the multipart series is an Information Viewpoint specification as defined by the Open Distributed Processing ? Reference model: Overview (ISO/IEC 10746-1). This document is not intended to specify the internal architecture or database design of EHR systems.
Abstract
Overview
ISO 13606-1:2019 - Health informatics: Electronic health record communication - Part 1: Reference model defines an interoperable reference model for communicating part or all of an electronic health record (EHR) between systems or between systems and a centralized EHR repository. It is an Information Viewpoint specification (per the Open Distributed Processing reference model - ISO/IEC 10746‑1) and is explicitly not a prescription of internal architecture or database design. The standard supports direct clinical care, self‑care, and population monitoring (e.g., disease registries, public health surveillance); secondary uses (research, audit) may also benefit from the model.
Key topics and technical requirements
The document focuses on an information model and key concepts needed for accurate, auditable EHR exchange:
- Actors and roles: representation of people and systems involved in care and documentation (composer, committer, subject of care, information provider).
- Common record component properties: definitions for base, record and structure components used across EHR content.
- Attestation and audit: metadata and requirements for attestation, provenance and audit trails to ensure trust and legal acceptability.
- Linking and references: mechanisms to link record components and to communicate referenced components or external links.
- Data types and element values: standardized datatypes (strings, coded values, quantities, dates/times, identifiers, attachments) and rules for data values.
- EHR components: canonical building blocks such as folders, compositions, content/sections, entries, items, clusters and elements.
- EHR and demographic extracts: how to package and exchange extracts of clinical and demographic information.
- Conformance: guidance on compliance with the reference model and informative annexes (e.g., ISO 21090 datatype profiling, alignment with HL7 FHIR).
Practical applications and who uses it
ISO 13606-1 is used by:
- EHR vendors and system integrators to design interoperable exchange formats and APIs that preserve provenance and structure.
- Healthcare IT architects implementing federated EHR systems, or centralized repositories and clinical middleware (decision support, CDS).
- Clinical application developers and personal health app makers needing to access or provide structured EHR data.
- Health information exchanges (HIEs) and public health agencies for standardized extract formats.
- Secondary stakeholders (researchers, auditors) may use the model where structured, de‑identified extracts are required.
Related standards
- ISO 13606 (multipart series) - Part 1 is the Reference model.
- ISO/IEC 10746-1 - Open Distributed Processing (Information Viewpoint).
- ISO 21090 - datatype profiles (informative annex).
- HL7 FHIR - alignment and mapping considerations (informative annex).
Keywords: ISO 13606-1:2019, EHR communication, reference model, health informatics, interoperability, EHR extract, audit, attestation, FHIR.
Технические детали
- Технический комитет
- ISO/TC 215 - Health informatics
- SKU
- ISO 13606-1:2019
Похожие стандарты
Стандарты, упомянутые в описании