SIST EN ISO 13606-1:2019 PDF

Overview

SIST EN ISO 13606-1:2019 - Health informatics - Electronic health record communication - Part 1: Reference model - defines a standardized information viewpoint for exchanging part or all of an electronic health record (EHR) between systems. Published as the Reference Model (ISO 13606-1:2019), it describes how EHR data and metadata should be represented so EHR systems, repositories, clinical applications, middleware and personal health apps can communicate and interoperate. It is an Information Viewpoint specification aligned with the Open Distributed Processing reference model (ISO/IEC 10746-1) and is not intended to prescribe internal system architectures or database designs.

Key Topics and Technical Requirements

The standard specifies structured concepts and requirements for EHR communication, including:

• Actors and roles - definitions for Subject of Care, Composer, Committer and other actors involved in care documentation and data exchange.
• EHR components - a compositional model that includes Folders, Compositions, Sections and Entries to represent clinical record structure.
• Data types and elements - canonical datatypes and element definitions (Boolean, String, Attachment, Coded values, Instance identifiers, Date/Time, Physical quantities, etc.) to ensure consistent data representation.
• Common properties - base, record and structural component properties that apply across EHR fragments.
• Attestation and audit - requirements for documenting authorisation, verification and audit trails to support provenance, accountability and medico-legal traceability.
• Linking and references - mechanisms for linking record components and handling external references between distributed records.
• Privacy/security and information management - terms and constructs to support confidentiality, access control and responsible information handling (conceptual level).

These elements together enable the creation of an interoperable EHR extract suitable for direct care, self‑care and population monitoring.

Practical Applications and Who Uses It

ISO 13606-1 is practical for organizations and professionals focused on EHR interoperability:

• EHR vendors and system architects implementing standardized exchange formats.
• Health IT integrators and interoperability engineers building interfaces between hospital systems, registries and centralized repositories.
• Developers of clinical applications, middleware and decision‑support tools that need to consume or contribute structured EHR data.
• Public health agencies and registry operators enabling population monitoring and surveillance.
• Device and personal health application developers exchanging patient data with clinical systems.
• Standards bodies and implementers who require a formal reference model for semantic and structural consistency.

While oriented to direct care and monitoring, the model also supports secondary uses (audit, research, reporting) when appropriate anonymization or aggregation is applied.

Related Standards

• ISO 13606 multipart series (Reference Model is Part 1)
• Open Distributed Processing - Reference model: Overview (ISO/IEC 10746-1)
• ISO/TC 215 (Health informatics) guidance and related interoperability standards

Keywords: EHR communication, ISO 13606-1, electronic health record, reference model, health informatics, interoperability, EHR extract, audit, attestation, data types.