Overview
EN ISO 13606-3:2019 - Health informatics - Electronic health record communication - Part 3: Reference archetypes and term lists (ISO 13606-3:2019) defines archetypes and controlled term lists to support consistent, interoperable exchange of part or all of an electronic health record (EHR). It is part of the ISO 13606 series and works with the ISO 13606-1 Reference Model to enable EHR communication between systems, repositories, clinical applications, middleware (e.g., decision support), personal health apps/devices, and federated record systems. This edition (2019) supersedes the 2008 version and was prepared under ISO/TC 215 and CEN/TC 251.
Key topics and technical requirements
- Reference archetypes: Normative and informative archetypes for frequently occurring EHR structures (e.g., demographic entities, medicinal product, clinical items such as Health condition, Dosage, ClinicalContext).
- Term lists (controlled vocabularies): Predefined lists for attributes of the ISO 13606-1 Reference Model (examples include SUBJECT_CATEGORY, VERSION_STATUS, MODE and various LINK description lists).
- Attribute and class coverage: Term lists and archetypes cover classes and attributes such as LINK, EXTERNAL_LINK, ELEMENT, DEMOGRAPHIC_ELEMENT, ATTACHMENT (including integrity check algorithm options), and null_flavour handling.
- Conformance guidance: Mechanisms to ensure implementations adhere to the Reference Model and use archetypes/termlists consistently for exchange.
- Contsys-based information structures: Guidance for creating clinical reference information structures as a basis for archetype development and reuse.
- Multilingual/publisher context: Published as EN ISO and recognized across CEN member states (English/French/German).
Practical applications and users
Who benefits:
- EHR vendors implementing archetype-based exchange and EHR export/import features.
- Health information exchange (HIE) architects and national EHR repositories enabling standardized data sharing.
- Developers of clinical applications, middleware (decision support, analytics), and personal health devices that consume or produce EHR data.
- Standards, interoperability and clinical informatics teams defining data models, conformance profiles, and mapping strategies.
Typical uses:
- Packaging and transmitting patient record fragments with consistent structure and semantics.
- Reusing reference archetypes to reduce ambiguity in shared clinical data (demographics, medications, conditions).
- Mapping local data to standardized term lists for consistent interpretation across systems.
Related standards
- ISO 13606-1 (Reference Model) - foundational model referenced by Part 3.
- Other parts of the ISO 13606 series and ISO/TC 215 health informatics standards for EHR interoperability.
Keywords: EN ISO 13606-3:2019, ISO 13606-3, EHR communication, reference archetypes, term lists, electronic health record interoperability, health informatics.
