Overview
ISO 18308:2011 - "Health informatics - Requirements for an electronic health record architecture" defines the architectural requirements for systems that process, manage and communicate electronic health record (EHR) information. The standard focuses on an EHR architecture (EHRA) rather than on individual application features, ensuring EHRs are clinically valid, ethically and legally sound, support good clinical practice and enable reliable data analysis. ISO 18308 addresses shared EHR information across distributed repositories, and is inclusive of personal health records (PHRs) in its scope.
Key topics and technical requirements
ISO 18308 organizes requirements to guide EHR architecture design. Major technical topics include:
- Representation of clinical information: requirements for standardized, computer-processable models that support fidelity to clinical needs and lifelong health records.
- Communication and interoperability: requirements for safe, reliable exchange and federation of EHR data across systems and repositories (centralized, indexed or distributed query models).
- Ethical and legal requirements: privacy, consent, access control and compliance constraints that govern EHR information use.
- Fair information principles and governance: policies for data quality, provenance, accountability and stewardship to support reuse (clinical care, audit, research).
- EHR business objectives: goals for health system, clinical practice and citizen inclusion that inform architectural choices (Clause 5).
- Conformance model: mandatory “shall” requirements in Clause 6 for architecture conformance; some “should” statements reflect recommended or context-dependent practices.
Keywords naturally covered: ISO 18308, EHR architecture, electronic health record requirements, health informatics, interoperability, data governance, clinical data models.
Practical applications and users
Who uses ISO 18308 and why:
- Health IT architects and system integrators - to design EHR architectures that support secure, interoperable sharing and aggregation of clinical data.
- EHR vendors and developers - to align product architectures with international requirements for reliability, clinical validity and governance.
- Health system planners and policymakers - to inform national or regional e‑health infrastructures, indexing and repository strategies.
- CIOs, clinical safety officers and compliance teams - to assess conformance, privacy controls and legal/ethical safeguards.
- Researchers and data warehouse teams - to plan data flows between EHR repositories and clinical data warehouses while preserving provenance and quality.
Practical use cases:
- Designing federated EHR systems that assemble holistic patient records from distributed sources.
- Establishing governance policies and access-control models consistent with ethical and legal requirements.
- Defining interoperability and messaging strategies that enable cross‑organization data exchange.
Related standards
ISO 18308 complements and references several EHR and health‑IT standards and guides, including:
- ISO/HL7 10781 (HL7 EHR-S functional model)
- ISO 13606, HL7 Clinical Document Architecture (CDA), HL7 v3 messaging
- openEHR approaches
- ISO/TR 22221 and ISO/TS 29585 (clinical data warehouse practice)
- TOGAF and RM-ODP architectural perspectives
ISO 18308 is intended as an architecture-level normative reference for anyone designing or governing electronic health record systems and infrastructures.
