ISO 18308-2011 PDF
Name in English:
St ISO 18308-2011
Name in Russian:
Ст ISO 18308-2011
Original standard ISO 18308-2011 in PDF full version. Additional info + preview on request
Full title and description
Health informatics — Requirements for an electronic health record architecture. This International Standard defines the set of clinical and technical requirements for an EHR architecture intended to ensure EHR information is clinically valid, ethically and legally sound, supports healthcare delivery and data analysis, and facilitates trustworthy communication and management of electronic health record information.
Abstract
ISO 18308:2011 specifies requirements for the architecture of systems that process, manage and communicate electronic health record (EHR) information. It focuses on architectural requirements (not full product specifications) that support fidelity to clinical needs, data integrity, confidentiality, interoperability and governance of EHR information across care settings and usages.
General information
- Status: Published; reviewed and confirmed as current (review noted 2023).
- Publication date: April 2011 (Edition 1:2011).
- Publisher: International Organization for Standardization (ISO), developed under ISO/TC 215.
- ICS / categories: 35.240.80 (IT applications in health care technology).
- Edition / version: Edition 1 (2011).
- Number of pages: 25 (ISO published PDF length).
Scope
Defines a set of requirements for an electronic health record architecture (EHR architecture) that supports using, sharing and exchanging EHR information across different care settings, organisational boundaries and national contexts. The standard addresses architectural-level requirements (structure, governance, security, provenance, interoperability and clinical validity) but does not prescribe concrete implementation or full system specifications.
Key topics and requirements
- Architectural principles for EHR systems: modularity, scalability and maintainability.
- Clinical fidelity and semantic integrity to preserve intended clinical meaning.
- Data governance: provenance, auditability, retention and legal/ethical considerations.
- Security and privacy requirements: access control, confidentiality and protection of sensitive data.
- Interoperability and information exchange readiness (support for standardized terminologies, structured content and communications).
- Reliability, availability and mechanisms for safe clinical use (data consistency and error handling).
- Support for analytics and secondary use while ensuring appropriate de-identification and governance.
Typical use and users
Used by health informatics architects, EHR product vendors, health IT implementers, standards bodies, healthcare organisations, clinical safety officers and policymakers to define, evaluate or procure EHR architectures that meet clinical, legal and interoperability requirements.
Related standards
ISO 18308:2011 follows and replaces ISO/TS 18308:2004 (withdrawn) and is part of the broader ISO/TC 215 health informatics family. Related and complementary standards to consider include ISO/EN standards for EHR communication and interoperability (for example standards addressing EHR communication models, information model specifications and security in health informatics).
Keywords
electronic health record (EHR), EHR architecture, health informatics, interoperability, data governance, clinical validity, security, provenance, ISO 18308
FAQ
Q: What is this standard?
A: ISO 18308:2011 is an International Standard that specifies requirements for the architecture of systems that process, manage and communicate electronic health record information.
Q: What does it cover?
A: It covers architectural-level requirements to ensure clinical validity, data integrity, privacy/security, provenance, interoperability readiness and governance of EHR information; it does not provide detailed implementation specifications for particular products.
Q: Who typically uses it?
A: Health IT architects, EHR vendors, implementers, clinical safety and governance teams, and standards bodies use it to guide architecture design, procurement and evaluation of EHR systems.
Q: Is it current or superseded?
A: ISO 18308:2011 is the published edition and was reviewed and confirmed current in 2023. The earlier ISO/TS 18308:2004 was withdrawn and replaced by this 2011 edition. ISO indicates the standard may be subject to future revision under ISO/TC 215 processes.
Q: Is it part of a series?
A: It is part of the ISO health informatics work under ISO/TC 215 and should be considered alongside other EHR and health informatics standards (information models, messaging and security standards) rather than as a numbered multi‑part series specific to 18308.
Q: What are the key keywords?
A: EHR, architecture, health informatics, interoperability, governance, security, clinical validity, provenance.