Overview
ISO/TR 9143:2023 - Health informatics - Sex and gender in electronic health records is a technical report that surveys how sex and gender information is documented, exchanged and used across electronic health records (EHRs). Rather than prescribing mandatory rules, the report:
- Describes current challenges in collecting, storing and sharing sex/gender data in diverse clinical, cultural and jurisdictional contexts.
- Identifies the current state of international standards and specifications that include sex and gender constructs.
- Summarizes findings and opportunities to improve clarity, consistency and interoperability while safeguarding individual identities and clinical use cases.
This guidance is intended for health informatics stakeholders seeking consistent, non-pathologizing approaches to sex and gender data in EHR systems.
Key topics and technical guidance
ISO/TR 9143:2023 covers technical and conceptual topics essential to designing inclusive EHRs:
- Terms and definitions: clear definitions for sex, gender, cisgender, transgender (including nonbinary), gender-diverse and intersex to support consistent implementation.
- Background and current state: historical practices, systemic inconsistencies and how existing ontologies and terminologies (e.g., ICD‑11, SNOMED CT) interact with EHR logic.
- Challenges:
- EHR-related (single-field limitations, clinical decision support, reference intervals, identity matching, diagnostics, alerts).
- Person-level (privacy, identity documentation, fragmentation of data).
- Cultural and linguistic (local legal and social contexts, translation and semantics).
- Opportunities and benefits: actionable directions to reduce information loss, enable interoperability, and better represent marginalized groups.
- Informative annexes: examples of nonbinary and gender-diverse identities, intersex conditions, and a compilation of published data elements for gender and sex in international standards.
Note: The document contains no normative references; it is an informative technical report intended to guide standards development and implementation.
Applications and who should use it
ISO/TR 9143:2023 is practical for:
- EHR vendors and system architects designing demographic and clinical data models.
- Standards bodies and terminology maintainers updating data element definitions and value sets.
- Health informaticians and clinical informatics teams assessing clinical decision support, lab reference ranges and workflows that depend on sex/gender data.
- Policymakers, public health agencies and researchers needing consistent population-level data for equity, surveillance and research.
- Patient advocacy groups advising on respectful, non-pathologizing data practices.
Related standards and initiatives
Relevant references and initiatives discussed include HL7’s Gender Harmony Project, ICD‑11, SNOMED CT, and several national approaches (e.g., Australia, Canada, New Zealand). ISO/TR 9143:2023 provides context to harmonize these efforts and improve interoperability for sex and gender data in global health informatics.