Overview
ISO/TR 23358:2022 - "Health informatics - A case study on establishing standardized measurement data in cardiac examination reports" - documents a practical approach for creating and maintaining standardized cardiac examination export measurement data (CE-EMD). The technical report summarizes lessons from Japan’s SEAMAT program and focuses on enabling secondary use of CE-EMD for medical research, registries and large-scale analytics. It is limited to cardiac examination reporting and does not prescribe specific content or formatting requirements.
Key topics
- Stakeholder coalition establishment
- Methodology for convening representative committees including clinicians, device vendors and academic societies.
- Defined roles: proposal of items, consensus selection, unified naming, and society-level endorsement.
- Semantic content standardization
- Unification of names: consistent terminology, units and valid ranges to support semantic interoperability.
- Standardized coding: use of established code systems (e.g., LOINC®, ISO/IEEE 11073) and a process for provisional codes where gaps exist.
- Report formatting: guidance to encode CE-EMD in widely used document formats (example shown using HL7® CDA).
- Specification maintenance
- Processes for change requests, revision history, public disclosure and a small maintenance team to review updates.
- Governance & implementation considerations
- Licensing, implementation resources (schemas, XML), and business factors that affect adoption and secondary use.
Practical applications and who should use it
ISO/TR 23358:2022 is a guidance resource, valuable for:
- Health informatics architects and implementers designing cardiac reporting workflows and export pipelines.
- Medical device manufacturers and PACS/reporting vendors seeking to make CE-EMD interoperable across systems.
- Hospital IT teams and clinical informatics groups standardizing data ingestion into clinical databases and registries.
- Clinical researchers and registry managers who need consistent, coded cardiac measurement data for secondary analysis and “big data” research.
- Standards bodies and national programs planning to adopt or adapt a governance model for measurement-data standardization (e.g., SEAMAT-style programs).
Practical benefits:
- Reduced conversion cost and manual re-entry by harmonizing device and report outputs.
- Improved data quality for multicenter studies and registries.
- Clear governance model to keep CE-EMD specifications current and trustworthy.
Related standards
- DICOM®, MFER (medical waveform formats)
- HL7® CDA (document format example)
- LOINC® and ISO/IEEE 11073 (coding schemes)
- IHE and regional initiatives such as SS-MIX2 and SEAMAT (case study source)
ISO/TR 23358:2022 is a practical blueprint for achieving semantic interoperability of cardiac measurement data to support clinical care, device integration and secondary research use.