Overview
ISO/TR 18727:2026 addresses quality management processes for health data integration in real-world environments. This technical report, developed by ISO Technical Committee 215 (Health informatics), provides a case study from the MID-NET® Project. It focuses on integrating and managing medical information storage using a hierarchical structure across multiple medical sites, applying standardized codes, and supporting reliable data sharing and analysis. The report illustrates practical methodologies for improving data quality, reducing duplication, and enhancing the secondary use of health data, all while ensuring system interoperability. Please note that issues like patient privacy, network security, and patient identifier management are outside this document’s scope.
Key Topics
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Real-world data (RWD) quality
Demonstrates how systematic processes can standardize and validate medical data collected from daily medical practice, enhancing the overall reliability of real-world evidence (RWE).
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Hierarchical health data storage
Describes methods for structuring and storing medical data in multiple layers, supporting better organization and integration of electronic medical records (EMR) from diverse sites.
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Standard code mapping
Explains the use of mapping tables to convert local codes (e.g., for diseases, drugs, lab tests) into standardized codes, ensuring consistent data interpretation and exchange.
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Data validation and governance
Presents quality management steps such as real-time validation tools (RTVT) for checking mapping completeness, and message syntax verification tools (MSVT) for HL7 message compliance.
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Stakeholder roles
Outlines the involvement of project owners, medical sites, EMR/LIS vendors, code maintenance organizations, and external governance centers in the data quality management process.
Applications
Implementing the ISO/TR 18727:2026 quality management approach provides several important benefits for health informatics professionals and organizations:
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Enhanced data integration
Enables seamless collection and harmonization of medical data from diverse electronic systems and multiple healthcare sites, improving large-scale data analytics.
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Improved clinical research efficiency
Supports the use of high-quality RWD, crucial for clinical trials, pharmacovigilance, and regulatory decision-making.
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Consistent secondary data use
Facilitates the secondary use of health data for research, quality improvement, and healthcare analytics by ensuring data consistency through standardization and robust validation.
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Interoperability support
Through standardized code mapping and validation, supports interoperability between local and centralized data systems, aligning with global health informatics goals.
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Resource optimization
Reduces redundancy and data management costs by enabling standardized, automated processes for mapping, validation, and governance of health data assets.
Related Standards
- ISO/TS 24289: Specifies requirements for hierarchical storage structures for health data, referenced by the MID-NET® Project for constructing and managing HL7 message files.
- ISO/TR 24291:2021: Defines terms related to electronic medical records (EMR) and health data systems.
- ISO/TR 20514:2005: Provides terminology concerning electronic health records (EHR), supporting shared understanding for data integration.
- International Classification of Diseases (ICD-10): Used for standardized disease coding.
- Japanese national code systems (HOT9, JLAC10, JANIS): Referenced for medication, lab, and infection surveillance coding in the case study, with guidance to substitute with global codes as needed.
By implementing ISO/TR 18727:2026, organizations can establish a standardized process for health data quality management in distributed, real-world contexts, ensuring reliable evidence generation and supporting the global advancement of health informatics.
Open preview (PDF)Health informatics — Quality management of health data in the real world — Case study
