Overview
ISO/TS 5346:2022 - Health informatics - Categorial structure for representation of traditional Chinese medicine clinical decision support system (TCMCDSS) defines a formal, semantic classification framework for TCM clinical decision support systems. The technical specification specifies domain constraints and a set of sanctioned characteristics (characterizing categories) composed of explicit relationships and applicable information models. It aims to standardize concept representation in TCMCDSS to improve data exchange, semantic interoperability, and the safety and effectiveness of TCM diagnosis and treatment recommendations.
Note: ISO/TS 5346:2022 is not applicable to Western medicine, Japanese Kampo medicine, or the design and management of artificial intelligence diagnosis and treatment.
Key topics and requirements
- Categorial structure: Defines the formal concept representation system composed of characterizing categories and semantic links.
- Characterizing categories (examples):
- TCMCDSS (traditional Chinese medicine clinical decision support system)
- Knowledge base and algorithm
- Patient information, four-diagnostic information, constitution
- Diagnosis recommendation, intervention recommendation, medication, physical therapy
- Semantic links (relationship types specified):
- is the base of (e.g., knowledge base → algorithm)
- is part of (e.g., physical therapy → intervention recommendation)
- produce (e.g., TCMCDSS → intervention recommendation)
- is applied with (e.g., algorithm → TCMCDSS)
- optimize (e.g., TCMCDSS → diagnosis recommendation)
- affect (e.g., diagnosis recommendation → intervention recommendation)
- is processed by (e.g., patient information → TCMCDSS)
- Domain constraints: Establish sanctioned characteristics and relationships to guide consistent modeling and information exchange across TCM systems.
Applications
- Standardizing semantic frameworks for TCM clinical decision support to enable reliable data sharing between institutions, registries, and EHR systems.
- Guiding development of TCMCDSS components such as knowledge bases, rule engines, and algorithm integration while improving recommendation completeness and accuracy.
- Supporting clinical workflows for prescription of Chinese materia medica (CMM), treatment-scheme recommendations, and non-medication therapies (e.g., acupuncture).
- Laying a foundation for future interoperability, research, and secondary use of TCM clinical data.
Who should use this standard
- Health informatics architects and EHR integrators working with TCM systems
- Software vendors and developers building TCMCDSS or knowledge bases
- TCM hospitals, clinics, and IT teams seeking standardized clinical decision support
- Standards bodies, researchers, and policymakers focused on TCM data interoperability
Related standards
Relevant references include ISO/TS 17938, ISO 19465, ISO/TS 22756, ISO 19440, ISO/TR 20831 and WHO TCM terminology - useful for complementary guidance on TCM terminology, semantic networks, knowledge bases, and medication management.