Overview
ISO/TS 22835:2018, titled Health Informatics - Information Model of Combination of Decoction Pieces in Chinese Medicines, is a technical specification published by ISO that establishes a structured information model for representing combinations of Chinese medicines, specifically focusing on decoction pieces. The document targets the health informatics domain and addresses the need for standardized terminologies and relationship representations governing multi-herb prescriptions in Traditional Chinese Medicine (TCM).
This specification defines domain constraints through a set of sanctioned characteristics and relationships, enabling clear and consistent data representation for Chinese medicinal formulas. Importantly, it excludes Kampo medicine, which is a related but distinct traditional practice.
Key Topics
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Information Model
The document specifies an information model that graphically and textually represents entities such as decoction pieces, herbs, and their combinations along with the relationships among them to enable better health informatics interoperability and clinical data synthesis.
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Domain Constraints and Relationships
Essential relationships such as consist of, enhance, reduce, affect, and be avoided define how individual medicinal substances interact when combined in formulas. These relationships reflect concepts like mutual reinforcement, mutual restraint, toxicity reduction, and prohibited combinations.
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Terminology and Definitions
Clear definitions are provided for key terms including combination, decoction pieces (medicinal slices), mutual reinforcement, mutual suppression, toxicity, and constitution. These standardized definitions ensure uniform understanding across practitioners, researchers, and health informatics systems.
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Conformance Principles
ISO/TS 22835 outlines compliance requirements for terminological systems incorporating these models, emphasizing conformance with ISO 17115 vocabulary standards and the inclusion of minimal domain constraints suitable for clinical and research applications.
Applications
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Clinical Decision Support Systems
By using this standardized information model, healthcare systems can improve the accuracy of prescribing and evaluating Chinese medicinal formulas, ensuring safe and effective combinations based on known mutual effects and prohibitions.
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Health Informatics Integration
Facilitates interoperability among electronic health records (EHRs), traditional medicine registries, and research databases by providing a consistent framework to represent complex herbal combinations.
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Research and Meta-Analyses
Enables comprehensive, semantically clear clinical data reporting for Chinese medicine formulas, improving data synthesis and interpretation in clinical studies and meta-analyses.
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Pharmacovigilance and Safety Monitoring
Helps in identifying toxic or antagonistic combinations, thus supporting monitoring of medicine safety and reducing adverse effects through informed prescription practices.
Related Standards
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ISO 17115: Health Informatics - Vocabulary of Compositional Terminological Systems
Provides the foundational vocabulary for organizing healthcare entities and relationships used in ISO/TS 22835.
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ISO/TS 17938:2014: Health Informatics - Semantic Network Framework of Traditional Chinese Medicine Language System
Supports semantic frameworks relevant to traditional Chinese medicine terminologies referenced in this standard.
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ISO/TS 20282-2:2013: Usability of Consumer Products and Products for Public Use - Summative Test Method
Pertinent for assessing effectiveness in user interactions with health product interfaces including digital TCM systems.
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ISO 19440:2007: Enterprise Integration - Constructs for Enterprise Modelling
Related to defining relationships and entities relevant in complex information modeling.
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ISO/IEC 19763-12:2015: Information Technology - Metamodel Framework for Interoperability - Part 12: Metamodel for Information Model Registration
This standard informs the structural approach to representing interoperable information models like the one in ISO/TS 22835.
This ISO technical specification advances the standardization of health informatics related to Traditional Chinese Medicine by providing a detailed model to represent the combination of decoction pieces. Its implementation supports improved clinical use, data interoperability, and safety in the growing field of integrative medicine.