ISO/TS 5346:2022

Health informatics — Categorial structure for representation of traditional Chinese medicine clinical decision support system

This document specifies the categorial structure within the field of traditional Chinese medicine clinical decision support system by defining a set of domain constraints of sanctioned characteristics, each composed of a relationship and an applicable information model. This document is not applicable to Western medicine and Japanese Kampo medicine. It is not applicable to the design and management of artificial intelligence diagnosis and treatment.

Informatique de santé — Structure catégorielle pour la représentation du système d'aide à la décision clinique en médecine traditionnelle chinoise

General Information

• Status: Published
• Publication Date: 01-Jun-2022
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: ISO/TC 215 - Health informatics
• Drafting Committee: ISO/TC 215 - Health informatics
• Current Stage: 9092 - International Standard to be revised
• Start Date: 04-Dec-2025
• Completion Date: 14-Feb-2026

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.

Standards Content (Sample)

TECHNICAL ISO/TS
SPECIFICATION 5346
First edition
Health informatics — Categorial
structure for representation of
Traditional Chinese medicine clinical
decision support system
PROOF/ÉPREUVE
Reference number
© ISO 2022
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
PROOF/ÉPREUVE © ISO 2022 – All rights reserved

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
3.1 General . 1
3.2 Characterizing categories . 2
4 Categorial structure of TCM clinical decision support system .4
4.1 Overview . 4
4.2 semantic link . 4
4.2.1 is the base of . 4
4.2.2 is part of . 4
4.2.3 produce . 4
4.2.4 is applied with . 4
4.2.5 optimize . 4
4.2.6 affect . 5
4.2.7 is processed by . 5
Bibliography . 7
iii
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 215, Health informatics.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
iv
PROOF/ÉPREUVE © ISO 2022 – All rights reserved

Introduction
The aim of Traditional Chinese medicine clinical decision support systems (TCMCDSS) is to help
prescribe Chinese materia medica (CMM) and other therapies that fit the patient’s personal situation
with respect to effectiveness and toxicity of the medicine. The imbalance between supply and demand
of medical resources leads to a huge demand for TCMCDSS, through which TCM diagnosis and treatment
schemes can be optimized and the effectiveness and safety of primary medical care can be improved.
Hence the establishment of TCMCDSS is in line with clinical practice needs and it has the requirements
of real application scenarios. However, different TCMCDSS lack a unified semantic information
framework, which affects the data exchange and sharing among different institutions and databases.
In conclusion, a unified semantic classification framework will greatly enhance the completeness,
accuracy of TCMCDSS, which will establish a solid foundation for the sharing and utilization of the data
in the future.
v
TECHNICAL SPECIFICATION ISO/TS 5346:2022(E)
Health informatics — Categorial structure for
representation of Traditional Chinese medicine clinical
decision support system
1 Scope
This document specifies the categorial structure within the field of Traditional Chinese medicine
clinical decision support system by defining a set of domain constraints of sanctioned characteristics,
each composed of a relationship and an applicable information model.
This document is not applicable to Western medicine and Japanese Kampo medicine. It is not applicable
to the design and management of artificial intelligence diagnosis and treatment.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1 General
3.1.1
concept
unit of knowledge created by a unique combination of characteristics
[SOURCE: ISO 1087:2019, 3.2.7, modified — Notes to entry deleted.]
3.1.2
entity
concrete or abstract thing of interest
Note 1 to entry: Some information modelling methods use entity for their main information modelling construct,
whilst others use entity type.
3.1.3
relationship
association between two or mo
...

ISO/TS 5346
ISO TC 215
Date: 2022-04-19
Secretariat: ANSI
Health Informatics — Categorial structure for representation of Traditional Chinese
Medicinemedicine clinical decision support system

Publication stage
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or
utilized otherwise in any form or by any means, electronic or mechanical, including photocopying,
or posting on the internet or an intranet, without prior written permission. Permission can be
requested from either ISO at the address below or ISO's member body in the country of the
requester.
ISO copyright office
Case postale 56 • CP 401 • Ch. de Blandonnet 8
CH-12111214 Vernier, Geneva 20
Tel.+ Phone: [phone]
Fax+ : [phone]
E-mailcopyrightEmail: [e-mail]
Webwww.iso.org
Website: www.iso.org
Published in Switzerland.
ii © ISO 2022 – All rights reserved

Contents
Foreword . 4
Introduction. 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 List of relationships for TCMCDSS . 9
5 Categorial structure of TCM clinical decision support system . 10
Bibliography . 4

Foreword . 4
Introduction. 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
3.1 General . 6
3.2 Characterizing categories . 7
4 Categorial structure of TCM clinical decision support system . 9
4.1 Overview . 9
4.2 semantic link . 9
4.2.1 is the base of . 9
4.2.2 is part of . 9
4.2.3 produce . 10
4.2.4 is applied with . 10
4.2.5 optimize . 10
4.2.6 affect . 10
4.2.7 is processed by . 10
Figure 1 — Categorial structure of representation of TCMCDSS . 3
Bibliography . 4

Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO
collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any
patent rights identified during the development of the document will be in the Introduction and/or on
the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the World
Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 215, Health informatics.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
iv © ISO 2022 – All rights reserved

Introduction
The aim of Traditional Chinese Medicinemedicine clinical decision support systemsystems (TCMCDSS) is
to help prescribe the Chinese materia medica (CMM) and other therapies that fitsfit the patient’s personal
situation inwith respect ofto effectiveness and toxicity of the medicine. The imbalance between supply
and demand of medical resources leadleads to a huge demand for TCMCDSS, through which TCM
diagnosis and treatment schemes can be optimized, and the effectiveness and safety of primary medical
care can be improved. SoHence the establishment of TCMCDSS is in line with clinical practice needneeds
and it has the requirements of real application scenarios. However, different TCMCDSS lack a unified
semantic information framework, which affects the data exchange and sharing among different
institutions and databases.
In conclusion, a unified semantic classification framework will greatly enhance the completeness,
accuracy of TCMCDSS, which will establish a solid foundation for the sharing and utilization of the data
in the future.
Health Informatics —informatics — Categorial structure for representation of Traditional
Chinese Medicinemedicine clinical decision support system
1 1 Scope
This document specifies the categorial structure within the subject field of TCMTraditional Chinese
medicine clinical decision support system by defining a set of domain constraints of sanctioned
characteristics, each composed of a relationship and an applicable information model in order to
represent the concept of TCM clinical decision support system. The Western medicine and Japanese
Kampo medicine are out of this scope. TCMCDSS shall not be used for these medicines. The design and
management of artificial intelligence diagnosis and treatment systems is out of the scope.
2 This document is not applicable to Western medicine and Japanese Kampo medicine. It is not applicable
to the design and management of artificial intelligence diagnosis and treatment.
2 Normative references
The following documents, are referred to in wholethe text in such a way that some or in part, are
normatively referenced inall of their content constitutes requirements of this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 17115:2020 Health informatics —Representation of categorial structures of terminology
(CatStructure)
3 3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminologicalterminology databases for use in standardization at the following
addresses:
— ISO Online browsing platform: http://www.iso.org/obpavailable at https://www.iso.org/obp
— IEC Electropedia: http://www.electropedia.org/available at https://www.electropedia.org/
3.1General
3.1 General
3.1.1
concept
unit of knowledge created by a unique combination of characteristics
[SOURCE: ISO 1087:2019, 3.2.7, modified notes— Notes to entry deleted].]
3.1.2
entity
any concrete or abstract thing of interest
Note 1 to entry: Some information modelling methods use entity for their main information modelling construct,
whilst others use entity type; in this part of ISO/IEC 19763 the term entity type is used in preference to entity.
[SOURCE: ISO/IEC 10746-2:2009, 6.1, modified note added.]
vi © ISO 2022 – All rights reserved

3.1.3
relationship
association between two or more entities that is significant for some intended purpose
Note 1to 1 to entry: Can also be known as an association when the infor
...

TECHNICAL ISO/TS
SPECIFICATION 5346
First edition
2022-06
Health informatics — Categorial
structure for representation of
traditional Chinese medicine clinical
decision support system
Informatique de santé — Structure catégorielle pour la
représentation du système d'aide à la décision clinique en médecine
traditionnelle chinoise
Reference number
© ISO 2022
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
3.1 General . 1
3.2 Characterizing categories . 2
4 Categorial structure of TCM clinical decision support system .4
4.1 Overview . 4
4.2 semantic link . 4
4.2.1 is the base of . 4
4.2.2 is part of . 4
4.2.3 produce . 4
4.2.4 is applied with . 4
4.2.5 optimize . 4
4.2.6 affect . 5
4.2.7 is processed by . 5
Bibliography . 7
iii
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 215, Health informatics, in collaboration
with Technical Committee ISO/TC 249, Traditional Chinese medicine.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
iv
Introduction
The aim of traditional Chinese medicine clinical decision support systems (TCMCDSS) is to help
prescribe Chinese materia medica (CMM) and other therapies that fit the patient’s personal situation
with respect to effectiveness and toxicity of the medicine. The imbalance between supply and demand
of medical resources leads to a huge demand for TCMCDSS, through which TCM diagnosis and treatment
schemes can be optimized and the effectiveness and safety of primary medical care can be improved.
Hence the establishment of TCMCDSS is in line with clinical practice needs and it has the requirements
of real application scenarios. However, different TCMCDSS lack a unified semantic information
framework, which affects the data exchange and sharing among different institutions and databases.
In conclusion, a unified semantic classification framework will greatly enhance the completeness,
accuracy of TCMCDSS, which will establish a solid foundation for the sharing and utilization of the data
in the future.
v
TECHNICAL SPECIFICATION ISO/TS 5346:2022(E)
Health informatics — Categorial structure for
representation of traditional Chinese medicine clinical
decision support system
1 Scope
This document specifies the categorial structure within the field of traditional Chinese medicine
clinical decision support system by defining a set of domain constraints of sanctioned characteristics,
each composed of a relationship and an applicable information model.
This document is not applicable to Western medicine and Japanese Kampo medicine. It is not applicable
to the design and management of artificial intelligence diagnosis and treatment.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1 General
3.1.1
concept
unit of knowledge created by a unique combination of characteristics
[SOURCE: ISO 1087:2019, 3.2.7, modified — Notes to entry deleted.]
3.1.2
entity
concrete or abstract thing of interest
Note 1 to e
...