ISO/TS 18790-1:2015

TECHNICAL ISO/TS
SPECIFICATION 18790-1
First edition
2015-05-01
Health informatics — Profiling
framework and classification for
Traditional Medicine informatics
standards development —
Part 1:
Traditional Chinese Medicine
Informatique de santé — Cadre de profilage et classification pour
le développement de normes informatiques relatives à la médecine
chinoise —
Partie 1: Médecine chinoise traditionnelle
Reference number
ISO/TS 18790-1:2015(E)
©
ISO 2015

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ISO/TS 18790-1:2015(E)

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© ISO 2015, Published in Switzerland
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ISO/TS 18790-1:2015(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
1.1 General . 1
1.2 Main purpose . 1
1.3 Benefits . 1
1.4 Target groups . 2
2 Normative references . 2
3 Terms and definitions . 2
4 TCM Informatics Profiling Framework (TCMIPF) . 3
4.1 Overview . 3
4.2 Levels of specificity . 4
4.3 Elements of Informatics . 4
4.3.1 Terminology . 5
4.3.2 Data . 5
4.3.3 Information system . 6
4.3.4 Device . 7
4.4 Business Domain . 7
4.4.1 TCM Healthcare . . . 7
4.4.2 TCM Clinical Research . 7
4.4.3 TCM Information Management (IM). 8
4.4.4 TCM Culture and Education. 8
4.4.5 TCM medicinal products manufacture and marketing . 8
4.4.6 Surveillance of Chinese materia medica resources . 8
4.5 How to use the TCM informatics profiling framework (TCMIPF) . 9
4.5.1 The “Specificity-Informatics” Matrix . 9
4.5.2 The “Domain-Informatics” Matrix .10
Bibliography .12
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ISO/TS 18790-1:2015(E)

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 on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT) see the following URL: Foreword - Supplementary Information
The committee responsible for this document is ISO/TC 215, Health informatics.
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ISO/TS 18790-1:2015(E)

Introduction
This Technical Specification provides a common framework for describing the artefacts of informatics
standards for Traditional Chinese Medicine (TCM), which is intended for use by TCM informatics
standard developers, reviewers, and users.
This Technical Specification brings order to the description of diverse TCM informatics standards
artefacts by representing the complexity of TCM informatics as a matrix of understandable components.
A common means of description is necessary to facilitate the coordination, communication, and
comparability of TCM informatics standards across and between disciplines and Standards Development
Organizations (SDOs), and this is provided by this Technical Specification for TCM informatics standards
published by ISO/TC 215, ISO/TC 249, WHO, and other SDOs.
The framework addresses different needs of TCM informatics and provides a way to compare various
health informatics standards. It specifies a capability to comprehensively define and classify TCM
informatics standards artefacts, facilitate the coordination, communication, and comparability of TCM
informatics standards through a common understanding of intended users and content, helps identify and
coordinate TCM informatics standards development, promotes TCM informatics standards integration
and alignment within and between standards from different SDOs, and provides a framework to assist
with the coordination of ISO/TC 215 work items both within the technical committee and with related
TCs, including ISO/TC 249 and ISO/TC 46.
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TECHNICAL SPECIFICATION ISO/TS 18790-1:2015(E)
Health informatics — Profiling framework and
classification for Traditional Medicine informatics
standards development —
Part 1:
Traditional Chinese Medicine
1 Scope
1.1 General
Traditional Chinese Medicine (TCM) is a form of traditional medicine that originated in China, and is
characterized by holism and treatment based on pattern identification/syndrome differentiation. The
Technical Specification establishes common concepts and a vocabulary for describing the complex
domain of various Traditional Chinese Medicine (TCM) informatics standards initiatives and their
supporting artefacts. It provides a useful profiling framework to align existing and developing TCM
informatics standards and to reference health informatics standards. It promotes the reuse of TCM
informatics knowledge and improves the identification of opportunities for TCM informatics standards
alignment, collaboration, and coordination.
Topics considered outside the scope of this Technical Specification include:
— profiling framework and classification for informatics standards of Kampo, Korean medicine, and
other traditional medicine.
1.2 Main purpose
The framework has been developed to address different needs of TCM informatics and compare with
health informatics standards. The specific needs addressed in this Technical Specification are the
following:
— provide the capability to comprehensively define and classify TCM informatics standards artefacts;
— facilitate the coordination, communication, and comparability of TCM informatics standards
through a common understanding of intended users and content;
— help identify and coordinate TCM informatics standards development;
— promote TCM informatics standards integration and alignment within and between standards from
different Standards Development Organizations (SDOs); and
— provide a framework to assist with the coordination of ISO/TC 215 work items both within the
technical committee and with related TCs, including ISO/TC 249 and ISO/TC 46.
1.3 Benefits
The potential benefits of the Technical Specification include the following:
— introduction of classification concepts and terminology for TCM informatics standard artefacts;
— enhancement of TCM informatics standards development coordination through the identification of
potential duplication between standards initiatives;
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ISO/TS 18790-1:2015(E)

— enhancement of global understanding of TCM informatics standards in support of their knowledge
management.
1.4 Target groups
The target groups include the following:
— managers and reviewers of TCM informatics standards;
— developers of TCM informatics standards;
— users of TCM informatics standards.
2 Normative references
The following documents, in whole or in part, are normatively referenced in 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/TR 17119:2005, Health informatics - Health informatics profiling framework
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
artefact
any model, document, or work product
3.2
concept
unit of knowledge created by a unique combination of characteristics
[SOURCE: ISO 1087-1:2000, 3.2.1]
3.3
entity
any concrete or abstract thing of interest
[SOURCE: ISO/IEC 10746-2, 6.1]
3.4
category
type of entity (3.3) shared by all the individual instances in existence in the present, past, and future
3.5
categorial structure
minimal set of categories (3.4) and the valid relationships between them for representing concepts (3.2)
in terminological systems (3.7) for a specified subject field
[SOURCE: ISO 18104:2014, 4.2]
3.6
characteristic
abstraction of a property of an object or of a set of objects
[SOURCE: ISO 1087-1:2000, A.3.2.4]
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ISO/TS 18790-1:2015(E)

3.7
terminological system
structured human and machine-readable representation of concepts (3.1) required directly or indirectly
to describe certain domain and allow their subsequent retrieval or analysis
Note 1 to entry: Also the relationship of the terminology to the specifications for organizing, communicating, and
interpreting such a set of concepts.
[SOURCE: ISO 18104:2014, 4.9]
3.8
data
“raw” alphanumeric text, objects, and symbols defined without any context in such a way that by itself
one cannot tell its correct meaning
[SOURCE: ISO/TR 17119:2005, 2.5]
3.9
framework
structure for supporting or enclosing something else, often acting to partition something complex into
simple components
[SOURCE: ISO/TR 17119:2005, 2.6]
4 TCM Informatics Profiling Framework (TCMIPF)
4.1 Overview
This Technical Specification defines a profiling framework for the standardization in the area of
Traditional Chinese medicine informatics (TCM informatics), which provides a means to classify
and compare TCM informatics standards. The scope of “TCM informatics standards” refers to the
standardization of TCM information area, which includes TCM healthcare informatics, TCM management
information, TCM scientific research information, TCM culture and education information, TCM
resources information, TCM products manufacture and marketing information. The objective is to reach
the standardization of management for TCM terminology, data, information system, and knowledge to
promote the interoperability between TCM information system and other health information systems.
As shown in Figure 1, the classification framework is represented as a three-dimensional structure (i.e.
cube) whose axes are the Level of Specificity, the Elements of Informatics, and the Business Domain.
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ISO/TS 18790-1:2015(E)

Figure 1 — The Elements of Informatics, Level of Specificity, and Business Domains involving
TCM
The three dimensions are briefly described as follows:
— Level of Specificity provides differentiation of TCM informatics standards by defining levels that
move from abstract to exact implementation specifications. The main categories are Conceptual,
Logical, and Physical Design;
— Elements of Informatics provides differentiation of TCM informatics standards by defining the
essential elements of standards from the perspective of informatics. The main categories are
Terminology, Data, Information System, and Device;
— Business Domain provides differentiation of TCM informatics standards by defining the application
domains of TCM informatics standards. The main categories are TCM Healthcare, TCM clinical
research, TCM Culture and Education, TCM information management, TCM medicinal products
manufacture and marketing, and Surveillance of Chinese materia medica.
4.2 Levels of specificity
Levels of specificity provides differentiation of TCM informatics standards artefacts by defining levels
that move from abstract to exact implementation specifications. The main categories are conceptual,
logical, and physical design.
— Conceptual layer: This specificity level contains classes of things of interest within TCM informatics.
This level has no specifics, but contains shared fundamental meanings.
— Logical layer: This specificity level contains generalized models or informatics standards. It deals
with specifics that provide coherence, without concern for technological constraints.
— Physical design layer: The specificity level contains informatics standards with concern for
technological constrains.
4.3 Elements of Informatics
Elements of Informatics is a classification dimension for differentiating TCM informatics standards
based on their essential elements in terms of informatics. The main categories are terminology, data,
information system, and device. Each category has characteristic standards, and the values can be
extended as needed. The characteristic standards and currently specified values are listed as below.
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ISO/TS 18790-1:2015(E)

4.3.1 Terminology
Terminology category includes standards for TCM terminological systems, including classification,
coding scheme, coding system, and reference terminology for TCM. Fo
...