ISO/TS 16277-1:2015

Health informatics — Categorial structures of clinical findings in traditional medicine — Part 1: Traditional Chinese, Japanese and Korean medicine

ISO/TS 16277-1:2015 defines a categorial structure for clinical findings in terminological systems for Traditional Chinese Medicine, Traditional Japanese Medicine, and Traditional Korean Medicine (TM-CJK). This Technical Specification defines three subcategories: pattern-TM, disorder-TM and sign&symptom-TM. Concept representations within these three categories are used to describe the states of patients in clinical records and communications. This Technical Specification is not applicable to: - a comprehensive categorial structure for TM-CJK; - an exhaustive list of all possible characterizing concepts that could be used to describe clinical findings; - terms/descriptions for individual TM-CJK concepts; - a detailed terminology of clinical findings in TM-CJK; - categorical structure of diagnosis and treatment on clinical findings in TM-CJK. NOTE This Technical Specification is limited to a subpopulation of clinical findings in traditional medicine. Other types of clinical findings are represented in ISO/TS 22789 although it has not been tested for this purpose.

Informatique de santé — Structures catégorielles des recherches cliniques en médecine traditionnelle — Partie 1: Médecine traditionnelle de l'Asie de l'est

General Information

• Status: Published
• Publication Date: 22-Apr-2015
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: ISO/TC 215 - Health informatics
• Drafting Committee: ISO/TC 215/WG 3 - Semantic content
• Current Stage: 9093 - International Standard confirmed
• Completion Date: 19-Jul-2022

Standards Content (Sample)

TECHNICAL ISO/TS
SPECIFICATION 16277-1
First edition
2015-05-01
Health informatics — Categorial
structures of clinical findings in
traditional medicine —
Part 1:
Traditional Chinese, Japanese and
Korean medicine
Informatique de santé — Structures catégorielles des recherches
cliniques en médecine traditionnelle —
Partie 1: Médecine traditionnelle de l’Asie de l’est
Reference number
ISO/TS 16277-1:2015(E)
©
ISO 2015

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ISO/TS 16277-1:2015(E)

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ISO/TS 16277-1:2015(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
3.1 General . 1
3.2 Core categories . 3
3.3 Characterizing categories . 4
3.4 Semantic links (3.1.10) with domain constraints (3.1.7) . 6
3.5 Semantic links (3.1.10) adopted from ISO/TS 22789:2010 . 7
4 Categorial structure (3.1.2) for clinical findings in TM-CJK . 8
4.1 General considerations . 8
4.2 Principles . 8
4.3 Domain constraints (3.1.7) . 8
4.4 Category names in Clause 3 . 9
4.5 Adoption from and harmonization with existing standards . 9
Annex A (informative) Comparison of semantic links with ISO/TS 22789:2010 .11
Annex B (informative) Guidance notes for using categorial structures .13
Bibliography .17
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ISO/TS 16277-1:2015(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 16277-1:2015(E)

Introduction
In most countries there are many types of traditional medicine that are distinct from the health care
system based on biomedicine. In some countries this traditional medicine has been institutionalized;
in other countries it may have a significant role in health care as an alternative medicine. One type
of traditional medicine is traditional Chinese, traditional Japanese, and traditional Korean medicine
(TM-CJK), which has spread from ancient China to other East Asian regions over thousands of years.
TM-CJK is now relatively homogenous in terms of theory and practice including: disease classification;
diagnostic methods; and treatment modalities such as acupuncture and use of herbs.
As in biomedicine, health care professionals specializing in this clinical discipline use specific
terminologies in their clinical records and documentations as well as in their practice, research and
education. There will be several standard TM-CJK terminologies used around the world in Electronic
Health Record (EHR) systems both in separate systems supporting TM-CJK practice and in systems
combining TM-CJK and biomedicine content. Interoperability of health record systems is a core objective
of informatics standards; this can be supported by standards for terminologies such as those used in
TM-CJK and biomedicine.
This Technical Specification provides categorial structures of clinical findings in TM-CJK for the
requirements. An essential requirement for sematic interoperability of TM-CJK health records is
a categorial-structure driven terminology system for TM-CJK diagnosis. Although there are many
terminological resources in TM-CJK in electronic format and also some International Standard TM-CJK
terminologies, there are none that meet the requirements of health informatics such as interoperability
between systems and machine readability. However, the ICD-11 Traditional Medicine (TM) chapter and
ICTM are being developed by the World Health Organization (WHO) and will meet this criteria with
[15]
their formal content model which identifies TM diagnostic entities, their properties and value sets.
Hence This Technical Specification refers to the ICTM content model.
This Technical Specification describes the core, underlying components of terminological expressions
(i.e. the Categorial Structure) of clinical findings in TM-CJK. It is aligned with ISO/TS 22789:2010 Health
informatics — Conceptual framework for patient findings and problems in terminologies, which deals with
the same domain in biomedicine. It specifies a concept system detailing the categories of the domain
(clinical findings in TM-CJK) and a domain constraint of sanctioned characteristics, each composed of a
semantic link and an applicable characterizing category. An item enclosed by single brackets <> refers
to a category of domain or a characterizing category that can be specialized to various concepts as
required. An item enclosed within the text by single accolades { } identifies a semantic link.
The Technical Specification does not specify the names of individual TM-CJK concepts in the definitions.
However, when it is necessary to give examples with names of concepts in TM-CJK, the WHO
International Standard Terminologies on Traditional Medicine in the Western Pacific Region is used.
[1]
Also current ICD-11 Traditional Medicine chapter(Beta Draft), which is the global reference point,
[15]
will serve as a repository for examples in the next revision. International Standard Chinese-English
Basic Nomenclature of Chinese Medicine of World Federation of Chinese Medicine Societies (WFCMS)
[13]
was accessible and considerable for the Technical Specification. A future revision of this Technical
Specification will incorporate examples from other authorized standards when they are fully established.
When a unique category is introduced and its name is already used in biomedicine, the ‘-TM’ after the
name is used to indicate that the term has a different concept in TM-CJK, for example, ‘disorder-TM’ is a
different concept from ‘disorder’ in the biomedicine field.
Comparison and alignment with ISO/TS 22789:2010 is presented in Annex A. In Annex B, an informative
description of Categorial Structures and their implementation in terms of intersection between
terminology models and information models is provided.
The building methodology of the categorial structure in this Technical Specification is the one that was
[2]
defined by CEN in EN 12264 and applied to different domains, from surgical procedures (EN 1828 ) to
[3]
nursing care (ISO 18104 ) and clinical findings of the biomedicine area (ISO/TS 22789).
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ISO/TS 16277-1:2015(E)

The potential uses for this categorial structure are to:
— provide a core model to describe the structure of TM-CJK, and facilitate improved semantic
correspondence with information models;
— facilitate the representation of TM-CJK using a standard core model in a manner suitable for
computer processing;
— support developers of new terminology systems concerning TM-CJK clinical findings;
— support developers of new detailed content areas of existing terminology systems concerning TM-
CJK clinical findings ;
— facilitate the mapping or integration between TM-CJK terminologies and biomedicine
terminological systems.
The direct users for this Technical Specification are:
— developers of terminology systems concerning TM-CJK patient findings;
— developers of information systems that require a structured framework of concepts of TM-CJK
patient findings to facilitate implementation.
The following will benefit from this Technical Specification;
— informaticians, analysts and epidemiologists who require common models of knowledge to facilitate
analysis of current and legacy data from one or more information systems;
— clinicians and coders, to provide greater consistency in structure and organization when entering
and retrieving data using one or more terminology systems.
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TECHNICAL SPECIFICATION ISO/TS 16277-1:2015(E)
Health informatics — Categorial structures of clinical
findings in traditional medicine —
Part 1:
Traditional Chinese, Japanese and Korean medicine
1 Scope
This Technical Specification defines a categorial structure for clinical findings in terminological
systems for Traditional Chinese Medicine, Traditional Japanese Medicine, and Traditional Korean
Medicine (TM-CJK). This Technical Specification defines three subcategories: pattern-TM, disorder-TM
and sign&symptom-TM. Concept representations within these three categories are used to describe the
states of patients in clinical records and communications.
This Technical Specification is not applicable to:
— a comprehensive categorial structure for TM-CJK;
— an exhaustive list of all possible characterizing concepts that could be used to describe clinical findings;
— terms/descriptions for individual TM-CJK concepts;
— a detailed terminology of clinical findings in TM-CJK;
— categorical structure of diagnosis and treatment on clinical findings in TM-CJK.
NOTE This Technical Specification is limited to a subpopulation of clinical findings in traditional medicine.
Other types of clinical findings are represented in ISO/TS 22789 although it has not been tested for this purpose.
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/TS 22789:2010, Health informatics — Conceptual framework for patient findings and problems in
terminologies
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1 General
3.1.1
concept
unit of knowledge created by a unique combination of characteristics
[SOURCE: ISO 1087-1:2000, definition 3.2.1]
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3.1.2
categorial structure
minimal set of categories (3.1.4) and the valid relationships between them for representing concepts
(3.1.1) in terminological systems for a specified subject field
[SOURCE: ISO 18104, definition 3.1.2]
3.1.3
characterizing category
category (3.1.4) which is allowed by a domain constraint (3.1.7) to specialise a concept (3.1.1) in a
particular domain
EXAMPLE in {performedUsing} ; {hasLocation} ,
“” and “” is the characterizing category (3.1.3).
Note 1 to entry: (3.1.1).
3.1.4
category
type of entity (3.1.8) shared by all the individual instances in existence in the present, past and future
EXAMPLE The category (3.1.4) is instantiated by oral route and all other routes that meet the
defining characteristics (3.5) for .
Note 1 to entry: category (3.1.4) is usually described by a superordinate and generic concept (3.1.1).
Note 2 to entry: categories (3.1.4) may be more or less general. Where one category (3.1.4) is subsumed by another,
the isA relation is asserted to obtain a hierarchy between the more specific or subsumed category (3.1.4) and the
more general or subsuming category (3.1.4). For example, parenteral route is more general than intravenous route.
Note 3 to entry: Each entity (3.1.8) instantiates some category (3.1.4).
[SOURCE: ISO 18104, definition 3.1.3]
3.1.5
characteristic
abstraction of a property of an object or of a set of objects
[SOURCE: ISO 1087-1:2000, definition 3.2.4]
EXAMPLE Red and gold are the characteristic (3.1.5) colours of autumn.
Note 1 to entry: Characteristics (3.5) are used for describing concepts (3.1.1).
3.1.6
clinical findings-TM
any state observed directly or indirectly concerning a patient and their relationship with the environment
according to TM-CJK theories
Note 1 to entry: Modified from ISO/TS 22789 for TM-CJK theories.
3.1.7
domain constraint
rule prescribing the set of sanctioned characteristics(3.1.9) that are valid to specialise a concept
representation in a certain subject field
EXAMPLE “Infection possibly hasLocation SkeletalStructure” explains that an infection in a certain context
can be located in a structure that is a kind of skeletal structure.
[SOURCE: ISO 17115:2007, definition 2.3.2]
Note 1 to entry: The rule describes the set of sanctioned characteristics (3.1.9) by combining the semantic link
(3.1.10) and the characterizing category (3.1.3)
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ISO/TS 16277-1:2015(E)

3.1.8
entity
any concrete or abstract thing of interest
EXAMPLE Aspirin, environment, parent, symptom, mobility.
Note 1 to entry: While in general the word entity can be used to refer to anything, in the context of modelling it is
reserved to refer to things in the universe of discourse being modelled.
[4]
Note 2 to entry: This definition is similar to that for object in ISO:1087–1 which is: anything perceivable or
conceivable. ISO 1087-1 notes that Objects may be material (e.g. an engine, a sheet of paper, a diamond), immaterial
(e.g. conversion ratio, a project plan) or imagined (e.g. a unicorn). However, the term object is normally interpreted
as representing a material thing, therefore entity is preferred.
3.1.9
sanctioned characteristic
formal representation of a type of characteristic (3.1.5)
[SOURCE: ISO 17115:2007, definition 2.3.1]
EXAMPLE {performedUsing} ; {hasLocation} ,
where “{performedUsing}” and “{hasLocation}” are the semantic links (3.1.10), and “” and
“” is the characterizing category (3.1.3).
Note 1 to entry: A sanctioned characteristic (3.1.9) is typically made up of a combination of a semantic link (3.1.10)
and a characterizing category (3.1.3), and can be used in domain constraints (3.1.7).
3.1.10
semantic link
formal representation of a directed associative relation or partitive relation between two concepts (3.1.1)
[SOURCE: ISO 17115:2007, definition 2.2.3]
EXAMPLE {hasLocation} (with inverse {isLocationOf}) and {isCauseOf} (with inverse {hasCause}).
Note 1 to entry: A semantic link (3.1.10) always has an inverse, i.e. another semantic link (3.1.10) with the opposite
direction. The inverse may or may not be explicitly stated.
3.2 Core categories
3.2.1
pattern-TM
condition which represents a typical constellation of symptoms or complete clinical presentation of
patients including symptoms at a given moment in time and is a known or assumed dysfunction of body
function-TM(3.3.3.2), body structure-TM (3.3.1) or body substance-TM (3.3.2.1)
EXAMPLE is a pattern marked by sudden profuse sweating and cold skin,
reversal cold of limbs, feeble breathing, palpitations, clouding or loss of consciousness, pale complexion and
[1]
hardly perceptible pulse. is a pattern caused by pathogenic cold attacking
the greater yang meridian, chiefly manifested by fever, chills, absence of sweat and floating pulse, also called the
[1]
greater yang cold damage.
Note 1 to entry: pattern-TM (3.2.1) indicates a set of signs and symptoms at a given moment in time that can be
captured by body system-TM (3.3.1.1) and their derivatives based on TM-CJK.
Note 2 to entry: This concept (3.1.1) may be expressed by pattern, syndrome, or disease pattern in English, 证 or
證 in Chinese and Japanese and 증 in Korean in TM-CJK related literature.
Note 3 to entry: This concept (3.1.1) is subcategories of clinical findings-TM and it can be used for
characterizing category (3.1.3) with semantic link(3.1.10) such as hasAssociatedPattern-TM(3.4.5) and
hasAssociatedFinding-TM(3.4.6).
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3.2.2
disorder-TM
condition which represents a set of dysfunction with associated manifestations and is often defined
by typical chief symptom, sequential pathological process-TM (3.3.3.3), body state-TM (3.3.3.1), or
aetiology according to TM-CJK theories
EXAMPLE , , , , ,
.
Note 1 to entry: Disorder-TM may have multiple underlying causes, corresponding multiple patterns-TM (3.2.1),
and consequently multiple different treatments.
Note 2 to entry: It is useful to capture an individual health condition over time using a fixed concept (3.1.1) in
disorder-TM while pattern-TM may change over time.
Note 3 to entry: This concept (3.1.1) may be expressed by disease or disorder in English, 病 in Chinese and
Japanese, and 병 in Korean in TM-CJK related literature.
Note 4 to entry: This concept (3.1.1) is subcategories of clinical findings-TM and it can be used for
characterizing category (3.1.3) with semantic link (3.1.10) such as hasAssociatedPattern-TM (3.4.5) and
hasAssociatedFinding-TM (3.4.6).
3.2.3
sign&symptom-TM
manifestation of a dysfunction classified only by TM-CJK
EXAMPLE , , , , , pulse>, , , .
[6]
Note 1 to entry: sign&symptom (3.2.3) may be identifiable by the affected person or the health worker.
Note 2 to entry: This concept (3.1.1) is subcategories of clinical findings-TM and it can be used for
characterizing category (3.1.3) with semantic link(3.1.10) such as hasAssociatedPattern-TM (3.4.5) and
hasAssociatedFinding-TM (3.4.6)
3.3 Characterizing categories
3.3.1
body structure-TM
abstract or physical arrangement of parts of the body for explanatory framework according to TM-CJK
3.3.1.1
body system-TM
body structure-TM (3.3.1) that works to perform a certain task as a part of a whole in intimate
interconnection according to TM-CJK
EXAMPLE 1 , , and .
EXAMPLE 2 , and of meridian system and also
and .
Note 1 to entry: A body system-TM (3.3.1.1) can include anatomical structure, functional system and abstract
notion for its constituents. They are mutually independent as well as complementary because they may reflect
different aspects of body and health problems and are also closely related to each other.
Note 2 to entry: Body system-TM (3.3.1.1) may have subcategories according to different needs of the terminology
system. Meridian system, Sanjiao system and Four constitutional system could be examples.
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3.3.1.2
body part-TM
body structure-TM (3.3.1) that is physical anatomical entity (3.1.8), has a spatial dimension, and is
uniquely used in TM-CJK
EXAMPLE 1 Any acupuncture points.
EXAMPLE 2 that is the bony area including the styloid process of the radius.
EXAMPLE 3 that refers to the eyes, ears, mouth and nose.
3.3.2
substance-TM
continuous abstract or physical entity (3.1.8) that has no inherent shape according to TM-CJK
3.3.2.1
body substance-TM
substance-TM (3.3.2) that is originated in body
Note 1 to entry: This refers to an entity (3.1.8) which is contained by body structure-TM (3.3.1). Because the body
structure-TM (3.3.1) is abstract as well as physical, the body substance (3.3.2.1) is abstract or physical.
EXAMPLE 1 , , .
EXAMPLE 2 , < static blood-TM>, , which
deficiency of yin fluid give rise to, .
3.3.2.2
non-body substance-TM
substance-TM (3.3.2) that is not originated in body
EXAMPLE Cold of .
3.3.3
state-TM
series of abstract or physical actions over time or condition in certain time in body according to TM-CJK
Note 1 to entry: While (3.3.1.1) has an explanatory framework for human body and health
problems, many individual findings also can be related to (3.3.3). It includes functional aspects like
(3.3.3.1) among entities of (3.3.1.1) and also
(3.3.3.3) impairing the normal (3.3.3.2) in TM-CJK.
3.3.3.1
body state-TM
normal or abnormal condition of body structure-TM (3.3.1) or body substance-TM (3.3.2.1)
EXAMPLE 1 , , , in eight principle.
EXAMPLE 2 of four constitutional medicine, .
Note 1 to entry: There can be more specific or subsumed category (3.1.4) like normal body state-TM (3.3.3.1) or
abnormal body state-TM (3.3.3.1) if needed.
Note 2 to entry: body state-TM (3.3.3.1) refers to relatively static condition of body and sometimes refers to consequence
of body function-TM (3.3.3.2). Dynamic change in body is described by pathological process-TM (3.3.3.3).
Note 3 to entry: body state-TM (3.3.3.1) includes constitutional characteristics of patients, which are the
characteristics of an individual, including structural and functional characteristics, temperament, capability of
adapting to environments. See Example 2.
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3.3.3.2
body function-TM
activity or purpose natural to or intended for body structure-TM (3.3.1) or body substance-TM (3.3.2.1)
EXAMPLE 1 and function,
of , , TM> as collaborated function between and .
EXAMPLE 2 Functional interaction between (3.3.1.1) or between
(3.3.1.1) such as , .
3.3.3.3
pathological process-TM
process occurring as consequence or induction of clinical finding-TM (3.1.6)
EXAMPLE , , , intimidating the heart>.
3.3.4
causal property-TM
aetiological factor that give rise to or influence clinical finding-TM (3.1.6) according to TM-CJK
EXAMPLE (3.3.2.1) such as and , concepts
(3.1.1) related to weather factors such as , , and
; (3.3.3.3) such as and disturbance>; (3.3.3.1) such as , , , , sector excessiveness-TM>; concepts (3.1.1) related emotional state or trait such as ,
; life styles such as .
Note 1 to entry: (3.3.4) may include concepts (3.1.1) from (3.3.2.1)
and (3.3.3) when those work as aetiological factors.
Note 2 to entry: (3.3.4) also includes underlying explanatory construct or environment
for aetiological factor in TM-CJK, such as weather factors, emotional factors, life style or many other risk factors.
3.4 Semantic links (3.1.10) with domain constraints (3.1.7)
NOTE For the semantic links (3.1.10) in this Technical Specification, general semantic links (3.1.10) such
as one that connects (3.1.6) and (3.3.1) are proposed rather than
specific links such as one that connects (3.1.6) and (3.3.1.1). It is because
the user of this Technical Specification will be given more flexibility. If more specific semantic links (3.1.10) are
needed, the next revision will consider this.
3.4.1
hasAssociatedBodyStructure-TM
semantic link (3.1.10) between the (3.1.6) and the characterizing category (3.1.3)
(3.3.1)
EXAMPLE {hasAssociatedBodyStructure-TM (3.4.1)} .
3.4.2
hasAssociatedSubstance-TM
semantic link (3.1.10) between the (3.1.6) and the characterizing category (3.1.3)
(3.2.2)
EXAMPLE {hasAssociatedBodySubstance-TM(3.4.2)} .
3.4.3
hasAssociatedState-TM
semantic link (3.1.10) between the (3.1.6) and the characterizing category (3.1.3)
(3.3.3)
EXAMPLE 1 {hasAssociatedState-TM (3.4.3)} .
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