1、BSI Standards PublicationPD ISO/TS 16277-1:2015Health informatics Categorial structures of clinicalfindings in traditional medicinePart 1: Traditional Chinese, Japanese andKorean medicinePD ISO/TS 16277-1:2015 PUBLISHED DOCUMENTNational forewordThis Published Document is the UK implementation of ISO
2、/TS 16277-1:2015.The UK participation in its preparation was entrusted to TechnicalCommittee IST/35, Health informatics.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contr
3、act. Users are responsible for its correctapplication. The British Standards Institution 2015. Published by BSI Standards Limited 2015ISBN 978 0 580 83593 3ICS 35.240.80Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the autho
4、rity of theStandards Policy and Strategy Committee on 31 May 2015.Amendments/corrigenda issued since publicationDate Text affectedPD ISO/TS 16277-1:2015 ISO 2015Health informatics Categorial structures of clinical findings in traditional medicine Part 1: Traditional Chinese, Japanese and Korean medi
5、cineInformatique de sant Structures catgorielles des recherches cliniques en mdecine traditionnelle Partie 1: Mdecine traditionnelle de lAsie de lestTECHNICAL SPECIFICATIONISO/TS16277-1Reference numberISO/TS 16277-1:2015(E)First edition2015-05-01PD ISO/TS 16277-1:2015 ISO/TS 16277-1:2015(E)ii ISO 20
6、15 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2015All 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, wi
7、thout prior written permission. Permission can be requested from either ISO at the address below or ISOs member body in the country of the requester.ISO copyright officeCase postale 56 CH-1211 Geneva 20Tel. + 41 22 749 01 11Fax + 41 22 749 09 47E-mail copyrightiso.orgWeb www.iso.orgPublished in Swit
8、zerlandPD ISO/TS 16277-1:2015 ISO/TS 16277-1:2015(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 13.1 General . 13.2 Core categories . 33.3 Characterizing categories 43.4 Semantic links (3.1.10) with domain constraints (3.1.7) . 63.5 Semantic links (3.1.10) a
9、dopted from ISO/TS 22789:2010 74 Categorial structure (3.1.2) for clinical findings in TM-CJK 84.1 General considerations 84.2 Principles . 84.3 Domain constraints (3.1.7) . 84.4 Category names in Clause 3 . 94.5 Adoption from and harmonization with existing standards . 9Annex A (informative) Compar
10、ison of semantic links with ISO/TS 22789:2010 11Annex B (informative) Guidance notes for using categorial structures 13Bibliography .17 ISO 2015 All rights reserved iiiContents PagePD ISO/TS 16277-1:2015 ISO/TS 16277-1:2015(E)ForewordISO (the International Organization for Standardization) is a worl
11、dwide 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
12、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 do
13、cument 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 Direct
14、ives, 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 developm
15、ent 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 spec
16、ific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 215, Health informa
17、tics.iv ISO 2015 All rights reservedPD ISO/TS 16277-1:2015 ISO/TS 16277-1:2015(E)IntroductionIn 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 o
18、ther 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. T
19、M-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
20、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
21、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 fo
22、r 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 ter
23、minologies, 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 the
24、ir formal content model which identifies TM diagnostic entities, their properties and value sets.15Hence 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)
25、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 i
26、n 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 ite
27、m 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 Terminolo
28、gies on Traditional Medicine in the Western Pacific Region is used.1Also current ICD-11 Traditional Medicine chapter(Beta Draft), which is the global reference point, will serve as a repository for examples in the next revision.15International Standard Chinese-English Basic Nomenclature of Chinese M
29、edicine of World Federation of Chinese Medicine Societies (WFCMS) was accessible and considerable for the Technical Specification.13A future revision of this Technical Specification will incorporate examples from other authorized standards when they are fully established.When a unique category is in
30、troduced 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 Ann
31、ex 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 defined by CE
32、N in EN 12264 and applied to different domains, from surgical procedures (EN 18282) to nursing care (ISO 181043) and clinical findings of the biomedicine area (ISO/TS 22789). ISO 2015 All rights reserved vPD ISO/TS 16277-1:2015 ISO/TS 16277-1:2015(E)The potential uses for this categorial structure a
33、re 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 co
34、ncerning 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 Spec
35、ification 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,
36、 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 termino
37、logy systems.vi ISO 2015 All rights reservedPD ISO/TS 16277-1:2015 Health informatics Categorial structures of clinical findings in traditional medicine Part 1: Traditional Chinese, Japanese and Korean medicine1 ScopeThis Technical Specification defines a categorial structure for clinical findings i
38、n 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 an exhaustive list of all possible characterizing concepts that could be used
39、 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 findin
40、gs 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 referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For
41、 dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) appliesISO/TS 22789:2010, Health informatics Conceptual framework for patient findings and problems in terminologies3 Terms and definitionsFor the purpo
42、ses of this document, the following terms and definitions apply.3.1 General3.1.1conceptunit of knowledge created by a unique combination of characteristicsSOURCE: ISO 1087-1:2000, definition 3.2.1TECHNICAL SPECIFICATION ISO/TS 16277-1:2015(E) ISO 2015 All rights reserved 1PD ISO/TS 16277-1:2015 ISO/
43、TS 16277-1:2015(E)3.1.2categorial structureminimal 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 fieldSOURCE: ISO 18104, definition 3.1.23.1.3characterizing categorycategory (3.1.4) which is allo
44、wed by a domain constraint (3.1.7) to specialise a concept (3.1.1) in a particular domainEXAMPLE in performedUsing ; hasLocation , “” and “” is the characterizing category (3.1.3).Note 1 to entry: (3.1.1).3.1.4categorytype of entity (3.1.8) shared by all the individual instances in existence in the
45、present, past and futureEXAMPLE 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 m
46、ore 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.N
47、ote 3 to entry: Each entity (3.1.8) instantiates some category (3.1.4).SOURCE: ISO 18104, definition 3.1.33.1.5characteristicabstraction of a property of an object or of a set of objectsSOURCE: ISO 1087-1:2000, definition 3.2.4EXAMPLE Red and gold are the characteristic (3.1.5) colours of autumn.Not
48、e 1 to entry: Characteristics (3.5) are used for describing concepts (3.1.1).3.1.6clinical findings-TMany state observed directly or indirectly concerning a patient and their relationship with the environment according to TM-CJK theoriesNote 1 to entry: Modified from ISO/TS 22789 for TM-CJK theories
49、.3.1.7domain constraintrule prescribing the set of sanctioned characteristics(3.1.9) that are valid to specialise a concept representation in a certain subject fieldEXAMPLE “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 2.3.2Note 1 to entry: The rule describes the set of sanctioned characteristics (3.1.9) by combining the semantic link (3.1.10)