1、BSI Standards Publication Health informatics Profiling framework and classification for Traditional Medicine informatics standards development Part 1: Traditional Chinese Medicine PD ISO/TS 18790-1:2015National foreword This Published Document is the UK implementation of ISO/TS 18790-1:2015. The UK
2、participation in its preparation was entrusted to Technical Committee IST/35, Health informatics. A list of organizations represented on this committee can be obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a contract. Users are resp
3、onsible for its correct application. The British Standards Institution 2015. Published by BSI Standards Limited 2015 ISBN 978 0 580 85834 5 ICS 35.240.80 Compliance with a British Standard cannot confer immunity from legal obligations. This Published Document was published under the authority of the
4、 Standards Policy and Strategy Committee on 31 May 2015. Amendments/corrigenda issued since publication Date Text affected PUBLISHED DOCUMENT PD ISO/TS 18790-1:2015 ISO 2015 Health informatics Profiling framework and classification for Traditional Medicine informatics standards development Part 1: T
5、raditional Chinese Medicine Informatique de sant Cadre de profilage et classification pour le dveloppement de normes informatiques relatives la mdecine chinoise Partie 1: Mdecine chinoise traditionnelle TECHNICAL SPECIFICATION ISO/TS 18790-1 Reference number ISO/TS 18790-1:2015(E) First edition 2015
6、-05-01 PD ISO/TS 18790-1:2015 ISO/TS 18790-1:2015(E)ii ISO 2015 All rights reserved COPYRIGHT PROTECTED DOCUMENT ISO 2015, Published in Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electr
7、onic 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 ISOs member body in the country of the requester. ISO copyright office Ch. de Blandonnet 8 CP 401 CH-1214 Verni
8、er, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749 09 47 copyrightiso.org www.iso.org PD ISO/TS 18790-1:2015 ISO/TS 18790-1:2015(E)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
9、 . 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
10、 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
11、 The “Domain-Informatics” Matrix .10 Bibliography .12 ISO 2015 All rights reserved iii Contents Page PD ISO/TS 18790-1:2015 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
12、 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
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14、O/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 possibil
15、ity 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 pa
16、tent 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 in
17、formation about ISOs 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.iv ISO 2015 All rights reserved PD ISO/TS 18790-1:2015 ISO/TS 18790-
18、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 or
19、der 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 a
20、cross 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
21、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,
22、 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 a
23、nd with related TCs, including ISO/TC 249 and ISO/TC 46. ISO 2015 All rights reserved v PD ISO/TS 18790-1:2015 Health informatics Profiling framework and classification for Traditional Medicine informatics standards development Part 1: Traditional Chinese Medicine 1 Scope 1.1 General Traditional Chi
24、nese 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
25、 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
26、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 othe
27、r 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
28、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
29、 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 Benefi
30、ts 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 betwee
31、n standards initiatives; TECHNICAL SPECIFICATION ISO/TS 18790-1:2015(E) ISO 2015 All rights reserved 1 PD ISO/TS 18790-1:2015 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
32、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.
33、 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, t
34、he 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
35、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 SO
36、URCE: 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.3.2.42 ISO 2015 All rights reserved PD ISO/TS 18790-1:2015 ISO/TS 18790-1:2015(E) 3.7 terminological system structured human and machine-readable representation of co
37、ncepts (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
38、 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 sim
39、ple 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 a
40、nd 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 infor
41、mation, 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
42、 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. ISO 2015 All rights reserved 3 PD ISO/TS 18790-1:2015 ISO/TS 18790-1:2015(E) Figure 1 The Elements of Informatic
43、s, 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 Con
44、ceptual, 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 provide
45、s 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
46、 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 lay
47、er: 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,
48、 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
49、 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.4 ISO 2015 All rights reserved PD ISO/TS 18790-1:2015 ISO/TS 18790-1:2015(E) 4.3.1 Terminology Terminology category includes standards for TCM terminological systems, including classificat
