ISO TC 215/SC N1205 ISO/PDTS ISO 2013 All rights reserved. Date: ISO TC 215/SC /WG 3. Secretariat: ANSI.

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1 ISO 2013 All rights reserved ISO TC 215/SC N1205 Date: ISO/PDTS ISO TC 215/SC /WG 3 Secretariat: ANSI Health Informatics Profiling Framework and Classification for Traditional Medicine Informatics Standards Development Part 1: Traditional Chinese Medicine Warning This document is not an ISO International Standard. It is distributed for review and comment. It is subject to change without notice and may not be referred to as an International Standard. Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to provide supporting documentation. Document type: Technical Specification Document subtype: Document stage: (20) Preparatory Document language: E STD Version 2.1c2

2 ISO/PDTS Copyright notice This ISO document is a working draft or committee draft and is copyright-protected by ISO. While the reproduction of working drafts or committee drafts in any form for use by participants in the ISO standards development process is permitted without prior permission from ISO, neither this document nor any extract from it may be reproduced, stored or transmitted in any form for any other purpose without prior written permission from ISO. Requests for permission to reproduce this document for the purpose of selling it should be addressed as shown below or to ISO's member body in the country of the requester: Reproduction for sales purposes may be subject to royalty payments or a licensing agreement. Violators may be prosecuted. ii ISO 2013 All rights reserved

3 ISO/PDTS Contents Page Foreword...iv Introduction...v 1 Scope General Main purpose Benefits Target groups Normative references Terms and definitions Concept Categorical structure Category Characteristic Entity Terminological system Classification Framework for TCM Informatics Standards Overview Levels of specificity Elements of Informatics Terminology Data Information system Device Business Domain Diagrams The Specificity-Informatics Matrix The Domain-Informatics Matrix...8 Bibliography...9 Annex A (informative) Reference Model for Specificity-Informatics Matrix...1 Annex B (informative) Examples for Applying this Framework...3 ISO 2013 All rights reserved iii

4 ISO/PDTS 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. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. In other circumstances, particularly when there is an urgent market requirement for such documents, a technical committee may decide to publish other types of normative document: an ISO Publicly Available Specification (ISO/PAS) represents an agreement between technical experts in an ISO working group and is accepted for publication if it is approved by more than 50 % of the members of the parent committee casting a vote; an ISO Technical Specification (ISO/TS) represents an agreement between the members of a technical committee and is accepted for publication if it is approved by 2/3 of the members of the committee casting a vote. An ISO/PAS or ISO/TS is reviewed after three years in order to decide whether it will be confirmed for a further three years, revised to become an International Standard, or withdrawn. If the ISO/PAS or ISO/TS is confirmed, it is reviewed again after a further three years, at which time it must either be transformed into an International Standard or be withdrawn. 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. ISO/TS was prepared by Technical Committee ISO/TC 215, Health Informatics, Subcommittee SC,. This second/third/... edition cancels and replaces the first/second/... edition (), [clause(s) / subclause(s) / table(s) / figure(s) / annex(es)] of which [has / have] been technically revised. iv ISO 2013 All rights reserved

5 ISO/PDTS Introduction This new work item proposal (NWIP) is a proposal to provide a common description framework for TCM informatics standards artifacts. The item targets for technical specification (TS). The target users include TCM informatics standards developers, and users of TCM informatics standards. The TS is designed to bring order to the description of TCM informatics standards artefacts. One of the key benefits of the work is that it will provide for the complexity of TCM informatics into understandable components. The aim is to reach the consensus for describing and classifying artefacts within the domain of TCM informatics standards in ISO/TC215,ISO/TC249,WHO and other SDOs. A common means of description is necessary to facilitate the coordination, communication and comparability of TCM informatics standards across and between disciplines and SDOs. The framework will be developed to address different needs of TCM informatics and compare with health informatics standards.to 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 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/TC249,ISO/ TC46. ISO 2013 All rights reserved v

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7 WORKING DRAFT ISO/PDTS Health Informatics Profiling Framework and Classification for Traditional Medicine Informatics Standards Development Part 1: Traditional Chinese Medicine 1 Scope 1.1 General The Technical Specification (TS) establishes common concepts and a vocabulary for describing the complex domain of various TCM informatics standards initiatives and their supporting artefacts. It should promote the reuse of TCM informatics knowledge and improve the identification of opportunities for TCM informatics standards alignment, collaboration and coordination. The TS describes the variety of artefacts within the domain of TCM informatics standards. This TS provides a useful descriptive tool to describe existing and developing TCM informatics standards and the corresponding health informatics standards. 1.2 Main purpose The framework will be developed to address different needs of TCM informatics and compare with health informatics standards. It is the aim of the specification to: provide the capability to comprehensively define and classify TCM informatics standards artifacts, 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 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/TC249, ISO/TC Benefits The potential benefits of this specification include: Introduction of classification concepts and terminology for TCM informatics standard artifacts, Enhancement of TCM informatics standards development coordination through the identification of potential duplication between standards initiatives, and Enhancement of global understanding of TCM informatics standards in support of their knowledge management. ISO 2013 All rights reserved 1

8 ISO/PDTS Target groups The target users include TCM informatics standards manager and reviewers, standards developers, and users of TCM informatics standards. 2 Normative references The following referenced documents contain requirements, which, through reference in this text, constitute provisions of this International Standard. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 22789:2010, Health informatics-conceptual framework for patient findings and problems in terminologies ISO/DIS 18104:2012 Health Informatics - Categorial structures for representation of nursing diagnoses and nursing actions in terminological systems pren ISO 1828 Health informatics - Categorial structure for terminological systems of surgical procedures ISO 17115:2007, Health informatics Vocabulary for terminological systems ISO :2000, Terminology work Vocabulary Part 1: Theory and application EN 12264:2005 Health Informatics - Categorial structure for systems of concepts EN :2006 Health Informatics System of concepts to support continuity of care - Part 1: Basic concepts EN 12381:2005 Health Informatics Time standards for health care specific problems 3 Terms and definitions Where there are terms that are used in this document and are not defined in this section, they are considered to be generic to the English language or not specific to this document. In cases where they are not defined in this document or generic to the English language, terms can be found at the international health informatics Standards Knowledge Management Tool and Glossary (SKMTglossary) website For the purposes of this document, the following terms and definitions apply. Note that several of these definitions are being reviewed as part of the revision of ISO 17115:2007 Health Informatics Vocabulary for terminological systems. If required, they will be updated here prior to issue of final version of this TS. 3.1 Concept Unit of knowledge created by a unique combination of characteristics. [ISO :2000, definition 3.2.1] 3.2 Categorical structure Minimal set of categories (4.3) and the valid relationships between them for representing concepts (4.1) in terminological systems (4.6) for a specified subject field. [ISO/DIS 18104:2012, definition 4.2] 2 ISO 2013 All rights reserved

9 ISO/PDTS Category Type of entity (4.5) shared by all the individual instances in existence in the present, past and future. 3.4 Characteristic Abstraction of a property of an object or of a set of objects. [ISO ] 3.5 Entity Any concrete or abstract thing of interest. [ISO/IEC , definition 6.1] 3.6 Terminological system Structured human and machine-readable representation of concepts (4.1) required directly or indirectly to describe certain domain and allow their subsequent retrieval or analysis. Also the relationship of the terminology to the specifications for organizing, communicating and interpreting such a set of concepts (4.1). [ISO/DIS 18104, definition 4.9] 4 Classification Framework for TCM Informatics Standards 4.1 Overview This Technical Specification defines a classification framework for the standardization in the area of TCM informatics, which provides a means to classify and compare TCM informatics standards. Figure 1. The major activities, actors, and information of business domains involving Traditional Chinese medicine. As shown in Figure 1, the classification framework is essentially a three-dimensional structure (i.e., cube) consisting of the Level of Specificity, the Elements of Informatics, and the Business Domain. A TCM informatics standard can be mapped into one or more cells according to its characteristics. For example, the famous SNOMED CT can be mapped into the Conceptual-Healthcare-Terminology cell. The three dimensions are briefly described as follows: ISO 2013 All rights reserved 3

10 ISO/PDTS 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 Healthcare, Management, Industry, Education, Culture, and Research. This framework provides great capacity and makes the standards artifacts related systematically. It will benefit for the planning, developing and generalizing of TCM informatics standards. 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 physician design. Conceptual: This specificity level contains classes of things of interest within TCM informatics. This level has no specifics, but contains shared fundamental meanings. Logical: This specificity level contains generalized models or informatics standards. It deals with specifics that provide coherence, without concern for technological constraints. Physical design: The specificity level contains generalized models or informatics standards. It deals with specifics that provide coherence, without concern for technological constraints. 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 Terminology This category includes standards for TCM terminological systems, such as subject headings, classification systems, encoding schemes. Characteristic standards within this category are: Vocabularies and terminology definitions (e.g., IST); Categorical structure of acupoint, clinical finding, needling, cupping, moxibustion, electroacupuncture procedure, Tuina procedure, herbal drugs; Semantic categories and relations of TCM clinical terms; Semantic types and relations of TCM language system; Content models; 4 ISO 2013 All rights reserved

11 ISO/PDTS Domain ontologies. Related health informatics standards include: Categorical structure of nursing, surgical procedure, anatomy; Hierarchical categories and semantic relation of SNOMED-CT; Semantic types and semantic relation of UMLS; Conceptual model for SNOMED-CT; LONIC; ICD 11; Data This category includes standards that define the format, structure, and meaning of various datasets, used for the construction, management, and sharing of TCM data resources. Characteristic standards within this category are: Logical and physical data models; Classification of data sets; Intrinsic characteristics models (attributes such as height, weight); Clinical data architecture; Entity relationship diagrams (include attribute, defined relationships and data typing); Data flow models; XML(eXtensible Markup Language); Document Type Definitions (DTDs); Language syntax; Data element. Related health standards include: HL7 RIM and HL7 CDA Information system This category includes standards for TCM information systems and their development, management, and running. Characteristic standards within this category are: Goals, strategies, guidelines, and plans of the development of information systems; General and context-dependent processes for developping information systems; Classification of information systems; ISO 2013 All rights reserved 5

12 ISO/PDTS Workflow models of information systems; State transition models of informations systems; Life cycle models of information systems; Management policies for information systems; Use case models of informations systems; Business rules, methodologies of information system development; Architectures and architectural models of information systems; Security models (firewall); Functional models; Test area models; Physical designs of information systems; Plans and tasks of information system development; Communication protocols of information systems; Information system designs; User manuals of information systems; Security policies of information systems; Programming language syntax; Network architectures (routers, WANs, LANs); Laboratory plans. Health informatics standards include: Business needs of EMR; ISO Architecture for information system; ISO 10781:2009 Electronic Health Record-System Functional Model Device This perspective includes standards for various TCM information and communicatin devices and their developemnt, management, and running. Characteristic standards within this category are: Business goals, guidelines, and business plans of devise manufacturing; General and context-dependent processes for devise manufacturing; 6 ISO 2013 All rights reserved

13 ISO/PDTS Classification of devices; Management policies for information systems; Business goals and plans of devices; Guidelines of device manufacturing; Logical and physical designs of devices; Communication protocols of devices; Technical architechture (firewalls, Servers, etc.); Security policies of devices; Related health informatics standards include: Personal Health Device Communication Part 1: Device Specialization -Pulse Oximeter. 4.4 Business Domain Business Domain provides differentiation of TCM informatics standards by defining the application domains of TCM informatics standards. As shown in the following table, each business domain has its own form of information flow, and therefore may require different informatics standards. The main categories are Healthcare, Management, Industry, Education, Culture, and Research. Business Domain Major Activities Major Actors Major Information Produced Healthcare Clinical Practice, Diagnostics, Treatment Healthcare Institutions TCM EHRs Management Enterprise Management Department of Management TCM Statistical Information Industry Pharmaceutical Manufacturing Pharmaceutical Manufacturer Information about Traditional Chinese medical Production/ /Resources Education Teaching, Learning, Training Universities TCM Knowledge database, Courseware, Tutorials Culture Cultural Heritage Preservation Libraries, Museums TCM literature database, TCM ancient books database E-library Research Scientific Experiments, Clinical Trials Research Institutions, Laboratories TCM Experimental Datasets, TCM clinical Trial Research data ISO 2013 All rights reserved 7

14 ISO/PDTS Diagrams The Specificity-Informatics Matrix As shown in the following table, the Specificity-Informatics Matrix including two dimensions: Levels of specificity (contains three rows) and Elements of Informatics (contains four columns). This matrix provides a means of identifying and classifying the content of an informatics standard. There are 12 cells, each of which lies at the intersection of an element of informatics and a level of specificity. This classification matrix provides a classfication system for standards with a focus on characteristics of informatics. Informatics Terminology Data System Device Specificity Conceptual -Conceptual Model - Data Model - Requirements - Requirements Logical -Ontology - E-R Model - Architecture - Functional Model Physical -Encoding Scheme - Data Element -Programming Interface -Communication Protocol - Device Interface The Domain-Informatics Matrix As shown in the following table, the Domain-Informatics Matrix including two dimensions: Business Domain (contains six rows) and Elements of Informatics (contains four columns). This matrix provides a means of identifying and classifying the content of an informatics standard. Domain Healthcare Management Industry Education Culture Research Informatics Terminology Data System Device SNO-TCM EHR Clinical Decision- Support TCM statistical indicators Statistical Data Healthcare Information System TCM decoction pieces Pharmaceutical Data GMP information --- system Unified TCM language TCM education data E-Learning system --- system (U-TCM-LS) resources TCM Subject Heading (TC-MeSH) Clinical Research terminology TCMedLine E-Library/E-Museum --- TCM Clinical Data Interchange Standards (TCM-CDISC) TCM Clinical Trial records TCM Diagnostic Device interoperability --- There are 24 cells, each of which lies at the intersection of an element of informatics and a business domain. This classification matrix provides a classification system for TCM informatics standards that takes into consideration both domain and informatics factors ISO 2013 All rights reserved

15 ISO/PDTS Bibliography [1] International Health Terminology Standards Development Organization, SNOMED Clinical Terms [Last accessed 20th October 2011]. [2] World Health Organisation western pacific region(2007) WHO International Standard Terminologies on Traditional Medicine in the Western Pacific Region, WHO. [3] ISO/AWI TS 17948, Traditional Chinese medicine literature metadata [4] ISO/AWI TS 17938, Health informatics -- Semantic network framework of traditional Chinese medicine language system [5] GB/T , Basic theory nomenclature of traditional Chinese medicine [6] GB/T , Classification and codes of diseases and ZHENG Of Traditional Chinese Medicine [7] GB/T , Clinic terminology of traditional Chinese medical diagnosis treatment-diseases [8] GB/T , Clinic terminology of traditional Chinese medical diagnosis treatment-syndromes [9] GB/T , Clinic terminology of traditional Chinese medical diagnosis treatment-therapeutic methods [10] EN 12264:2005, Health Informatics Categorial structure for systems of concepts [11] ISO 17115:2007, Health informatics Vocabulary for terminological systems ISO 2013 All rights reserved 9

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17 WORKING DRAFT ISO/PDTS Annex A (informative) Reference Model for Specificity-Informatics Matrix The following table gives recommendations on how to map informatics standards into the Specificity-Informatics Matrix. In each cell, the TCM informatics standard artifacts and their related health informatics standards is shown. Informatics Terminology Data Information system Device Level of Specificity Conceptual -Vocabularies and terminology definitions (e.g - TCM Data models, conceptual and associative -Goals, strategies, guidelines, and plans of the - Business goals, guidelines, and IST) - classification of data sets development of information systems business plans of devise -Categories of TCM clinical terms - General and context-dependent processes for manufacturing -Semantic types of TCM language system (Related Health Informatics Standards: HL7 developping information systems - General and context-dependent RIM) - Classification of information systems processes for devise manufacturing (Related Health Informatics Standards: ICD10, - Workflow models of information systems - Classification of devices Hierachical categories for SNOMED-CT, - State transition models of informations systems - Management policies for information semantic types of UMLS) - Life cycle models of information systems systems - Management policies for information systems (Related HI standards: Personal (Related HI standards: Business needs of EMR, Health Device Communication - Part ISO Architecture for information system) 10404: Device Specialization - Pulse Oximeter ISO 2013 All rights reserved 1

18 ISO/PDTS Content model -Logical data model - Use case models of informations systems - Business goals and plans of devices -Categorial structure of - Intrinsic characteristics models (attributes such - Business rules - Guidelines of device manufacturing Logical Acupoint/clinical finding/needling/cupping/ as height, weight) - Methodologies of information system - Logical designs of devices moxibustion /electro-acupunture - Clinical data architecture development procedure/tuina procedure/herbal drugs. -Entity relationship diagrams - Architectures and architectural models of - Semantic relation of TCM language system. (include attribute, information systems - Semantic relation of SNO-TCM. defined relationships and data typing) - Security models (firewall) - Domain ontologies - Data flow models - Functional models - Test area models (Related Health Informatics standards: (Related HI standards: HL7 CDA) Categorial structure of nursing/ surgical (Related HI standards: ISO 10781:2009 procedure/ anatomy,semantic relation of Electronic Health Record-System Functional SNOMED-CT,Semantic relation of Model) UMLS,Conceptual model for SNOMED- CT,LONIC,ICD11) Physical - OWL (Web Ontology Language) -XML(eXtensible Markup Language) -Physical designs of information systems - Physical designs of devices Design - SKOS (Simple Knowledge Organization - Document Type Definitions (DTDs) - Plans and tasks of information system - Plans and tasks of device System) -Physical data model development manufacturing -data elements - Communication protocols of information - Communication protocols of devices -Language syntax, e.g., Data Definition systems Medical facility Language (DDL) - Information system designs - Technical architechture (firewalls, - Data elements - User manuals of information systems Servers, etc.) - Security Policies of information systems - Security Policies of devices - Programming language syntax - Laboratory plans - Network architectures (routers, WANs, LANs) - Laboratory plans 2 ISO 2013 All rights reserved

19 WORKING DRAFT ISO/PDTS Annex B (informative) Examples for Applying this Framework This annex describes the examples for classifying TCM informatics standards using this framework. In this following table, we classify a set of terminology standards with the dimension of business domain. Terminology GB/T Classification and codes of diseases and ZHENG Of Traditional Chinese Medicine Healthcare (EHR) GB/T Clinic terminology of traditional Chinese medical diagnosis treatment- Diseases GB/T Clinic terminology of traditional Chinese medical diagnosis treatment- Syndromes Traditional Chinese Medicine -Categories of TCM Clinical Terminological System Management (TCM statistics) Industry Education (TCM Knowledge) Culture (TCM literature) Traditional Chinese Medicine and Materia Medica Subject Headings Chinese terms in traditional Chinese medicine and pharmacy International standard Chinese-English basic nomenclature of Chinese medicine. ISO/AWI TS Health informatics -- Semantic network framework of traditional Chinese medicine language system Chinese Traditional Medicine and Materia Medica Subject Headings ISO/AWI TS Health informatics -- Semantic network framework of traditional Chinese medicine language system Traditional Chinese Medicine and Materia Medica Subject Headings ISO/AWI TS Traditional Chinese medicine literature metadata GB/T Basic theory nomenclature of traditional Chinese medicine Research (TCM clinical trial) Chinese Traditional Medicine and Materia Medica Subject Headings Chinese terms in traditional Chinese medicine and pharmacy ISO 2013 All rights reserved 3

20 ISO/PDTS In this following table, we classify a set of terminology standards with the dimension of business domain. Specificity Informatics Terminology Data Information System Device Conceptual -ICD10, - HL7 RIM - ISO Architecture - Personal Health Device -Hierachical categories for information Communication Part for SNOMED-CT, system 10404: Device -Semantic types of Specialization -Pulse UMLS Oximeter Logical - Semantic relation of - HL7 CDA - ISO 10781:2009 SNOMED-CT, Electronic Health - Semantic relation of Record-System UMLS, - Conceptual model for Functional Model) ---- SNOMED-CT, - LONIC, - ICD11 Physical Design - OWL (Web Ontology -XML Language) - SKOS (Simple -DTDs --- Knowledge Organization System) 4 ISO 2013 All rights reserved