1、BSI Standards PublicationBS ISO 14199:2015Health informatics Information models Biomedical Research IntegratedDomain Group (BRIDG) ModelBS ISO 14199:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO 14199:2015.The UK participation in its preparation was entr
2、usted 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 contract. Users are responsible for its correctapplication. The Britis
3、h Standards Institution 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 87622 6ICS 35.240.80Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 September
4、 2015.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dBS ISO 14199:2015 ISO 2015Health informatics Information models Biomedical Research Integrated Domain Group (BRIDG) ModelInformatique de sant Modle dinformation Modle de groupe de domaine intgr de recherche biomdicale (B
5、RIDG)INTERNATIONAL STANDARDISO14199First edition2015-09-15Reference numberISO 14199:2015(E)BS ISO 14199:2015ISO 14199:2015(E)ii ISO 2015 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2015, Published in SwitzerlandAll rights reserved. Unless otherwise specified, no part of this publication may
6、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, without prior written permission. Permission can be requested from either ISO at the address below or ISOs member body in the country of the r
7、equester.ISO copyright officeCh. de Blandonnet 8 CP 401CH-1214 Vernier, Geneva, SwitzerlandTel. +41 22 749 01 11Fax +41 22 749 09 47copyrightiso.orgwww.iso.orgBS ISO 14199:2015ISO 14199:2015(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Abbreviated terms
8、25 Overview of conceptual representations of the BRIDG model . 26 UML-based canonical representations 46.1 General considerations 46.2 Sub-domain UML views . 46.2.1 Common 46.2.2 Adverse event . 46.2.3 Protocol representation . 46.2.4 Regulatory . 46.2.5 Statistical analysis . 56.2.6 Study conduct .
9、 56.3 UML-based models and views . 57 RIM-based HL7 representation . 57.1 General considerations 57.2 RIM-based models . 68 Ontological OWL-based representation . 79 Other additional information . 79.1 Uses of BRIDG 79.2 Users guide for the BRIDG model 79.3 Release notes 79.4 BRIDG maintenance proce
10、ss . 79.5 BRIDG change list . 7Bibliography 8 ISO 2015 All rights reserved iiiContents PageBS ISO 14199:2015ISO 14199:2015(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing Internationa
11、l 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,
12、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
13、. 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 elem
14、ents 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 receive
15、d (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 ISOs adhere
16、nce 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 informatics.iv ISO 2015 All rights reservedBS ISO 14199:2015ISO 14199:2015(E)IntroductionThe Biomedical Rese
17、arch Integrated Domain Group (BRIDG) model was developed in response to a growing global demand for solutions to help enhance the opportunities to more closely integrate medical research information with healthcare, as well as integrate information within medical research. Currently, clinical resear
18、ch data processes use a variety of meanings, formats, and data types that inhibit the ability and potential to more widely share, integrate, and disseminate clinical research data resulting in slowing, and in many cases, dead-ending, promising drug discovery and development processes. Vast bodies of
19、 medical knowledge data either do not exist in an electronic format that is useful for todays dynamic decision support systems or are electronic, but are locked into discrete proprietary systems. Once freed, information that is locked away in static documents and discrete databases is able to flow t
20、hrough the processes of medical research. In an ideal world, critical data could be read, accessed, and aggregated by any tool at any point in the process. The tools would become the effective means of communication crossing all the existing boundaries and would enable automation of many procedures
21、that currently take place manually. Removing the time-consuming procedure of translating and transcribing data contained in dissimilar and proprietary information stores would allow scientists to focus on science and innovation.In order for all of this to become reality, medical research data need t
22、o be machine-readable and semantically interoperable.The BRIDG model provides an approach to remove semantic ambiguities present in the world of medical research. As a domain analysis model (DAM), BRIDG is intended to represent a shared view of the semantics of the domain of protocol-driven research
23、 and its associated regulatory artefacts. The need for this International Standard came as a result of various projects which contributed to its semantic content. These source projects are documented in the model through the use of tags in each class and attribute (and many an association as well).
24、These tags indicate the source project elements from which the concept was derived or to which the element maps.More information about the projects contributing to the BRIDG content can be found in the BRIDG users guide in the section entitled “Projects Contributing to the BRIDG Model” and in the BR
25、IDG mapping spreadsheet (available at: http:/www.cdisc.org). ISO 2015 All rights reserved vBS ISO 14199:2015BS ISO 14199:2015Health informatics Information models Biomedical Research Integrated Domain Group (BRIDG) Model1 ScopeThis International Standard defines a set of models collectively referred
26、 to as the Biomedical Research Integrated Domain Group (BRIDG) model for use in supporting development of computer software, databases, metadata repositories, and data interchange standards. It supports technology solutions that enable semantic (meaning-based) interoperability within the biomedical/
27、clinical research arena and between research and the healthcare arena. The clinical research semantics are represented as a set of visual diagrams which describe information relationships, definitions, explanations, and examples used in protocol-driven biomedical research. These diagrams are express
28、ed using the iconography and grammar of the Unified Modelling Language (UML), the HL7 Reference Information Model (RIM), and a Web Ontology Language (OWL).This International Standard establishes the links between protocol-driven research and its associated regulatory artefacts including the data, or
29、ganization, resources, rules, and processes involved in the formal assessment of the utility, impact, or other pharmacological, physiological, or psychological effects of a drug, procedure, process, subject characteristic, or device on a human, animal, or other subject or substance along with all as
30、sociated regulatory artefacts required for or derived from this effort, including data specifically associated with post-marketing adverse event reporting.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its app
31、lication. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO/HL7 21731, Health informatics HL7 version 3 Reference information model Release 4BRIDG Model, UML-Based Comprehensive Model Dia
32、gram1)3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.3.1adverse eventany unfavourable and unintended sign, symptom, disease, or other medical occurrence with a temporal association with the use of a medical product, procedure, or other therapy, or
33、 in conjunction with a research study, regardless of causal relationshipEXAMPLE Death, back pain, headache, pulmonary embolism, heart attack.3.2attributedescriptive feature of a class (3.3) depicted as being contained within the class3.3classconcept of primary importance, i.e. the domain of interest
34、1) Available at http:/www.cdisc.org/bridg.INTERNATIONAL STANDARD ISO 14199:2015(E) ISO 2015 All rights reserved 1BS ISO 14199:2015ISO 14199:2015(E)3.4domain analysis modelDAMabstract representation of a subject area of interest that is the basis for development of lower-level design artefacts for co
35、mputer software, databases, or data exchange standardsNote 1 to entry: In this case, the subject area of interest is protocol-driven research.3.5unified modelling languageUMLstandardized general-purpose modelling language used to specify semantic requirements for a particular domain3.6web ontology l
36、anguageOWLweb-based language designed for use in applications that need to process the content of information3.7web ontology language description logicOWL-DLfamily of knowledge representation languages or ontology languages for authoring ontololgies or knowledge bases4 Abbreviated termsCDISC Clinica
37、l Data Interchange Standards ConsortiumDAM domain analysis modelFDA Food and Drug AdministrationHL7 Health Level Seven Inc.NCI National Cancer InstituteOWL web ontology languageOWL-DL web ontology language description logicRIM Reference Information ModelSCC Semantic Coordination CommitteeUML Unified
38、 Modelling Language5 Overview of conceptual representations of the BRIDG modelThe BRIDG model is a formal domain analysis model (DAM). DAM can be defined by the following characteristics: an implementation-independent view of a domain of interest; shared understanding of concepts; use of domain term
39、inology, understandable to domain experts who may have little or no information technology knowledge, but are a primary consumers; unambiguous definitions;2 ISO 2015 All rights reservedBS ISO 14199:2015ISO 14199:2015(E) use of complex data types designed specifically for the domain of focus, in the
40、case of this International Standard, the clinical research area of healthcare; good modelling practices; built by analysts and subject matter experts who develop consensus.The BRIDG model is a conceptual model from which detailed design level artefacts for computer-related systems can be built. At p
41、resent, this domain analysis model is focused on the static (or data) semantics of the domain of clinical research that is the representation of the structures of and relationships between information within the domain. Therefore, the majority of domain semantics are represented as UML class diagram
42、s.The term “analysis” refers to the fact that the model is specifically constructed to be implementation-independent, i.e. the semantics of the model are restricted to those that characterize the “problem domain” as described by the domain experts. The BRIDG model specifies the use of tags in each c
43、lass and attribute (and many an association as well). These tags indicate the source project elements from which the concept was derived or to which the element maps.The multiple representations specified in this International Standard are in accordance with the models specified in the BRIDG model a
44、nd form an integral part of this International Standard. The following representations of the model are (see Figure 1):a) the canonical representation comprises a set of UML models (class diagrams) of all the harmonized semantics. There is one large comprehensive UML model and six sub-domain specifi
45、c model views;b) the HL7 representation comprises several HL7 models representing the harmonized semantics in accordance with ISO/HL7 21731 using unambiguous RIM constructs;c) the ontological representation comprises a single OWL file and is intended to be used for semantic validation and inferencin
46、g.Figure 1 Diagram depicting the BRIDG multi-representation approach ISO 2015 All rights reserved 3BS ISO 14199:2015ISO 14199:2015(E)6 UML-based canonical representations6.1 General considerationsThe UML representation is considered to be the canonical representation of the BRIDG model. UML offers a
47、 variety of diagrams to visually represent the semantics. BRIDG primarily uses class and instance diagrams to visualize the data semantics of clinical research.There is one large comprehensive UML model and six sub-domain specific model views. The comprehensive model is large and complex so the sub-
48、domain views were created to allow for easier access and understandability. The sub-domain views which are described more fully in 6.2 are the following:a) common;b) adverse event;c) protocol representation;d) regulatory;e) statistical analysis;f) study conduct.Other sub-domains may be defined as ne
49、eds arise.6.2 Sub-domain UML views6.2.1 CommonThis sub-domain defines the semantics that are common to all (or most) of the other sub-domains. Most of the content not only spans clinical research, but also might be common to any healthcare-related domain analysis model and includes semantics for such things as people, organizations, places, and materials.The common sub-domain is not intended for any one specific audience.6.2.2 Adverse eventThis sub-domain consists of safety issues involving people or products. It also
