1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 12967-1:2011Health informatics Service architecturePart 1: Enterprise viewpoint (ISO 12967-1:2009)BS EN ISO 12967-1:2011 BRITISH STANDARDNational forewordThis British S
2、tandard is the UK implementation of EN ISO 12967-1:2011. It is identical to ISO 12967-1:2009. It supersedes BS EN 12967-1:2007, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee IST/35, Health informatics.A list of organizations represented on this commi
3、ttee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. BSI 2011 ISBN 978 0 580 72272 1 ICS 35.240.80 Compliance with a British Standard cannot confer immunity from le
4、gal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 April 2011.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 12967-1 March 2011 ICS 35.240.80 Supersedes EN 12967-1
5、:2007English Version Health informatics - Service architecture - Part 1: Enterprise viewpoint (ISO 12967-1:2009) Informatique de sant - Architecture de service - Partie 1: Point de vue dentreprise (ISO 12967-1:2009) Medizinische Informatik - Servicearchitektur - Teil 1: Unternehmenssicht (ISO 12967-
6、1:2009) This European Standard was approved by CEN on 10 March 2011. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographic
7、al references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility
8、of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hung
9、ary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centr
10、e: Avenue Marnix 17, B-1000 Brussels 2011 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 12967-1:2011: EBS EN ISO 12967-1:2011 EN ISO 12967-1:2011 (E) 3 Foreword The text of ISO 12967-1:2009 has been prepared by Technical Comm
11、ittee ISO/TC 215 “Health informatics” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 12967-1:2011 by Technical Committee CEN/TC 251 “Health informatics” the secretariat of which is held by NEN. This European Standard shall be given the status of a natio
12、nal standard, either by publication of an identical text or by endorsement, at the latest by September 2011, and conflicting national standards shall be withdrawn at the latest by September 2011. Attention is drawn to the possibility that some of the elements of this document may be the subject of p
13、atent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN 12967-1:2007. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this Europ
14、ean Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and th
15、e United Kingdom. Endorsement notice The text of ISO 12967-1:2009 has been approved by CEN as a EN ISO 12967-1:2011 without any modification. BS EN ISO 12967-1:2011ISO 12967-1:2009(E) ISO 2009 All rights reserved iiiContents Page Foreword .v Introductionvi 1 Scope1 2 Normative references2 3 Terms an
16、d definitions .2 3.1 System concepts .2 3.2 Concepts relating to organization .3 3.3 Community concepts 3 3.4 Behaviour concepts 4 3.5 Policy concepts .5 3.6 Accountability concepts.5 4 Symbols and abbreviations7 5 Methodology for the specification of the architecture 7 5.1 Viewpoints for the specif
17、ication of the architecture7 5.2 The HISA specification procedure.8 5.2.1 The Strategic Paradigm 8 5.2.2 Specification of the enterprise viewpoint .9 5.2.3 Specification of the information viewpoint.9 5.2.4 Specification of the computational viewpoint10 5.3 Iterative specification10 5.4 Viewpoints s
18、pecification languages and notations.11 6 HISA overview11 6.1 General requirement .11 6.2 Enterprise viewpoint .12 6.3 Information viewpoint .13 6.4 Computational viewpoint14 7 Methodology for extensions.14 8 Conformance criteria 15 8.1 Conformance of specification documents to the HISA methodology
19、.15 8.2 Conformance of middleware products to the HISA architectural requirements 15 9 The HISA Enterprise viewpoint 16 9.1 Introduction (informative).16 9.1.1 General .16 9.1.2 The regional, inter-enterprise perspective17 9.1.3 The medical/clinical perspective .17 9.1.4 The operational/clinical and
20、 organizational process model perspective19 9.1.5 The Healthcare Information Services and their complexity25 9.2 The fundamental workflows and groups of users activities to be supported by the middleware.25 9.3 General information requirements for all users activities .26 9.3.1 Introduction26 9.3.2
21、Common attributes26 9.3.3 Extensibility .27 9.3.4 Versioning 27 9.3.5 Auditing 27 9.3.6 Handling of life cycle.27 9.4 Subject of care workflow 28 BS EN ISO 12967-1:2011ISO 12967-1:2009(E) iv ISO 2009 All rights reserved9.4.1 Textual description of requirements28 9.4.2 Use-case examples (informative)
22、.30 9.5 Clinical information workflow.33 9.5.1 Textual specification of requirements.33 9.5.2 Use-case examples (informative).34 9.6 Activity management workflow35 9.6.1 Textual description of requirements35 9.6.2 Use-case examples (informative).38 9.7 Resources management activities/Textual descrip
23、tion of requirements 40 9.8 Management activities for users and authorizations/Textual description of requirements 41 9.9 Classifications, coding and dictionaries management activities/Textual description of requirements 42 Annex A (informative) Highlights of Open Distributed Processing (ODP)45 Anne
24、x B (informative) Rationale for the federative structure of the Health Informatics Service Architecture48 Bibliography 51 BS EN ISO 12967-1:2011ISO 12967-1:2009(E) ISO 2009 All rights reserved vForeword ISO (the International Organization for Standardization) is a worldwide federation of national st
25、andards 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 o
26、rganizations, 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 giv
27、en 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
28、75 % of the member bodies casting a vote. 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 12967-1 was prepared by Technical Committee ISO/TC 215,
29、 Health informatics, based on the European Standard EN 12967-1:2007 with minor editorial amendments. ISO 12967 consists of the following parts, under the general title Health informatics Service architecture: Part 1: Enterprise viewpoint Part 2: Information viewpoint Part 3: Computational viewpoint
30、BS EN ISO 12967-1:2011ISO 12967-1:2009(E) vi ISO 2009 All rights reservedIntroduction The healthcare organizational structure consists of networks of centres (hospital cooperations within, for example, counties, individual hospitals, clinics, etc.) distributed over the territory, characterized by a
31、high degree of heterogeneity and diversity, from organizational, logistic, clinical, technological and even cultural perspectives. The structure of individual centres evolves from a vertical, aggregated organization towards the integration of a set of specialized functional areas (e.g. unit of labor
32、atory analyses, unit of surgery), with specific needs and characteristics, nevertheless needing to share common information and to operate according to integrated workflows. Such a situation determines two main needs which conflict with each other in a certain way. On the one hand it is necessary to
33、 effectively support the specific requirements of each unit or user in the most appropriate and cost-effective way whilst, on the other hand, it is vital to ensure the consistency and integration of the overall organization, at local and territorial levels. This integration requirement is not only r
34、elated to the need for improving clinical treatments to the subject of care but is also demanded by the urgent necessity of all countries to control and optimize the current level of expenditure for health, whilst ensuring the necessary qualitative level of services to all subjects of care. The larg
35、e number of databases and applications, mutually isolated and incompatible, which are already available on the market and operational in healthcare organizations to support specific needs of users, cannot be underestimated. Even within the same centre, healthcare information systems are frequently f
36、ragmented across a number of applications, data and functionalities, isolated and scarcely consistent with each other. In the present circumstances, the main need for care delivery organizations is to integrate and to make available the existing information assets, and to make possible the integrati
37、on and interoperability of existing applications, thereby protecting investments. During integration activities, continuity of service needs to be achieved whilst gradual migration of existing proprietary, monolithic systems towards the new concepts of openness and modularity occurs. The cost-effect
38、iveness of the solutions, especially when projected on the scale of the whole healthcare organization, represents another crucial aspect to be evaluated carefully. The goal can be achieved through a unified, open architecture based on middleware independent from specific applications and capable of
39、integrating common data and business logic and of making them available to diverse, multi-vendor applications through many types of deployment. According to the integration objectives at organizational level, all aspects (i.e. clinical, organizational and managerial) of the healthcare structure must
40、 be supported by the architecture, which must therefore be able to comprise all relevant information and all business workflows, structuring them according to criteria and paradigms independent from specific sectorial aspects, temporary requirements or technological solutions. Standards and technolo
41、gical solutions already exist and will continue to be defined for supporting specific requirements, both in terms of in situ user operations and with respect to the movement of information. The architecture must be able to accommodate such requirements by allowing the specific models to be integrate
42、d with the complete information assets of the healthcare organization and the communication messages to be “services” extracting or importing data from/to the common information shown in Figure 1. On the basis of these considerations, the purpose of ISO 12967 is twofold: identify a methodology to de
43、scribe healthcare information systems through a language, notation and paradigms suitable to facilitate the planning, design and comparison of systems; identify the fundamental architectural aspects enabling the openness, integration and interoperability of healthcare information systems. The archit
44、ecture is therefore intended as a basis both for working with existing systems and for the planning and construction of new systems. BS EN ISO 12967-1:2011ISO 12967-1:2009(E) ISO 2009 All rights reserved viiCommon, neutral, HISA model(e.g. RIM, DICOM, GPICs, etc.)Common, neutral, organisation - wide
45、 HISA modelSpecific models Part 2 specifies the information viewpoint of the architecture; Part 3 specifies the computational viewpoint of the architecture. Each part is self-consistent and is also independently utilizable for the intended purposes by different types of users (this part being more o
46、riented to the managerial level, Parts 2 and 3 being more dedicated to the design activities). Nevertheless, it must be understood that they represent three aspects of the same architecture. Mutual references therefore exist between the different parts and evolutions of the individual documents must
47、 be carried out according to the defined methodology to preserve the overall integrity and consistency of the specification. The overall architecture is formalized according to ISO/IEC 10746 (all parts) and is therefore structured through the following three viewpoints. a) Enterprise viewpoint: spec
48、ifies a set of fundamental common requirements at enterprise level with respect to the organizational purposes, scopes and policies that must be supported by the information and functionality of the middleware. It also provides guidance on how one individual enterprise (e.g. a regional healthcare au
49、thority, a large hospital or any other organization where this model is applicable) can specify and document additional specific business requirements, with a view to achieving a complete specification, adequate for the characteristics of that enterprise. Enterprise viewpoint is specified in this part of ISO 12967. b) Information viewpoint: specifies the fundamental semantics of the information model to be implemented by the middleware to integrate the common enterprise data and to support the enterprise requirements formalized in
