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1、BRITISH STANDARD BS EN 12967-1:2007 Health informatics Service architecture Part 1: Enterprise viewpoint The European Standard EN 12967-1:2007 has the status of a British Standard ICS 35.240.80 ? Licensed Copy: London South Bank University, London South Bank University, Thu Dec 20 02:34:44 GMT+00:00
2、 2007, Uncontrolled Copy, (c) BSI BS EN 12967-1:2007 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 November 2007 BSI 2007 ISBN 978 0 580 53668 7 National foreword This British Standard is the UK implementation of EN 12967-1:2007. Togethe
3、r with BS EN 12967-2:2007 and BS EN 12967-3:2007, it supersedes DD ENV 12967-1:1998 which is withdrawn.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 committee can be obtained on request to its sec
4、retary. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard cannot confer immunity from legal obligations. Amendments issued since publication Amd. No. DateComments Licensed Cop
5、y: London South Bank University, London South Bank University, Thu Dec 20 02:34:44 GMT+00:00 2007, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 12967-1 October 2007 ICS 35.240.80Supersedes ENV 12967-1:1998 English Version Health informatics - Service architecture -
6、 Part 1: Enterprise viewpoint Informatique de la sant - Architecture de service - Partie 1 : Point de vue Entreprise Medizinische Informatik - Servicearchitektur - Teil 1: Unternehmenssicht This European Standard was approved by CEN on 16 September 2007. CEN members are bound to comply with the CEN/
7、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 bibliographical references concerning such national standards may be obtained on application to the CEN Management Centre or to
8、 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 of a CEN member into its own language and notified to the CEN Management Centre has the same status as the official versio
9、ns. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spa
10、in, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2007 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national
11、Members. Ref. No. EN 12967-1:2007: E Licensed Copy: London South Bank University, London South Bank University, Thu Dec 20 02:34:44 GMT+00:00 2007, Uncontrolled Copy, (c) BSI EN 12967-1:2007 (E) 2 Contents Page Foreword4 Introduction.5 1 Scope 8 2 Normative references9 3 Terms and definitions .9 3.1
12、 System concepts .9 3.2 Concepts relating to organisation .10 3.3 Community concepts 10 3.4 Behaviour concepts 11 3.5 Policy concepts12 3.6 Accountability concepts .13 4 Symbols and abbreviations14 5 Methodology for the specification of the architecture.14 5.1 The viewpoints for the specification of
13、 the architecture.14 5.2 The HISA specification procedure.15 5.2.1 The strategic paradigm .15 5.2.2 Specification of the Enterprise viewpoint.16 5.2.3 Specification of the Information viewpoint.17 5.2.4 Specification of the Computational viewpoint17 5.3 Iterative specification18 5.4 Viewpoints speci
14、fication languages and notations.18 6 HISA overview19 6.1 General requirement19 6.2 Enterprise viewpoint .19 6.3 Information viewpoint .20 6.4 Computational viewpoint21 7 The methodology for extensions.22 8 Conformance criteria.23 8.1 Conformance of specification documents to the HISA methodology23
15、8.2 Conformance of middleware products to the HISA architectural requirements.23 9 The HISA Enterprise viewpoint 24 9.1 Introduction (informative).24 9.1.1 General24 9.1.2 The regional, inter-enterprise perspective24 9.1.3 The medical/clinical perspective25 9.1.4 The operational/clinical and organis
16、ational process model perspective26 9.1.5 The Healthcare Information Services and their complexity32 9.2 The fundamental workflows and groups of users activities to be supported by the middleware.32 9.3 General information requirements for all users activities34 9.3.1 Introduction34 9.3.2 Common att
17、ributes34 9.3.3 Extensibility34 9.3.4 Versioning 35 9.3.5 Auditing 35 9.3.6 Handling of lifecycle35 9.4 Subject of Care workflow36 Licensed Copy: London South Bank University, London South Bank University, Thu Dec 20 02:34:44 GMT+00:00 2007, Uncontrolled Copy, (c) BSI EN 12967-1:2007 (E) 3 9.4.1 Tex
18、tual description of requirements .36 9.4.2 Use case examples (informative).38 9.5 Clinical information workflow 42 9.5.1 Textual specification of requirements.42 9.5.2 Use case examples (informative).43 9.6 Activity management workflow44 9.6.1 Textual description of requirements .44 9.6.2 Use case e
19、xamples (informative).47 9.7 Resources management activities / Textual description of requirements50 9.8 Users and Authorisations management activities / Texutual description of requirements50 9.9 Classifications, coding and dictionaries management activities / Textual description of requirements52
20、Annex A (informative) Highlights on ODP.55 Annex B (informative) Rationale on the federative structure of the Health Informatics Systems architecture58 Bibliography61 Licensed Copy: London South Bank University, London South Bank University, Thu Dec 20 02:34:44 GMT+00:00 2007, Uncontrolled Copy, (c)
21、 BSI EN 12967-1:2007 (E) 4 Foreword This document (EN 12967-1:2007) has been prepared 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 national standard, either by publication of an identical text o
22、r by endorsement, at the latest by April 2008, and conflicting national standards shall be withdrawn at the latest by April 2008. This document, together with EN 12967-2 and EN 12967-3, supersedes ENV 12967-1:1998. This three part European standard is a major revision of the ENV 12967-1 that was pro
23、duced under a mandate given to CEN by the European Commission and the European Free Trade Association. This multi-part standard under the general heading: Health informatics Service architecture consists of the following parts: Part 1: Enterprise viewpoint Part 2: Information viewpoint Part 3: Compu
24、tational viewpoint Parts 1, 2 and 3 are jointly replacing ENV 12967-1:1997 Medical informatics Healthcare Information System Architecture (HISA) - Part 1: Healthcare middleware layer. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries a
25、re bound to implement this European Standard: Austria, Belgium, Bulgaria, 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, Swe
26、den, Switzerland and United Kingdom. Licensed Copy: London South Bank University, London South Bank University, Thu Dec 20 02:34:44 GMT+00:00 2007, Uncontrolled Copy, (c) BSI EN 12967-1:2007 (E) 5 Introduction Healthcare organisational structure consists of networks of centres (hospital co-operation
27、s within e.g. counties, individual hospitals, clinics etc.) distributed over the territory, characterised by a high degree of heterogeneity and diversity, from organisational, logistic, clinical, technological and even cultural perspectives. The structure of individual centres is evolving from a ver
28、tical, aggregated organisation towards the integration of a set of specialised functional areas (e.g. unit of laboratory analyses, unit of surgery), with specific needs and characteristics, nevertheless needing to share common information and to operate according to integrated workflows. Such a situ
29、ation determines two main needs which conflict with each other in a certain way. On the one hand it is necessary to 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 in
30、tegration of the overall organisation, both at local and territorial level. This integration requirement is not only related 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 optimise the current level of
31、 expenditure for health, whilst ensuring the necessary qualitative level of services to all subjects of care. The large number of databases and applications, mutually isolated and incompatible which are, already, available on the market and operational in healthcare organisations to support specific
32、 needs of users, cannot be underestimated. Even within the same centre, healthcare information systems are frequently fragmented across a number of applications, data and functionalities, isolated and scarcely consistent with each other. Under the present circumstances, the main need for care delive
33、ry organisations is to integrate and to make available the existing information assets, to make possible the integration and interoperability of existing applications, thereby protecting investments. During integration activities, continuity of service needs to be achieved whilst gradual migration o
34、f existing proprietary, monolithic systems towards the new concepts of openness and modularity occurs. The cost-effectiveness of the solutions, especially when projected on the scale of the whole healthcare organisation, represents another crucial aspect to be evaluated carefully. The goal can be ac
35、hieved through a unified, open architecture based on a middleware independent from specific applications and capable of 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 objecti
36、ves at organisational level, all aspects (i.e. clinical, organisational and managerial) of the healthcare structure must be supported by the architecture, which must be able therefore to comprise all relevant information and all business workflows, structuring them according to criteria and paradigm
37、s independent from specific sectorial aspects, temporary requirements or technological solutions. Standards and technological 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 inf
38、ormation. The architecture must be able to accommodate such requirements by allowing the specific models to be integrated with the complete information assets of the healthcare organisation and the communication messages to be “services” extracting or importing data from/to the common information as
39、 shown in Figure 1. On the basis of these considerations, the purpose of this standard is twofold: identify a methodology to describe healthcare information systems through a language, notation and paradigms suitable to facilitate the planning, design and comparison of systems; identify the fundamen
40、tal architectural aspects enabling the openness, integration and interoperability of healthcare information systems. The architecture is therefore intended as a basis both for working with existing systems as well as for the planning and construction of new systems. Licensed Copy: London South Bank
41、University, London South Bank University, Thu Dec 20 02:34:44 GMT+00:00 2007, Uncontrolled Copy, (c) BSI EN 12967-1:2007 (E) 6 Figure 1 Complementarity and positioning of the architecture with other standards and models It is pointed out that this standard does not aim at defining a unique model for
42、 clinical, organisational, managerial or administrative activities, but rather defines a set of workflows, information and services common to all healthcare information systems, relevant for any healthcare sector and usable by any application also for facilitating the mutual interworking. Similarly,
43、 the standard does not aim to represent a final, complete set of specifications. On the contrary, it formalises only fundamental aspects, identified as common in all European countries and considered to be - today - essential in any advanced healthcare information system. Specifications are formalis
44、ed, avoiding any dependency on specific technological products and/or solutions. The standard, therefore, is an open framework that - according to the specification methodology and preserving the compatibility with previous versions - can be extended during time according to the evolution of the hea
45、lthcare organisation both in the individual - national and local - contexts and through international standardisation initiatives. A European pre-standard, ENV 12967-1, was developed according to such rationale during 1993 to 1997 and has been the basis for several implementations of middleware prod
46、ucts and implemented integrations in healthcare regions. In 2000 the CEN/TC 251 Short Strategic Study on Health Information Infrastructure also identified a number of other new architectures and health infrastructure initiatives as well as the requirements and possibilities for alignment with the la
47、rge body of information model standards developed by CEN for various communication purposes. Furthermore, European standardization initiatives have delivered a number of object oriented domain models and message descriptions that include an architecture for the Electronic Health Record (EN 13606). C
48、ooperation between CEN and HL7 has also started, that, on the basis of the CEN modelling principles and HL7 Reference Information Model, has led to the definition of a set of “General Purpose Information Components”, usable for developing messages across information systems. This standard evolves an
49、d refines the ENV 12967-1 pre-standard taking into account the outcomes from its practical utilisations during the past years, as well as the other above-mentioned initiatives occurred in CEN. With such a view, the following qualifying aspects can be highlighted: architecture is described according to the methodology of ISO/IEC 10746 (all parts) Information technology - Open Distributed Processing Reference model, to provide a formal, comprehensive and non ambiguous specification s
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