1、Mai 2006DEUTSCHE NORM Normenausschuss Medizin (NAMed) im DINPreisgruppe 14DIN Deutsches Institut fr Normung e.V. Jede Art der Vervielfltigung, auch auszugsweise, nur mit Genehmigung des DIN Deutsches Institut fr Normung e.V., Berlin, gestattet.ICS 35.240.80!,dA“9659530www.din.deDDIN EN 14822-1Medizi
2、nische Informatik Allgemein verwendbare Informationskomponenten Teil 1: berblick;Englische Fassung EN 14822-1:2005Health informatics General purpose information components Part 1: Overview;English version EN 14822-1:2005Informatique de sant Unit dinformation dans les messages Partie 1: Vue densemble
3、;Version anglaise EN 14822-1:2005Alleinverkauf der Normen durch Beuth Verlag GmbH, 10772 Berlin www.beuth.deGesamtumfang 29 SeitenB55EB1B3E14C22109E918E8EA43EDB30F09CC9B7EF8DD9NormCD - Stand 2007-03 DIN EN 14822-1:2006-05 2 Nationales Vorwort Diese Norm enthlt unter Bercksichtigung des Prsidialbesch
4、lusses 13/1983 den englischen Originaltext der Europischen Norm EN 14822-1:2005-10. Die Europische Norm wurde in der WG I Information Models“ des CEN/TC 251 Medizinische Informatik“ erarbeitet, dessen Sekretariat von NEN (Niederlande) gehalten wird. Der Arbeitsausschuss NA 063-07-02 AA Interoperabil
5、itt“ des Fachbereichs 07 Medizinische Informatik“ des Normenausschusses Medizin im DIN hat an der Erarbeitung mitgewirkt. Diese Europische mehrteilige Norm legt generelle Anforderungen fr allgemein verwendbare Informationskomponenten, die in Normen zum Datenaustausch eingesetzt werden, unter gesundh
6、eits-spezifischen Aspekten fest. Die Komponenten, die durch diese Norm festgelegt werden, sind die am hufigsten gebrauchten, grundlegenden Bausteine fr derartige Normen. Diese knnen allerdings weitere Spezialisierungen und Ergnzungen fr bestimmte Anwendungen bentigen, die nicht durch die hier beschr
7、iebenen generell anwendbaren Komponenten abgedeckt werden. Dieser Teil 1 gibt einen informativen berblick ber die Reihe von Normen und beinhaltet Regeln fr die Anwendung der Komponenten, wie sie in den anderen Teilen beschrieben werden. B55EB1B3E14C22109E918E8EA43EDB30F09CC9B7EF8DD9NormCD - Stand 20
8、07-03 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 14822-1 October 2005 ICS 35.240.80 English Version Health informatics General purpose information components Part 1: Overview Informatique de sant Unit dinformation dans les messages Partie 1: Vue densemble Medizinische Informatik Allgemein
9、verwendbare Informationskomponenten Teil 1: berblick This European Standard was approved by CEN on 16 August 2005. 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
10、alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by t
11、ranslation under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greec
12、e, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre:
13、 rue de Stassart, 36 B-1050 Brussels 2005 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 14822-1:2005: EB55EB1B3E14C22109E918E8EA43EDB30F09CC9B7EF8DD9NormCD - Stand 2007-03 EN 14822-1:2005 (E) 2 Contents Page Foreword3 Introductio
14、n.4 1 Scope 5 2 Normative references5 3 Terms and definitions .5 4 Symbols and abbreviations5 5 General Purpose Information Components their design .5 5.1 Basic design objectives5 5.2 General Purpose Information Components and the Health Level Seven RIM 6 5.3 Health Level 7 (HL7) Reference Informati
15、on Model .8 6 Common features of the general purpose information components.18 7 Use of general purpose information components in communication .20 8 Localisation of the general purpose information components 20 9 Overview of the content of EN 14822-2 and EN 14822-3 .21 9.1 EN 14822-2 GPICs: Non-Cli
16、nical 21 9.2 EN 14822-3 GPICs: Clinical.21 Annex A (informative) How to read the models .22 A.1 Introduction22 A.2 Classes .22 A.3 Associations between classes.22 A.4 Generalisation/specialisation.23 Annex B (informative) HL7 RIM Class specialisations 24 B.1 Introduction24 B.2 Entity class and its s
17、pecialisations .24 B.3 Role class and its specialisations .25 B.4 Act class and its specialisations .26 Bibliography27 B55EB1B3E14C22109E918E8EA43EDB30F09CC9B7EF8DD9NormCD - Stand 2007-03 EN 14822-1:2005 (E) 3 Foreword This European Standard (EN 14822-1:2005) has been prepared by Technical Committee
18、 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 or by endorsement, at the latest by April 2006, and conflicting national standards shall be withdrawn at the
19、latest by April 2006. This is part one of a multipart standard under the heading: Health informatics - General purpose information components with the following parts: Part 1: Overview Part 2: Non-clinical Part 3: Clinical According to the CEN/CENELEC Internal Regulations, the national standards org
20、anizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
21、Slovenia, Spain, Sweden, Switzerland and United Kingdom. B55EB1B3E14C22109E918E8EA43EDB30F09CC9B7EF8DD9NormCD - Stand 2007-03 EN 14822-1:2005 (E) 4 Introduction Many previous messaging and information structure standards for health have overlapping parts with a number of objects being defined in sep
22、arate documents, sometimes with small variations making implementation of conformant applications more difficult. It therefore makes sense to define a set of general purpose components that can be used for definition of communication structures for different purposes. This approach was suggested and
23、 approved as a strategy for CEN/TC 251 in the Short Strategic Study on message standards alignment in 1999 examining a set of five European prestandards for messages. This standard is aiming to provide such a set of components and has been developed jointly with a new European Standard for Service R
24、equest and Report messages that is using the components defined herein. Another important background to the development of this European Standard has been the wish for a harmonisation of information models for health developed in Europe and the USA expressed in the collaboration agreement entered Ma
25、rch 2000 between CEN/TC 251 and HL7 (Health Level Seven, Ann Arbor. Michigan). The goal was set for a maximum degree of alignment while maintaining their independence and need to serve the business requirements of the respective markets but also to make the results available to ISO for possible inte
26、rnational standardization. HL7 have adapted a general strategy similar to CEN/TC 251 using information modelling expressed in UML (Unified Modelling Language) for their new standards and a lot of interaction and information sharing has occurred between CEN experts and HL7 in an open spirit of collab
27、oration. This European Standard includes a large number of objects which are technically similar to descriptions in draft documents of HL7, although partly described differently due to the fact that CEN is following the ISO rules for drafting and presentation of standards which HL7 is not. CEN wishe
28、s to express its gratitude towards HL7 experts for generously sharing their models with the European expert team. B55EB1B3E14C22109E918E8EA43EDB30F09CC9B7EF8DD9NormCD - Stand 2007-03 EN 14822-1:2005 (E) 5 1 Scope This European Standard specifies General Purpose Information Components to be used in s
29、tandards for information exchange and information models supporting various health specific business requirements. The components defined in this standard are the most commonly needed basic building blocks for such standardization but these components may require further specialisation and be comple
30、mented by other objects required for specific purposes not met by these generally useful components. Such standardization using these general purpose information components could be performed both on a European (CEN) level or be done nationally or for specific user communities regionally as well as
31、internationally. This European Standard provides an informative overview of this series of standards and includes rules for using the components defined in the other parts and on conformance claims. 2 Normative references Not applicable. 3 Terms and definitions For the purposes of this European Stan
32、dard, the following terms and definitions apply. 3.1 General Purpose Information Component GPIC commonly useful information component that is a specialisation of classes in an international reference information model which is intended to be used in the specification of an information service for he
33、alth or of a communication between health information systems 3.2 Health Related Service service provided to one or more persons or other living subjects aiming at improving the health status or diminishing the probability of disease service provided to one or more persons or other living subjects a
34、iming at improving the health status or diminishing the probability of disease 4 Symbols and abbreviations HL7 Health Level Seven Inc. GPIC General Purpose Information Component RIM Reference Information Model UML Unified Modelling Language 5 General Purpose Information Components their design 5.1 B
35、asic design objectives The healthcare information components which are presented in EN 14822-1 and EN 14822-2 and have been selected to meet major requirements from existing European message standards and some projected requirements for other types of information exchange. B55EB1B3E14C22109E918E8EA4
36、3EDB30F09CC9B7EF8DD9NormCD - Stand 2007-03 EN 14822-1:2005 (E) 6 It is noteworthy that this document may be useful in the design of interacting components in a local application as well as for remote communication across organisational boundaries. The information components defined in this series ca
37、n support database design, interacting objects using SOAP (Simple Object Access Protocol), COM (Common Object Model) or CORBA (Common Object Request Broker Architecture) as well as traditional store and forward messaging systems. 5.2 General Purpose Information Components and the Health Level Seven
38、RIM A General Purpose Information Component (GPIC) is a specification of a component of an information system or of a communication between such systems and we may use a number of these components in order to build a larger systems or communications. In particular, the GPICs which are the subject of
39、 this multipart standard are generated so as to provide a set of generic templates for commonly encountered concepts that are found in healthcare information systems and in the communication between such systems. Given that GPICs are a set of components that may be used in combination to describe a
40、larger whole, there is a need to have consistency in the internal design principles of the GPICs and also in the external interfaces which allow components to be combined in a consistent manner. If such principles are rigorously adhered to it becomes easier to provide tools to support the developmen
41、t of messaging and other communication systems. Achieving the necessary degree of consistency in the internal design and external interfacing of the GPICs has been facilitated by the use of the Health Level Seven (HL7) Reference Information Model (RIM). It shall be understood that this RIM is NOT a
42、model of healthcare nor of healthcare records; rather it is a high level model of healthcare information elements and the relationships between these elements. The RIM therefore provides us with an abstract model from which those elements that we need in order to design the relevant GPICs can be sel
43、ected. In effect the RIM provides the basic building blocks from which we construct larger building blocks: the GPICs (see Figure 1). B55EB1B3E14C22109E918E8EA43EDB30F09CC9B7EF8DD9NormCD - Stand 2007-03 EN 14822-1:2005 (E) 7 Figure 1 HL7 reference information model and GPIC design Figure 1 illustrat
44、es that RIM classes are being used to construct a number of different GPICs which may be further combined, either with additional RIM classes or other GPICs to make larger, more complex GPICs. An example may be used to illustrate the basics of the process. The RIM contains a concept of person which
45、could be used in GPICs which describe patients, doctors, nurses, next of kin, animal owners etc. A GPIC design will use those attributes of the Person class which are appropriate to the function of the particular GPIC and then combine this with another RIM concept of Role to produce a tailored description of the person/role that describes the person playing the role of patient, nurse etc. The RIM provides the generic classes such as Act, Entity an