1、DRAFT FOR DEVELOPMENT Medical Informatics - Healthcare Information Framework (HIF) ICs 35.240.80 DD ENV 12443:2001 NO COPING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW DD ENV 12443:ZOOl Board, was published under the Amd. No. authority of the Standards Committee and comes into effec
2、t on 15 August 2001 National foreword Date Comments This Draft for Development is the English language version of ENV 12443:1999. This publication is not to be regarded as a British Standard. It is being issued in the Draft for Development series of publications and is of a provisional nature due to
3、 the limited duration of the European Prestandard. It should be applied on this provisional basis, so that information and experience of its practical application may be obtained. Comments arising from the use of this Draft for Development are requested so that UK experience can be reported to the E
4、uropean organization responsible for its conversion into a European Standard. A review of this publication will be initiated 2 years after its publication by the European organization so that a decision can be taken on its status at the end of its three-year life. The commencement of the review peri
5、od will be notified by an announcement in Update Standards. According to the replies received by the end of the review period, the responsible BSI Committee will decide whether to support the conversion into a European Standard, to extend the life of the prestandard or to withdraw it. Comments shoul
6、d be sent in writing to the Secretary of BSI Technical Committee ISTi35, Health Informatics, at 389 Chiswick High Road, London W4 4AL, giving the document reference and clause number and proposing, where possible, an appropriate revision of the text. A list of organizations represented on this commi
7、ttee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by us
8、ing the “Find” facility of the BSI Standards Electronic Catalogue. Summary of pages This document comprises a front cover, an inside front cover, the ENV title page, pages 2 to 31 and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Q BSI
9、 08-2001 ISBN O 580 34320 O I l EUROPEAN PRESTANDARD ENV 12443 O PRNORME EUROPENNE EUROPISCHE VORNORM November 1999 ICs 11.020; 35.240.70 English version - . Medical Informatics - Healthcare Information Framework (HIF) This European Prestandard (ENV) was approved by CEN on 7 November 1996 as a prosp
10、ective standard for provisional application. The period of validity of this ENV is limited initially to three years. After two years the members of CEN Will be requested to submit their comments, paiuculariy on the question whether the ENV can be converted into a ropean an standard. CEN members are
11、required to announce the existence oi this ENV in the same way as for an EN and to make lhe ENV available promptly at national level In an appropriate form. It Is permissible to keep conflicting national standards in force (in parallel to the ENV) until the final decision about the possible conversi
12、on of the ENV into an EN is reached. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmerk, Finland, France, Germany, Qreece, Iceland, Ireland, Itely, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. 0 EUROPEAN COMMITTEE F
13、OR STANDARDIZATION EUROPISCHES KOMITEE FOR NORMUNG COMITE EUROPEN DE NORMALISATION Central Secretartat: Ne de Stassart, 36 - multiple architectures are needed to provide optimised support for different healthcare processes and healthcare users; - healthcare organisational structures, processes and t
14、echnologies evolve continuously due to external and internal pressures for change; - a topdown approach may be used. The Healthcare Information Framework also takes into account that doctors should finally have access to technology, which is not the case at the moment, and therefore shows how techno
15、logy should support their work in the future. Page 5 ENV 12443:1999 1 Scope This European hestandard establishes the Healthcare Information Framework mapping between the healthcare environment and informatics applications which support and facilitate clinical and other functions. This European Prest
16、andard specifies the set of requirements, recommendations and guidelines which apply to developments within.CENlC 25 1 urhicheieolution of healthcare domain specific informatics standards. This European Prestandard is applicable to, and will be pridly used by. healthcare domain specific infonnatics
17、standards writers and, in particular, those writing Healthcare Reference Architectures standards. as a logical 2 Normative references This European Prestandard incorporates by dated or undated reference, provisions from other publications. These normative references are cited at the appropriate plac
18、es in the text and the publications are listed hereafter. For dated references, subsequent amendments to, or revisions of any of these publications apply to this European Prestandard only when incorporated in it by amendment or revision. For undated references, the latest edition of the publication
19、referred to applies. O IS0 1087 1990 Terminology - Vocabulary IS0 7498 ISO/IEC 2382-1 ISO/IEC 2382-20 ISO/IEC 9646-1 1994 Information technology - Open Systems Interconnection - 1992 1993 1990 Infoxmation processing systems - Open Systems Interconnection - Basic Reference Model Information technolog
20、y - Vocabulary -Part 1 : Fundamental terms Information technology - Vocabulary - Part 20 System development Conformance testing methodology and framework - Part 1: General concepts Page 6 ENV 12443:1999 3 Definitions NOTE: Definitions fall into three categories: those single tem defined in the Short
21、er Oxford English Dictionary, those terms that are defined within this European Prestandard applicable to other standards and those terms used expressly for the understanding of this European h.estandard. For the purpose of this European Prestandard, the following definitions apply: 3.1 compatibiity
22、 capability of a functional unit to meet the requirements of a specified interface without appreciable modification ISOIIEC 2382-11 3.2 concept unit of thought constituted through abstraction on the basis of properties common to a set 6f objects IS0 10871 3.3 Conceptuai Architectural Framework colIe
23、ctive term for: healthcare domain view, technology view and performance requirements view NOTE: In this European Prestandard the abbreviation “CAF“ is used. 3.4 heaithcare domain View abstraction of a set of entities that are uniform in some property or properties such as knowledge, skills, expertis
24、e, or the existence of a single controlling influence which governs the whole 3.5 Healthcare Information Framework collective term for Conceptual Architecturai Framework, Healthcare Reference Architectures. their interactions and conformance testing NOTE: in this European Prestandard the abbreviatio
25、n “HIF is used. 3.6 Healthcare Reference Architecture specialisation of the Conceptual Architectural Framework (CAF) for a particular healthcare domain. NOTE: In this European Prestandard the abbreviation “RA“ is used. 3.7 interface shared boundary between two functional units defined by various cha
26、racteristics pertaininn to the functions, physical interconnections, signai exchanges and other characteristics appropriate ISOAEC 2382-11 3.8 topdown pertaining to a method or procedure that starts at the highest level of abstraction and proceeds towards the lowest level ISOAEC 2382-201 Page 7 ENV
27、12443:1999 4 Conceptual Architecturai Framework The Conceptual Architectural Framework (CAF) is the collective term for. healthcare domain view, technology view and performance requirements view. These three views are separate but interrelated: - heaithcare domain view projection of a specific healt
28、hcare domain using the concepts of objects, knowledge, processes and management of change; - technology view projection of the infonnation systems supporting the-heaiihcare domainusingaiehree layers of healthcare application, healthcare middleware and healthcare bitways; - performance requirements v
29、iew projection of the users requirements using the charactenstics of functionality, dependability and controllability. NOTE: The Conceptual Architectural Framework (CAF) translates the reality of the healthcare professional and infomation processing world into the infomation technology world. 4.1 He
30、aithcare domain view O The heaithcare domain view shall be described by modelling a structured set of concepts which may include - objects which include patients (subjects of care), agents, resources; - knowledge structured as repositories; - healthcare processes. The specific modelling formalism us
31、ed shall be declared by the developer of health- domain specific informatics standards, Models of a healthcare domain which embody any of the following concepts at any level of specialisation shall be accompanied by a suitable domain schema and show relationships to any of the following concepts whi
32、ch are embodied : e - patients (subjects of care); - agents; - resources; - healthcare domain processes; - knowledge concepts. Page 8 ENV 12443:1999 4.2 Technology view The technology view is described as three ordered layers: - healthcare application layer; - healthcare middleware layer; - healthca
33、re bitways layer. The developer of a heaftficare domain specific mfonnatics standad shall declare the specific layer) used, The interface between the specific layer used and the succeeding layer is. healthcare bitways layer to healthcare middleware layer, healthcare middeware layer to healthcare app
34、lication layer, shall be defined to allow for compatibility. NOTE: More than one specific layer may be used. Heaithcare application layer models the data flows required to support healthcare processes There are applications consisting of application-processes which perform information processing. An
35、 aspect of these application-processes and the protocols by which they communicate comprise the healthcare application layer as the highest layer of the ISO/OSI architecture. PSO 7498 J Heaithcare middleware layer models shared services required to support the application layer EXAMPLE: healthcare s
36、pecific common components and generic common components such as electronic mail, file transfer and video services. NOTE: Healthcare middleware layer is also known as basic services or enabling services. Heaithcare bitways layer models telematic infrastructure which provides services to the middlewar
37、e layer NOTE: Healthcare bitways layer is also known as networking or physical infrastnicture. Page 9 ENV 12443:1999 43 Performance requirements view The performance requirements view shall be described by modelling three fundamental characteristics: - functionality; - dependability; - controllabili
38、ty. Developers of heaithcare domain specific infomatics standards - performance; - relationship to environment. Dependability is derived from three characteristics: - security; - reliability; - safety. Controllability is derivei - control ; - measurement; - evolution. From three characteristics: a 5
39、 Healthcare Reference Architectures A Healthcare Reference Architecture (HRA) is a specialisation of the Conceptual Architectural Framework (CAF) for a particular healthcare domain which conforms to the Healthcare information Framework (HF). The relationship between Healthcare Reference Architecture
40、s (HRA) and the Conceptual Architecturai Framework (CAF) shall be declared by the developer of a heaithcare domain specific informatics standard. Page 10 ENV 12443:1999 6. Conformance requirements Developers of healthcare domain specific informatics standards shall declare the process by which confo
41、rmance is demonstrated. For the purpose of creating the conformance requirements the following basic principles taken from ISOLEC 9646-1 shall apply: - conformance requirements can be a) mandatory requirements: these are wbe o%served hiail cases; b) conditional requirements: these are to be observed
42、 if the conditions set out in the specification apply; c) optional requirements: these can be selected to suit the implementation, provided that any requirements applicable to the option are observed. - conformance requirements can be stated a) positively: they state what is required to be done; b)
43、negatively: they state what is required not to be done. Page 11 ENV 12443:1999 Annex A (informative): Conformance to the Healthcare Information Framework Conformance to this European Presandard is laid out in this annex. For case of rcading the statements that require conformance testing are listed
44、in this annex along with the appropriate clause reference. Each statement is preceded by the required test result to demonstrate conformance and succeeded by a test to demonstrate conformance. 1. The heaithcare domain view shall be described by modelling a stmctured set of concepts. (Clause4.1) . Po
45、sitive results to the following tests will demonstrate conformance: Test 1 : Does the standard contain a model? Test 2: Does the model contain a structured set of concepts? 2. The specific modelling formalism used shall be declared by the developer of a healthcare domain specific informatics standar
46、d. (Clause 4.1) Positive results to the following tests will demonstrate conformance: Test 1 : Is there a specific formalism declared ? Test 2: Has the specific formalism been named? 3. Models of a healthcare domain which embody any of the following concepts at any level of specialisation shall be a
47、ccompanied by a suitable domain schema and shall show relationships to any of the concepts which are embodied (Clause 4.1) A positive result to the following test is not required to demonstrate conformance Test 1 : Does the healthcare domain model any of the following: patients (subjects of care); a
48、gents; resources; healthcare domain processes; knowledge concepts? A positive resultfront the test above will require a positive result to the following test to demonstrate conformance. Test 2: Is there a domain schema ? Test 3: Is there a declared relationship between the domain schema and the conc
49、epts of the healthcare domain model? Page 12 ENV 12443:1999 4. The specific layer used shall be declared by the developer of a healthcare domain specific informatics standard. Clause 4.2) A positive result to the following test will demonstrate conformance. Test: Has a specific layer been named from the following: healthcare application layer; healthcare middleware layer; heaithcare bitways layer? S. The interface between the specific layer used and the succeeding layer i.e. healthcare bitways layer to healthcare middleware layer, healthcare middleware layer to
