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1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | DRAFT FOR DEVELOPMENT DD ENV 13606-2:2000
2、ICS 35.240.80 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Health informatics Electronic healthcare record communication Part 2: Domain term list Licensed Copy: London South Bank University, London South Bank University, Sat Dec 09 04:10:27 GMT+00:00 2006, Uncontrolled Copy
3、, (c) BSI This British Standard, having been prepared under the direction of the DISC Board, was published under the authority of the Standards Committee and comes into effect on 15 August 2000 BSI 08-2000 ISBN 0 580 35481 4 DD ENV 13606-2:2000 Amendments issued since publication Amd. No.DateComment
4、s National foreword This Draft for Development is the English language version of ENV 13606-2:2000. 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 the limited duration of the E
5、uropean 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 the UK experience can be reported to the European organization respo
6、nsible 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 period will be notified by an
7、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 should be sent in writing to th
8、e Secretary of BSI Technical Committee IST/35, 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 committee can be obtained on re
9、quest 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 using the Find facility of the
10、 BSI Standards Electronic Catalogue. Summary of pages This document comprises a front cover, an inside front cover, the ENV title page, pages 2 to 59 and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Licensed Copy: London South Bank Un
11、iversity, London South Bank University, Sat Dec 09 04:10:27 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN PRESTANDARD PRNORME EUROPENNE EUROPISCHE VORNORM ENV 13606-2 May 2000 ICS 01.040.35; 35.240.80 English version Health informatics - Electronic healthcare record communication - Part 2: Dom
12、ain term list This European Prestandard (ENV) was approved by CEN on 29 July 1999 as a prospective 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, particularly
13、 on the question whether the ENV can be converted into a European Standard. CEN members are required to announce the existence of this ENV in the same way as for an EN and to make the ENV available promptly at national level in an appropriate form. It is permissible to keep conflicting national stan
14、dards in force (in parallel to the ENV) until the final decision about the possible conversion of the ENV into an EN is reached. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherla
15、nds, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Central Secretariat: rue de Stassart, 36 B-1050 Brussels 2000 CENAll rights of exploitation in any form and by any means reserved
16、 worldwide for CEN national Members. Ref. No. ENV 13606-2:2000 E Licensed Copy: London South Bank University, London South Bank University, Sat Dec 09 04:10:27 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 2 ENV 13606-2:2000 Contents FOREWORD .4 INTRODUCTION4 1SCOPE .5 1.1GENERAL.5 1.2TARGET GROUP
17、S OF THIS DOCUMENT.6 1.3TOPICS CONSIDERED OUTSIDE THE SCOPE OF THIS DOCUMENT.6 2NORMATIVE REFERENCES7 3TERMS, DEFINITIONS AND ABBREVIATIONS.8 4PROVISIONS13 4.1 GENERAL.13 4.2 SPECIALISATIONS OF ORIGINAL COMPONENT COMPLEX.13 4.3 CATEGORIES FOR NAMES OF COMPOSITIONS AND HEADED SECTIONS14 4.3.1 General
18、.14 4.3.2 Folder.14 4.3.3 Composition.15 4.3.4 Headed section.15 4.3.5 Cluster15 4.4 ANNOTATION IDENTIFIERS15 4.4.1 General.15 4.4.2 Annotation types and Basic Descriptors.15 4.4.3 Annotation of Clusters16 4.4.4 Reliability of annotations .16 4.4.5 Coherence of Annotations with the information that
19、is annotated16 4.4.6 Exclusion of default and inheritance mechanisms16 4.5 CATEGORISATION OF NAMES OF RELATIONSHIPS WITHIN LINK SET ITEMS.16 4.6 ARCHETYPES AND FINE-GRAINED DESCRIPTORS16 4.6.1 General.16 4.6.2 Table of archetypes17 4.6.3 Fine grained descriptors.17 4.7 OTHER ENUMERATED LISTS17 4.8 F
20、ORMAT OF CROSS-REFERENCE TABLES18 5CHARACTERISTICS OF CONFORMANCE 19 5.1 GENERAL19 5.2 SPECIALISATION OF ORIGINAL COMPONENT COMPLEXES.19 5.3 CATEGORIES FOR NAMES OF COMPOSITIONS AND HEADED SECTIONS19 5.4 ANNOTATION IDENTIFIERS20 5.5 CATEGORISATION OF NAMES OF RELATIONSHIPS WITHIN LINK SET ITEMS.20 5
21、.6 ARCHETYPES AND FINE-GRAINED DESCRIPTORS21 5.7 OTHER ENUMERATED LISTS22 5.8 FORMAT OF CROSS-REFERENCE TABLES22 Licensed Copy: London South Bank University, London South Bank University, Sat Dec 09 04:10:27 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 3 ENV 13606-2:2000 ANNEX A (NORMATIVE) CATEG
22、ORIES FOR NAMES OF COMPOSITIONS AND HEADED SECTIONS.23 A.1 SET OF CATEGORIES FOR NAMES OF COMPOSITIONS23 A.2 SET OF CATEGORIES FOR NAMES OF HEADED SECTIONS25 ANNEX B (NORMATIVE) ANNOTATION IDENTIFIERS26 ANNEX C (NORMATIVE) CATEGORISATION OF NAMES OF RELATIONSHIPS WITHIN LINK SET ITEMS 28 ANNEX D (IN
23、FORMATIVE) ARCHETYPES AND FINE-GRAINED DESCRIPTORS 30 D.1 LIST OF ARCHETYPES30 D.2 LIST OF FINE-GRAINED DESCRIPTORS.33 ANNEX E (NORMATIVE) OTHER ENUMERATED TERM LISTS.37 ANNEX F (NORMATIVE) FORMAT OF CROSS-REFERENCE TABLES46 ANNEX G (INFORMATIVE) DESCRIPTIVE OVERVIEW47 G.1 BACKGROUND.47 G.2 SCOPE48
24、G.3 SPECIALISATIONS OF ORIGINAL COMPONENT COMPLEX50 G.4 SET OF CATEGORIES FOR NAMES OF COMPOSITIONS AND HEADED SECTIONS50 G.4.1 General50 G.4.2 Folder51 G.4.3 Composition51 G.4.4 Headed Section52 G.4.5 Cluster.53 G.5 ANNOTATION IDENTIFIERS.53 G.5.1 Annotation Types54 G.5.2 Annotation Guidance Notes.
25、55 G.6 CATEGORISATION OF NAMES OF RELATIONSHIPS WITHIN LINK SET ITEMS56 G.7 ARCHETYPES AND FINE-GRAINED DESCRIPTORS.57 G.8 OTHER ENUMERATED LISTS.58 G.9 FORMAT OF CROSS-REFERENCE TABLES.58 BIBLIOGRAPHY59 Licensed Copy: London South Bank University, London South Bank University, Sat Dec 09 04:10:27 G
26、MT+00:00 2006, Uncontrolled Copy, (c) BSI Page 4 ENV 13606-2:2000 Foreword This European Prestandard has been prepared by Technical Committee CEN/TC 251 “Health informatics“, the secretariat of which is held by SIS. According to the CEN/CENELEC Internal Regulations, the national standards organizati
27、ons of the following countries are bound to announce this European Prestandard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. This is Part 3 of a mult
28、ipart standard on Electronic Healthcare Record Communication. The multipart standard consists of the following parts: - Part 1: Extended architecture - Part 2: Domain term list - Part 3: Distribution rules - Part 4: Messages for the exchange of information This Prestandard was drafted using the conv
29、entions of the ISO/IEC directive part 3. Annexes A, B, C, E, F are normative. Annexes D and G are informative. Introduction For the convenience of the reader, the following conventions have been used within this document: architecture constructs generic to the overall standard are shown with initial
30、 capitalisation: class names are shown in normal font and attributes are shown in bold font; constructs and formalisms specific to this part of ENV 13606 are shown in italics. The definitions of terms used within the document are given in Clause 3 of this part of ENV 13606. The principal normative p
31、rovisions are given in Clause 4 of this part of ENV 13606. These make reference to normative tables that are given in Annexes A, B, C, E and F and to the informative tables given in Annex D. Requirements for conformance to this part of ENV 13606 are given in Clause 5. A fuller description of the mea
32、sures defined here is provided in Annex G (Informative). Readers unfamiliar with this part of ENV 13606 are strongly recommended to read this first. Licensed Copy: London South Bank University, London South Bank University, Sat Dec 09 04:10:27 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 5 ENV 13
33、606-2:2000 Health informatics - Electronic healthcare record communication - Part 2: Domain term list 1 Scope 1.1 General The Domain Termlist part of ENV 13606 provides a set of measures to support various degrees of interoperability of the EHCRs created on different systems or by different teams on
34、 the same system. These measures aim to enhance the likelihood that EHCR entries can be accessed or communicated in a way that: supports the visual interpretation of original entries by the end-user of a recipient system; facilitates record navigation; enables a limited level of amalgamation of rece
35、ived data sufficient to permit the generation of longitudinal views; and allows for a limited degree of automated processing, e.g. information retrieval. These are intended to complement the communication of structural organisation within record entries provided by the architecture (Part 1) and mess
36、age (Part 4) provisions of ENV 13606. The real world of health and health care is made up of individual clinical situations (see Clause 3), which are described by an EHCR author as clinical statements. Within an EHCR system each clinical statement will be expressed as an elementary healthcare record
37、 entry. This will usually combine a set of clinical concepts (perhaps a core concept with some qualification e.g. site, laterality) with a set of contextual information (much of which may also be represented through qualification e.g. certainty, negation). Significant meaning may be conveyed through
38、 these qualifiers, but there is no consistent means of assuring that such detailed meaning will be reproducibly communicated between dissimilar systems. The measures in this part of ENV 13606 are intended to provide a high-level and coarse- grained “shadow” representation of intended meaning that ca
39、n be applied in a consistent manner even though a wide diversity will (quite properly) continue to exist in the way clinical details are actually recorded within EHCR entries. The coarse-grained annotations on Clusters and Data Items attempts to summarise the most important aspects of this detail, p
40、rimarily to reduce the risk of serious misinterpretation. It is not appropriate for this work to attempt a complete and rigorous “mirror” of the detailed clinical entries themselves. It is therefore important to appreciate that these measures are not considered sufficient to assure the safe automati
41、c processing of EHCR data from heterogeneous sources for clinical decision making. Nevertheless, a measure is provided as a framework to build fine-grained coding systems supporting more advanced levels of interoperability in particular communities of users. The common framework will assist to avoid
42、 unnecessary diversity and will facilitate a future convergence of the local coding systems. Licensed Copy: London South Bank University, London South Bank University, Sat Dec 09 04:10:27 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 6 ENV 13606-2:2000 These proposals are presented as a set of sev
43、en measures. The measures are complementary, applied to different classes or parts of a Record Component hierarchy, and offer different degrees of interoperability. Each of these measures is defined within Clause 4 (Provisions) and Annexes A (Normative), B (Normative), C (Normative), D (Informative)
44、, E (Normative) and F (Normative) of this part of ENV 13606, and is explained in more detail in Annex G (Informative). 1.2 Target groups of this document This document is applicable to: a) developers of standards on interchange formats for messages involving clinical information; b) developers of EH
45、CR architecture standards, c) developers of categorial structures and terminological systems on sub-domains where clinical information need to be covered, d) information modellers and knowledge engineers building models for record systems, e) developers of information systems which need to handle an
46、 explicit system of clinical concepts for internal organisation, data warehouse management and middleware services, f)developers of mark-up standards for the representation of healthcare documents. 1.3 Topics considered outside the scope of this document This document is not intended to: a) provide
47、value sets to replace original values of either names or content of record components; b) represent administrative and organisational context i.e. data about the patient, the professional, and the healthcare organisation, such as names, addresses, identifiers, locations, attestation data: these topi
48、cs are addressed by other parts of ENV 13606; c) regulate how details shall be used either within names or within content of record items: in particular, it is not overlapping with categorial structures defined by CEN ENV 12264; d) define precise names for or the content of Record Components; e) pro
49、pose large or exhaustive lists of acceptable names for low-level Record Components (as, for example, provided by LOINC 18). Licensed Copy: London South Bank University, London South Bank University, Sat Dec 09 04:10:27 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 7 ENV 13606-2:2000 2 Normative references This European Prestandard incorporates by dated or undated reference, provisions from other publications. These normative references are cited in the appropriate places in the text, and the publication