1、 Reference number ISO 13606-3:2009(E) ISO 2009INTERNATIONAL STANDARD ISO 13606-3 First edition 2009-02-01 Health informatics Electronic health record communication Part 3: Reference archetypes and term lists Informatique de sant Communication du dossier de sant informatis Partie 3: Archtypes de rfre
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7、6-3:2009(E) ISO 2009 All rights reserved iii Contents Page Foreword iv Introduction v 1 Scope . 1 2 Terms and definitions. 1 3 Abbreviations 2 4 Conformance. 3 5 Term lists . 3 5.1 Introduction . 3 5.2 Term list SUBJECT_CATEGORY, Class ENTRY, attribute subject_of_information_category. 3 5.3 Term lis
8、t ITEM_CATEGORY, Class ITEM, attribute item_category . 4 5.4 Term list VERSION_STATUS, Class AUDIT_INFO, attribute version_status 5 5.5 Term list MODE, Class FUNCTIONAL_ROLE, attribute mode 6 5.6 Term list ACT_STATUS, Class ENTRY, attribute act_status 7 5.7 Term list LINK_NATURE, Class LINK, attribu
9、te nature. 8 5.8 Term list LINK_ROLE, Optional term list for LINK attribute role (informative) 9 5.9 Term list STRUCTURE_TYPE, Class CLUSTER, attribute structure_type 16 Annex A (informative) Reference archetypes 17 Annex B (informative) Clinical example of the mapping between HL7 v3 and the ISO 136
10、06 series 36 Bibliography . 46 ISO 13606-3:2009(E) iv ISO 2009 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out throug
11、h 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 organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborat
12、es closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standard
13、s. 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 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of thi
14、s document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 13606-3 was prepared by Technical Committee ISO/TC 215, Health informatics. ISO 13606 consists of the following parts, under the general title Health informatics Elect
15、ronic health record communication: Part 1: Reference model Part 2: Archetype interchange specification Part 3: Reference archetypes and term lists Part 5: Interface specification The following part is in preparation: Part 4: Security ISO 13606-3:2009(E) ISO 2009 All rights reserved v Introduction 0.
16、1 Summary This part of ISO 13606 contains two kinds of specification: 1) a normative set of (coded) term lists that each define a controlled vocabulary for a Reference Model attribute that is defined in ISO 13606-1; 2) an informative set of reference archetypes, expressed as mappings that each speci
17、fy how the Reference Model in ISO 13606-1 should be used to represent information originating from the set of HL7 Version 3 Acts that form part of the Clinical Statement Pattern (Draft Standard for Trial Use), and the specializations of ENTRY that are defined in the openEHR Reference Model. 0.2 Term
18、 lists Each term list is referenced by its corresponding attribute as an invariant constraint in ISO 13606-1, by referring to its term list name. For each term list, every code value is accompanied by a phrase and description; however, in each case it is the code that is to be used as the Reference
19、Model attribute value. Language translations of the phrase and description will therefore not affect the instances of RECORD_COMPONENT that are communicated using this part of ISO 13606. Should any revision to these term lists prove necessary in the future, a technical revision to this part of ISO 1
20、3606 will be required. Such a revised version must specify an updated Reference Model identifier that shall then be used as the value of the rm_id of an EHR_EXTRACT, to inform the recipient of the version of this part of ISO 13606 that was used in its creation. A cross-mapping of the term list for L
21、INK.role to HL7 actRelationship typecodes is also provided, for the convenience of those wishing to adopt or interface this part of ISO 13606 with HL7 Version 3. This is part of a longer-term vocabulary harmonization project between the health informatics standards development organizations (SDOs),
22、and might therefore be extended in the future via other publications, such as the planned HL7-13606 Implementation Guide (see below). It is therefore informative in this document. 0.3 Reference archetypes Each reference archetype is represented in this part of ISO 13606 as a mapping correspondence t
23、able to indicate the way in which the ITEM structure within an ISO 13606-1 ENTRY is to be used to represent the classes and attributes of relevant HL7 v3 and openEHR classes. These two external models have been chosen for inclusion as these are the most likely internationally used source models from
24、 which fine-grained clinical data may need to be transformed into this document for communication. These reference archetypes are included as an aid to those adopting this part of ISO 13606 and wishing to transform Electronic Health Record (EHR) data from existing HL7 v3 or openEHR instances or mess
25、ages. It is recognised that full two-way interoperability between these various representations requires more detail, including rich vocabulary and data type harmonization, and a corresponding set of technical artefacts such as eXtensible Markup Language (XML) Schemata and Extensible Stylesheet Lang
26、uage Transformation (XSLT) scripts. Such interoperability is very much the goal of current SDO harmonization efforts, and will be published as an HL7-13606 Implementation Guide, possibly as an open-access and regularly updated resource. However, the outstanding work required to achieve this level of
27、 interoperability might take up to another year after publication of this part of ISO 13606. It has therefore been decided to offer what does exist towards harmonization in an informative form within this part of ISO 13606, as an aid to those already needing to make such data transformations. A work
28、ed example of the HL7 v3 to ISO 13606 mapping is given in Annex B. INTERNATIONAL STANDARD ISO 13606-3:2009(E) ISO 2009 All rights reserved 1 Health informatics Electronic health record communication Part 3: Reference archetypes and term lists 1 Scope This part of ISO 13606 is for the communication o
29、f part or all of the electronic health record (EHR) of a single identified subject of care between EHR systems, or between EHR systems and a centralized EHR data repository. It may also be used for EHR communication between an EHR system or repository and clinical applications or middleware componen
30、ts (such as decision support components) that need to access or provide EHR data, or as the representation of EHR data within a distributed (federated) record system. This part of ISO 13606 (EHR Communications Standard Series), defines term lists that each specify the set of values that particular a
31、ttributes of the Reference Model defined in ISO 13606-1 may take. It also defines informative reference archetypes that correspond to ENTRY-level compound data structures within the Reference Models of openEHR and HL7 Version 3, to enable those instances to be represented within a consistent structu
32、re when communicated using this part of ISO 13606. 2 Terms and definitions For the purposes of this document, the following terms and definitions apply. 2.1 archetype instance individual metadata class instance of an Archetype Model, specifying the clinical concept and the value constraints that app
33、ly to one class of Record Component instance in an electronic health record extract 2.2 clinical information information about a person, relevant to his or her health or health care 2.3 committed information that has been persisted within an electronic health record system and which constitutes part
34、 of the electronic health record for a subject of care 2.4 committer agent (party, device or software) whose direct actions have resulted in data being committed to an electronic health record 2.5 composer agent (party, device or software) responsible for creating, synthesising or organizing informa
35、tion that is committed to an electronic health record ISO 13606-3:2009(E) 2 ISO 2009 All rights reserved2.6 electronic health record extract part or all of the electronic health record for a subject of care, communicated in compliance with the ISO 13606 series of International Standards 2.7 electron
36、ic health record system system for recording, retrieving and manipulating information in electronic health records 2.8 entries health record data in general (clinical observations, statements, reasoning, intentions, plans or actions) without particular specification of their formal representation, h
37、ierarchical organization or of the particular Record Component class(es) that might be used to represent them 2.9 Record Component part of the electronic health record extract of a single subject of care, represented as a node within a hierarchical data structure conforming to the ISO 13606 series o
38、f International Standards 2.10 state (of a process) condition or situation during the lifecycle of an object during which it satisfies some condition, performs some activity or waits for some event ISO/TS 18308:2004, definition 3.39 2.11 subject of care patient person scheduled to receive, receiving
39、, or having received health care 3 Abbreviations CEN Comit Europen de Normalisation (European Committee for Standardization) CEN/TC 251 CEN Technical Committee 251, Health informatics EHR electronic health record EU European Union HISA Health Information Systems Architecture HL7 Health Level Seven I
40、SO International Organization for Standardization UML Unified Modeling Language XML Extensible Mark-up Language ISO 13606-3:2009(E) ISO 2009 All rights reserved 3 4 Conformance When electronic health record information is to be communicated using the ISO 13606 series of International Standards and w
41、here an attribute of the Reference Model defined in ISO 13606-1 requires a value to be taken from a bounded set of codes from a named term list, the code shall be one of those defined in Clause 5 of this part of ISO 13606 for the correspondingly named term list. 5 Term lists 5.1 Introduction The Ref
42、erence Model defined in ISO 13606-1 defines several attributes whose values are to be selected from a fixed list of values. This clause defines those value lists (term lists) for each of those attributes. Attributes not included in this clause may take any value that conforms to the data type and in
43、variant specifications defined in ISO 13606-1. 5.2 Term list SUBJECT_CATEGORY, Class ENTRY, attribute subject_of_information_category This attribute provides a coarse-grained definition of the person who is the subject of an ENTRY. The default value is DS00 (the patient, or subject of care). A more
44、fine-grained definition of the information subject (such as the precise relative with a family history) can be specified through the ENTRY.subject_of_information.relationship attribute. Code Meaning Description DS00 subject of care the subject of care DS01 relative of subject of care any human relat
45、ive, without limitation to biological or adoptive relatives DS02 foetus or neonate or infant the baby or babies being described by an ENTRY in the EHR of the mother DS03 mother the mother of a foetus or neonate, if being described in the EHR of a baby (e.g. during pregnancy) DS04 donor The donor of
46、an organ or body specimen being described by an ENTRY in the EHR of the recipient DS05 unrelated person any other person not related to the subject of care, such as an employer, friend, carer NOTE If ENTRY.subject_of_information_category is null, the value DS00 is assumed. ISO 13606-3:2009(E) 4 ISO
47、2009 All rights reserved5.3 Term list ITEM_CATEGORY, Class ITEM, attribute item_category Some kinds of ENTRY might have a complex internal data structure, comprising the main values of interest and other kinds of context. This optional attribute in the Reference Model permits the communication of th
48、e category of information for each ELEMENT or CLUSTER. This may be of value to a receiving EHR system, to enable easier processing of the data. Code Meaning Description IC01 Principal or “core” value The CLUSTERS or ELEMENTS that contain the main values that are the subject of the ENTRY IC02 Supplem
49、entary/complementary details about the value Contextual information that most users would regard as necessary to interpret the core values IC03 Patient state/circumstances Contextual information about the subject of cares circumstances when an observation is made, e.g. fasting, standing IC04 Method details Contextual information about the method of an observation, such as the technique or device used IC05 Clinical reasoning Any explanatory information provided by the author to explain a clinical decision or interpr
