Health informatics - Electronic health record communication - Part 1: Reference model

This European Standard specifies the communication of 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 centralised EHR data repository.
It may also be used for EHR communication between an EHR system or repository and clinical applications or middleware components (such as decision support components) that need to access or provide EHR data.
This European Standard will predominantly be used to support the direct care given to identifiable individuals, or to support population monitoring systems such as disease registries and public health surveillance. Uses of health records for other purposes such as teaching, clinical audit, administration and reporting, service management, research and epidemiology, which often require anonymisation or aggregation of individual records, are not the focus of this European Standard but such secondary uses might also find the standard useful.
This Part 1 of the multipart series is an Information Viewpoint specification as defined by the Open Distributed Processing – Reference model: Overview (ISO/IEC 10746-1). This European Standard is not intended to specify the internal architecture or database design of EHR systems.

Medizinische Informatik - Kommunikation von Patientendaten in elektronischer Form - Teil 1: Referenzmodell

Informatique de la santé - Communication des dossiers de santé informatisés - Partie 1 : Modèle de référence

La présente norme spécifie la communication de tout ou partie du dossier informatisé de santé (DIS) d'un seul sujet de soins identifié entre systèmes de DIS, ou entre des systèmes de DIS et un réceptacle de données de DIS centralisé.
Elle peut également être utilisée pour la communication de DIS entre un système ou réceptacle de DIS et des applications médicales ou composants intergiciels (tels que des composants d'aide à la prise de décision) nécessitant d'avoir d'accès aux ou de fournir des données DIS.
La présente Norme européenne est destinée à être principalement utilisée pour prendre en charge les soins directs dispensés à des personnes identifiables, ou les systèmes d'observation de la population tels que les registres de maladies et l'observation de la santé publique. L’utilisation des dossiers de santé pour d’autres finalités telles que l'enseignement, l'évaluation médicale, l’administration et l'établissement de rapports, la gestion des services de santé, la recherche et l’épidémiologie, qui nécessitent l’agrégation de dossiers individuels de personnes physiques ne constitue pas l’objet de la présente Norme européenne ; néanmoins, ces applications secondaires sont susceptibles de trouver un intérêt à cette norme.
La présente partie 1 de cette norme constituée de plusieurs parties est une spécification édictée d'un point de vue informationnel tel que défini dans la norme "Traitement réparti ouvert - Modèle de référence : présentation générale" (ISO/CEI 10746-1). La présente Norme européenne n’a pas pour vocation de spécifier l’architecture interne ou la conception de la base de données des systèmes de DIS.

Zdravstvena informatika - Komunikacija z elektronskimi zapisi na področju zdravstva - 1. del: Referenčni model

General Information

Status
Withdrawn
Publication Date
27-Feb-2007
Withdrawal Date
02-Oct-2012
Current Stage
9960 - Withdrawal effective - Withdrawal
Start Date
03-Oct-2012
Completion Date
03-Oct-2012

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EN 13606-1:2008
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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Health informatics - Electronic health record communication - Part 1: Reference modelSRGURþMXInformatique de santé - Dossier de santé informatisé et communication - Partie 1: Modele de référenceMedizinische Informatik - Kommunikation von Patientendaten in elektronischer Form - Teil 1: ReferenzmodellTa slovenski standard je istoveten z:EN 13606-1:2007SIST EN 13606-1:2008en35.240.80Uporabniške rešitve IT v zdravstveni tehnikiIT applications in health care technologyICS:SIST ENV 13606-1:20031DGRPHãþDSLOVENSKI
STANDARDSIST EN 13606-1:200801-februar-2008

EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 13606-1February 2007ICS 35.240.80Supersedes ENV 13606-1:2000
English VersionHealth informatics - Electronic health record communication -Part 1: Reference modelInformatique de santé - Dossier de santé informatisé etcommunication - Partie 1: Modèle de référenceMedizinische Informatik - Kommunikation vonPatientendaten in elektronischer Form - Teil 1:ReferenzmodellThis European Standard was approved by CEN on 15 December 2006.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the CEN Management Centre or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.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, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2007 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 13606-1:2007: E

UML profile.63 Annex B (informative)
Relationship to other standards.65 Annex C (informative)
Clinical Example.77 Annex D (informative)
Mapping to statements of requirement.90 Bibliography.96

3 messages. A mapping from the existing prestandard is also provided to support implementers of existing conformant systems. The technical approach to producing this European Standard has taken into account several contemporary areas of requirement. a. In addition to a traditional message-based communication between isolated clinical systems, the Electronic Health Record will in some cases be implemented as a middleware component (a record server) using distributed object technology and/or web services. b.
“Customers” of such record services will be not only other electronic health record systems but also other middleware services such as security components, workflow systems, alerting and decision support services and other medical knowledge agents. c. There is wide international interest in this work, and this European Standard has been drafted jointly through CEN and ISO with significant input from many member countries.

Given the diversity of deployed EHR systems, this European Standard has made most features of EHR communication optional rather than mandatory. However, some degree of prescription is required to make EHR Extracts safely processable by an EHR recipient system, which is reflected through mandatory properties within the models in Parts 1, 2, and 4 of this series, and through normative term lists (defined in Part 3 of this series). This European Standard will, in practice, usually be adopted alongside other health informatics standards that define particular aspects of health data representation. Annex B explains how this European Standard can be used alongside key complementary standards, including the HL7 Version 3 Reference Information Model (RIM), EN 14822-1, EN 14822-2, EN 14822-3, CEN/TS 14822-4 (GPIC), prEN 12967 (HISA) and prEN13940 (CONTSYS). The Dual Model approach The challenge for EHR interoperability is to devise a generalised approach to representing every conceivable kind of health record data structure in a consistent way. This needs to cater for records arising from any profession, speciality or service, whilst recognising that the clinical data sets, value sets, templates etc. required by different health care domains will be diverse, complex and will change frequently as clinical practice and medical knowledge advance. This requirement is part of the widely acknowledged health informatics challenge of semantic interoperability. The approach adopted by this European Standard distinguishes a Reference Model, defined in this European Standard and used to represent the generic properties of health record information, and Archetypes (conforming to an Archetype Model, defined in Part 2 of this series), which are meta-data used to define patterns for the specific characteristics of the clinical data that represents the requirements of each particular profession, speciality or service. The Reference Model represents the global characteristics of health record components, how they are aggregated, and the context information required to meet ethical, legal and provenance requirements. This model defines the set of classes that form the generic building blocks of the EHR. It reflects the stable characteristics of an electronic health record, and would be embedded in a distributed (federated) EHR environment as specific messages or interfaces (as specified in Part 5 of this series). This generic information model needs to be complemented by a formal method of communicating and sharing the organisational structure of predefined classes of EHR fragment correspon
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