EN ISO 13606-1:2012

Health informatics - Electronic health record communication - Part 1: Reference model (ISO 13606-1:2008)

ISO 13606-1:2008 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 centralized 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, or as the representation of EHR data within a distributed (federated) record system.
ISO 13606-1:2008 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. Use of health records for other purposes such as teaching, clinical audit, administration and reporting, service management, research and epidemiology, which often require anonymization or aggregation of individual records, are not the focus of ISO 13606-1:2008 but such secondary uses might also find this document useful.

Medizinische Informatik - Kommunikation von Patientendaten in elektronischer Form - Teil 1: Referenzmodell (ISO 13606-1:2008)

Informatique de santé - Communication du dossier de santé informatisé - Partie 1: Modèle de référence (ISO 13606-1:2008)

L'ISO 13606-1:2008 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 dans un système réparti (fédéré).
L'ISO 13606-1:2008 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 l'ISO 13606-1:2008; néanmoins, ces applications secondaires sont susceptibles de trouver un intérêt à cette norme.

Zdravstvena informatika - Komunikacija z elektronskimi zapisi na področju zdravstva - 1. del: Referenčni model (ISO 13606-1:2008)

Ta del standarda ISO 13606 določa komunikacijo dela ali vseh elektronskih zdravstvenih kartonov (EHR) identificiranega predmeta med sistemi EHR oziroma med sistemi EHR in centralizirano bazo podatkov EHR. Lahko se uporablja tudi za komunikacijo med sistemom EHR, aplikacijami za shranjevanje in kliničnimi aplikacijami oziroma komponentami vmesne programske opreme (kot so podporne komponente odločanja), ki potrebujejo dostop do podatkov EHR ali zagotavljajo podatke EHR, ali za predstavitev podatkov EHR v okviru porazdeljenega (združenega) sistema evidentiranja. Ta del standarda ISO 13606 se uporablja predvsem za podpiranje neposredne nege za prepoznavne posameznike ali za podpiranje sistemov nadzorovanja prebivalstva, kot so arhivi bolezni in nadzor javnega zdravja. Uporaba zdravstvenih arhivov za druge namene, kot so učenje, klinična presoja, upravljanje in poročanje, upravljanje storitev, raziskave in epidemiologija, ki pogosto zahtevajo anonimizacijo ali združevanje posameznih arhivov, niso osrednji predmet tega dela standarda ISO 13606, vendar je ta dokument lahko uporaben tudi za tovrstno sekundarno uporabo. Ta del večdelne serije, ISO 13606, je specifikacija z informacijskega vidika, kot je opredeljeno v standardu ISO/IEC 10746-1. Namen tega dela standarda ISO 13606 ni določitev notranje arhitekture ali oblikovanja podatkovne zbirke sistemov EHR.

General Information

• Status: Withdrawn
• Publication Date: 02-Oct-2012
• Withdrawal Date: 02-Jul-2019
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: CEN/TC 251 - Medical informatics
• Drafting Committee: CEN/TC 251/WG 1 - Information models
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 03-Jul-2019
• Ref Project: SIST EN ISO 13606-1:2012 - Health informatics - Electronic health record communication - Part 1: Reference model (ISO 13606-1:2008)

Relations

• Replaces: EN 13606-1:2007 - Health informatics - Electronic health record communication - Part 1: Reference model
• Effective Date: 08-Oct-2012
• Replaced By: EN ISO 13606-1:2019 - Health informatics - Electronic health record communication - Part 1: Reference model (ISO 13606-1:2019)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
01-december-2012
1DGRPHãþD
SIST EN 13606-1:2008
=GUDYVWYHQDLQIRUPDWLND.RPXQLNDFLMD]HOHNWURQVNLPL]DSLVLQDSRGURþMX
]GUDYVWYDGHO5HIHUHQþQLPRGHO,62
Health informatics - Electronic health record communication - Part 1: Reference model
(ISO 13606-1:2008)
Medizinische Informatik - Kommunikation von Patientendaten in elektronischer Form -
Teil 1: Referenzmodell (ISO 13606-1:2008)
Informatique de santé - Communication du dossier de santé informatisé - Partie 1:
Modèle de référence (ISO 13606-1:2008)
Ta slovenski standard je istoveten z: EN ISO 13606-1:2012
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 13606-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2012
ICS 35.240.80 Supersedes EN 13606-1:2007
English Version
Health informatics - Electronic health record communication -
Part 1: Reference model (ISO 13606-1:2008)
Informatique de santé - Communication du dossier de Medizinische Informatik - Kommunikation von
santé informatisé - Partie 1: Modèle de référence (ISO Patientendaten in elektronischer Form - Teil 1:
13606-1:2008) Referenzmodell (ISO 13606-1:2008)
This European Standard was approved by CEN on 24 August 2012.

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 alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN-CENELEC 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 translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same
status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 13606-1:2012: E
worldwide for CEN national Members.

Contents Page
Foreword .3

Foreword
The text of ISO 13606-1:2008 has been prepared by Technical Committee ISO/TC 215 “Health informatics” of
the International Organization for Standardization (ISO) and has been taken over as EN ISO 13606-1:2012 by
Technical Committee 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 2013, and conflicting national standards shall be withdrawn at the
latest by April 2013.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 13606-1:2007.
According to the CEN/CENELEC Internal Regulations, the national standards organisations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 13606-1:2008 has been approved by CEN as a EN ISO 13606-1:2012 without any
modification.
INTERNATIONAL ISO
STANDARD 13606-1
FIrst edition
2008-02-15
Health informatics — Electronic health
record communication —
Part 1:
Reference model
Informatique de santé — Communication du dossier de santé
informatisé —
Partie 1: Modèle de référence
Reference number
ISO 13606-1:2008(E)
©
ISO 2008
ISO 13606-1:2008(E)
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ii © ISO 2008 – All rights reserved

ISO 13606-1:2008(E)
Contents Page
Foreword. iv
0 Introduction. v
1 Scope .1
2 Normative references .1
3 Terms and definitions .2
4 Abbreviations.6
5 Conformance.7
5.1 EHR System conformance.7
5.2 Member country conformance .7
6 Reference model.8
6.1 Index to packages.8
6.2 Package: EXTRACT package.9
6.3 Package: DEMOGRAPHICS package.26
6.4 Package: SUPPORT package .34
6.5 Primitive data types.42
Annex A (informative) UML profile .43
Annex B (informative) Relationship to other standards.45
Annex C (informative) Clinical example.59
Annex D (informative) Mapping to statements of requirement .72
Bibliography .80

ISO 13606-1:2008(E)
Foreword
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 through 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 collaborates 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 Standards. 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 this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 13606-1 was prepared by Technical Committee ISO/TC 215, Health informatics.
ISO 13606 consists of the following parts, under the general title Health informatics — Electronic health record
communication:
⎯ Part 1: Reference model
⎯ Part 2: Archetype interchange specification
⎯ Part 3: Reference archetypes and term lists
⎯ Part 5: Interface specification
iv © ISO 2008 – All rights reserved

ISO 13606-1:2008(E)
0 Introduction
0.1 Preface
The overall goal of ISO 13606 is to define a rigorous and stable information architecture for communicating
part or all of the Electronic Health Record (EHR) of a single subject of care (patient). This is to support the
interoperability of systems and components that need to communicate (access, transfer, add or modify) EHR
data via electronic messages or as distributed objects:
⎯ preserving the original clinical meaning intended by the author;
⎯ reflecting the confidentiality of that data as intended by the author and patient.
ISO 13606 is not intended to specify the internal architecture or database design of EHR systems or
components. Nor is it intended to prescribe the kinds of clinical application that might require or contribute
EHR data in particular settings, domains or specialities. For this reason, the information model proposed here
is called the EHR Extract, and might be used to define a message, an XML document or schema, or an object
interface. The information model in this part of ISO 13606 is an ISO Reference Model for Open Distributed
Processing (RM-ODP) RM-ODP Information Viewpoint of the EHR Extract.
ISO 13606 considers the EHR to be the persistent longitudinal and potentially multi-enterprise or multi-
national record of health and care provision relating to a single subject of care (the patient), created and
stored in one or more physical systems in order to inform the subject’s future healthcare and to provide a
medico-legal record of care that has been provided. Whilst an EHR service or system will need to interact with
many other services or systems providing terminology, medical knowledge, guidelines, workflow, security,
persons registries, billing etc., ISO 13606 has only touched on those areas if some persistent trace of such
interactions is required in the EHR itself, and requires specific features in the reference model to allow their
communication.
ISO 13606 may offer a practical and useful contribution to the design of EHR systems but will primarily be
realised as a common set of external interfaces or messages built on otherwise heterogeneous clinical
systems.
This part of ISO 13606 is the first part to be published of a five-part series. In this part of ISO 13606
dependency upon one of the other parts of this series is explicitly stated where it applies.
0.2 Technical approach
ISO 13606 has drawn on the practical experience that has been gained in implementing a European precursor
prestandard, ENV 13606, other EHR-related standards and specifications, commercial systems and
demonstrator pilots in the communication of whole or part of patients’ EHRs, and on fifteen years of research
findings in the field. ISO 13606 builds on ENV 13606, in order to provide a more rigorous and complete
specification, to accommodate new requirements identified, to incorporate a robust means of applying the
generic models to indivi
...