EN ISO 13606-1:2019

Health informatics - Electronic health record communication - Part 1: Reference model (ISO 13606-1:2019)

This document specifies a means for communicating part or all of the electronic health record (EHR) of one or more identified subjects of care between EHR systems, or between EHR systems and a centralised EHR data repository.
It can also be used for EHR communication between an EHR system or repository and clinical applications or middleware components (such as decision support components), or personal health applications and devices, that need to access or provide EHR data, or as the representation of EHR data within a distributed (federated) record system.
This document will predominantly be used to support the direct care given to identifiable individuals or self-care by individuals themselves, 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 anonymization or aggregation of individual records, are not the focus of this document but such secondary uses might also find the document 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 document 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 (ISO 13606-1:2019)

Informatique de santé - Communication du dossier de santé informatisé - Partie 1: Modèle de référence (ISO 13606-1:2019)

Le présent document spécifie un moyen de communication de tout ou partie du dossier de santé informatisé (DSI) d'un seul ou de plusieurs sujets des soins identifiés entre systèmes de DSI, ou entre des systèmes de DSI et un référentiel de données de DSI centralisé.
Il peut également être utilisé pour la communication de DSI entre un système ou référentiel de DSI et des applications médicales ou composants intergiciels (tels que des composants d'aide à la prise de décision) ou des applications et appareils de santé personnels nécessitant d'avoir accès aux ou de fournir des données de DSI, ou pour la représentation des données de DSI dans un système réparti (fédéré).
Le présent document est destiné à être principalement utilisé pour prendre en charge les soins directs dispensés à des personnes identifiables ou les soins auto-administrés par les personnes elles-mêmes, 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'anonymisation ou l'agrégation de dossiers individuels de personnes physiques ne constitue pas l'objet du présent document; néanmoins, ces applications secondaires sont susceptibles de trouver un intérêt à ce document.
La présente Partie 1 de la série en plusieurs parties est une spécification de point de vue d'information telle que définie par le Traitement réparti ouvert — Modèle de référence: Aperçu général (ISO/IEC 10746-1). Le présent document n'a pas pour vocation de spécifier l'architecture interne ou la conception de la base de données des systèmes de DSI.

Zdravstvena informatika - Komunikacija z elektronskimi zdravstvenimi zapisi - 1. del: Referenčni model (ISO 13606-1:2019)

Ta dokument določa sredstva za posredovanje dela ali celotnega elektronskega zdravstvenega kartona (EHR) enega ali več opredeljenih oseb v zdravstveni oskrbi med sistemi EHR ali med sistemi EHR in centralizirano zbirko 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) ali osebne zdravstvene aplikacije in naprave, ki potrebujejo dostop do podatkov EHR ali zagotavljajo podatke EHR, ali za predstavitev podatkov EHR
v okviru porazdeljenega (združenega) sistema evidentiranja.
Ta dokument se uporablja predvsem za omogočanje neposredne nege za prepoznavne posameznike ali samooskrbe posameznikov ali za podporo za sisteme 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 ter epidemiologija, ki pogosto zahtevajo anonimizacijo ali združevanje posameznih arhivov, ni osrednji predmet tega dela dokumenta, vendar je ta dokument lahko uporaben tudi za tovrstno sekundarno uporabo.
Ta 1. del večdelne skupine je specifikacija informacijskega vidika, kot je opredeljeno v Odprti porazdeljeni obdelavi – Referenčni model: Pregled (ISO/IEC 10746-1). Namen tega dokumenta ni:
določitev notranje arhitekture ali načrtovanja baz podatkov sistemov EHR.

General Information

• Status: Published
• Publication Date: 02-Jul-2019
• Withdrawal Date: 30-Jan-2020
• 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: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 03-Jul-2019
• Completion Date: 03-Jul-2019
• Ref Project: SIST EN ISO 13606-1:2019 - Health informatics - Electronic health record communication - Part 1: Reference model (ISO 13606-1:2019)

Relations

• Replaces: EN ISO 13606-1:2012 - Health informatics - Electronic health record communication - Part 1: Reference model (ISO 13606-1:2008)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2019
Nadomešča:
SIST EN ISO 13606-1:2012
Zdravstvena informatika - Komunikacija z elektronskimi zapisi na področju
zdravstva - 1. del: Referenčni model (ISO 13606-1:2019)
Health informatics - Electronic health record communication - Part 1: Reference model
(ISO 13606-1:2019)
Medizinische Informatik - Kommunikation von Patientendaten in elektronischer Form -
Teil 1: Referenzmodell (ISO 13606-1:2019)
Informatique de santé - Communication du dossier de santé informatisé - Partie 1:
Modèle de référence (ISO 13606-1:2019)
Ta slovenski standard je istoveten z: EN ISO 13606-1:2019
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.

EN ISO 13606-1
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2019
EUROPÄISCHE NORM
ICS 35.240.80 Supersedes EN ISO 13606-1:2012
English Version
Health informatics - Electronic health record
communication - Part 1: Reference model (ISO 13606-
1:2019)
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:
13606-1:2019) Referenzmodell (ISO 13606-1:2019)
This European Standard was approved by CEN on 2 July 2019.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 13606-1:2019 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 13606-1:2019) has been prepared by Technical Committee ISO/TC 215 "Health
informatics" in collaboration with 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 January 2020, and conflicting national standards shall
be withdrawn at the latest by January 2020.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 13606-1:2012.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 13606-1:2019 has been approved by CEN as EN ISO 13606-1:2019 without any
modification.
INTERNATIONAL ISO
STANDARD 13606-1
Second edition
2019-06
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 13606-1:2019(E)
©
ISO 2019
ISO 13606-1:2019(E)
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved

ISO 13606-1:2019(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
3.1 Actors . 1
3.2 Concepts and terms . 3
3.3 Information management . 3
3.4 Privacy and security . 5
3.5 Process management . 6
4 Abbreviations. 6
5 Overview . 7
5.1 Overview of the reference model . 7
5.2 Representing roles and responsibilities within the EHR _EXTRACT. 8
5.2.1 General. 8
5.2.2 Actors playing a role in the actual healthcare process . 8
5.2.3 Actors contributing to the process of documenting care within the EHR . 8
5.2.4 Actors confirming the validity of the EHR documentation . 8
5.2.5 Subject of care . 9
5.2.6 Composer . 9
5.2.7 Committer .10
5.2.8 Subject of information . .10
5.2.9 Information provider .10
5.3 About the use of datatypes in this document .10
6 Common Properties of Record Components .11
6.1 Base, record and structure components .11
6.1.1 General.11
6.1.2 Base component .13
6.1.3 Electronic health record component .14
6.1.4 Structure component .15
6.2 Attestation.16
6.2.1 General.16
6.2.2 Attestation information .18
6.3 Audit information .19
6.4 Linking record components .22
6.4.1 General.22
6.4.2 Link usages .22
6.4.3 Communicating referenced record components .24
6.4.4 Link .24
6.4.5 External link .25
7 Elements and Data Values .26
7.1 General .26
7.2 Data value .27
7.2.1 Boolean .29
7.2.2 Attachment .29
7.2.3 String .32
7.2.4 Simple text .
...

SLOVENSKI STANDARD
01-september-2019
Nadomešča:
SIST EN ISO 13606-1:2012
Zdravstvena informatika - Komunikacija z elektronskimi zdravstvenimi zapisi - 1.
del: Referenčni model (ISO 13606-1:2019)
Health informatics - Electronic health record communication - Part 1: Reference model
(ISO 13606-1:2019)
Medizinische Informatik - Kommunikation von Patientendaten in elektronischer Form -
Teil 1: Referenzmodell (ISO 13606-1:2019)
Informatique de santé - Communication du dossier de santé informatisé - Partie 1:
Modèle de référence (ISO 13606-1:2019)
Ta slovenski standard je istoveten z: EN ISO 13606-1:2019
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.

EN ISO 13606-1
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2019
EUROPÄISCHE NORM
ICS 35.240.80 Supersedes EN ISO 13606-1:2012
English Version
Health informatics - Electronic health record
communication - Part 1: Reference model (ISO 13606-
1:2019)
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:
13606-1:2019) Referenzmodell (ISO 13606-1:2019)
This European Standard was approved by CEN on 2 July 2019.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 13606-1:2019 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 13606-1:2019) has been prepared by Technical Committee ISO/TC 215 "Health
informatics" in collaboration with 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 January 2020, and conflicting national standards shall
be withdrawn at the latest by January 2020.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 13606-1:2012.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 13606-1:2019 has been approved by CEN as EN ISO 13606-1:2019 without any
modification.
INTERNATIONAL ISO
STANDARD 13606-1
Second edition
2019-06
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 13606-1:2019(E)
©
ISO 2019
ISO 13606-1:2019(E)
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved

ISO 13606-1:2019(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
3.1 Actors . 1
3.2 Concepts and terms . 3
3.3 Information management . 3
3.4 Privacy and security . 5
3.5 Process management . 6
4 Abbreviations. 6
5 Overview . 7
5.1 Overview of the reference model . 7
5.2 Representing roles and responsibilities within the EHR _EXTRACT. 8
5.2.1 General. 8
5.2.2 Actors playing a role in the actual healthcare process . 8
5.2.3 Actors contributing to the process of documenting care within the EHR . 8
5.2.4 Actors confirming the validity of the EHR documentation . 8
5.2.5 Subject of care . 9
5.2.6 Composer . 9
5.2.7 Committer .10
5.2.8 Subject of information . .10
5.2.9 Information provider .10
5.3 About the use of datatypes in this document .10
6 Common Properties of Record Components .11
6.1 Base, record and structure components .11
6.1.1 General.11
6.1.2 Base component .13
6.1.3 Electronic health record component .14
6.1.4 Structure component .15
6.2 Attestation.16
6.2.1 General.16
6.2.2 Attestation information .18
6.3 Audit information .19
6.4 Linking record components .22
6.4.1 General.22
6.4.2 Link usages .22
6.4.3 Communicating referenced record components .24
6.4.4 Link .24
6.4.5 External link .25
7 Elements and Data Values .26
7.1 General .26
7.2 Data value .27
7.2.1 Boolean .29
7.2.2 Attachment .29
7.2.3 String .32
7.2.4 Simple text .
...