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
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
03-Jul-2019
Completion Date
03-Jul-2019

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SLOVENSKI STANDARD
SIST EN ISO 13606-1:2019
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
SIST EN ISO 13606-1:2019 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 13606-1:2019
---------------------- Page: 2 ----------------------
SIST EN ISO 13606-1:2019
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.
---------------------- Page: 3 ----------------------
SIST EN ISO 13606-1:2019
EN ISO 13606-1:2019 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

---------------------- Page: 4 ----------------------
SIST EN ISO 13606-1:2019
EN ISO 13606-1:2019 (E)
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.
---------------------- Page: 5 ----------------------
SIST EN ISO 13606-1:2019
---------------------- Page: 6 ----------------------
SIST EN ISO 13606-1:2019
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
---------------------- Page: 7 ----------------------
SIST EN ISO 13606-1:2019
ISO 13606-1:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© 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: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 13606-1:2019
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 ..........................................................................................................................................................................33

7.2.5 Coded simple value .....................................................................................................................................................33

7.2.6 Coded value .......................................................................................................................................................................34

7.2.7 Instance identifier ...................................................................... ..................................................................................37

7.2.8 URI .............................................................................................................................................................................................39

7.2.9 Physical quantity...........................................................................................................................................................40

© ISO 2019 – All rights reserved iii
---------------------- Page: 9 ----------------------
SIST EN ISO 13606-1:2019
ISO 13606-1:2019(E)

7.2.10 Duration................................................................................................................................................................................41

7.2.11 Real ...........................................................................................................................................................................................42

7.2.12 Integer ....................................................................................................................................................................................43

7.2.13 Date time ..............................................................................................................................................................................43

7.2.14 Date ..........................................................................................................................................................................................44

7.2.15 Time .........................................................................................................................................................................................45

7.2.16 Point in time ......................................................................................................................................................................45

8 EHR Components ...............................................................................................................................................................................................46

8.1 General ........................................................................................................................................................................................................46

8.2 Folder ...........................................................................................................................................................................................................47

8.2.1 General...................................................................................................................................................................................47

8.2.2 Folder ......................................................................................................................................................................................48

8.3 Compositions .........................................................................................................................................................................................49

8.3.1 General...................................................................................................................................................................................49

8.3.2 Composition ......................................................................................................................................................................50

8.4 Content and sections .......................................................................................................................................................................51

8.4.1 General...................................................................................................................................................................................51

8.4.2 Content ..................................................................................................................................................................................51

8.4.3 Section....................................................................................................................................................................................52

8.5 Entries .........................................................................................................................................................................................................53

8.5.1 General...................................................................................................................................................................................53

8.5.2 Entry ........................................................................................................................................................................................53

8.6 Items and clusters .............................................................................................................................................................................55

8.6.1 Item ..........................................................................................................................................................................................55

8.6.2 Cluster ....................................................................................................................................................................................56

8.7 Element.......................................................................................................................................................................................................57

9 EHR Extract ..............................................................................................................................................................................................................57

9.1 General ........................................................................................................................................................................................................57

9.2 EHR extract..............................................................................................................................................................................................58

9.3 Extracted component set ............................................................................................................................................................59

9.4 Demographic extract .......................................................................................................................................................................60

10 Demographics .......................................................................................................................................................................................................61

10.1 General ........................................................................................................................................................................................................61

10.2 Demographic folder .........................................................................................................................................................................62

10.3 Demographic entity .........................................................................................................................................................................63

10.4 Demographic item .............................................................................................................................................................................64

10.5 Demographic cluster .......................................................................................................................................................................65

10.6 Demographic element ....................................................................................................................................................................66

11 Conformance ..........................................................................................................................................................................................................67

Annex A (informative) About the ISO 21090:2011 profile for datatypes ....................................................................68

Annex B (informative) Alignment with HL7 FHIR ................................................................................................................................72

Annex C (informative) Cross-Domain Interoperability ..................................................................................................................73

Bibliography .............................................................................................................................................................................................................................78

iv © ISO 2019 – All rights reserved
---------------------- Page: 10 ----------------------
SIST EN ISO 13606-1:2019
ISO 13606-1:2019(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.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/directives).

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. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www .iso .org/patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www .iso

.org/iso/foreword .html.

This document was prepared by Technical Committee ISO/TC 215, Health Informatics.

This second edition cancels and replaces the first edition (ISO 13606-1:2008), which has been technically

revised. The main changes compared to the previous edition are summarised in the Introduction.

A list of all parts in the ISO 13606 series can be found on the ISO website.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/members .html.
© ISO 2019 – All rights reserved v
---------------------- Page: 11 ----------------------
SIST EN ISO 13606-1:2019
ISO 13606-1:2019(E)
Introduction
0.1 Preface

The overall goal of this document 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),

or for a group of patients whose information might need to be communicated together (for example, a

family). This is to support the interoperability of systems (see Annex C). and components that need to

communicate (access, transfer, add or modify) EHR data:
— preserving the original clinical meaning intended by the author;

— incorporating the necessary provenance metadata to inform the recipient or receiving system about

the context in which the EHR data were obtained and composed;

— observing and communicating the confidentiality of that data as intended by the author and subject

of care.

This document considers the EHR to be the persistent longitudinal and potentially multi-organisation

or multi-national record of health and care provision, most often relating to a single subject of care (the

patient), created and stored in one or more physical systems in order to inform each subject’s future

healthcare and to provide a medico-legal record of care that has been provided. This corresponds to the

definition provided in ISO 18308:2011 (Requirements for an Electronic Health Record Architecture).

This document 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 applications that might request 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. These might be used to communicate EHR data between

two repositories, to update a centralised regional or national EHR repository, or within a distributed

network of EHR components, systems and services. 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. this document 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.

This document 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

...

SLOVENSKI STANDARD
SIST EN ISO 13606-1:2019
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
SIST EN ISO 13606-1:2019 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 13606-1:2019
---------------------- Page: 2 ----------------------
SIST EN ISO 13606-1:2019
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.
---------------------- Page: 3 ----------------------
SIST EN ISO 13606-1:2019
EN ISO 13606-1:2019 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

---------------------- Page: 4 ----------------------
SIST EN ISO 13606-1:2019
EN ISO 13606-1:2019 (E)
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.
---------------------- Page: 5 ----------------------
SIST EN ISO 13606-1:2019
---------------------- Page: 6 ----------------------
SIST EN ISO 13606-1:2019
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
---------------------- Page: 7 ----------------------
SIST EN ISO 13606-1:2019
ISO 13606-1:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© 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: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 13606-1:2019
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 ..........................................................................................................................................................................33

7.2.5 Coded simple value .....................................................................................................................................................33

7.2.6 Coded value .......................................................................................................................................................................34

7.2.7 Instance identifier ...................................................................... ..................................................................................37

7.2.8 URI .............................................................................................................................................................................................39

7.2.9 Physical quantity...........................................................................................................................................................40

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7.2.10 Duration................................................................................................................................................................................41

7.2.11 Real ...........................................................................................................................................................................................42

7.2.12 Integer ....................................................................................................................................................................................43

7.2.13 Date time ..............................................................................................................................................................................43

7.2.14 Date ..........................................................................................................................................................................................44

7.2.15 Time .........................................................................................................................................................................................45

7.2.16 Point in time ......................................................................................................................................................................45

8 EHR Components ...............................................................................................................................................................................................46

8.1 General ........................................................................................................................................................................................................46

8.2 Folder ...........................................................................................................................................................................................................47

8.2.1 General...................................................................................................................................................................................47

8.2.2 Folder ......................................................................................................................................................................................48

8.3 Compositions .........................................................................................................................................................................................49

8.3.1 General...................................................................................................................................................................................49

8.3.2 Composition ......................................................................................................................................................................50

8.4 Content and sections .......................................................................................................................................................................51

8.4.1 General...................................................................................................................................................................................51

8.4.2 Content ..................................................................................................................................................................................51

8.4.3 Section....................................................................................................................................................................................52

8.5 Entries .........................................................................................................................................................................................................53

8.5.1 General...................................................................................................................................................................................53

8.5.2 Entry ........................................................................................................................................................................................53

8.6 Items and clusters .............................................................................................................................................................................55

8.6.1 Item ..........................................................................................................................................................................................55

8.6.2 Cluster ....................................................................................................................................................................................56

8.7 Element.......................................................................................................................................................................................................57

9 EHR Extract ..............................................................................................................................................................................................................57

9.1 General ........................................................................................................................................................................................................57

9.2 EHR extract..............................................................................................................................................................................................58

9.3 Extracted component set ............................................................................................................................................................59

9.4 Demographic extract .......................................................................................................................................................................60

10 Demographics .......................................................................................................................................................................................................61

10.1 General ........................................................................................................................................................................................................61

10.2 Demographic folder .........................................................................................................................................................................62

10.3 Demographic entity .........................................................................................................................................................................63

10.4 Demographic item .............................................................................................................................................................................64

10.5 Demographic cluster .......................................................................................................................................................................65

10.6 Demographic element ....................................................................................................................................................................66

11 Conformance ..........................................................................................................................................................................................................67

Annex A (informative) About the ISO 21090:2011 profile for datatypes ....................................................................68

Annex B (informative) Alignment with HL7 FHIR ................................................................................................................................72

Annex C (informative) Cross-Domain Interoperability ..................................................................................................................73

Bibliography .............................................................................................................................................................................................................................78

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SIST EN ISO 13606-1:2019
ISO 13606-1:2019(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.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/directives).

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. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www .iso .org/patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www .iso

.org/iso/foreword .html.

This document was prepared by Technical Committee ISO/TC 215, Health Informatics.

This second edition cancels and replaces the first edition (ISO 13606-1:2008), which has been technically

revised. The main changes compared to the previous edition are summarised in the Introduction.

A list of all parts in the ISO 13606 series can be found on the ISO website.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/members .html.
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SIST EN ISO 13606-1:2019
ISO 13606-1:2019(E)
Introduction
0.1 Preface

The overall goal of this document 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),

or for a group of patients whose information might need to be communicated together (for example, a

family). This is to support the interoperability of systems (see Annex C). and components that need to

communicate (access, transfer, add or modify) EHR data:
— preserving the original clinical meaning intended by the author;

— incorporating the necessary provenance metadata to inform the recipient or receiving system about

the context in which the EHR data were obtained and composed;

— observing and communicating the confidentiality of that data as intended by the author and subject

of care.

This document considers the EHR to be the persistent longitudinal and potentially multi-organisation

or multi-national record of health and care provision, most often relating to a single subject of care (the

patient), created and stored in one or more physical systems in order to inform each subject’s future

healthcare and to provide a medico-legal record of care that has been provided. This corresponds to the

definition provided in ISO 18308:2011 (Requirements for an Electronic Health Record Architecture).

This document 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 applications that might request 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. These might be used to communicate EHR data between

two repositories, to update a centralised regional or national EHR repository, or within a distributed

network of EHR components, systems and services. 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. this document 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.

This document may offer a practical and useful contribution to the design of EHR systems but

will primarily be realised as a common set of externa
...

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