Health informatics - International patient summary (ISO 27269:2021)

This standard formalises the dataset required to share information about the medical background and history of a patient from the patient’s country of affiliation with a healthcare professional in another country where unscheduled treatment is required. It uses the European guidelines (version 2, November 2016) as an official source for the requirements.
The scope for the ‘Patient Summary for Unscheduled, Cross-border Care’ standard is of international significance. This standard, therefore, complements co-ordinated international efforts to maximise its utility and value, providing an interoperable dataset specification.
The dataset is minimal and non-exhaustive, providing a robust, well-defined set of items that are specialty-agnostic, condition-independent and usable by all clinicians for the unscheduled care of a person. The dataset will also be usable as a valuable subset of data items for scheduled care. The dataset enables cross-border application and it will support national communication of patient summary data, thereby providing wider applicability and greater benefit from the standard for the continuity of care of a person in need.
This international standard does not cover workflow processes of data entry, data collection, the summarisation act nor subsequent data presentation. Implementation guidance for specifically European concerns, e.g., Directives, terminologies, formats etc., is in the associated Technical Specification.

Medizinische Informatik - Die internationale Patienten-Kurzakte (ISO 27269:2021)

Informatique de santé - Résumé international du dossier médical du patient (ISO 27269:2021)

Le présent document définit le jeu de données de base d'un document de synthèse appelé «résumé du dossier médical du patient», servant à étayer la continuité et la coordination des soins de santé d'une personne. Il vise spécifiquement à faciliter le scénario d'utilisation de «soins transfrontaliers non planifiés» et doit aboutir à la création d'un «résumé international de dossier médical du patient» (IPS). Même si le jeu de données est minimal et non exhaustif, il fournit un ensemble d'éléments de données de base robuste et bien défini. Cette visée restreinte du cas d'utilisation permet d'utiliser également l'IPS dans les soins planifiés. Cela signifie que ce jeu de données peut être utilisé pour favoriser les soins planifiés et non planifiés dans des contextes locaux et nationaux, augmentant ainsi son utilité et sa valeur.
Le présent document utilise les lignes directrices européennes de l'eHN comme source initiale des exigences du résumé du dossier médical du patient, prend en considération d'autres projets internationaux relatifs au résumé du dossier médical du patient, afin de fournir une spécification de jeu de données interopérable visant une application mondiale.
Le présent document fournit une définition abstraite du résumé d'un dossier médical du patient, à partir de laquelle des modèles dérivés peuvent être mis en œuvre. De par sa nature, il convient que les lecteurs soient conscients que la conformité au présent document n'implique pas une interopérabilité technique automatique; le résultat, rendu possible par le présent document, peut être atteint avec la conformité aux normes indiquées dans les spécifications techniques et les guides d'implémentation associés.
Le présent document ne couvre pas les processus des séquences de tâches, à savoir saisie, collecte, compilation des données, pas plus que la présentation ultérieure, l'assimilation ou l'agrégation de ces données. De plus, le présent document ne couvre pas l'acte de compilation proprement dite, c'est-à-dire l'intelligence, le savoir-faire et les compétences qui résultent de la séquence de tâches liée à la compilation des données.
Il ne s'agit pas d'un guide d'implémentation traitant des différentes couches techniques se trouvant sous la couche application. Des recommandations de mise en œuvre concernant spécifiquement des questions propres à une juridiction, par exemple, des directives, des terminologies, des formats, etc., ainsi qu’un exemple, sont fournies dans la spécification technique associée[3].
Notamment, la représentation par différents schémas de codage, les structures et les terminologies supplémentaires ne font pas partie du présent document. La terminologie et ses règles contraignantes sont traitées dans la Référence [3]. Les normes d'identification des médicaments (abrégées en IDMP de l'anglais «Identification of Medicinal Products») sont la cible recommandée pour la liste récapitulative des traitements médicamenteux liée au présent document. Toutefois, avant la mise en œuvre complète des normes IDMP dans la pratique, la présente norme IPS ne peut pas insister, à l'heure actuelle, sur leur utilisation et reconnaît que des schémas provisoires pourraient être nécessaires jusqu'à ce que l'IDMP soit établie comme norme.

Zdravstvena informatika - Mednarodni povzetek podatkov o pacientu (ISO 27269:2021)

General Information

Status
Published
Public Enquiry End Date
06-Feb-2022
Publication Date
15-Jun-2022
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
11-May-2022
Due Date
16-Jul-2022
Completion Date
16-Jun-2022

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SLOVENSKI STANDARD
SIST EN ISO 27269:2022
01-julij-2022
Nadomešča:
SIST EN 17269:2020
Zdravstvena informatika - Mednarodni povzetek podatkov o pacientu (ISO
27269:2021)
Health informatics - International patient summary (ISO 27269:2021)
Medizinische Informatik - Die internationale Patienten-Kurzakte (ISO 27269:2021)
Informatique de santé - Résumé international du dossier médical du patient (ISO
27269:2021)
Ta slovenski standard je istoveten z: EN ISO 27269:2022
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST EN ISO 27269:2022 en,fr,de

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

---------------------- Page: 1 ----------------------
SIST EN ISO 27269:2022
---------------------- Page: 2 ----------------------
SIST EN ISO 27269:2022
EN ISO 27269
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2022
EUROPÄISCHE NORM
ICS 35.240.80 Supersedes EN 17269:2019
English Version
Health informatics - International patient summary (ISO
27269:2021)

Informatique de santé - Résumé international du Medizinische Informatik - Die internationale Patienten-

dossier médical du patient (ISO 27269:2021) Kurzakte (ISO 27269:2021)
This European Standard was approved by CEN on 20 March 2022.

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

© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 27269:2022 E

worldwide for CEN national Members.
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SIST EN ISO 27269:2022
EN ISO 27269:2022 (E)
Contents Page

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

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SIST EN ISO 27269:2022
EN ISO 27269:2022 (E)
European foreword

The text of ISO 27269:2021 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 27269:2022 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 September 2022, and conflicting national standards

shall be withdrawn at the latest by September 2022.

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 17269:2019.

Any feedback and questions on this document should be directed to the users’ national standards body.

A complete listing of these bodies can be found on the CEN website.

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 27269:2021 has been approved by CEN as EN ISO 27269:2022 without any modification.

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SIST EN ISO 27269:2022
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SIST EN ISO 27269:2022
INTERNATIONAL ISO
STANDARD 27269
First edition
2021-04
Health informatics — International
patient summary
Informatique de santé — Résumé international du dossier médical
du patient
Reference number
ISO 27269:2021(E)
ISO 2021
---------------------- Page: 7 ----------------------
SIST EN ISO 27269:2022
ISO 27269:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

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
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 27269:2022
ISO 27269:2021(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................vi

Introduction ..............................................................................................................................................................................................................................vii

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

3.1 Healthcare ................................................................................................................................................................................................... 2

3.2 Healthcare actor ..................................................................................................................................................................................... 2

3.3 Healthcare matter................................................................................................................................................................................. 3

3.4 Healthcare activity ............................................................................................................................................................................... 3

3.5 Healthcare planning ........................................................................................................................................................................... 3

3.6 Time .................................................................................................................................................................................................................. 4

3.7 Responsibility .......................................................................................................................................................................................... 4

3.8 Information Management .............................................................................................................................................................. 4

3.8.1 Concepts .................................................................................................................................................................................. 4

3.8.2 Models ....................................................................................................................................................................................... 5

3.8.3 Data ............................................................................................................................................................................................. 6

3.8.4 Process ...................................................................................................................................................................................... 7

4 Abbreviations........................................................................................................................................................................................................... 8

5 Conformance ............................................................................................................................................................................................................. 8

5.1 Introduction .............................................................................................................................................................................................. 8

5.2 IPS Conformance Detail ................................................................................................................................................................10

6 Descriptors for the IPS Data Set.........................................................................................................................................................13

6.1 Patterns within the IPS Data Set ...........................................................................................................................................14

6.1.1 General...................................................................................................................................................................................14

6.1.2 Label Concept ..................................................................................................................................................................14

6.1.3 List .............................................................................................................................................................................................14

6.1.4 Reference .............................................................................................................................................................................15

6.1.5 Person Name ....................................................................................................................................................................15

6.1.6 Coded Element ................................................................................................................................................................15

6.1.7 Date Time ............................................................................................................................................................................16

6.1.8 Identifier ..............................................................................................................................................................................16

6.1.9 Address..................................................................................................................................................................................16

6.1.10 Telecom .................................................................................................................................................................................16

6.1.11 Organization Name .....................................................................................................................................................17

6.1.12 Text ...........................................................................................................................................................................................17

6.1.13 Any ............................................................................................................................................................................................17

6.1.14 Range ......................................................................................................................................................................................17

6.1.15 Quantity ................................................................................................................................................................................17

6.1.16 Period .....................................................................................................................................................................................18

6.1.17 General Time Specification ..................................................................................................................................18

6.1.18 String .......................................................................................................................................................................................18

6.1.19 Ratio .........................................................................................................................................................................................18

6.2 Model Extensibility ...........................................................................................................................................................................19

7 Definition of the IPS Document (IPS) ...........................................................................................................................................19

7.1 Overview Description: THE IPS DOCUMENT (Table 4) ....................................................................................19

7.2 Detailed Description: THE IPS DOCUMENT ................................................................................................................20

8 Definition for IPS Attribute Collection: PATIENT ATTRIBUTES.........................................................................23

8.1 Overview Description: PATIENT ATTRIBUTES (Table 5) ................................................................................23

8.2 Detailed Description: PATIENT ATTRIBUTES ...........................................................................................................23

9 Definition for IPS Attribute Collection: HEALTHCARE PROVIDER ..................................................................25

9.1 Overview Description for HEALTHCARE PROVIDER (Table 6) ..................................................................25

© ISO 2021 – All rights reserved iii
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SIST EN ISO 27269:2022
ISO 27269:2021(E)

9.2 Detailed Description for HEALTHCARE PROVIDER .............................................................................................25

10 Definition for IPS Attribute Collection: PATIENT’S ADDRESS BOOK ............................................................25

10.1 Overview Description for PATIENT’S ADDRESS BOOK (Table 7) .............................................................25

10.2 Detailed Description for PATIENT’S ADDRESS BOOK ........................................................................................26

11 Definition for IPS Section: ADVANCE DIRECTIVES ..........................................................................................................27

11.1 Overview Description for ADVANCE DIRECTIVES (Table 8) ........................................................................27

11.2 Detailed Description for ADVANCE DIRECTIVES ...................................................................................................28

12 Definition for IPS Section: ALLERGIES and INTOLERANCES .................................................................................30

12.1 Overview Description for ALLERGIES and INTOLERANCES (Table 9) ................................................30

12.2 Detailed Description for ALLERGIES and INTOLERANCES ...........................................................................30

13 Definition for IPS Section: FUNCTIONAL STATUS .............................................................................................................34

13.1 Overview Description for FUNCTIONAL STATUS (Table 10) .......................................................................34

13.2 Detailed Description for FUNCTIONAL STATUS ......................................................................................................34

14 Definition for IPS Section: HISTORY OF PAST PROBLEMS .......................................................................................36

14.1 Overview Description for HISTORY OF PAST PROBLEMS (Table 11) ...................................................36

14.2 Detailed Description for HISTORY OF PAST PROBLEMS .................................................................................36

15 Definition for IPS Section: HISTORY OF PREGNANCY ..................................................................................................38

15.1 Overview Description for HISTORY OF PREGNANCY (Table 12) .............................................................38

15.2 Detailed Description for HISTORY OF PREGNANCY ............................................................................................38

16 Definition for IPS Section: HISTORY OF PROCEDURES ...............................................................................................41

16.1 Overview Description for HISTORY OF PROCEDURES (Table 13) ...........................................................41

16.2 Detailed Description for HISTORY OF PROCEDURES .........................................................................................41

17 Definition for IPS Section: IMMUNIZATIONS ........................................................................................................................43

17.1 Overview Description for IMMUNIZATIONS (Table 14) ..................................................................................43

17.2 Detailed Description for IMMUNIZATIONS .................................................................................................................43

18 Definition for IPS Section: MEDICAL DEVICES ....................................................................................................................45

18.1 Overview Description for MEDICAL DEVICES (Table 15)...............................................................................45

18.2 Detailed Description for MEDICAL DEVICES .............................................................................................................45

19 Definition for IPS Section: MEDICATION SUMMARY .....................................................................................................46

19.1 Overview Description for MEDICATION SUMMARY (Tables 16 and 17) ...........................................46

19.2 The IPS Medication Summary and IDMP ......................................................................................................................46

19.3 Detailed Description for MEDICATION SUMMARY ...............................................................................................47

20 Definition for IPS Section: PLAN OF CARE ...............................................................................................................................50

20.1 Overview Description for PLAN OF CARE (Table 18) .........................................................................................50

20.2 Detailed Description for PLAN OF CARE .......................................................................................................................50

21 Definition for IPS Section: PROBLEMS ........................................................................................................................................52

21.1 Overview Description for PROBLEMS (Table 19) ..................................................................................................52

21.2 Detailed Description for PROBLEMS.................................................................................................................................52

22 Definition for IPS Section: RESULTS ...............................................................................................................................................54

22.1 Overview Description for RESULTS (Table 20) ........................................................................................................54

22.2 Detailed Description for RESULTS ......................................................................................................................................54

23 Definition for IPS Section: SOCIAL HISTORY .........................................................................................................................56

23.1 Overview Description for SOCIAL HISTORY (Table 21) ...................................................................................56

23.2 Detailed Description for SOCIAL HISTORY ..................................................................................................................56

24 Definition for IPS Section: VITAL SIGNS .....................................................................................................................................58

24.1 Overview Description for VITAL SIGNS (Table 22)...............................................................................................58

24.2 Detailed Description for VITAL SIGNS .............................................................................................................................58

25 Definition for IPS Attribute Collection: Cross Border .................................................................................................60

25.1 Overview Description for CROSS BORDER (Table 23).......................................................................................60

25.2 Detailed Description for CROSS BORDER .....................................................................................................................60

iv © ISO 2021 – All rights reserved
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SIST EN ISO 27269:2022
ISO 27269:2021(E)

26 Definition for IPS Attribute Collection: Provenance Metadata ..........................................................................61

26.1 Overview Description for PROVENANCE (Table 24) ...........................................................................................61

26.2 Detailed Description for PROVENANCE .........................................................................................................................61

Annex A (informative) The first IPS Scenario focussed on ‘unscheduled, cross-border care’ ...............63

Annex B (informative) Explicit Trace between eHN Guideline Version 2 ....................................................................70

Annex C (informative) The eHN Guideline, the JIC PS Standards Set, and IPS ........................................................74

Bibliography .............................................................................................................................................................................................................................75

© ISO 2021 – All rights reserved v
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SIST EN ISO 27269:2022
ISO 27269:2021(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 European Committee for Standardization (CEN) (as EN 17269:2019)

and was adopted, with the following modifications by Technical Committee ISO/TC 215, Health

informatics.
— changed "this European Standard" to "this document";
— changed any "EN ISO xxxx" references to "ISO xxxx" references;
— changed "section" to "Clause", if appropriate;
— definitions of IPS terms in body of text were moved to Clause 3;
— Clause 3 was reorganized based upon existing ContSys hierarchy;

— more description on conformance, data blocks, more examples in concept values and updated

definition citations given in response.

— on implementation evidence from HL7 FHIR ® , the requirement to require/enable the expression

of the name data element as a single string as well as the structured representation to permit the

natural way of expression in some eastern countries and facilitate cross-border use;

— ‘Healthcare Provider’ became an Attribute Collection data block, defined and positioned in Clause 3

rather than be treated as a data type.
— complete editorial revision.

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.

1) HL7 FHIR is the registered trademark of Health Level Seven International. This information is given for the

convenience of users of this document and does not constitute an endorsement by ISO of the product named.

vi © ISO 2021 – All rights reserved
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SIST EN ISO 27269:2022
ISO 27269:2021(E)
Introduction

The goal of this document is to deliver a single, common International Patient Summary (IPS),

comprising core content.

This document achieves that goal by defining a minimal yet non-exhaustive data set and its associated

business rules. This document is implementation independent yet still supportive of any implementation

by providing formal definition and clear description of a small data set. The primary input to the data

[1]

set is the second revision of the European eHealth Network’s (eHN) data set , which, in turn, builds

[2]

upon significant clinical input from the European Patients-Smart Open Services (epSOS) pilot project .

This document defines the IPS, with the initial focus upon unplanned care across national borders.

Starting from this focus, and building upon it, the specification is intended to be used and be useful in

national and local applications and also to be supportive of both planned and unplanned care. The IPS

is designed to provide clinical information to assist care across any jurisdictional border (e.g. local,

regional, state/provincial, national). It emphasizes the data required and the associated business

rules to support use and the necessary conformance of the use case for an international patient

summary. Even though the data set is relatively small, there is no expectation that the full data set

has to be realized for a conformant implementation or conformant specification to be produced. Such

artefacts need not specify all the optional IPS elements, given that they should assure t

...

SLOVENSKI STANDARD
oSIST prEN ISO 27269:2022
01-februar-2022
Zdravstvena informatika - Mednarodni povzetek podatkov o pacientu (ISO
27269:2021)
Health informatics - International patient summary (ISO 27269:2021)
Medizinische Informatik - Die internationale Patienten-Kurzakte (ISO 27269:2021)
Informatique de santé - Résumé international du dossier médical du patient (ISO
27269:2021)
Ta slovenski standard je istoveten z: prEN ISO 27269
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
oSIST prEN ISO 27269:2022 en,fr,de

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

---------------------- Page: 1 ----------------------
oSIST prEN ISO 27269:2022
---------------------- Page: 2 ----------------------
oSIST prEN ISO 27269:2022
INTERNATIONAL ISO
STANDARD 27269
First edition
2021-04
Health informatics — International
patient summary
Informatique de santé — Résumé international du dossier médical
du patient
Reference number
ISO 27269:2021(E)
ISO 2021
---------------------- Page: 3 ----------------------
oSIST prEN ISO 27269:2022
ISO 27269:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

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
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
---------------------- Page: 4 ----------------------
oSIST prEN ISO 27269:2022
ISO 27269:2021(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................vi

Introduction ..............................................................................................................................................................................................................................vii

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

3.1 Healthcare ................................................................................................................................................................................................... 2

3.2 Healthcare actor ..................................................................................................................................................................................... 2

3.3 Healthcare matter................................................................................................................................................................................. 3

3.4 Healthcare activity ............................................................................................................................................................................... 3

3.5 Healthcare planning ........................................................................................................................................................................... 3

3.6 Time .................................................................................................................................................................................................................. 4

3.7 Responsibility .......................................................................................................................................................................................... 4

3.8 Information Management .............................................................................................................................................................. 4

3.8.1 Concepts .................................................................................................................................................................................. 4

3.8.2 Models ....................................................................................................................................................................................... 5

3.8.3 Data ............................................................................................................................................................................................. 6

3.8.4 Process ...................................................................................................................................................................................... 7

4 Abbreviations........................................................................................................................................................................................................... 8

5 Conformance ............................................................................................................................................................................................................. 8

5.1 Introduction .............................................................................................................................................................................................. 8

5.2 IPS Conformance Detail ................................................................................................................................................................10

6 Descriptors for the IPS Data Set.........................................................................................................................................................13

6.1 Patterns within the IPS Data Set ...........................................................................................................................................14

6.1.1 General...................................................................................................................................................................................14

6.1.2 Label Concept ..................................................................................................................................................................14

6.1.3 List .............................................................................................................................................................................................14

6.1.4 Reference .............................................................................................................................................................................15

6.1.5 Person Name ....................................................................................................................................................................15

6.1.6 Coded Element ................................................................................................................................................................15

6.1.7 Date Time ............................................................................................................................................................................16

6.1.8 Identifier ..............................................................................................................................................................................16

6.1.9 Address..................................................................................................................................................................................16

6.1.10 Telecom .................................................................................................................................................................................16

6.1.11 Organization Name .....................................................................................................................................................17

6.1.12 Text ...........................................................................................................................................................................................17

6.1.13 Any ............................................................................................................................................................................................17

6.1.14 Range ......................................................................................................................................................................................17

6.1.15 Quantity ................................................................................................................................................................................17

6.1.16 Period .....................................................................................................................................................................................18

6.1.17 General Time Specification ..................................................................................................................................18

6.1.18 String .......................................................................................................................................................................................18

6.1.19 Ratio .........................................................................................................................................................................................18

6.2 Model Extensibility ...........................................................................................................................................................................19

7 Definition of the IPS Document (IPS) ...........................................................................................................................................19

7.1 Overview Description: THE IPS DOCUMENT (Table 4) ....................................................................................19

7.2 Detailed Description: THE IPS DOCUMENT ................................................................................................................20

8 Definition for IPS Attribute Collection: PATIENT ATTRIBUTES.........................................................................23

8.1 Overview Description: PATIENT ATTRIBUTES (Table 5) ................................................................................23

8.2 Detailed Description: PATIENT ATTRIBUTES ...........................................................................................................23

9 Definition for IPS Attribute Collection: HEALTHCARE PROVIDER ..................................................................25

9.1 Overview Description for HEALTHCARE PROVIDER (Table 6) ..................................................................25

© ISO 2021 – All rights reserved iii
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oSIST prEN ISO 27269:2022
ISO 27269:2021(E)

9.2 Detailed Description for HEALTHCARE PROVIDER .............................................................................................25

10 Definition for IPS Attribute Collection: PATIENT’S ADDRESS BOOK ............................................................25

10.1 Overview Description for PATIENT’S ADDRESS BOOK (Table 7) .............................................................25

10.2 Detailed Description for PATIENT’S ADDRESS BOOK ........................................................................................26

11 Definition for IPS Section: ADVANCE DIRECTIVES ..........................................................................................................27

11.1 Overview Description for ADVANCE DIRECTIVES (Table 8) ........................................................................27

11.2 Detailed Description for ADVANCE DIRECTIVES ...................................................................................................28

12 Definition for IPS Section: ALLERGIES and INTOLERANCES .................................................................................30

12.1 Overview Description for ALLERGIES and INTOLERANCES (Table 9) ................................................30

12.2 Detailed Description for ALLERGIES and INTOLERANCES ...........................................................................30

13 Definition for IPS Section: FUNCTIONAL STATUS .............................................................................................................34

13.1 Overview Description for FUNCTIONAL STATUS (Table 10) .......................................................................34

13.2 Detailed Description for FUNCTIONAL STATUS ......................................................................................................34

14 Definition for IPS Section: HISTORY OF PAST PROBLEMS .......................................................................................36

14.1 Overview Description for HISTORY OF PAST PROBLEMS (Table 11) ...................................................36

14.2 Detailed Description for HISTORY OF PAST PROBLEMS .................................................................................36

15 Definition for IPS Section: HISTORY OF PREGNANCY ..................................................................................................38

15.1 Overview Description for HISTORY OF PREGNANCY (Table 12) .............................................................38

15.2 Detailed Description for HISTORY OF PREGNANCY ............................................................................................38

16 Definition for IPS Section: HISTORY OF PROCEDURES ...............................................................................................41

16.1 Overview Description for HISTORY OF PROCEDURES (Table 13) ...........................................................41

16.2 Detailed Description for HISTORY OF PROCEDURES .........................................................................................41

17 Definition for IPS Section: IMMUNIZATIONS ........................................................................................................................43

17.1 Overview Description for IMMUNIZATIONS (Table 14) ..................................................................................43

17.2 Detailed Description for IMMUNIZATIONS .................................................................................................................43

18 Definition for IPS Section: MEDICAL DEVICES ....................................................................................................................45

18.1 Overview Description for MEDICAL DEVICES (Table 15)...............................................................................45

18.2 Detailed Description for MEDICAL DEVICES .............................................................................................................45

19 Definition for IPS Section: MEDICATION SUMMARY .....................................................................................................46

19.1 Overview Description for MEDICATION SUMMARY (Tables 16 and 17) ...........................................46

19.2 The IPS Medication Summary and IDMP ......................................................................................................................46

19.3 Detailed Description for MEDICATION SUMMARY ...............................................................................................47

20 Definition for IPS Section: PLAN OF CARE ...............................................................................................................................50

20.1 Overview Description for PLAN OF CARE (Table 18) .........................................................................................50

20.2 Detailed Description for PLAN OF CARE .......................................................................................................................50

21 Definition for IPS Section: PROBLEMS ........................................................................................................................................52

21.1 Overview Description for PROBLEMS (Table 19) ..................................................................................................52

21.2 Detailed Description for PROBLEMS.................................................................................................................................52

22 Definition for IPS Section: RESULTS ...............................................................................................................................................54

22.1 Overview Description for RESULTS (Table 20) ........................................................................................................54

22.2 Detailed Description for RESULTS ......................................................................................................................................54

23 Definition for IPS Section: SOCIAL HISTORY .........................................................................................................................56

23.1 Overview Description for SOCIAL HISTORY (Table 21) ...................................................................................56

23.2 Detailed Description for SOCIAL HISTORY ..................................................................................................................56

24 Definition for IPS Section: VITAL SIGNS .....................................................................................................................................58

24.1 Overview Description for VITAL SIGNS (Table 22)...............................................................................................58

24.2 Detailed Description for VITAL SIGNS .............................................................................................................................58

25 Definition for IPS Attribute Collection: Cross Border .................................................................................................60

25.1 Overview Description for CROSS BORDER (Table 23).......................................................................................60

25.2 Detailed Description for CROSS BORDER .....................................................................................................................60

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26 Definition for IPS Attribute Collection: Provenance Metadata ..........................................................................61

26.1 Overview Description for PROVENANCE (Table 24) ...........................................................................................61

26.2 Detailed Description for PROVENANCE .........................................................................................................................61

Annex A (informative) The first IPS Scenario focussed on ‘unscheduled, cross-border care’ ...............63

Annex B (informative) Explicit Trace between eHN Guideline Version 2 ....................................................................70

Annex C (informative) The eHN Guideline, the JIC PS Standards Set, and IPS ........................................................74

Bibliography .............................................................................................................................................................................................................................75

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oSIST prEN ISO 27269:2022
ISO 27269:2021(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 European Committee for Standardization (CEN) (as EN 17269:2019)

and was adopted, with the following modifications by Technical Committee ISO/TC 215, Health

informatics.
— changed "this European Standard" to "this document";
— changed any "EN ISO xxxx" references to "ISO xxxx" references;
— changed "section" to "Clause", if appropriate;
— definitions of IPS terms in body of text were moved to Clause 3;
— Clause 3 was reorganized based upon existing ContSys hierarchy;

— more description on conformance, data blocks, more examples in concept values and updated

definition citations given in response.

— on implementation evidence from HL7 FHIR ® , the requirement to require/enable the expression

of the name data element as a single string as well as the structured representation to permit the

natural way of expression in some eastern countries and facilitate cross-border use;

— ‘Healthcare Provider’ became an Attribute Collection data block, defined and positioned in Clause 3

rather than be treated as a data type.
— complete editorial revision.

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.

1) HL7 FHIR is the registered trademark of Health Level Seven International. This information is given for the

convenience of users of this document and does not constitute an endorsement by ISO of the product named.

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Introduction

The goal of this document is to deliver a single, common International Patient Summary (IPS),

comprising core content.

This document achieves that goal by defining a minimal yet non-exhaustive data set and its associated

business rules. This document is implementation independent yet still supportive of any implementation

by providing formal definition and clear description of a small data set. The primary input to the data

[1]

set is the second revision of the European eHealth Network’s (eHN) data set , which, in turn, builds

[2]

upon significant clinical input from the European Patients-Smart Open Services (epSOS) pilot project .

This document defines the IPS, with the initial focus upon unplanned care across national borders.

Starting from this focus, and building upon it, the specification is intended to be used and be useful in

national and local applications and also to be supportive of both planned and unplanned care. The IPS

is designed to provide clinical information to assist care across any jurisdictional border (e.g. local,

regional, state/provincial, national). It emphasizes the data required and the associated business

rules to support use and the necessary conformance of the use case for an international patient

summary. Even though the data set is relatively small, there is no expectation that the full data set

has to be realized for a conformant implementation or conformant specification to be produced. Such

artefacts need not specify all the optional IPS elements, given that they should assure the openness and

extensibility of the derived model.

The data set described is intended for global use beginning with a shared vision from a collaboration

between CEN /TC 251 and HL7® , but now involving five Standard Development Organizations

each contributing artefacts to support the single solution IPS going forward. From the IPS reference

model it is possible to derive a number of compliant logical models that constrain it, and these lead to

implementable specifications, such as the IPS CDA and FHIR Implementation Guides. These guides are

2) 2) 2)

formalized in the HL7 CDA IG® and HL7 IG® and in the IHE IPS® profile. The IPS Dataset is not

bound by any terminology, although it does anticipate the use of the IDMP standard for medication.

SNOMED® International has provided a Global Patient Set for the IPS implementations. CEN has

[3]

produced a separate Technical Specification , that provides a European-specific guideline for IPS

implementation, which can also be used as an example for other jurisdictions.

The ‘International’ element of the IPS emphasizes the need to provide generic solutions for global

application moving beyond a particular region or country; consequently, wherever possible, reference

is made to international standards, rather than local ones. However, different international contexts

will offer a variety of requirements that need to be considered to ensure that patient safety is not

compromised. The IPS is underpinned by ISO 13940, which is a system of concepts to support continuity

[4]

of care and uses those concepts in the initial IPS scenario, which is fully described in Annex A.

This document focuses upon the overall structure of the patient summary as well as the individual data

elements that comprise it. The layout of this document (see Table 1) uses a hierarchy of levels (H0 to H7)

to facilitate more detailed description with the purpose of supporting consistent implementation of the

data set. The level ‘H0’ describes the IPS Document as a whole, whilst levels H1-H7 describe the IPS Data

Blocks with attributes. Descriptors are added to each data element to better define the characteristics.

The ‘H0’ level document structure and constraints will be described first, the components start with

H1 (e.g. IPS Sections, IPS Attribute Collections).

2) HL7, HL7 CDA IG, HL7 IG and HL7 IPS are the registered trademark of Health Level Seven International. This

information is given for the convenience of users of this document and does not constitute an endorsement by ISO

of the products named.

3) SNOMED is the registered trademark of International Health Terminology Standards Development Organization.

This information is given for the convenience of users of this document and does not constitute an endorsement by

ISO of the product named.
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Table 1 — Description of IPS Data Set concepts and their hierarchical relationships

Descriptive hierar- H0 H1 H2 – H7
chy

IPS Data Transfer IPS Docu- All possible IPS and the Non-IPS Further detail is provided within the

Object ment components are identified IPS Data Blocks’ clauses

IPS Data Blocks - Individual IPS Sections, Hierarchical description of data elements

IPS Attribute Collections

The ordering of the IPS Data Blocks in this document is within three broad categories of Non-Clinical

[5]

Data, Clinical Data and Metadata. This follows the eHDSI patient summary deployment project and

here is used purely to help presentation. However, in practice it is recognized that individual attributes

might appear in different categories depending on dynamic use rather than static classification.

As the amount of information for each data element is variable, and can be extensive, this document

presents the information using a table with descriptors for each IPS Data Block; the table provides an

overview of the hierarchical structure and its requirement with explicit links to more de

...

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