Health informatics -- International patient summary

This document defines the core data set for a patient summary document that supports continuity of care for a person and coordination of their healthcare. It is specifically aimed at supporting the use case’ scenario for ‘unplanned, cross border care’ and is intended to be an international patient summary (IPS). Whilst the data set is minimal and non-exhaustive, it provides a robust, well-defined core set of data items. The tight focus on this use case also enables the IPS to be used in planned care. This means that both unplanned and planned care can be supported by this data set within local and national contexts, thereby increasing its utility and value. It uses the European Guideline from the eHN as the initial source for the patient summary requirements, then takes into consideration other international patient summary projects to provide an interoperable data set specification that has global application. This document provides an abstract definition of a Patient Summary from which derived models are implementable. Due to its nature therefore, readers should be aware that the compliance with this document does not imply automatic technical interoperability; this result, enabled by this document, can be reached with the conformity to standards indicated in the associated technical specification and implementation guides. This document does not cover the workflow processes of data entry, data collection, data summarization, subsequent data presentation, assimilation, or aggregation. Furthermore, this document does not cover the summarization act itself, i.e. the intelligence/skill/competence that results in the data summarization workflow. It is not an implementation guide that is concerned with the various technical layers beneath the application layer. Implementation guidance for specifically jurisdictional concerns, e.g. Directives, terminologies, formats, etc., an example is specified in the associated Technical Specification[3]. In particular, representation by various coding schemes, additional structures and terminologies are not part of this document. Terminology and its binding are addressed in Reference [3]. The Identification of Medicinal Products standards (abbreviated to IDMP) are the recommended target for the Medication Summary related to this document but, prior to IDMP’s full implementation in practice, this IPS standard cannot insist in its use at this point in time and recognizes that interim schemes might be necessary until IDMP becomes established as a norm.

Informatique de santé -- Résumé international du dossier médical du patient

General Information

Status
Published
Publication Date
07-Apr-2021
Current Stage
5060 - Close of voting Proof returned by Secretariat
Start Date
18-Feb-2021
Completion Date
17-Feb-2021
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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: 1 ----------------------
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: 2 ----------------------
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

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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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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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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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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 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.
© ISO 2021 – All rights reserved vii
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ISO 27269:2021(E)

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 details using a

consistent set of descriptors. Those attributes in the table that do not have a link to further detail are

either self-explanatory or explained by the hierarchical context. Note, the order of sibling attributes

is arbitrary and has no implication for implementations of this document. The name of the element is

contextualized by the hierarchy so as to avoid any misunderstanding. For example, the term ‘Device

Type’ will be used rather than just “Type” albeit that it refers to a data element positioned within the

Medical Device IPS Data Block.
viii © ISO 2021 – All rights reserved
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INTERNATIONAL STANDARD ISO 27269:2021(E)
Health informatics — International patient summary
1 Scope

This document defines the core data set for a patient summary document that supports continuity of

care for a person and coordination of their healthcare. It is specifically aimed at supporting the use

case’ scenario for ‘unplanned, cross border care’ and is intended to
...

FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 27269
ISO/TC 215
Health informatics — International
Secretariat: ANSI
patient summary
Voting begins on:
2020­12­23
Informatique de santé — Résumé international du dossier médical du
patient
Voting terminates on:
2021­02­17
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/FDIS 27269:2020(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN­
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. ISO 2020
---------------------- Page: 1 ----------------------
ISO/FDIS 27269:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

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
CH­1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/FDIS 27269:2020(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.........................................................................22

8.1 Overview Description: PATIENT ATTRIBUTES (Table 5) ................................................................................22

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

9 Definition for IPS Attribute Collection: HEALTHCARE PROVIDER ..................................................................24

9.1 Overview Description for HEALTHCARE PROVIDER (Table 6) ..................................................................24

© ISO 2020 – All rights reserved iii
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ISO/FDIS 27269:2020(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 ........................................................................................25

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 ...................................................................................................27

12 Definition for IPS Section: ALLERGIES and INTOLERANCES .................................................................................29

12.1 Overview Description for ALLERGIES and INTOLERANCES (Table 9) ................................................29

12.2 Detailed Description for ALLERGIES and INTOLERANCES ...........................................................................29

13 Definition for IPS Section: FUNCTIONAL STATUS .............................................................................................................33

13.1 Overview Description for FUNCTIONAL STATUS (Table 10) .......................................................................33

13.2 Detailed Description for FUNCTIONAL STATUS ......................................................................................................33

14 Definition for IPS Section: HISTORY OF PAST PROBLEMS .......................................................................................35

14.1 Overview Description for HISTORY OF PAST PROBLEMS (Table 11) ...................................................35

14.2 Detailed Description for HISTORY OF PAST PROBLEMS .................................................................................35

15 Definition for IPS Section: HISTORY OF PREGNANCY ..................................................................................................36

15.1 Overview Description for HISTORY OF PREGNANCY (Table 12) .............................................................36

15.2 Detailed Description for HISTORY OF PREGNANCY ............................................................................................37

16 Definition for IPS Section: HISTORY OF PROCEDURES ...............................................................................................40

16.1 Overview Description for HISTORY OF PROCEDURES (Table 13) ...........................................................40

16.2 Detailed Description for HISTORY OF PROCEDURES .........................................................................................40

17 Definition for IPS Section: IMMUNIZATIONS ........................................................................................................................41

17.1 Overview Description for IMMUNIZATIONS (Table 14) ..................................................................................41

17.2 Detailed Description for IMMUNIZATIONS .................................................................................................................42

18 Definition for IPS Section: MEDICAL DEVICES ....................................................................................................................43

18.1 Overview Description for MEDICAL DEVICES (Table 15)...............................................................................43

18.2 Detailed Description for MEDICAL DEVICES .............................................................................................................43

19 Definition for IPS Section: MEDICATION SUMMARY .....................................................................................................45

19.1 Overview Description for MEDICATION SUMMARY (Tables 16 and 17) ...........................................45

19.2 The IPS Medication Summary and IDMP ......................................................................................................................45

19.3 Detailed Description for MEDICATION SUMMARY ...............................................................................................46

20 Definition for IPS Section: PLAN OF CARE ...............................................................................................................................49

20.1 Overview Description for PLAN OF CARE (Table 18) .........................................................................................49

20.2 Detailed Description for PLAN OF CARE .......................................................................................................................49

21 Definition for IPS Section: PROBLEMS ........................................................................................................................................51

21.1 Overview Description for PROBLEMS (Table 19) ..................................................................................................51

21.2 Detailed Description for PROBLEMS.................................................................................................................................51

22 Definition for IPS Section: RESULTS ...............................................................................................................................................53

22.1 Overview Description for RESULTS (Table 20) ........................................................................................................53

22.2 Detailed Description for RESULTS ......................................................................................................................................53

23 Definition for IPS Section: SOCIAL HISTORY .........................................................................................................................54

23.1 Overview Description for SOCIAL HISTORY (Table 21) ...................................................................................54

23.2 Detailed Description for SOCIAL HISTORY ..................................................................................................................55

24 Definition for IPS Section: VITAL SIGNS .....................................................................................................................................56

24.1 Overview Description for VITAL SIGNS (Table 22)...............................................................................................56

24.2 Detailed Description for VITAL SIGNS .............................................................................................................................56

25 Definition for IPS Attribute Collection: Cross Border .................................................................................................58

25.1 Overview Description for CROSS BORDER (Table 23).......................................................................................58

25.2 Detailed Description for CROSS BORDER .....................................................................................................................58

iv © ISO 2020 – All rights reserved
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ISO/FDIS 27269:2020(E)

26 Definition for IPS Attribute Collection: Provenance Metadata ..........................................................................59

26.1 Overview Description for PROVENANCE (Table 24) ...........................................................................................59

26.2 Detailed Description for PROVENANCE .........................................................................................................................60

Annex A (informative) The first IPS Scenario focussed on ‘unscheduled, cross-border care’ ...............62

Annex B (informative) Explicit Trace between eHN Guideline Version 2 ....................................................................69

Annex C (informative) The eHN Guideline, the JIC PS Standards Set, and IPS ........................................................73

Bibliography .............................................................................................................................................................................................................................74

© ISO 2020 – All rights reserved v
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ISO/FDIS 27269:2020(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 non­governmental, 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 2020 – All rights reserved
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ISO/FDIS 27269:2020(E)
Introduction

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

comprising core content specification.

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

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

implementation by providing formal definition and clear description of a small data set. The primary

[1]

input to the data set is the second revision of the European eHealth Network’s (eHN) data set , which,

in turn, builds upon significant clinical input from the European Patients-Smart Open Services (epSOS)

[2]
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 5 SDO’s 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 formalized in the HL7 CDA IG® and

2) 2)

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

[3]

Global Patient Set for the IPS implementations. CEN has 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 H1­H7 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.
© ISO 2020 – All rights reserved vii
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ISO/FDIS 27269:2020(E)

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 Non­IPS 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 Non­Clinical

[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 details using a

consistent set of descriptors. Those attributes in the table that do not have a link to further detail are

either self-explanatory or explained by the hierarchical context. Note, the order of sibling attributes

is arbitrary and has no implication for implementations of this document. The name of the element is

contextualized by the hierarchy so as to avoid any misunderstanding. For example, the term ‘Device

...

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