SIST EN ISO 13940:2016

SLOVENSKI STANDARD
oSIST prEN ISO 13940:2013
01-februar-2013
Zdravstvena informatika - Sistem pojmov za podporo neprekinjeni oskrbi (ISO/DIS
13940:2012)
Health informatics - System of concepts to support continuity of care (ISO/DIS
13940:2012)
Medizinische Informatik - System von Konzepten zur Unterstützung der
ununterbrochenen Pflege (ISO/DIS 13940:2012)
Informatique de santé - Système de concepts en appui de la continuité des soins
(ISO/DIS 13940:2012)
Ta slovenski standard je istoveten z: prEN ISO 13940 rev
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
oSIST prEN ISO 13940:2013 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 13940:2013

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oSIST prEN ISO 13940:2013


EUROPEAN STANDARD
DRAFT
prEN ISO 13940 rev
NORME EUROPÉENNE

EUROPÄISCHE NORM

December 2012
ICS 35.240.80 Will supersede EN 13940-1:2007
English Version
Health informatics - System of concepts to support continuity of
care (ISO/DIS 13940:2012)
Informatique de santé - Système de concepts en appui de Medizinische Informatik - System von Konzepten zur
la continuité des soins (ISO/DIS 13940:2012) Unterstützung der ununterbrochenen Pflege (ISO/DIS
13940:2012)
This draft European Standard is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical Committee
CEN/TC 251.

If this draft becomes a European Standard, 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.

This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other language
made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

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

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 supporting documentation.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.


EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN ISO 13940 rev:2012: E
worldwide for CEN national Members.

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oSIST prEN ISO 13940:2013
prEN ISO 13940:2012 (E)
Contents Page
Foreword .3

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oSIST prEN ISO 13940:2013
prEN ISO 13940:2012 (E)
Foreword
This document (prEN ISO 13940:2012) has been prepared by Technical Committee ISO/TC 215 "Health
informatics" in collaboration with Technical Committee CEN/TC 251 “Health informatics” the secretariat of
which is held by NEN.
This document is currently submitted to the parallel Enquiry.
This document will supersede EN 13940-1:2007.
Endorsement notice
The text of ISO/DIS 13940:2012 has been approved by CEN as a prEN ISO 13940:2012 without any
modification.
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oSIST prEN ISO 13940:2013

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oSIST prEN ISO 13940:2013

DRAFT INTERNATIONAL STANDARD ISO/DIS 13940
ISO/TC 215 Secretariat: ANSI
Voting begins on Voting terminates on

2012-12-13 2013-05-13
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION  •  МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ  •  ORGANISATION INTERNATIONALE DE NORMALISATION


Health informatics — System of concepts to support continuity
of care
Informatique de santé — Système de concepts en appui de la continuité des soins

ICS 35.240.80





ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for Standardization (ISO), and
processed under the ISO-lead mode of collaboration as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member bodies for a parallel
five-month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments received, will be
submitted to a parallel two-month approval vote in ISO and formal vote in CEN.

To expedite distribution, this document is circulated as received from the committee
secretariat. ISO Central Secretariat work of editing and text composition will be undertaken at
publication stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.



THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE
REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN NATIONAL REGULATIONS.
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 SUPPORTING DOCUMENTATION.
©  International Organization for Standardization, 2012

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oSIST prEN ISO 13940:2013
ISO/DIS 13940

Copyright notice
This ISO document is a Draft International Standard and is copyright-protected by ISO. Except as permitted
under the applicable laws of the user’s country, neither this ISO draft nor any extract from it may be
reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic,
photocopying, recording or otherwise, without prior written permission being secured.
Requests for permission to reproduce should be addressed to either ISO at the address below or ISO’s
member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Reproduction may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.

ii © ISO 2012 – All rights reserved

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oSIST prEN ISO 13940:2013
 ISO 13940 (E)

Contents Page
0. Introduction . 10
0.1 General . 10
0.2 Aims for this standard . 10
0.3 Target groups . 10
0.4 Business oriented architecture of the system of concepts . 10
0.5 Description and display of concepts. 11
0.6 About the concept of health . 12
0.7 Healthcare versus social care . 12
0.8 Explanatory comments . 12
0.8.1 Process and workflow . 12
0.8.1.1. Process concepts in general . 12
0.8.1.2. Workflow in general . 14
0.8.2 Types of processes in healthcare . 14
0.8.2.1. Healthcare and clinical processes . 14
0.8.2.2. Healthcare research process . 15
0.8.2.3. Healthcare educational process . 15
0.8.3 Workflow in healthcare . 16
0.8.4 The Clinical process model . 16

1. Scope . 18
2. Normative references . 19
3. Terms and definitions . 20
3.1 clinical data . 20
3.2 clinical information . 20
3.3 commitment . 20
3.4 concept . 20
3.5 consent . 20
3.6 continuity of care . 20
3.7 data . 20
3.8 deprecated term . 20
3.9 entity . 20
3.10 healthcare . 20
3.11 information . 21
3.12 information model . 21
3.13 knowledge . 21
3.14 medical device . 21
3.15 organization . 22
3.16 organizational pattern . 22
3.17 organization role . 22
3.18 party . 22
3.19 person . 22
3.20 person role . 22
3.21 process . 22
3.22 process model . 22
3.23 quality in healthcare . 22
3.24 quality management . 22
3.25 quality assurance . 22
3.26 quality control. 23
3.27 quality management system . 23
3.28 resource . 23
3.29 risk . 23
3.30 role . 23
3.31 system of concepts . 23
3.32 unintended event . 23
3.33 workflow . 23
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ISO 13940 (E)
4. Symbols and abbreviations . 24

5. Actors in continuity of care . 25
5.1 General . 25
5.2 Healthcare actor . 27
5.2.1 Subject of care . 29
5.2.2 Healthcare provider . 31
5.2.2.1. Healthcare organization . 33
5.2.3 Healthcare personnel . 35
5.2.3.1. Healthcare employment . 36
5.2.3.2. Healthcare professional . 37
5.2.3.3. Healthcare professional entitlement . 39
5.2.4 Healthcare third party . 40
5.2.4.1. Other carer . 41
5.2.4.2. Healthcare supporting organization . 42
5.2.5 Next of kin . 43
5.2.6 Subject of care proxy . 44
5.2.7 Legally authorized proxy . 45
5.2.7.1. Healthcare funds . 46

6. Health issues and their management . 47
6.1 General . 47
6.2 Health issue . 48
6.2.1 Health state . 50
6.2.1.1. Input health state . 51
6.2.1.2. Output health state . 52
6.2.2 Health condition . 53
6.2.2.1. Perceived condition . 54
6.2.1.2.1 Assessed condition . 55
6.2.2.2. Possible health condition . 56
6.2.2.2.1 Considered condition . 57
6.2.2.2.2 Target condition . 58
6.2.2.2.3 Prognostic condition . 59
6.2.2.2.4 Risk condition . 60
6.3 Health issue thread . 61
6.3.1 Clinical process interest . 63
6.3.2 Health concern . 64
6.3.2.1. Health problem list . 65
6.3.2.2. Health condition thread . 66

7. Time-related concepts in continuity of care . 67
7.1 General . 67
7.2 Mandated period of care . 68
7.2.1 Healthcare activity period . 70
7.2.1.1. Contact. 71
7.2.1.2. Non-contact period . 72
7.2.1.3. Self care period . 73
7.2.1.4. Initial contact . 74
7.2.2 Healthcare activity period element . 75
7.2.3 Healthcare appointment . 76
7.3 Health related period . 77
7.3.1 Healthcare activity delay . 78
7.3.2 Health condition delay . 79
7.3.3 Resource delay . 80
7.3.4 Subject of care preference delay . 81
7.3.5 Episode of care . 82
7.3.5.1. Health approach . 84
7.3.6 Clinical process related episode . 85
7.4 Episodes of care bundle . 86

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8. Process related concepts . 87
8.1 General . 87
8.2 Healthcare process . 88
8.2.1 Clinical process . 90
8.3 Healthcare workflow . 91
8.4 Healthcare quality management . 92
8.5 Healthcare resources management . 93
8.6 Healthcare administration . 94
8.7 Healthcare resource . 95
8.7.1 Point of care . 96
8.7.2 Healthcare Device . 97
8.7.3 Medicinal product . 98
8.8 Adverse event . 99
8.9 Adverse event handling . 100

9. Concepts related to the use of clinical knowledge and decision support in continuity of care. 101
9.1 General . 101
9.2 Care plan . 102
9.2.1 Standardized care plan template . 104
9.2.2 Uniprofessional care plan . 105
9.3 Clinical guidelines. 106
9.4 Protocol . 107
9.5 Clinical pathway . 108
9.6 Health objective . 109
9.7 Healthcare goal . 110
9.8 Healthcare activities bundle . 111

10. Concepts related to activity . 112
10.1 General . 112
10.2 Healthcare activity . 113
10.2.1 Healthcare treatment . 115
10.2.2 Healthcare investigation . 116
10.2.3 Healthcare activity management. 117
10.2.4 Healthcare assessment . 118
10.2.5 Healthcare evaluation . 119
10.2.6 Healthcare provider activity . 120
10.2.7 Needs assessment . 122
10.2.7.1. Healthcare planning . 123
10.2.7.2. Healthcare process evaluation . 124
10.2.7.3. Clinical process outcome evaluation . 125
10.2.8 Health self care activity . 126
10.2.9 Prescribed self care . 127
10.2.10 Healthcare contributing activity . 128
10.2.10.1. Prescribed contributing care . 129
10.2.11 Healthcare automated activity . 130
10.3 Healthcare activity directory . 131

11. Concepts related to responsibility in Continuity of Care . 132
11.1 General . 132
11.2 Demand for care . 133
11.2.1 Demand for initial contact . 134
11.2.2 Referral . 135
11.2.3 Request . 136
11.2.4 Need for healthcare . 137
11.3 Healthcare mandate .
...