ISO/PAS 24305:2025

Health informatics — Guidelines for implementation of HL7 FHIR based on ISO 13940:2015, ISO 13606-1:2019 and ISO 13606-3:2019

This document provides guidance on how four complementary international standards can be used in combination by developers of health ICT systems and infrastructures. These standards, three published by CEN and ISO and one by HL7, are — ISO 13940:2015, — ISO 13606-1:2019, — ISO 13606-3:2019, and — HL7 Fast Health Interoperability Resources (FHIR) Release 4. This document defines mappings between these standards: between ISO 13940 and HL7 FHIR in both directions, between ISO 13606 and HL7 FHIR in both directions, it proposes the content of an HL7 FHIR profile corresponding to the ISO 13606-1:2019 “COMPOSITION” class. It also provides guidance and worked examples of the mapping between ISO 13606-3 Reference Archetypes corresponding to ISO 13940 and HL7 FHIR. This document also summarizes the extent to which the source concept is broader than or narrower than the best fit target concept. It also highlights mapping issues that adopters will need to be mindful of, where the representation capability of the standards differs.

Informatique de santé — Lignes directrices pour l'implémentation de HL7 FHIR à partir de l'ISO 13940:2015, l'ISO 13606-1:2019 et de l'ISO 13606-3:2019

General Information

• Status: Published
• Publication Date: 02-Jul-2025
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: ISO/TC 215 - Health informatics
• Drafting Committee: ISO/TC 215/WG 1 - Architecture, Frameworks and Models
• Current Stage: 6060 - International Standard published
• Start Date: 03-Jul-2025
• Completion Date: 03-Jul-2025

Standards Content (Sample)

Publicly
Available
Specification
ISO/PAS 24305
First edition
Health informatics — Guidelines for
2025-07
implementation of HL7 FHIR based
on ISO 13940:2015, ISO 13606-
1:2019 and ISO 13606-3:2019
Informatique de santé — Lignes directrices pour
l'implémentation de HL7 FHIR à partir de l'ISO 13940:2015, l'ISO
13606-1:2019 et de l'ISO 13606-3:2019
Reference number
© ISO 2025
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
Contents Page
Foreword .vi
Introduction .vii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Summary of the ISO 13940:2015 to FHIR R4 map . 2
4.1 Goals .2
4.2 Approach .2
4.3 Findings .2
4.4 Mapping issues .2
5 Mapping of concepts from 13940:2015 to FHIR R4 . 2
5.1 Mapping of concepts related to healthcare actors .2
5.2 Mapping of concepts related to healthcare matters .6
5.3 Mapping of concepts related to activities . 12
5.4 Mapping of concepts related to process . 22
5.5 Mapping of concepts related to healthcare planning . 25
5.6 Mapping of concepts related to time . 29
5.7 Mapping of concepts related to responsibilities . 35
5.8 Mapping of concepts related to information management . 39
6 Summary of the FHIR R4 to ISO 13940:2015 map .46
6.1 Goals . 46
6.2 Approach . 46
6.3 Findings . 46
6.4 Mapping issues . 46
7 Mapping of concepts from FHIR R4 to ISO 13940:2015 . 47
7.1 Mapping of concepts related to foundation ‒ conformance .47
7.2 Mapping of concepts related to foundation ‒ terminology . 49
7.3 Mapping of concepts related to foundation ‒ security .51
7.4 Mapping of concepts related to foundation ‒ documents . 53
7.5 Mapping of concepts related to base ‒ individuals . 55
7.6 Mapping of concepts related to base ‒ entities#1 . 58
7.7 Mapping of concepts related to base ‒ entities#2. .61
7.8 Mapping of concepts related to base ‒ workflow . 63
7.9 Mapping of concepts base ‒ management . 65
7.10 Mapping of concepts related to clinical ‒ summary .67
7.11 Mapping of concepts related to clinical ‒ diagnostics .70
7.12 Mapping of concepts related to clinical – medications . 73
7.13 Mapping of concepts clinical ‒ care provisions .76
7.14 Mapping of concepts related to clinical ‒ request and response . 80
7.15 Mapping of concepts related to financial ‒ support . 83
7.16 Mapping of concepts related to financial ‒ billing . 85
7.17 Mapping of concepts related to financial ‒ payment . 87
7.18 Mapping of concepts related to financial ‒ general . 89
7.19 Mapping of concepts related to specialized ‒ public health and research .91
7.20 Mapping of concepts related to specialized ‒ definitional artifacts . 93
7.21 Mapping of concepts related to specialized ‒ evidence-based medicine . 97
7.22 Mapping of concepts related to specialized ‒ quality reporting and testing . 99
7.23 Mapping of concepts related to specialized ‒ medication definition . 101
8 Summary of the ISO 13606-1:2019 from/to FHIR R4 map .107
8.1 Goals . 107
8.2 Approach . 107
8.3 Findings . 107

iii
8.4 Mapping issues . 107
9 Mapping of concepts from ISO 13606-1:2019 to FHIR .108
9.1 Mapping of concepts related to EHR Component ‒ EHR Extract . 108
9.2 Mapping of concepts related to EHR Component ‒ Folder .110
9.3 Mapping of concepts related to EHR Component ‒ Composition . 112
9.4 Mapping of concepts related to EHR Component ‒ Entry .114
9.5 Mapping of concepts related to EHR Component ‒ Item .116
9.6 Mapping of concepts related to EHR component ‒ Common properties of record
components . 118
9.7 Mapping of concepts related to EHR component ‒ Base component . 118
9.8 Mapping of concepts related to EHR component ‒ Record component . 120
9.9 Mapping of concepts related to EHR component ‒ Attestation . 122
9.10 Mapping of concepts related to EHR component ‒ Link . 124
9.11 Mapping of concepts related to EHR component ‒ External link . 126
9.12 General principles for mapping elements and data values .128
9.13 Mapping of concepts related to Elements and data values ‒ Instance identifier . 133
9.14 Mapping of concepts related to Elements and data values ‒ URI . 135
9.15 Mapping of concepts related to Elements and data values ‒ uid . 137
9.16 Mapping of concepts related to Elements and data values ‒ Attachment . 139
9.17 Mapping of concepts related to Elements and data values ‒ SampleData .142
9.18 Mapping of concepts related to Elements and data values ‒ Point in time. 144
9.19 Mapping of concepts related to Elements and data values ‒ Date time. 146
9.20 Mapping of concepts related to Elements and data values ‒ Date . 148
9.21 Mapping of concepts related to Elements and data values ‒ Time . 150
9.22 Mapping of concepts related to Elements and data values ‒ Period. 152
9.23 Mapping of concepts related to Elements and data values ‒ Timing .154
9.24 Mapping of concepts related to Elements and data values ‒ Physical Quantity . 156
9.25 Mapping of concepts related to Elements and data values ‒ Coded value . 159
9.26 Mapping of concepts related to Elements and data values ‒ Coded simple .161
9.27 Mapping of concepts related to Elements and data values ‒ Simple text . 163
9.28 Mapping of concepts related to Elements and data values ‒
...

FINAL DRAFT
Publicly
Available
Specification
ISO/DPAS 24305
ISO/TC 215
Health informatics — Guidelines for
Secretariat: ANSI
implementation of HL7 FHIR based
Voting begins on:
on ISO 13940:2015, ISO 13606-
2025-04-15
1:2019 and ISO 13606-3:2019
Voting terminates on:
2025-06-10
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
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
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.
Reference number
ISO/DPAS 24305:2025(en) © ISO 2025

FINAL DRAFT
ISO/DPAS 24305:2025(en)
Publicly
Available
Specification
ISO/DPAS 24305
ISO/TC 215
Health informatics - Guidelines for
Secretariat: ANSI
implementation of HL7 FHIR based
Voting begins on:
on ISO 13940:2015, ISO 13606-
1:2019 and ISO 13606-3:2019
Voting terminates on:
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.
© ISO 2025
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland Reference number
ISO/DPAS 24305:2025(en) © ISO 2025

ii
ISO/DPAS 24305:2025(en)
Contents Page
Foreword .vi
Introduction .vii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Summary of the ISO 13940:2015 to FHIR R4 map . 2
4.1 Goals .2
4.2 Approach .2
4.3 Findings .2
4.4 Mapping issues .2
5 Mapping of concepts from 13940:2015 to FHIR R4 . 2
5.1 Mapping of concepts related to healthcare actors .2
5.2 Mapping of concepts related to healthcare matters .6
5.3 Mapping of concepts related to activities . 12
5.4 Mapping of concepts related to process . 22
5.5 Mapping of concepts related to healthcare planning . 25
5.6 Mapping of concepts related to time . 29
5.7 Mapping of concepts related to responsibilities . 35
5.8 Mapping of concepts related to information management . 39
6 Summary of the FHIR R4 to ISO 13940:2015 map .46
6.1 Goals . 46
6.2 Approach . 46
6.3 Findings . 46
6.4 Mapping issues . 46
7 Mapping of concepts from FHIR R4 to ISO 13940:2015 . 47
7.1 Mapping of concepts related to foundation ‒ conformance .47
7.2 Mapping of concepts related to foundation ‒ terminology . 49
7.3 Mapping of concepts related to foundation ‒ security .51
7.4 Mapping of concepts related to foundation ‒ documents . 53
7.5 Mapping of concepts related to base ‒ individuals . 55
7.6 Mapping of concepts related to base ‒ entities#1 . 58
7.7 Mapping of concepts related to base ‒ entities#2. .61
7.8 Mapping of concepts related to base ‒ workflow . 63
7.9 Mapping of concepts base ‒ management . 65
7.10 Mapping of concepts related to clinical ‒ summary .67
7.11 Mapping of concepts related to clinical ‒ diagnostics .70
7.12 Mapping of concepts related to clinical – medications . 73
7.13 Mapping of concepts clinical ‒ care provisions .76
7.14 Mapping of concepts related to clinical ‒ request and response . 80
7.15 Mapping of concepts related to financial ‒ support . 83
7.16 Mapping of concepts related to financial ‒ billing . 85
7.17 Mapping of concepts related to financial ‒ payment . 87
7.18 Mapping of concepts related to financial ‒ general . 89
7.19 Mapping of concepts related to specialized ‒ public health and research .91
7.20 Mapping of concepts related to specialized ‒ definitional artifacts . 93
7.21 Mapping of concepts related to specialized ‒ evidence-based medicine . 97
7.22 Mapping of concepts related to specialized ‒ quality reporting and testing . 99
7.23 Mapping of concepts related to specialized ‒ medication definition . 101
8 Summary of the ISO 13606-1:2019 from/to FHIR R4 map .107
8.1 Goals . 107
8.2 Approach . 107
8.3 Findings . 107

iii
ISO/DPAS 24305:2025(en)
8.4 Mapping issues . 107
9 Mapping of concepts from ISO 13606-1:2019 to FHIR .108
9.1 Mapping of concepts related to EHR Component ‒ EHR Extract . 108
9.2 Mapping of concepts related to EHR Component ‒ Folder .110
9.3 Mapping of concepts related to EHR Component ‒ Composition . 112
9.4 Mapping of concepts related to EHR Component ‒ Entry .114
9.5 Mapping of concepts related to EHR Component ‒ Item .116
9.6 Mapping of concepts related to EHR component ‒ Common properties of record
components . 118
9.7 Mapping of concepts related to EHR component ‒ Base component . 118
9.8 Mapping of concepts related to EHR component ‒ Record component . 120
9.9 Mapping of concepts related to EHR component ‒ Attestation . 122
9.10 Mapping of concepts related to EHR component ‒ Link . 124
9.11 Mapping of concepts related to EHR component ‒ External link . 126
9.12 General principles for mapping elements and data values .128
9.13 Mapping of concepts related to Elements and data values ‒ Instance identifier . 133
9.14 Mapping of concepts related to Elements and data values ‒ URI . 135
9.15 Mapping of concepts related to Elements and data values ‒ uid . 137
9.16 Mapping of concepts related to Elements and data values ‒ Attachment . 139
9.17 Mapping of concepts related to Elements and data values ‒ SampleData .142
9.18 Mapping of concepts related to Elements and data values ‒ Point in time. 144
9.19 Mapping of concep
...

ISO/DPAS 24305
ISO/TC 215 / WG 1
Secretariat: ANSI
Date: 2024-12-062025-03-31
Health informatics — - Guidelines for implementation of HL7 FHIR
based on ISO 13940:2015, ISO 13606-1:2019 and ISO 13606-3:2019

DPAS stage
ISO/DPAS 24305:(en)
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
EmailE-mail: [e-mail]
Website: www.iso.orgwww.iso.org
Published in Switzerland
ii
ISO/DPAS 24305:(en)
Contents
Foreword . vi
Introduction . vii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Summary of the ISO 13940:2015 to FHIR R4 map . 2
4.1 Goals . 2
4.2 Approach . 2
4.3 Findings . 2
4.4 Mapping issues . 2
5 Mapping of concepts from 13940:2015 to FHIR R4 . 2
5.1 Mapping of concepts related to healthcare actors . 2
5.2 Mapping of concepts related to healthcare matters . 7
5.3 Mapping of concepts related to activities . 14
5.4 Mapping of concepts related to process . 25
5.5 Mapping of concepts related to healthcare planning . 29
5.6 Mapping of concepts related to time . 34
5.7 Mapping of concepts related to responsibilities . 42
5.8 Mapping of concepts related to information management . 48
6 Summary of the FHIR R4 to ISO 13940:2015 map . 0
6.1 Goals . 0
6.2 Approach . 0
6.3 Findings . 0
6.4 Mapping issues . 1
7 Mapping of concepts from FHIR R4 to ISO 13940:2015 . 2
7.1 Mapping of concepts related to foundation ‒ conformance . 2
7.2 Mapping of concepts related to foundation ‒ terminology . 5
7.3 Mapping of concepts related to foundation ‒ security . 7
7.4 Mapping of concepts related to foundation ‒ documents . 9
7.5 Mapping of concepts related to base ‒ individuals . 11
7.6 Mapping of concepts related to base ‒ entities#1 . 14
7.7 Mapping of concepts related to base ‒ entities#2. . 17
7.8 Mapping of concepts related to base ‒ workflow . 19
7.9 Mapping of concepts base ‒ management . 22
7.10 Mapping of concepts related to clinical ‒ summary . 24
7.11 Mapping of concepts related to clinical ‒ diagnostics . 27
7.12 Mapping of concepts related to clinical – medications. 31
7.13 Mapping of concepts clinical ‒ care provisions . 35
7.14 Mapping of concepts related to clinical ‒ request and response . 39
7.15 Mapping of concepts related to financial ‒ support . 42
7.16 Mapping of concepts related to financial ‒ billing . 44
7.17 Mapping of concepts related to financial ‒ payment . 46
7.18 Mapping of concepts related to financial ‒ general. 48
7.19 Mapping of concepts related to specialized ‒ public health and research . 51
7.20 Mapping of concepts related to specialized ‒ definitional artifacts . 53
7.21 Mapping of concepts related to specialized ‒ evidence-based medicine . 57
7.22 Mapping of concepts related to specialized ‒ quality reporting and testing . 60
7.23 Mapping of concepts related to specialized ‒ medication definition . 62
iii
ISO/DPAS 24305:(en)
8 Summary of the ISO 13606-1:2019 from/to FHIR R4 map . 0
8.1 Goals . 0
8.2 Approach . 0
8.3 Findings . 0
8.4 Mapping issues . 1
9 Mapping of concepts from ISO 13606-1:2019 to FHIR . 0
9.1 Mapping of concepts related to EHR Component ‒ EHR Extract . 1
9.2 Mapping of concepts related to EHR Component ‒ Folder . 3
9.3 Mapping of concepts related to EHR Component ‒ Composition . 5
9.4 Mapping of concepts related to EHR Component ‒ Entry. 7
9.5 Mapping of concepts related to EHR Component ‒ Item . 9
9.6 Mapping of concepts related to EHR component ‒ Common properties of record
components . 11
9.7 Mapping of concepts related to EHR component ‒ Base component . 11
9.8 Mapping of concepts related to EHR component ‒ Record component . 13
9.9 Mapping of concepts related to EHR component ‒ Attestation . 15
9.10 Mapping of concepts related to EHR component ‒ Link . 17
9.11 Mapping of concepts related to EHR component ‒ External link . 19
9.12 General principles for mapping elements and data values . 21
9.13 Mapping of concepts related to Elements and data values ‒ Instance identifier . 26
9.14 Mapping of concepts related to Elements and data values ‒ URI . 28
9.15 Mapping of concepts related to Elements and data values ‒ uid . 30
9.16 Mapping of concepts related to Elements and data values ‒ Attachment . 32
9.17 Mapping of concepts related to Elements and data values ‒ SampleData . 35
9.18 Mapping of concepts related to Elements and data values ‒ Point in time . 37
9.19 Mapping of concepts related to Elements and data values ‒ Date time . 39
9.20 Mapping of concepts related to Elements and data values ‒ Date . 41
9.21 Mapping of concepts related to Elements and data values ‒ Time . 43
9.22 Mapping of concepts related to Elements and data values ‒ Period . 45
9.23 Mapping of concepts related to Elements and data values ‒ Timing . 47
9.24 Mapping of concepts related to Elements and data values ‒ Physical Quantity . 49
9.25 Mapping of concepts related to Elements and data values ‒ Coded value . 53
9.26 Mapping of concepts related to Elements and data values ‒ Coded simple . 56
9.27 Mapping of concepts related to Elements and data values ‒ Simple text . 58
9.28 Mapping of concepts related to Elements and data values ‒ String . 61
9.29 Mapping of concepts related to Elements and data values ‒ Annotation . 63
9.30 Mapping of concepts related to Elements and data values ‒ Integer . 65
9.31 Mapping of concepts related to Elements and data values ‒ Real. 67
9.32 Mapping of concepts related to Elements and data values ‒ Boolean . 69
9.33 Mapping of concepts related to Demographics ‒ PersonName . 71
9.34 Mapping of concepts related to Demographics ‒ TelecommunicationAddress . 74
9.35 Mapping of concepts related to Demographics ‒ LocationAddress . 76
9.36 Mapping of concepts related to Demographics ‒ Attestation info . 79
9.37 Mapping of concepts related to value sets . 82
9.38 Mapping of concepts value set ‒ Link . 85
9.39 Mapping of concepts value set ‒ Version_status . 87
9.40 Mapping of concepts related to value Set ‒ Null_flavour . 88
10 Challenges, constraints, and recommendations for a standardization roadmap to align
the HL7 FHIR and ISO 13606-3:2019 standards . 90
10.1 Purpose of this Clause . 90
10.2 Importance of HL7 FHIR and ISO 13606-3:2019 alignment . 90
10.3 Overview of the HL7 FHIR functional/reporting model . 91
10.4 Overview of ISO 13606-3:2019 . 91
iv
ISO/DPAS 24305:(en)
10.5 Differences and similarities between the standards in terms of information structure
composition mechanisms . 92
10.6
...