ISO 5477:2023

FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 5477
ISO/TC 215
Health informatics — Interoperability
Secretariat: ANSI
of public health emergency
Voting begins on:
2023-09-15 preparedness and response
information systems
Voting terminates on:
2023-11-10
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
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/FDIS 5477:2023(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 2023

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ISO/FDIS 5477:2023(E)
FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 5477
ISO/TC 215
Health informatics — Interoperability
Secretariat: ANSI
of public health emergency
Voting begins on:
preparedness and response
information systems
Voting terminates on:
COPYRIGHT PROTECTED DOCUMENT
© ISO 2023
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.
RECIPIENTS OF THIS DRAFT ARE INVITED TO
ISO copyright office
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
CP 401 • Ch. de Blandonnet 8
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
CH-1214 Vernier, Geneva
DOCUMENTATION.
Phone: +41 22 749 01 11
IN ADDITION TO THEIR EVALUATION AS
Reference number
Email: copyright@iso.org
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/FDIS 5477:2023(E)
Website: www.iso.org
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
Published in Switzerland
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN­
DARDS TO WHICH REFERENCE MAY BE MADE IN
ii
  © ISO 2023 – All rights reserved
NATIONAL REGULATIONS. © ISO 2023

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ISO/FDIS 5477:2023(E)
Contents Page
Foreword .v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms, definitions and abbreviated terms . 1
3.1 Terms and definitions . 1
3.2 Abbreviated terms . 6
4 Requirements for PH EPR information systems . 7
4.1 Defining the PH EPR information system’s domain . 7
4.2 General principles of management and conformance . 8
4.2.1 Conformance with general incident management principles. 8
4.3 PH EPR data and information management (DIM) processes . 10
4.3.1 Background . 10
4.3.2 Establishing strategies and goals for the PH EPR DIM . 11
4.3.3 Defining goals for the PH EPR information syste
...

FINAL DRAFT INTERNATIONAL STANDARD
ISO/FDIS 5477:2023(E)
ISO /TC 215
Date: 2023-06-20
Secretariat: ANSI
Date: 2023-08-31
Health informatics – — Interoperability of public health
emergency preparedness and response information systems
FDIS stage

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ISO/FDIS 5477:2023(E)
© ISO 20222023
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: copyright@iso.org
Website: www.iso.orgwww.iso.org
Published in Switzerland
ii © ISO 2022 – All rights reserved

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ISO/FDIS 5477:2023(E)
Contents

© ISO 2022 – All rights reserved iii

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ISO/FDIS 5477:2023(E)
Contents
Foreword 8
Introduction 9
1 Scope 1
2 Normative references 1
3 Terms, definitions and abbreviated terms 1
3.1.    Terms and definitions……………………………………………………………………………………1
3.2     Abbreviated terms 7
4 Requirements for PH EPR information systems 9
4.1 Defining the PH EPR information system’s domain 9
4.2 General principles of management and conformance 10
4.2.1 Conformance with general incident management principles 10
4.3 PH EPR data and information management (DIM) processes 13
4.3.1 Background 13
4.3.2 Establishing strategies and goals for the PH EPR DIM 14
4.3.3 Defining goals for the PH EPR information system 14
4.4 Supporting PH EPR mission areas 16
4.5 Establishing data and information governance 16
4.5.1 Data and information governance: background and principles 16
4.5.2 Ongoing training 22
4.5.3 Defining Essential Elements of Information (EEIs) and Critical Information Requirements
(CIRs) 23
4.5.4 Establishing a process for the collection, development, and utilization of standardized
case definitions 25
4.6 Reporting 27
4.6.1 Data analytics and visualization. 27
5 Interoperability in PH EPR information systems 28
5.1 Background 28
5.2 Aligning the PH EPR information systems interoperability with the organizational
interoperability of the activated IMS and overall emergency response 28
5.3 Facilitating the improvement of organizational interoperability through organizational
emergency resilience 29
5.4 Assuring the expandability of PH EPR information systems without compromising
interoperability 30
5.5 Usability 32
5.6 Adaptability 33
5.7 Measure-driven capabilities for PH EPR information systems 34
6 Business requirements for collecting, developing and maintaining PH EPR terminology
and data vocabulary 35
iv © ISO 2022 – All rights reserved

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ISO/FDIS 5477:2023(E)
6.1 Background 35
6.2 Alignment of standardized PH EPR terminology and vocabulary with critical PH EPR
functions 36
6.3 Applying standardized terminology and vocabulary to emergency response to standard
operations procedures (SOPs) and disaster planning 39
6.3.1 Utilising event grading and classifications of emergencies 40
6.3.2 Using the WHO International Classification of Diseases (ICD) 42
6.4 Assuring relevance and coverage 43
6.5 Role of stakeholders’ involvement in collecting, developing, and maintaining a public
health preparedness and response data vocabulary 44
6.6 Assuring flexibility and scalability of PH EPR vocabulary 46
6.7 Supporting tasks for PH EPR vocabulary quality and integrity 47
6.8 Ongoing maintenance and updates 48
6.9 Assuring compliance and fulfilment of regulatory requirements 50
6.10 Providing adequate training and support 51
Annex A (informative) Recommendations on knowledge, skills and abilities for the fulfilment of
essential PH EOC functions 53
Appendix B (informative) Competencies for Public Health Emergency Preparedness and
Response Informatics Professionals 63
A.1 Recommended higher order information management knowledge, skills, and aptitudes,
KSA’s 63
A.1.1 Model leadership 63
A.1.1.1 Solving problems under emergency conditions 63
A.1.1.2 Managing behaviours associated with emotional responses in self and others 63
A.1.1.3 Facilitating collaboration with internal and external emergency response partners 64
A.1.1.4 Maintaining situational awareness 65
A.1.1.5 Demonstrating respect for all persons and cultures 65
A.1.1.6 Acting within the scope of one’s legal authority 66
A.1.2 Communicate and Manage Information 66
A.1.2.1 Manage information related to an emergency 66
A.1.2.2 Using principles of crisis and risk communication 66
A.1.2.3 Reporting in
...