ISO 6028:2023

Healthcare organization management — Pandemic response — Functional requirements for self-symptom checker app

This document specifies functional requirements for a self-initiated disease symptom checker app to be used for early screening and control of pandemics such as COVID-19. There are four functional components specified in this document: a) self-registration (see 7.2); b) symptom checking (see 7.3); c) guidance on screening stations (see 7.4); d) health consultation (see 7.5).

Management des organisations de soins de santé — Réponse en cas de pandémie — Exigences fonctionnelles relatives aux applications d'auto-contrôle des symptômes

General Information

• Status: Published
• Publication Date: 01-Jun-2023
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: ISO/TC 304 - Healthcare organization management
• Drafting Committee: ISO/TC 304 - Healthcare organization management
• Current Stage: 6060 - International Standard published
• Start Date: 02-Jun-2023
• Due Date: 01-Mar-2024
• Completion Date: 02-Jun-2023

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 6028
First edition
2023-06
Healthcare organization
management — Pandemic response
— Functional requirements for self-
symptom checker app
Management des organisations de soins de santé — Réponse en cas
de pandémie — Exigences fonctionnelles relatives aux applications
d'auto-contrôle des symptômes
Reference number
ISO 6028:2023(E)
© ISO 2023

---------------------- Page: 1 ----------------------
ISO 6028:2023(E)
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.
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
  © ISO 2023 – All rights reserved

---------------------- Page: 2 ----------------------
ISO 6028:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General . 2
5 The self-symptom checker app . 2
6 External services and applications of the self-symptom checker app .3
7 Functional components of the self-symptom checker app . 4
7.1 General . 4
7.2 Self-registration . 4
7.2.1 Self-registration component . 4
7.2.1.1 Enable alert . 4
7.2.1.2 Activate GPS. 5
7.2.1.3 Access camera . 6
7.2.1.6 Data elements for Self-registration component . 8
7.3 Symptom checking . 8
7.3.1 Asymptomatic case . 9
7.3.2 Symptom case . 10
7.3.3 Symptom checking error . . 11
7.3.4 Data elements for Symptom-checking component . 11
7.4 Guidance on screening stations .12
7.4.1 Check GPS location.12
7.4.2 Display of screening stations .12
7.4.3 Data elements for Guidance on screening stations component .13
7.5 Health consultation . 13
7.5.1 General .13
7.5.2 Application update.13
7.6 Termination of the use of the self-symptom checker app . 14
Annex A (informative) Consideration for quality requirements of self-symptom checker
apps .16
Bibliography .18
iii
© ISO 2023 – All rights reserved

---------------------- Page: 3 ----------------------
ISO 6028:2023(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 Technical Committee ISO/TC 304, Healthcare organization management.
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.
iv
  © ISO 2023 – All rights reserved

---------------------- Page: 4 ----------------------
ISO 6028:2023(E)
Introduction
[7]
In 2005, the International Health Regulations (IHR) declared that a global network of national health
systems should be established to facilitate coordinated defence against public health threats and ensure
the security of international public health. Four areas of work to achieve the envisioned network have
been established:
a) strengthening national prevention capacity;
b) introduction of global alert and response mechanisms;
c) containment of specific threats;
d) travel and transports.
With the first case reported on 31 December 2019, the WHO declared COVID-19 as a pandemic in
[6]
March 2020. The lack of effective vaccines and treatment created a crisis that has seen a significant
number of confirmed cases and deaths worldwide. The pandemic has imposed enormous pressure on,
and, in some countries, paralyzed public health systems, resulting in shortages of personal protective
equipment (PPE), extracorporeal membrane oxygenation (ECMO) machines, hospital beds and medical
personnel.
Each country has implemented various measures to block infection spread at entry points to the
country, which has required tremendous resources. Asymptomatic cases and long incubation periods
challenge infection prevention and control capacities of health care institutions and public health
agencies.
A self-symptom checker app for a pandemic enables individuals to record and report pandemic-related
symptoms, to provide information on screening test sites and to offer consultation channels that link
them to health experts for disease spread containment.
The self-symptom checker app is designed to act as a frontline defence that enables isolation and
quarantine of potentially infected individuals.
This document provides interested parties with guidance to support the development of applications
for self-monitoring of symptoms to support screening. Self-monitoring applications can be used to
support screening in businesses as well as border entry to contain the spread of infection and provide
critical information to health care providers to provide appropriate care.
[1]
Annex A uses ISO/TS 82304-2 , Annex E to provide additional guidance when considering a self-
symptom checker app.
v
© ISO 2023 – All rights reserved

---------------------- Page: 5 ----------------------
INTERNATIONAL STANDARD ISO 6028:2023(E)
Healthcare organization management — Pandemic
response — Functional requirements for self-symptom
checker app
1 Scope
This document specifies functional requirements for a self-initiated disease symptom checker app to be
used for early screening and control of pandemics such as COVID-19.
There are four functional components specified in this document:
a) self-registration (see 7.2);
b) symptom checking (see 7.3);
c) guidance on screening stations (see 7.4);
d) health consultation (see 7.5).
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
confirmed case
person who has been confirmed to be infected with the infectious disease pathogen according to the
diagnostic testing standard, regardless of clinical manifestations
[2]
[SOURCE: Korea Centers for Disease Control and Prevention ]
3.2
isolation
separation of sick people with a contagious disease from people who are not sick
[3]
[SOURCE: Centers for Disease Control and Prevention ]
3.3
pandemic
epidemic occurring worldwide, or over a very wide area, crossing international boundaries and usually
affecting a large number of people
[4]
[SOURCE: A dictionary of epidemiology ]
1
© ISO 2023 – All rights reserved

---------------------- Page: 6 ----------------------
ISO 6028:2023(E)
3.4
quarantine
separation and restriction of the movement of people who were exposed to a contagious disease to see
if they become sick
Note 1 to entry: These people have possibly been exposed to a disease and do not know it, or they possibly have
the disease but do not show symptoms.
[3]
[SOURCE: Centers for Disease Control and Prevention ]
3.5
self-symptom checker app
tool that enables individuals to record and report pandemic-related symptoms, and that provides
information on screening test sites, and offers consultation channels
Note 1 to entry: The consultation channels can provide a real time connection of the people with health experts
for disease spread containment.
[5]
[SOURCE: Korea Centers for Disease Control and Prevention, Self-symptom checker ]
4 General
To build or enhance the capacity to monitor and manage the spread of the disease at the points of entry
and onward, the following actions, at a minimum, should be taken.
— To maintain timely communication with visitors/entrants: it is an onerous task to contact entrants,
due to unanswered calls and/or phones being offline. This incurs delayed quarantine and extra
personnel to manage connection with entrants.
— To monitor the entrants’ health status: provision of information to entrants of public health control
measures includes quarantine and monitoring.
— Information technology (IT) and infrastructure to support communication and screening
applications: technology can enhance our response to pandemic management in a very significant
way. For example, it is possible for disease-pertinent symptoms of an entrant to emerge after
clearance from the point of entry due to a latent state of the virus. With the help of, for example, a
smart phone-based application, it is made possible to track, monitor and manage the health of the
entrant.
The purpose of this document is to provide guidelines towards the development of technology-
based symptom screening applications to improve the efficiencies of infection containment
practices.
5 The self-symptom checker app
Four core functional components of the self-symptom checker app are described in Figure 1. Each
functional component comprises a set of functions, each of which executes specific tasks.
The specific tasks of each functional component of the self-symptom checker app are as follows.
— Self-registration: after the self-symptom checker app has been installed on the smartphone, tablet
or personal computer of the individual, he/she shall register himself/herself to use the self-symptom
checker app.
— Symptom checking: the individual shall record and report through the self-symptom checker app
any symptoms he/she has experienced.
— Guidance on screening stations: the individual can at any time search and contact nearby screening
test sites, locations of which are determined by the GPS service, or other positioning service
available, of the device owned by the individual.
2
  © ISO 2023 – All rights reserved

---------------------- Page: 7 ----------------------
ISO 6028:2023(E)
— Health consultation: the individual can contact health experts through available communication
channels, such as chatbot, mobile messaging application or email.
Figure 1 — Functional components of the self-symptom checker app
6 External services and applications of the self-symptom checker app
The self-symptom checker app is the central application upon which either optional or external services
and applications, or both, can operate (see Figure 2).
For example, national health authorities, subject to user consensus, can gain access to demographic
and symptomatic data about the individuals who have exhibited potential symptoms, and reach out
pre-emptively to them for test and quarantine. State or national health centres can receive information
about the individuals who have been exhibiting symptoms for two or more days consecutively and
instruct them to visit a screening test site.
NOTE Local, regional or national guidelines on patient (or personal) information can apply.
Key
optional data link to external services and/or applications
Figure 2 — Function of the external services and applications of the self-symptom checker app
3
© ISO 2023 – All rights reserved

---------------------- Page: 8 ----------------------
ISO 6028:2023(E)
7 Functional components of the self-symptom checker app
7.1 General
For the core functional components of the self-symptom checker app, see Clause 5 and Figure 1.
7.2 Self-registration
The Self-registration component is a required component. It enables a user to register. It principally
initializes the self-symptom checker app by validating user credentials. The sub-components are shown
in Figure 3.
Figure 3 — Function of Self-registration component of the self-symptom checker app
7.2.1 Self-registration component
7.2.1.1 Enable alert
The Enable alert sub-component is a required component. It asks the individual to turn on the alerting
function. Alerts including sounds and icons can be included in alert messages. The individual should be
abl
...

ISO /FDIS 6028:2022(E)
ISO /TC 304/WG 4
Secretariat: ANSI
Date: 2023-02-16
Healthcare organization management
— — Pandemic response
— — Functional requirements for self-symptom checker app
First edition
Date: 2022-10-27

---------------------- Page: 1 ----------------------
FDIS stage

---------------------- Page: 2 ----------------------
ISO/DISFDIS 6028:20222023(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: [e-mail]
Website: www.iso.orgwww.iso.org
Published in Switzerland
© ISO 2022 – All rights reserved v
© ISO 2023 – All rights reserved v

---------------------- Page: 3 ----------------------
ISO/DISFDIS 6028:20222023(E)
Contents
Foreword . viii
Introduction . ix
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General . 2
5 The self-symptom checker app . 2
6 External services and applications of the self-symptom checker app . 3
7 Functional components of the self-symptom checker app . 4
7.1 General . 4
7.2 Self-registration . 4
7.2.1 Self-registration component . 5
7.2.2 Enable alert . 5
7.2.3 Activate GPS . 6
7.2.4 Access camera . 7
7.2.5 Data elements for Self-registration component . 10
7.3 Symptom checking . 10
7.3.1 Asymptomatic case . 11
7.3.2 Symptom case . 12
7.3.3 Symptom checking error . 14
7.3.4 Data elements for Symptom-checking component . 14
7.4 Guidance on screening stations . 14
7.4.1 Check GPS location . 15
7.4.2 Display of screening stations . 15
7.4.3 Data elements for Guidance on screening stations component . 16
7.5 Health consultation . 16
7.5.1 General . 16
7.5.2 Application update . 16
7.6 Termination of the use of the self-symptom checker app . 17
Annex A (informative) Consideration for quality requirements of self-symptom checker apps . 19
Bibliography . 21

Foreword 3
Introduction 4
1 Scope 5
2 Normative references 5
3 Terms and definitions 5
4 Background 7
5 Core functional components of the Checker 7
vi © ISO 2022 – All rights reserved
vi © ISO 2023 – All rights reserved

---------------------- Page: 4 ----------------------
ISO/DISFDIS 6028:20222023(E)
6 External services/applications 8
7 Functional components of the Checker 9
7.1 Major components 9
7.1.1 Self-registration 9
7.1.2 Enable alert 9
7.1.3 Activate GPS 10
7.1.4 Access Camera 10
7.1.5 Registration Error 11
7.1.6 Registration Data Entry 11
7.1.7 Data elements for Self-registration component 13
7.2 Symptom checking 13
7.2.1 Asymptomatic Case 14
7.2.2 Symptom Case 14
7.2.3 Symptom checking error 15
7.2.4 Data elements for Symptom-checking component 15
7.3 Guidance on screening stations 16
7.3.1 Check GPS location 16
7.3.2 List Screening Stations 17
7.3.3 Data elements for Guidance on screening stations component 17
7.4 Health Consultation 17
7.4.1 Application update 18
7.5 Termination of the use of the Checker 18
Annex A (informative) Consideration for quality requirements of a self-symptom checker 20
Bibliography 22
© ISO 2022 – All rights reserved vii
© ISO 2023 – All rights reserved vii

---------------------- Page: 5 ----------------------
ISO/DISFDIS 6028:20222023(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 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/patentswww.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.htmlwww.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 304, Healthcare organization management.
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.
Field Code Changed
viii © ISO 2022 – All rights reserved
viii © ISO 2023 – All rights reserved

---------------------- Page: 6 ----------------------
ISO/DISFDIS 6028:20222023(E)
Introduction
[7][7]
In 2005, the International Health Regulations (IHR) declared that a global network of national health
systems should be established that wouldto facilitate coordinated defence against public health threats
and that could ensure the security of international public health. Four areas of work to achieve the
envisioned network have been established:
a) 1) strengthening national prevention capacity;
b) 2) introduction of global alert &and response mechanisms;
c) 3) containment of specific threats; and
d) 4) travel and transports.
With the first case reported on 31 December 31, 2019, the WHO declared COVID-19 as a pandemic in
[6] [6]
March 2020 . The lack of effective vaccines and treatment created a crisis that has seen a significant
number of confirmed cases and deaths worldwide. The pandemic has imposed enormous pressure on,
and, in some countries, paralyzed public health systems, resulting in shortages of personal protective
equipment (PPE), extracorporeal membrane oxygenation (ECMO) machines, hospital beds and medical
personnel.
Each country has implemented various measures to block infection spread at entry points to the country,
which has required tremendous resources. Asymptomatic cases and long incubation periods challenge
infection prevention and control capacities of health care institutions and public health agencies.
A self-symptom checker app for a pandemic enables individuals to record and report pandemic-related
symptoms, to provide information on screening test sites and to offer consultation channels that link
them to health experts for disease spread containment.
The self-symptom checker app is designed to act as a frontline defence that enables isolation and
quarantine of potentially infected individuals.
This document provides interested parties with guidance to support the development of applications for
self-monitoring of symptoms to support screening. Self-monitoring applications maycan be used to
support screening in businesses as well as border entry to contain the spread of infection and provide
critical information to health care providers to provide appropriate care.
[1][1]
Annex A uses the informative Annex E of ISO/TS 82304-2 , Annex E to provide additional guidance
when considering a self-symptom checker app.


© ISO 2022 – All rights reserved ix
© ISO 2023 – All rights reserved ix

---------------------- Page: 7 ----------------------
DRAFT INTERNATIONAL STANDARD ISO/DIS 6028:2022(E)

Healthcare organization management — — Pandemic response —
Functional requirements for self-symptom checker app
1 Scope
This document specifies functional requirements for a self-initiated disease symptom checker app to be
used for early screening and control of pandemics such as COVID-19.
There are four functional components specified in this document:
1) 1) self-registration (Clause 7.1.1); see 7.2);
2) 2) symptom checking (Clause 7.2); see 7.3);
3) 3) guidance on screening stations (Clause 7.3); see 7.4);
4) 4) health consultation (Clause 7.4).see 7.5).
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— — ISO Online browsing platform: available at https://www.iso.org/obphttps://www.iso.org/obp
— — IEC Electropedia: available at https://www.electropedia.org/https://www.electropedia.org/
3.1
confirmed case
person who has been confirmed to be infected with the infectious disease pathogen according to the
diagnostic testing standard, regardless of clinical manifestations
[2] [2]
[SOURCE: Korea Centers for Disease Control and Prevention ] ]
3.2
isolation
separation of sick people with a contagious disease from people who are not sick
[3] [3]
[SOURCE: Centers for Disease Control and Prevention ] ]
3.3
pandemic
epidemic occurring worldwide, or over a very wide area, crossing international boundaries and usually
affecting a large number of people
[4] [4]
[SOURCE: A dictionary of epidemiology ] ]
3.4
quarantine
separation and restriction of the movement of people who were exposed to a contagious disease to see if
they become sick
© ISO 2022 – All rights reserved 1

---------------------- Page: 8 ----------------------
ISO/DISFDIS 6028:20222023(E)
Note 1 to entry: These people may have possibly been exposed to a disease and do not know it, or they
maypossibly have the disease but do not show symptoms.
[3] [3]
[SOURCE: Centers for Disease Control and Prevention ] ]
3.5
self-symptom checker app
tool that enables individuals to record and report pandemic-related symptoms, and that provides
information on screening test sites, and offers consultation channels
Note 1 to entry: The consultation channels can provide a real time connection of the people with health experts
for disease spread containment.
[5] [5]
[SOURCE: Korea Centers for Disease Control and Prevention, Self-symptom checker ] ]
4 General
To build or enhance the capacity to monitor and manage the spread of the disease at the points of entry
and onward, the following actions, at a minimum, should be taken:.
— — To maintain timely communication with visitors/entrants: Itit is an onerous task to contact
entrants, due to unanswered calls and/or phones being offline. This incurs delayed quarantine and
extra personnel to manage connection with entrants.
— — To monitor the entrants’ health status: Provisionprovision of information to entrants of public
health control measures including quarantine and monitoring.
— — Information technology (IT) and infrastructure to support communication and screening
applications: Technologytechnology can enhance our response to pandemic management in a very
significant way. For example, it is possible for disease-pertinent symptoms of an entrant to emerge
after clearance from the point of entry due to a latent state of the virus. With the help of, for example,
a smart phone-based application, it is made possible to track, monitor and manage the health of the
entrant.
The purpose of this document is to provide guidelines towards the development of technology-based
symptom screening applications to improve the efficiencies of infection containment practices.
5 The self-symptom checker app
5.1 General
Four core functional components of the self-symptom checker app are described in Figure 1.Figure 1.
Each functional component comprises a set of functions, each of which executes specific tasks.
The specific tasks of each functional component of the self-symptom checker app are as follows: .
— - Self-registration: after the self-symptom checker app has been installed on the smartphone, tablet
or personal computer of the individual, he/she shall register himself/herself to use the self-symptom
checker app.
— - Symptom checking: the individual shall record and report through the self-symptom checker app
any symptoms he/she has experienced.
— - Guidance on screening stations: the individual maycan at any time search and contact nearby
screening test sites, locations of which are determined by the GPS service, or other positioning service
available, of the device owned by the individual.
— - Health consultation: the individual maycan contact health experts through available communication
channels, such as chatbot, mobile messaging application or email.
2 © ISO 2022 – All rights reserved
2 © ISO 2023 – All rights reserved

---------------------- Page: 9 ----------------------
ISO/DISFDIS 6028:20222023(E)



Figure 1 — Functional components of the self-symptom checker app
6 External services and applications of the self-symptom checker app
The self-symptom checker app is the central application upon which either optional or external services
and applications, or both, can operate (see Figure 2).Figure 2).
For example, national health authorities, subject to user consensus, can gain access to demographic and
symptomatic data about the individuals who have exhibited potential symptoms, and reach out pre-
emptively to them for test and quarantine. State or national health centres can receive information about
the individuals who have been exhibiting symptoms for two or more days consecutively and instruct
them to visit a screening test site.
NOTE Local, regional or national guidelines on patient (or personal) information can apply.
© ISO 2022 – All rights reserved 3
© ISO 2023 – All rights reserved 3

---------------------- Page: 10 ----------------------
ISO/DISFDIS 6028:20222023(E)


Key
optional data link to external services and/or applications

Figure 2 — Function of the external services and applications of the self-symptom checker app
7 Functional components of the self-symptom checker app
7.1 General
For the core functional components of the self-symptom checker app, see Clause 5 and Figure 1. Clause 5
and Figure 1.
7.2 Self-registration
The Self-registration component is a required component. It enables a user to register. It principally
initializes the self-symptom checker app by validating user credentials. The sub-components are shown
in Figure 3.Figure 3.

4 © ISO 2022 – All rights reserved
4 © ISO 2023 – All rights reserved

---------------------- Page: 11 ----------------------
ISO/DISFDIS 6028:20222023(E)

Figure 3 — Function of Self-registration component of the self-symptom checker app
7.2.1 Self-registration component
7.2.2 7.2.1.1 Enable alert
The Enable alert sub-component is a required component. It asks the individual to turn on the alerting
function. Alerts including sounds and icons can be included in alert messages. The individual should be
able to configure this feature as he/she sees fit. An example screenshot for the sub-component is shown
in Figure 4.Figure 4.

© I
...

FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 6028
ISO/TC 304
Healthcare organization
Secretariat: ANSI
management — Pandemic response
Voting begins on:
2023-03-02 — Functional requirements for self-
symptom checker app
Voting terminates on:
2023-04-27
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 6028:2023(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

---------------------- Page: 1 ----------------------
ISO/FDIS 6028:2023(E)
FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 6028
ISO/TC 304
Healthcare organization
Secretariat: ANSI
management — Pandemic response
Voting begins on:
— Functional requirements for self-
symptom checker app
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: [phone]
IN ADDITION TO THEIR EVALUATION AS
Reference number
Email: [e-mail]
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/FDIS 6028:2023(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

---------------------- Page: 2 ----------------------
ISO/FDIS 6028:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General . 2
5 The self-symptom checker app . 2
6 External services and applications of the self-symptom checker app .3
7 Functional components of the self-symptom checker app . 4
7.1 General . 4
7.2 Self­registration . 4
7.2.1 Self­registration component . 4
7.2.1.1 Enable alert . 4
7.2.1.2 Activate GPS. 5
7.2.1.3 Access camera . 6
7.2.1.6 Data elements for Self­registration component . 8
7.3 Symptom checking . 8
7.3.1 Asymptomatic case . 9
7.3.2 Symptom case . 10
7.3.3 Symptom checking error . . 11
7.3.4 Data elements for Symptom-checking component . 11
7.4 Guidance on screening stations .12
7.4.1 Check GPS location.12
7.4.2 Display of screening stations .12
7.4.3 Data elements for Guidance on screening stations component .13
7.5 Health consultation . 13
7.5.1 General .13
7.5.2 Application update.13
7.6 Termination of the use of the self-symptom checker app . 14
Annex A (informative) Consideration for quality requirements of self-symptom checker
apps .16
Bibliography .18
iii
© ISO 2023 – All rights reserved

---------------------- Page: 3 ----------------------
ISO/FDIS 6028:2023(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 Technical Committee ISO/TC 304, Healthcare organization management.
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.
iv
  © ISO 2023 – All rights reserved

---------------------- Page: 4 ----------------------
ISO/FDIS 6028:2023(E)
Introduction
[7]
In 2005, the International Health Regulations (IHR) declared that a global network of national health
systems should be established to facilitate coordinated defence against public health threats and ensure
the security of international public health. Four areas of work to achieve the envisioned network have
been established:
a) strengthening national prevention capacity;
b) introduction of global alert and response mechanisms;
c) containment of specific threats;
d) travel and transports.
With the first case reported on 31 December 2019, the WHO declared COVID-19 as a pandemic in
[6]
March 2020. The lack of effective vaccines and treatment created a crisis that has seen a significant
number of confirmed cases and deaths worldwide. The pandemic has imposed enormous pressure on,
and, in some countries, paralyzed public health systems, resulting in shortages of personal protective
equipment (PPE), extracorporeal membrane oxygenation (ECMO) machines, hospital beds and medical
personnel.
Each country has implemented various measures to block infection spread at entry points to the
country, which has required tremendous resources. Asymptomatic cases and long incubation periods
challenge infection prevention and control capacities of health care institutions and public health
agencies.
A self-symptom checker app for a pandemic enables individuals to record and report pandemic-related
symptoms, to provide information on screening test sites and to offer consultation channels that link
them to health experts for disease spread containment.
The self-symptom checker app is designed to act as a frontline defence that enables isolation and
quarantine of potentially infected individuals.
This document provides interested parties with guidance to support the development of applications
for self-monitoring of symptoms to support screening. Self-monitoring applications can be used to
support screening in businesses as well as border entry to contain the spread of infection and provide
critical information to health care providers to provide appropriate care.
[1]
Annex A uses ISO/TS 82304-2 , Annex E to provide additional guidance when considering a self-
symptom checker app.
v
© ISO 2023 – All rights reserved

---------------------- Page: 5 ----------------------
FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 6028:2023(E)
Healthcare organization management — Pandemic
response — Functional requirements for self-symptom
checker app
1 Scope
This document specifies functional requirements for a self-initiated disease symptom checker app to be
used for early screening and control of pandemics such as COVID-19.
There are four functional components specified in this document:
1) self­registration (see 7.2);
2) symptom checking (see 7.3);
3) guidance on screening stations (see 7.4);
4) health consultation (see 7.5).
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
confirmed case
person who has been confirmed to be infected with the infectious disease pathogen according to the
diagnostic testing standard, regardless of clinical manifestations
[2]
[SOURCE: Korea Centers for Disease Control and Prevention ]
3.2
isolation
separation of sick people with a contagious disease from people who are not sick
[3]
[SOURCE: Centers for Disease Control and Prevention ]
3.3
pandemic
epidemic occurring worldwide, or over a very wide area, crossing international boundaries and usually
affecting a large number of people
[4]
[SOURCE: A dictionary of epidemiology ]
1
© ISO 2023 – All rights reserved

---------------------- Page: 6 ----------------------
ISO/FDIS 6028:2023(E)
3.4
quarantine
separation and restriction of the movement of people who were exposed to a contagious disease to see
if they become sick
Note 1 to entry: These people have possibly been exposed to a disease and do not know it, or they possibly have
the disease but do not show symptoms.
[3]
[SOURCE: Centers for Disease Control and Prevention ]
3.5
self-symptom checker app
tool that enables individuals to record and report pandemic-related symptoms, and that provides
information on screening test sites, and offers consultation channels
Note 1 to entry: The consultation channels can provide a real time connection of the people with health experts
for disease spread containment.
[5]
[SOURCE: Korea Centers for Disease Control and Prevention, Self-symptom checker ]
4 General
To build or enhance the capacity to monitor and manage the spread of the disease at the points of entry
and onward, the following actions, at a minimum, should be taken.
— To maintain timely communication with visitors/entrants: it is an onerous task to contact entrants,
due to unanswered calls and/or phones being offline. This incurs delayed quarantine and extra
personnel to manage connection with entrants.
— To monitor the entrants’ health status: provision of information to entrants of public health control
measures including quarantine and monitoring.
— Information technology (IT) and infrastructure to support communication and screening
applications: technology can enhance our response to pandemic management in a very significant
way. For example, it is possible for disease-pertinent symptoms of an entrant to emerge after
clearance from the point of entry due to a latent state of the virus. With the help of, for example, a
smart phone-based application, it is made possible to track, monitor and manage the health of the
entrant.
The purpose of this document is to provide guidelines towards the development of technology-
based symptom screening applications to improve the efficiencies of infection containment
practices.
5 The self-symptom checker app
Four core functional components of the self-symptom checker app are described in Figure 1. Each
functional component comprises a set of functions, each of which executes specific tasks.
The specific tasks of each functional component of the self-symptom checker app are as follows.
— Self-registration: after the self-symptom checker app has been installed on the smartphone, tablet
or personal computer of the individual, he/she shall register himself/herself to use the self-symptom
checker app.
— Symptom checking: the individual shall record and report through the self-symptom checker app
any symptoms he/she has experienced.
— Guidance on screening stations: the individual can at any time search and contact nearby screening
test sites, locations of which are determined by the GPS service, or other positioning service
available, of the device owned by the individual.
2
  © ISO 2023 – All rights reserved

---------------------- Page: 7 ----------------------
ISO/FDIS 6028:2023(E)
— Health consultation: the individual can contact health experts through available communication
channels, such as chatbot, mobile messaging application or email.
Figure 1 — Functional components of the self-symptom checker app
6 External services and applications of the self-symptom checker app
The self-symptom checker app is the central application upon which either optional or external services
and applications, or both, can operate (see Figure 2).
For example, national health authorities, subject to user consensus, can gain access to demographic
and symptomatic data about the individuals who have exhibited potential symptoms, and reach out
pre-emptively to them for test and quarantine. State or national health centres can receive information
about the individuals who have been exhibiting symptoms for two or more days consecutively and
instruct them to visit a screening test site.
NOTE Local, regional or national guidelines on patient (or personal) information can apply.
Key
optional data link to external services and/or applications
Figure 2 — Function of the external services and applications of the self-symptom checker app
3
© ISO 2023 – All rights reserved

---------------------- Page: 8 ----------------------
ISO/FDIS 6028:2023(E)
7 Functional components of the self-symptom checker app
7.1 General
For the core functional components of the self-symptom checker app, see Clause 5 and Figure 1.
7.2 Self-reg
...