ISO/TS 9166:2025

Health informatics - Guidelines for self-assessment questionnaire systems

This document provides guidelines for the self-assessment questionnaire systems to be used for health. This document includes the following: - structure and components of the self-assessment questionnaire systems; - guidelines for administering and managing the self-assessment questionnaire systems; - basic data elements for interacting with the self-assessment questionnaire systems. This document does not define the contents of the self-assessment questionnaire specialised in healthcare domains or departments. The questionnaires themselves are out of the scope of this document since they are dependent on the intended purpose of the self-assessment questionnaire systems.

Informatique de santé — Lignes directrices pour les systèmes de questionnaires d'auto-évaluation

General Information

• Status: Published
• Publication Date: 19-May-2025
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: ISO/TC 215 - Health informatics
• Drafting Committee: ISO/TC 215 - Health informatics
• Current Stage: 6060 - International Standard published
• Start Date: 20-May-2025
• Due Date: 14-Feb-2026
• Completion Date: 20-May-2025

Overview

ISO/TS 9166:2025 - Health informatics - Guidelines for self-assessment questionnaire systems (SAQS) provides practical guidance for designing, managing and interoperating electronic self-assessment questionnaire systems used in health contexts. This Technical Specification describes the structure and components of SAQS, recommended functionality, administration and management practices, and basic data elements for interaction. The document does not define clinical questionnaire content (domain-specific questions are out of scope).

Key topics and technical requirements

• SAQS architecture and components: guidance on core elements such as the user interface, questionnaire engine, data repository, SAQS management modules and knowledge resources.
• User types and interactions: roles include patients, guardians and caregivers; systems should support dynamic/adaptive questionnaire flows based on user input.
• Data handling: recommendations for storing user-specific health data and aggregated datasets to support personalized feedback and population-level analytics.
• Recommended functionality: interfaces between users and SAQS (question delivery, response capture, feedback) and between SAQS applications (data exchange, use of aggregated and individual data).
• Basic data elements: metadata for questionnaires (purpose, objective, category, source), questionnaire responses, and feedback items to enable consistent exchange and reuse.
• Interoperability examples: the specification includes informative examples (including an HL7 FHIR exchange example) to support integration with health IT ecosystems.
• Privacy & governance considerations: while the TS does not replace legal requirements, it highlights the need to manage personal data consistently with applicable regulations (e.g., GDPR/HIPAA) and EHR integration best practices.

Practical applications and target users

• Use cases:
  • Home and workplace health self-checks and triage
  • Remote monitoring of subjective health measures (mood, pain, symptoms)
  • Pre-visit screening and symptom tracking to inform clinical encounters
  • Public health surveillance and trend analysis using aggregated responses
  • Research and resource planning (e.g., medication or supply management)
• Who should use ISO/TS 9166:
  • Health IT vendors and SAQS application developers
  • Hospital IT teams and primary care providers adopting patient-facing tools
  • Public health authorities and researchers processing aggregated questionnaire data
  • EHR/PHR integrators, personal health device (PHD) manufacturers, and standards implementers aiming for interoperability

Related standards (if applicable)

• HL7 FHIR - example exchange formats illustrated in the TS
• Other relevant frameworks and considerations referenced in the TS: FHIR, CDA, IHE profiles, and privacy/regulatory regimes (e.g., GDPR, HIPAA) for lawful data handling.

This guidance supports interoperable, user-centered self-assessment questionnaire systems that enhance preventive care, self-care and public health analytics. Keywords: ISO/TS 9166, self-assessment questionnaire systems, SAQS, health informatics, interoperability, FHIR, patient-generated health data.

Standards Content (Sample)

Technical
Specification
ISO/TS 9166
First edition
Health informatics —
2025-05
Guidelines for self-assessment
questionnaire systems
Informatique de santé — Lignes directrices pour les systèmes de
questionnaires d'auto-évaluation
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
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Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Symbols and abbreviated terms. 2
5 Structure and components of self-assessment questionnaire systems (SAQS) . 2
5.1 General .2
5.2 Structure and components of SAQS .3
5.3 SAQS users .3
5.4 Components of self-assessment questionnaire systems .3
5.4.1 General .3
5.4.2 Data repository .3
5.4.3 SAQS management .4
5.4.4 Using user-specific health data .4
5.4.5 Using aggregated health data .4
5.4.6 Knowledge to support SAQS resources .5
5.5 SAQS applications .5
6 Recommended functionality of SAQS . . 5
6.1 Interface between SAQS users and SAQS .5
6.1.1 General .5
6.1.2 Providing questionnaires to SAQS users .6
6.1.3 Storing user-specific health data .7
6.1.4 Providing feedback . . .7
6.2 Interface between SAQS application and SAQS .8
6.2.1 General .8
6.2.2 Using user-specific health data .8
6.2.3 Using aggregated health data .9
7 Recommended data elements for SAQS . 9
7.1 General .9
7.2 Data elements for questionnaires . . .9
7.2.1 Purpose of using SAQS .9
7.2.2 Objective of the self-assessment .10
7.2.3 Category of the patient . .11
7.2.4 Source of questionnaires and feedback .11
7.3 Data elements for questionnaire responses . 12
7.4 Data elements for feedback . 12
Annex A (informative) Detailed description of SAQS components .13
Annex B (informative) Examples of questionnaires for SAQS . 19
Annex C (informative) Example for exchanging information from self-assessment questionnaire
using HL7 FHIR .23
Bibliography . 47

iii
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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
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 215, Health informatics.
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
Introduction
Self-assessment questionnaire systems utilising information technology can provide a series of questions
through a survey or interview allowing the patients to check their health condition in non-clinical settings,
such as at home or in the workplace, rather than in traditional point-of-care environments. During the
COVID-19 pandemic, the necessity and effectiveness of self-assessment questionnaire systems have been
recognised, leading to adoption and utilisation in many countries. These systems provide a convenient way
for individuals to track their health and receive timely advice before visiting healthcare facilities.
With the advent of various personal health devices (PHDs), objective health measurement information is
being collected from environments outside the medical domain, such as at home or in schools, aiding in
monitoring patients on various health parameters. However, PHDs have limitations, as they are unable to
capture subjective or qualitative health status, such as mood or discomfort. Therefore, there is a need for
different methods, such as a survey-based approach, to express subjective health status.
Self-assessment questionnaire systems can store and record the individual’s subjective conditions or moods
to enable the patients to regularly monitor and assess their health condition. Through the compilation of
the recorded data, it is possible to understand the health condition and identify potential health issues
proactively. The qualitative data can ensure continuous care by healthcare providers and also enhance
preventive medicine practices.
Through the analysis of the recorded data, the self-assessment questionnaire systems can provide guidelines
on action, suitable healthcare needs, and information about local healthcare services. By aggregating inputs
from numerous users, the self-assessment questionnaire systems can generate statistical information that
is used in understanding the local disease trends and managing the supply of necessary medical resources,
thereby contributing to public health.
Therefore, the self-assessment questionnaire systems contribute to traditional healthcare, self-care,
preventive medicine, and public health. However, there is no standardized approach to the functional
elements or management aspects. The lack of standardized guidelines on the systems and data exchange
aspects leads to the fragmentation of personal/patient-centric health data, leading to difficulties in
integrating personal/patient health records. This document aims to address these issues to establish
standardized guidelines to ensure consistent configuration and interoperable data for self-assessment
questionnaire systems.
v
Technical Specification ISO/TS 9166:2025(en)
Health informatics — Guidelines for self-assessment
questionnaire systems
1 Scope
This document provides guidelines for the self-assessment questionnaire systems to be used for health. This
document includes the following:
— structure and components of the self-assessment questionnaire systems;
— guidelines for administering and managing the self-assessment questionnaire systems;
— basic data elements for interacting with the self-assessment questionnaire systems.
This document does not define the contents of the self-assessment questionnaire specialised in healthcare
domains or departments. The questionnaires themselves are out of the scope of this document since they
are dependent on the intended purpose of the self-assessment questionnaire systems.
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
questionnaire
set of questions for a survey or a structured or semi-structured interview
Note 1 to entry: The questions may be closed (answerable by checking one of several predetermined answers) or open
(requiring participants to answer in their own words).
Note 2 to entry: The questionnaire may be paper-based or in electronic form.
[SOURCE: ISO 21248:2019, 3.74]
3.2
self-assessment
process of critically reviewing the quality of one’s own skills, knowledge, or confidence
Note 1 to entry: The reviewing is normally done through a paper-based or online questionnaire (3.1) where some or all
of the questions require respondents to rate themselves on a scale.
[SOURCE: ISO 16439:2014, 3.62]

3.3
self-assessment questionnaire systems
SAQS
structured and interactive system that consist of a series of questions that enable self-assessment (3.2) and
provide feedback and guidance
4 Symbols and abbreviated terms
CDA clinical document architecture
COVID-19 coronavirus disease 2019
EHR electronic health record
EMR electronic medical record
FHIR fast healthcare interoperability resources
GDPR general data protection regulation
HIPAA health insurance portability and accountability act
HL7 health level 7
IHE integrating the healthcare enterprise
MPI master patient index
OTC over-the-counter
PDQ patient demographic query
PHD personal health device
PHR personal health record
PIX patient identifier cross-referencing
SAQS self-assessment questionnaire system
XDM cross-enterprise document media interchange
XDR cross-enterprise document reliable interchange
XDS.b cross-enterprise document sharing, profile b
5 Structure and components of self-assessment questionnaire systems (SAQS)
5.1 General
Self-assessment questionnaire systems (SAQS) utilising information technology provide a series of questions
for users to assess their health condition, recognise the potential health concerns, and understand when to
seek medical or health-related assistance in non-clinical settings, such as at home, in the workplace, or in
schools. The questionnaires can be designed to help the user analyse the progress of their health condition
and to find the necessary social and health services.
The user can record various complaints or discomforts such as fever, fatigue, moods, pain, chronic cough,
digestive issues, and sleep disturbances on a daily basis. These compiled data can be used as a reference
in subsequent clinical encounters or healthcare services. Distinct from conventional paper-based ad-hoc
questionnaires, the questionnaire sequence within SAQS is designed to be dynamic and adaptable based

on the user’s input. This adaptation serves to identify preliminary areas of concern and subsequently guide
the user through more detailed queries tailored to their specific health-related queries. The questionnaire
responses are stored in the data repository to be used to customise future interactions.
The statistically gathered results from the SAQS can be used for more general purposes such as medical
research or to provide insights on health trends of the local community, including monitoring the spread of
infectious diseases. For example, SAQS collects data on complaints such as cough and fever from the local
community, enabling local pharmacies to effectively manage medical supplies.
5.2 Structure and components of SAQS
The structure and components of the SAQS are shown in Figure 1.
Figure 1 — Structure and components of self-assessment questionnaire systems
The structure consists of SAQS users, SAQS, and SAQS applications.
5.3 SAQS users
The SAQS users are individuals who interact with and utilise the SAQS for health-related purposes. The SAQS
users respond to various questionnaires and receive feedback from the SAQS. The SAQS users may include
patients, guardians, and caregivers. The guardians and caregivers interact with the SAQS on behalf of the
patients.
5.4 Components of self-assessment questionnaire systems
5.4.1 General
This clause outlines the components of the SAQS. More detailed descriptions and examples can be found in
Annex A.
5.4.2 Data repository
5.4.2.1 General
The SAQS may store the interacted results of the self-assessment questionnaires for each SAQS user in the
data repository.
5.4.2.2 User-specific health data
The user-specific health data component stores individual health data collected from self-assessment
questionnaires for each SAQS user account. The types of information stored include questionnaire responses,
personalised feedback, records of symptoms reported over time, notifications and reminders about health
activities and upcoming check-ups, etc. The user-specific health data is used to monitor health changes and
support personalised feedback. The user-specific health data can be integrated with PHRs or EHRs.
To ensure semantic interoperability, user-specific health data can be represented using international
terminology systems such as SNOMED-CT, LOINC, and terminology defined by WHO.
5.4.2.3 User profile management
The user profile management involves administering and maintaining individual SAQS user accounts. This
includes managing access to user-specific health data, maintaining user profiles, and ensuring user-specific
health data is accurately recorded, securely stored, and appropriately utilised.
This component can integrate user-specific health data with medical information systems such as EMRs
and PHRs. To facilitate this integration, a patient identifier cross-referencing (PIX) can be utilised, applying
technologies such as IHE PIX and PDQ.
5.4.2.4 Privacy and security
The data exchanged between SAQS users and SAQS contains personal health data that is secured. This
component ensures that all user-specific health data is protected against unauthorised access and breaches,
maintaining strict privacy and security standards. The SAQS aligns its data repository and security practices
with the applicable jurisdictions such as GDPR, HIPAA, etc.
5.4.3 SAQS management
The SAQS management component coordinates the various components of the SAQS. It ensures the
quality and reliability of SAQS resources. It supports SAQS users by providing appropriate and adaptive
questionnaires from the SAQS resources, and it generates practical and actionable feedback. It stores the
questionnaire responses in the data repository. It analyses and processes the user-specific health data to be
used by various SAQS applications.
5.4.4 Using user-specific health data
The user-specific health data can be used for both healthcare services and self-care. Healthcare professionals
may utilise these collected data as a reference when making clinical decisions. The collected data can aid in
self-care by tracking health changes or progress, helping users make necessary adjustments, or setting new
health goals. They are used to provide appropriate feedback to the patients, encouraging prompt medical
attention when needed.
The SAQS ensures data integrity and privacy protection when delivering user-specific health data to the
SAQS applications.
5.4.5 Using aggregated health data
With the increased use of the SAQS, it is possible to aggregate user-specific health data for statistical
purposes. The aggregated data can support clinical research enabling the study of specific phenomena,
trend analysis, geo-plotting, etc. The SAQS should implement anonymisation or pseudonymisation measures,
or both, to safeguard private data when generating statistical information. Consent from the SAQS user is
obtained when using user-specific health data for statistical purposes, even if the private data have been
deleted or anonymised.
5.4.6 Knowledge to support SAQS resources
5.4.6.1 General
This component is the foundational content for the questionnaires and includes relevant feedback based on
the questionnaire responses. Examples of SAQS questionnaires can be found in Annex B.
5.4.6.2 Location-based resources
The location-based resources are a collection of questionnaires and feedback that provide the patients with
health-related information specific to the geographical location. These resources help SAQS users to obtain
information about health-related conditions or to get assistance relevant to their current residence or a
location they are planning to visit.
EXAMPLE Questionnaire on patient’s current location, anticipated travel location, type of services needed, and
methods for accessing health and healthcare services.
5.4.6.3 Health-related resources
The health-related resources are a collection of questionnaires and feedback focused on symptoms and
primary health concerns. These tools assist SAQS users in identifying their health issues and provide
guidance on how to address concerns. The SAQS users respond to health-related questions about symptoms
and other chief complaints.
When designing health-related resources for SAQS, existing assessment scales and instruments should be
used. This ensures consistency across different SAQS implementations and enables meaningful comparisons
and integration.
EXAMPLE Health-related questionnaires include Short Form Health Survey (SF-36), Numeric Rating Scale (NRS),
Patient Health Questionnaire-9 (PHQ-9), World Health Organisation Quality of Life (WHOQOL), etc.
5.4.6.4 Other supporting resources
Other questionnaires and feedback vary depending on the intended support of SAQS. There are types of
resources that are not directly related to health but can affect self-assessment.
EXAMPLE Health-related jurisdiction, weather, traffic, living conditions.
5.4.6.5 SAQS resources management
The SAQS resources management component ensures that SAQS resources maintain consistency, accuracy,
and compliance with local regulations.
5.5 SAQS applications
The gathered data from SAQS can be used for healthcare services or personal health checks. The collected
data can also be utilised in medical research or for public use.
6 Recommended functionality of SAQS
6.1 Interface between SAQS users and SAQS
6.1.1 General
The following recommended functionality applies to the interaction between SAQS users and SAQS.

6.1.2 Providing questionnaires to SAQS users
— The SAQS should provide questionnaires based on the health status of the patient and various health-
related context information.
— The SAQS should provide questionnaires based on previous questionnaire responses, feedback, and the
context of the patient’s concern.
— The SAQS may provide one-time questionnaires to support pre-screening and preventive measures.
The responses to the one-time questionnaires should not be stored in the data repository but can be
aggregated for statistical purposes.
EXAMPLE 1 For pre-screening, a questionnaire is used during immigration or when entering hospital rooms
with patients who require absolute stability.
EXAMPLE 2 For preventative measures, questionnaires are used to enter symptoms that the individuals are
experiencing to determine if a particular disease is suspected or if an encounter with the healthcare providers
is needed.
— The SAQS may provide questionnaires to support the assessment of acute symptoms or intolerance. For
feedback, it offers quick home remedies for relieving acute pain, guidance on managing symptoms, and
recommendations for OTC medications. It may provide information on nearby healthcare facilities and
contact details based on the patient’s location.
EXAMPLE 3 Acute symptoms include acute headache, acute abdominal pain, high fever, severe bleeding, and
fainting.
— The SAQS may provide questionnaires to support the assessment of diseases that require ongoing
monitoring, such as chronic disease. The questionnaire responses should be stored with a timestamp to
track changes and monitor the patient’s condition over time.
EXAMPLE 4 Chronic diseases include diabetes, hypertension, asthma, arthritis, and depression.
— The SAQS may provide questionnaires to support the assessment of follow-up care and treatment.
NOTE Questionnaire covers the effectiveness and resolution of the symptoms from the use of the
recommended prescription.
EXAMPLE 5 Follow-up care and treatment includes rehabilitation therapy, nutrition orders, post-surgery
recovery, and medication adherence.
— The SAQS should provide security measures to protect questionnaires, responses, and feedback during
interaction with the SAQS users.
— The SAQS should provide functions to interactively adjust the questionnaire content based on the
response from the SAQS users.
EXAMPLE 6 In the smoking questionnaire, if the SAQS user indicates being a non-smoker, questionnaires about
smoking become inactive or are omitted.
— The SAQS should provide user-friendly interfaces and seamless navigation that encourages regular
engagement and a positive user experience.
The system’s appeal should be strong enough to encourage regular user engagement. The collected user-
specific health data remains meaningful and highly useful for various applications.
— The SAQS should support various types of input formats to accommodate different types of questionnaire
responses.
EXAMPLE 7 Input format includes single selection, multiple selection, narrative text, scale ratings, yes/no
options, date/time entries, dropdown menus, and sliders.
— The SAQS may guide how to handle incomplete or inaccurate user inputs to ensure data integrity.
EXAMPLE 8 SAQS users have the potential to mistype responses or misinterpret the questionnaire.

6.1.3 Storing user-specific health data
The following recommended functionality applies if the SAQS supports storing user-specific health data
collected through interactions with questionnaires and responses.
— The SAQS should provide options for the user to choose whether to store the user-specific health data.
NOTE 1 The SAQS user can use the SAQS to obtain information about a particular disease.
— The SAQS should be able to support simple testing or verification for one-time users. In this case, the
result should not be retained or stored.
The SAQS user should be informed that the information entered will not be stored. The user will need to
re-type the same data when using the SAQS in the future.
— The SAQS should store the user-specific health data with consent from the SAQS user.
NOTE 2 The SAQS user can store the data to track the progression of the health condition.
— The SAQS user should be informed of the issues of privacy protection.
— The SAQS may provide recommendations for the optimal frequency and timing of usage to enhance user
engagement and ensure information accuracy.
— The SAQS may use any telecommunication method, such as messaging, to send reminders to the SAQS user.
— The SAQS should consistently and historically manage questionnaires centred around the SAQS users.
EXAMPLE 1 For SAQS supporting smoking cessation, details such as the number of cigarettes smoked, the
interval between smoking, and other related smoking behaviours are consistently recorded and stored. The SAQS
changes the questionnaires interactively based on whether the SAQS user is adhering to the smoking cessation plan.
— The SAQS may store and manage the inputs from the SAQS user in a standardised format.
EXAMPLE 2 The standardised format includes HL7 FHIR, HL7 CDA, and ISO 13606.
— The SAQS should set the retention period for the questionnaire.
NOTE 3 Certain information can lose its significance after a certain period has elapsed. For example, travel
records become irrelevant after a certain duration when dealing with infectious diseases.
— The SAQS should include a timestamp when storing data.
NOTE 4 Timestamps can be used for monitoring health progress.
— The SAQS may request permission from the SAQS user to access information relevant to the health
concerns, such as family medical history, health check-up results, places visited, etc.
NOTE 5 The user can answer the questionnaire, or the SAQS can automatically import information from other
systems.
6.1.4 Providing feedback
— The SAQS should provide personalised health-related recommendations.
NOTE Personalised health-related recommendations include dietary adjustment, exercise recommendations,
smoking cessation, stress reduction, or chronic disease management.
— The SAQS should offer recommendations or suggestions on visits to the healthcare organisation.
— The SAQS may provide guidelines on the location of the healthcare organisation and what to expect
during the visit.
— The SAQS may provide feedback by compiling information, including health monitoring data, medical
history, and allergy information.

EXAMPLE 1 SAQS does not recommend hiking as a form of exercise to the patient with a fear of heights.
— The SAQS should integrate questionnaires and feedback from various SAQS resources enabling the SAQS
users to receive advice from various healthcare professionals.
— The SAQS should be able to provide health-related feedback from the healthcare professionals.
— If the SAQS suspects specific diseases, the SAQS should provide recommended action for that disease and
information on risk factors.
EXAMPLE 2 For infectious disease, outline direction for the patient and the close contacts, recommended self-
isolation period, self-care advice during self-isolation, symptom relief, links to clinical assistance, etc.
6.2 Interface between SAQS application and SAQS
6.2.1 General
The following recommended functionality applies to the interaction between the SAQS application and SAQS.
6.2.2 Using user-specific health data
— The SAQS should inform the SAQS user of their rights regarding the ownership of their user-specific
health data.
— The SAQS should provide a method for SAQS user to have full control over access to their health data,
including the capability to grant or withdraw consent for sharing health data.
— The SAQS should not provide user-specific health data to SAQS applications without consent from the
SAQS user.
— The SAQS should ensure the user health data is accurate and up-to-date.
NOTE 1 Providing accurate and up-to-date data is crucial for providing appropriate clinical care and avoiding
potential clinical errors.
— The SAQS should provide relevant data protection mechanisms to support user privacy and confidentiality.
NOTE 2 There are regulations and standards that are compliant with jurisdiction, such as the Health Insurance
Portability and Accountability Act (HIPAA), General Data Protection Regulation (GDPR), and Health Information
Technology for Economic and Clinical Health (HITECH) Act.
— The SAQS should support integration with other healthcare systems using standardised protocols and
data formats for interoperability.
EXAMPLE 1 The standardised protocol includes HL7 FHIR, IHE XDS.b, XDR, and XDM.
— The SAQS may integrate with EHRs to enhance the use of user-specific health data.
— The SAQS should support patient ID cross-referencing to ensure consistent and accurate sharing of user-
specific health data across different platforms and healthcare service providers.
EXAMPLE 2 The SAQS uses MPI using IHE PIX, PDQ profiles.
— The SAQS should provide user-specific health data to SAQS applications that are relevant to patient care.
— The SAQS should enable care coordination by providing a comprehensive view of user-specific health
data to the relevant healthcare service providers.
— The SAQS may combine other patient-related information to be used by the SAQS application.
EXAMPLE 3 Other patient-related information includes family history.

6.2.3 Using aggregated health data
The following guidelines apply if the SAQS supports statistical information utilising multiple user-specific
health data.
— The SAQS should obtain consent from SAQS users when using their user-specific health data.
— The SAQS should support pseudonymisation and de-identification mechanisms for user-specific health
data to ensure that aggregated health data cannot be traced back to individuals.
NOTE ISO 25237 can be adopted for pseudonymisation.
— The SAQS may support the analysis of aggregated data to identify trends to be used for public health
strategies.
— The SAQS may use aggregated questionnaire responses based on demographics.
— The SAQS may use aggregated questionnaire responses on epidemiological data to track disease patterns
and support public health.
— The SAQS may use aggregated questionnaire responses on lifestyle and behavioural factors.
EXAMPLE Lifestyle includes diet, exercise, sleep pattern, etc.
7 Recommended data elements for SAQS
7.1 General
The SAQS can provide questionnaires either upon request from a healthcare institution or healthcare
provider for clinical purposes, or generated independently by the SAQS personalised for the patient. The
content of the questionnaires depends on the clinical purposes and should be based on clinical information
models such as ISO 13972. To ensure interoperability with other clinical systems, the questionnaires are
delivered using HL7 FHIR questionnaire resources or HL7 CDA. An example of using HL7 FHIR questionnaire
resources is in Annex C.
This clause specifies the data elements exchanged by the components of the SAQS. The data elements
described in this document are specialised for the SAQS. These include the questionnaires provided by the
SAQS to the SAQS user, the questionnaire responses from the SAQS user to the SAQS, and the feedback from
the SAQS to the SAQS user.
7.2 Data elements for questionnaires
7.2.1 Purpose of using SAQS
The self-assessment questionnaire may include the purpose of self-evaluation. The purposes include, but are
not limited to, the following.
— Routine health management: SAQS users can use SAQS periodically to manage their health status. This
can be done daily, weekly, or monthly. A “ROUTINE” may be assigned for this purpose.
EXAMPLE 1 Routine health management includes alcohol consumption, smoking, obesity, exercise, and
nutrition.
EXAMPLE 2 In HL7 FHIR, “Questionnaire – purpose field” is assigned as “ROUTINE”. In ISO 13606, “Self-
reported data – Description – Purpose” is assigned as “ROUTINE”, while “Self-reported data – Description –
Keywords” is assigned as “questionnaire”.
— Specific symptom concern: SAQS users can use the SAQS when experiencing a sudden onset of specific
symptoms before seeking healthcare services. The SAQS can provide health-related recommendations
and feedback. “COMPLAINT” may be assigned for this purpose.

EXAMPLE 3 Feedback can be home remedies, visiting healthcare institutions, or online consultations.
EXAMPLE 4 In HL7 FHIR, “Questionnaire – purpose field” is assigned as “COMPLAINT”. In ISO 13606, “Self-
reported data – Description – Purpose” is assigned as “COMPLAINT”, while “Self-reported data – Description –
Keywords” is assigned as “questionnaire”.
— Request from healthcare: the healthcare service provider can request SAQS users to complete
questionnaires for clinical purposes. These questionnaires can be requested before clinical encounters.
The SAQS can provide the status and concerns of the patient to the healthcare service provider. A “REQ_
HEALTH_PROV” may be assigned for this purpose.
EXAMPLE 5 In HL7 FHIR, “Questionnaire – purpose field” is assigned as “REQ_HEALTH_PROV”. In ISO 13606,
“Self-reported data – Description – Purpose” is assigned as “REQ_HEALTH_PROV”, while “Self-reported data –
Description – Keywords” is assigned as “questionnaire”.
— Comprehensive health check-ups: the SAQS provides questionnaires covering a wide range of health
topics. Healthcare service providers can combine the responses from the SAQS with the examination
results to obtain a complete understanding of the patient’s overall health status. This enables the
healthcare providers to explain the patient’s comprehensive health conditions and provide tailored
advice for effective health management. A “COMPREHENSIVE_CHECKUP” may be assigned for this
purpose.
EXAMPLE 6 In HL7 FHIR, “Questionnaire – purpose field” is assigned as “COMPREHENSIVE_CHECKUP”. In
ISO 13606, “Self-reported data – Description – Purpose” is assigned as “COMPREHENSIVE_CHECKUP”, while
“Self-reported data – Description – Keywords” is assigned as “questionnaire”.
— Public health use: the aggregated user-specific health data can be utilised for various public health
objectives, such as tracking infectious diseases, monitoring health trends of a specific group, and
supporting preventive health measures. A “PUBLIC_USE” may be assigned for this purpose.
EXAMPLE 7 In HL7 FHIR, “Questionnaire – purpose field” is assigned as “PUBLIC_USE”. In ISO 13606, “Self-
reported data – Description – Purpose” is assigned as “PUBLIC_USE”, while “Self-reported data – Description –
Keywords” is assigned as “questionnaire”.
7.2.2 Objective of the self-assessment
The self-assessment questionnaire may include the objective of self-assessment. The objectives include, but
are not limited to, the following.
— Symptom relief: the SAQS can provide a method to self-manage and alleviate symptoms. An “ANESIS”
may be assigned for this objective.
EXAMPLE 1 In HL7 FHIR, “Questionnaire – pertainsToGoal(extension)” is assigned as “ANESIS”. In ISO 13606,
“Self-reported data – Description – pertainsToGoal(extension)” is assigned as “ANESIS”, while “Self-reported data
– Description – Keywords” is assigned as “questionnaire”.
— Recommending healthcare services: the SAQS can recommend appropriate healthcare services based
on the symptoms or health conditions of the patient. A “REC_HEALTH_ORG” may be assigned for this
objective.
EXAMPLE 2 In HL7 FHIR, “Questionnaire – pertainsToGoal(extension)” is assigned as “REC_HEALTH_ORG”. In
ISO 13606, “Self-reported data – Description – pertainsToGoal(extension)” is assigned as “REC_HEALTH_ORG”,
and “Self-reported data-Description-Keywords” is assigned as “questionnaire”.
— Public health management: the aggregated data from SAQS can be used to improve public health
initiatives within specific regions or demographic groups. By analysing this data, health authorities can
identify trends, monitor the spread of diseases, and design programs to enhance public health. This
approach allows for more efficient resource allocation, improved health outcomes, and the ability to
address public health concerns proactively and effectively. A “PUB_HEALTH” may be assigned for this
objective.
EXAMPLE 3 In HL7 FHIR, “Questionnaire – pertainsToGoal(extension)” is assigned as “PUB_HEALTH”. In
ISO 13606, “Self-reported data – Description – pertainsToGoal(extension)” is assigned as “PUB_HEALTH”, while
“Self-reported data – Description – Keywords” is assigned as “questionnaire”.

— Wellness enhancement: the feedback from SAQS can be used to enhance daily health activities. For instance,
a smoker can set a goal to quit smoking. SAQS can provide personalised feedback, offering evidence-
based strategies and supportive methods recommended by the medical community. “WELLNESS” may
be assigned for this objective.
EXAMPLE 4 In HL7 FHIR, “Questionnaire – pertainsToGoal(extension)” is assigned as “WELLNESS”. In
ISO 13606, “Self-reported data – Description – pertainsToGoal(extension)” is assigned as “WELLNESS”, while
“Self-reported data – Description – Keywords” is assigned as “questionnaire”.
7.2.3 Category of the patient
The self-assessment questionnaire may be customised based on the category of the patient. The categories
can include, but are not limited to, the following.
— Age groups: the SAQS can design questionnaires based on different age groups. For example, questions
for children will differ from those for adults or the elderly, as each age group has unique health concerns
and comprehension levels. An “AGE_GROUP” may be assigned for this category.
— Gender groups: the SAQS can design questionnaires based on different gender groups. Certain health
issues and medical histories are specific to men or women, and the questions should reflect these
differences
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