ISO/TS 9166:2025
(Main)Health informatics — Guidelines for self-assessment questionnaire systems
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
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
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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,
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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).
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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
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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 question
...
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