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.