ISO/TS 9491-2:2026

Description

This document specifies requirements and recommendations for designing, developing, and establishing integrated clinical decision support systems (CDSS) for research purposes in personalized medicine.

This document can be used as an implementation guideline for setting up computational modelling workflows to enable such systems. It addresses data quality, formatting and handling, as well as the processes generating such data, and the set-up, validation, simulation, storing and sharing of computational models used for this specific purpose in personalized medicine. This includes recommendations and rules for configuration, descriptions, annotations, interoperability, integration, access and provenance of such data and derived models in an interpretable and evidence-based manner. This document also specifies how to integrate these rules with clinical trials execution applying standard operating procedures. Furthermore, requirements and recommendations for data used to construct or required for validating such models are addressed.

This document does not apply for computational models used for diagnostic or therapeutic purposes in standard clinical practice, outside of a formal research or investigational setting.