ISO/TS 9491-1:2023

Biotechnology — Predictive computational models in personalized medicine research — Part 1: Constructing, verifying and validating models

Scope

This document specifies requirements and recommendations for the design, development and establishment of predictive computational models for research purposes in the field of personalized medicine. It addresses the set-up, formatting, validation, simulation, storing and sharing of computational models used for personalized medicine. Requirements and recommendations for data used to construct or required for validating such models are also addressed. This includes rules for formatting, descriptions, annotations, interoperability, integration, access and provenance of such data.
This document does not apply to computational models used for clinical, diagnostic or therapeutic purposes.