This document specifies requirements and recommendations for the design, development and implementation of predictive computational models for research purposes in the field of personalized medicine and health product development.

This document 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 specified. 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 standard routine clinical, diagnostic or therapeutic purposes.