In October 2021 the ISO Technical Specification draft "Biotechnology — Recommendations and requirements for predictive computational models in personalized medicine research — Part 1: Guidelines for constructing, verifying and validating models" has been approved as new work item proposal by the Technical Committee ISO/TC 276 Biotechnology.
The document, initiated by EU-STANDS4PM – a Coordinating and Support Action funded under the Horizon2020 framework programme of the European Commission whose core is a pan-European expert forum and network that combines extensive experience from its sixteen partners, including H2020 collaborative research projects, normative and regulatory agencies, large European infrastructures, Industry as well as ethical and legal expertise from eight European countries - defines challenges and requirements for predictive computational models constructed for research purposes in personalized medicine. It specifies recommendations and requirements for the setup, formatting, validation, simulation, storing and sharing of such models, as well as their application in clinical trials and other research areas. It summarizes specific challenges regarding data input, as well as verifying and validating of such models that can be considered as best practices for modelling in research and development in the field of personalized medicine.
This document also specifies recommendations and requirements for data used to construct or needed for validating models, including rules and requirements for formatting, description, annotation, interoperability, integration, accessing, as well as recording and documenting the provenance of such data.
You can find further information HERE
