ISO/CD TS 9491-2
Biotechnologie — Modèles informatiques prédictifs dans la recherche sur la médecine personnalisée — Partie 2: Lignes directrices relatives à la mise en oeuvre de modèles informatiques dans les systèmes intégrés d'aide à la décision clinique
Numéro de référence
ISO/CD TS 9491-2
Edition 1
Committee Draft
ISO/CD TS 9491-2
Examen du projet par le comité en cours.


This document specifies requirements and recommendations for designing, developing, and establishing integrated decisions support systems 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 these rules should be integrated 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 the clinical routine.

Informations générales

  •  : Projet
    : Clôture de la période des observations [30.60]
  •  : 1
  • ISO/TC 276
  • RSS mises à jour

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