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  • ISO
    ISO/TS 20428:2024 Genomics Informatics - Data elements and their metadata for describing structured clinical genomic sequence information in electronic health records
    Edition: 2024
    $454.91
    / user per year

Content Description

The document defines the data elements and the requisite metadata essential for implementing a structured clinical genomic sequencing report in electronic health records, particularly focusing on the genomic data generated by next-generation sequencing technology.

This document:

—     defines the composition of a structured clinical sequencing report (see Clause 6);

—     defines the required data fields and their metadata for a structured clinical sequencing report (see Clause 7);

—     defines the optional data (see Clause 8);

—     covers the DNA-level variation from human samples using whole genome sequencing, whole exome sequencing, and targeted sequencing (disease-targeted gene panels) by next-generation sequencing technologies (though whole transcriptome sequencing and other technologies are important to provide better patient care and enable precision medicine, this document only deals with DNA-level changes);

—     covers mainly clinical applications and clinical research such as clinical trials and translational research which uses clinical data (basic research and other scientific areas are outside the scope of this document);

—     does not cover the other biological species, i.e. genomes of viruses and microbes;

—     does not cover the Sanger sequencing methods.



About ISO

ISO, the International Organization for Standardization, brings global experts together to agree on the best way of doing things – for anything from making a product to managing a process. As one of the oldest non-governmental international organizations, ISO has enabled trade and cooperation between people and companies all over the world since 1946. The International Standards published by ISO serve to make lives easier, safer and better.
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