BS PD ISO/TS 20428:2017

Health informatics. Data elements and their metadata for describing structured clinical genomic sequence information in electronic health records

BSI Group , 07/18/2017

Publisher: BS

File Format: PDF

$154.00$309.88


BS PD ISO/TS 20428:2017 defines the data elements and their necessary metadata to implement a structuredclinical genomic sequencing report and their metadata in electronic health records particularlyfocusing on the genomic data generated by next generation sequencing technology.This document
  • defines the composition of a structured clinical sequencing report (see Clause 5),
  • defines the required data fields and their metadata for a structured clinical sequencing report (seeClause 6),
  • defines the optional data (see Clause 7),
  • covers the DNA-level variation from human samples using whole genome sequencing, whole exomesequencing, and targeted sequencing (disease-targeted gene panels) by next generation sequencingtechnologies. Though whole transcriptome sequencing and other technologies are important toprovide better patient care and enable precision medicine, this document only deals with DNA-levelchanges,
  • covers mainly clinical applications and clinical research such as clinical trials and translationalresearch which uses clinical data. However, the necessary steps such as de-identification or consentfrom patient should be applied. The basic research and other scientific areas are outside the scopeof this document,
  • does not cover the other biological species, i.e. genomes of viruses and microbes, and
  • does not cover the Sanger sequencing methods.
Cross References:ISO/TS 27527:2010ISO/TS 22220:2011 Ed 2ISO 11615:2012 ED1

BS PD ISO/TS 20428:2017 History

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