PD ISO/TS 20428:2017
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Health informatics. Data elements and their metadata for describing structured clinical genomic sequence information in electronic health records
Hardcopy , PDF
12-06-2024
English
18-07-2017
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Abbreviated terms
5 Use case scenario
6 Composition of a clinical sequencing report
7 Fields and their nomenclature of required data
8 Fields and their nomenclature of optional data
Annex A (informative) - Example structure of clinical
sequencing report
Annex B (informative) - Example layout of clinical
sequencing report
Bibliography
Describes the data elements and their necessary metadata to implement a structured clinical genomic sequencing report and their metadata in electronic health records particularly focusing on the genomic data generated by next generation sequencing technology.
| Committee |
IST/35
|
| DocumentType |
Standard
|
| Pages |
44
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
The document defines the data elements and their necessary metadata to implement a structured clinical genomic sequencing report and their metadata 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 Clause5),
defines the required data fields and their metadata for a structured clinical sequencing report (see Clause6),
defines the optional data (see Clause7),
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. However, the necessary steps such as de-identification or consent from patient should be applied. The 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, and
does not cover the Sanger sequencing methods.
| Standards | Relationship |
| ISO/TS 20428:2017 | Identical |
| ISO/TS 27527:2010 | Health informatics Provider identification |
| ISO 11615:2017 | Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated medicinal product information |
| ISO/TS 22220:2011 | Health informatics — Identification of subjects of health care |
| ISO 8601:2004 | Data elements and interchange formats Information interchange Representation of dates and times |
| ISO 25720:2009 | Health informatics — Genomic Sequence Variation Markup Language (GSVML) |
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