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NO.336 08.03.2017

International Standard for Sharing Clinical Genomic Sequencing Data Approved for First Time in the World

Professor Sooyong Shin developed and established the international standard that defines the data elements and necessary metadata of a structured clinical genomic sequencing for widespread clinical use


In June 2017, the international standard ISO/TS 20428 Health Informatics, developed and proposed by Professor Shin, was approved and published by the International Standard Organization (ISO) Central Secretariat: a world’s first in the area of clinical use of genomic sequencing data.


A critical bottleneck on putting genomic sequencing data to clinical use is how to incorporate the clinical genomic sequencing data into the electronic medical record (EMR) system used in hospitals, as there was no unified international standard for representing clinical sequencing results with a structured format for electronic health records. Consequently, the necessary genomic test results were not efficiently delivered to the clinicians.


Feeding EMR with genomic sequencing data in a structured format
The ISO/TS 20428 Health Informatics is the new international standard that defines the format of structured genomic sequencing data and their associated metadata for the use in the EMR. Previously, genomic sequencing data had no unified format compatible with the EMR. Instead, clinicians had to take delivery of the data in a text or pdf format, and either manually input the data into the EMR or do the analysis independently. Also, each hospital had their own unique format for the EMR, which made it difficult to simultaneously analyze the clinical data and the genomic sequencing data. It was also nigh impossible to do a global search of their medical database.


With this new international standard, however, all genomic sequencing data will be stored in a structured format with their associated meta data. This will not only significantly improve the efficiency of clinicians but also furnish a vastly superior environment for medical data science. It will make a giant leap forward toward precision medicine with revolutionary global search and analysis with Big Data, as all data will be in a unified, internationally compatible format and any part of its information can easily be shared and transferred as deemed necessary.

“Structured standardization of data eliminates errors before happening”
Professor Shin, who had majored in computer science, has been working in a hospital specializing in medical data system. He then participated in genomic data sequencing and expanded his areas of specialty to precision medicine, IT, and biotechnology, which contributed to his proposal and approval of clinical genomic data standard for the first time in the world.

Professor Shin said, “Data are useless unless they are formatted in a standard structure so that they can be sorted, analyzed, and utilized. A well-designed data standard can prevent many errors from happening. My future research goals will be developing new platforms to analyze the standardized data.”

Professor Shin, with the research funding by the Ministry of Trade, Industry and Energy, made the initial proposal for the ISO/TS 20428 in November 2014, and the committee draft was approved in September 2015. The CD was approved in November 2016 and the final text published in June 2017.

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