In 1946, Jorge Luis Borges wrote a story, “On Rigor in Science,” consisting of a single paragraph. The story recounts an empire where cartography was so advanced that it produced a map the same size as the empire itself. Today, the map in Borges’s story could serve as a metaphor for the human genome and the use of genetic testing.
Healthcare providers and researchers are increasingly using genetic and genomic testing in clinical practice and medical research which creates enormous amounts of extremely sensitive data. In fact, the volume of that data is expanding rapidly, as more private- and public-sector organizations tap the power of the genome. For example:
- The marketplace for genomic testing comprises firms who are for-profit enterprises such as 23andMe and Ancestry.com among others.
- Pharmaceutical companies are beginning to use specific genetic tests to determine if their drugs are appropriate for certain patients.
- Private firms, such as Myriad Genetics, operate genomic databases, algorithms and analytical tools.
- Finally, the National Institutes of Health (NIH) has a significant research interest in genomic data and testing and corresponding enormous data storage needs. There are already very large databases of genetic and genomic info in place, and these assets are only getting larger. NIH maintains ClinGen, one of the largest public genetic databases, and there are other public databases and associated resources within the academic medical community as well.
These databases and analytical capabilities represent some of the most valuable intellectual property for drug and treatment development in the world today. “Precision medicine,” or treatments based on a patient’s genes, lifestyle and other individual factors, is highly reliant on genetic and genomic data. The Food and Drug Administration (FDA) also issued 2018 guidance (PDF) on the regulation, use and data integrity of these databases in the clinical trials process, ensuring the use and growth of these resources for years to come.
All of this data is subject to compliance regimes consistent with HIPAA, and is also subject to the data breach reporting requirements of the Health Information Technology for Economic and Clinical Health Act (HITECH) Act, where breaches that affect 500 people or more must be reported and are subject to significant potential fines.
Database creators, owners, managers, users, and their IT teams need a plug-and-play data hosting and storage solution that is secure, compliant, scalable and resilient. Rather than retrofit, these stakeholders should look for existing infrastructure that provides these benefits of colocation today.
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