Posts Tagged ‘HIPAA’

Bringing Next-Generation Sequencing into a Sanger Lab

This is part two of our series on life in a CLIA lab. The first blog in this series explored the transition from working in a research-based facility to moving to a CLIA lab.  For the last two decades, Sanger sequencing was the gold standard in the clinical lab. It was perfect for the era when most genetic tests…

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Working in a CLIA Lab

Moving from Research to Working with CLIA Lab Regulations Moving to a CLIA lab after working in a research-based facility involved a steep learning curve. My attention was split between sequencing and learning CLIA and HIPAA rules and regulations, learning how to validate tests, software, and instruments, as well as learning the ropes of new documentation.  Needless to say,…

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Legal Obligations Surrounding NGS Data in the Cloud

Facilitating Compliance with Federal Regulations in the World of Cloud Computing The privacy of the patient is always a top priority for scientists and is especially important in the case of genome and exome sequencing. NGS labs are covered entities, meaning they create, maintain, transfer, use, and disclose personal health information (PHI). Therefore, they are…

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