Understanding Security, Privacy, and the Regulatory Landscape for Genomics in Research and Clinical Settings
Advances in DNA sequencing have created tremendous volumes of whole-genome sequence and multi-omics data, creating new opportunities to explore how the genome plays a role in human disease. However, in order to realize these opportunities requires overcoming challenges related to stringent controls on data security and regulatory compliance and the critical need for collaboration across borders and institutional firewalls.
As the use of human genomic information becomes more prevalent in research and clinical care, it is important to understand the responsibilities for handling of data in these contexts. Data security addresses confidentiality, integrity, and availability, and data privacy addresses the provenance and appropriate use of data. Both security and privacy are a shared responsibility between data owners and the services which they use to store, process and share data. Genomic information, particularly whole genome sequencing data, poses particular challenges, as it could be used to identify an individual, even in the absence of identifying metadata.
This webinar will describe security and privacy considerations for genomic information in the cloud, and the regulatory landscapes which define the policies and controls for compliant handling of Personally Identifiable Information (PII), and Protected Health Information (PHI), including HIPAA/HITRUST, CAP, CLIA, ISO 27001, 21 CFR relevant parts, and GxP.