Compliance

Atgenomix SeqsLab follows the most relevant security frameworks and regulations in the healthcare industry:

  • ISO/IEC 27001:2013 Information Security Management System

  • IEC 62304:2006+A1:2015 Medical Device - Software Life Cycle Processes

  • FDA Cybersecurity Guidance

  • FDA 21 CFR Part 11 Audit Trail

Security measures used on SeqsLab include:

  • Virtual private cloud

  • Role-based access control

  • Encryption at rest and in transit

  • Activity audit logs

  • Data, code, and execution integrity

  • Open standards

  • Code inspection

Combined with Microsoft Azure’s trusted cloud, SeqsLab is compliant with the following regulations out of the box:

  • Health Information Trust Alliance (HITRUST)

  • Health Insurance Portability & Accountability Act (HIPAA)

  • General Data Protection Regulation (GDPR)

  • ISO/IEC 27018 Code of Practice for Protecting Personal Data in the Cloud

As a Gold Member in Health Level Seven International (HL7)(external link), Atgenomix also supports the HL7 objective to create a suite of standard-based technologies for streamlining sophisticated data management and computational analysis of biomedical and multi-omics information.

compliance