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

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• ISO/IEC 27001:2022 Information Security Management System

• ISO/IEC 27018:2019 Personal Data Protection Act and its implementations rules

• ISO 13485 Quality Management Systems

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

• FDA Cybersecurity Guidance

• FDA 21 CFR Part 11 Audit Trail

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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

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As a Gold Member in Health Level Seven International (HL7), 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.