A Safe (and Compliant) Haven for Genomic Data in the Cloud

Despite a general comfort with putting personal information on Facebook or LinkedIn or plugging our credit card numbers into websites to book travel, buy birthday presents or rent movies, one of the earliest and most lasting concerns raised about storing genomic data in the cloud has been whether the data are secure.

And rightfully so. Data security isn’t a “nice-to-have” when it comes to personally-identifiable DNA sequence data; it’s essential. With genomic sequencing emerging as essential to clinical development and the delivery of both diagnostics and therapies, compliance with regulations that apply to the handling of genetic data and its subsequent integration into other medical data systems are equally critical. As raw data are converted into more meaningful information, they become an asset as valuable and sensitive as any other personal information, currency, or intellectual property.

We’ve taken a very proactive approach to security and compliance at DNAnexus. Just as hospitals put the highest possible premium on security of their data, so too do cloud platform providers — because their entire business rides on utilizing best-in-class measures to assure the security, integrity and availability of their customers’ data. Our platform was developed from the ground up with this in mind and includes a number of features that allow each user to create a secure and compliant environment that will meet their unique needs today and in the future.

More specifically, the DNAnexus platform was developed with the internationally accepted ISO 27002 controls for best practices in information security and includes a number of features to ensure the highest level of data security for both research and clinical use, including:

  • Data integrity:
    • SAS-70 and PCI certified physical security of data centers
    • Data encryption (with full-disk AES-256 for data storage and SSL/TLS for data transport)
    • Third-party security audit
  • Access control:
    • Member administrators control access and retention policies
    • Passwords must be complex and periodically changed
    • Accounts timeout when idle, and lock when unused, and after too many incorrect login attempts
  • Administrator restrictions:
    • Two-factor authentication required
    • All administrative access is controlled and logged
  • API access restrictions:
    • API key required and limited to a validity period

To provide additional assurance to our users, we received an independent auditors’ certification of our compliance with ISO-27001 with respect to the management of our information systems.

To comply with clinical requirements relating to data integrity and reproducability, DNAnexus supports data logging and auditability for 6 years, and versioned and reproducible analysis tools and results.  Collectively, the security and compliance features implemented in our platform enable compliance with HIPAA, CLIA, Good Clinical Practice (GCP), 21 CFR Parts 11, 58, 42 CFR part 493, European Data Privacy laws and regulations (EU Directive 95/46/EC) and dbGaP Best Practices. For additional details please review our following white papers on our security and compliance practices:

We also work closely with our partners at Amazon Web Services to develop and deploy security strategies that are often far more sophisticated than those used in, or even available to, most premises-based data centers. Whether your data is at rest or in motion as you share it across your project group, you can be sure it’s protected within the DNAnexus platform.

If you are interested in learning more about our security and compliance measures, please visit dnanexus.com.