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.

News: DNAnexus Offers Service for Clinical Testing Labs

This week we’re pleased to announce the launch of our specialized platform-as-a-service (PaaS) for the next-generation sequencing-based diagnostics market.

What does that mean? With this service, we are focusing specifically on clinical enterprises that want to eliminate the common costs and challenges associated with building clinically compliant pipelines for next-generation sequencing data analysis.

As demand for genomic data in the clinic ramps up, diagnostics companies that have traditionally used on-premise solutions are facing increasing challenges to scale their resources while meeting HIPAA and other regulatory requirements.

Clinical testing labs that are reconsidering those on-premise data centers need more than just a cloud provider; they also need a partner with expertise in genomics and bioinformatics to help build reliable, robust pipelines. That’s where we come in: with this PaaS, DNAnexus offers all of our usual rock-solid cloud computing along with access to our team of expert scientists and engineers who know this field inside and out.

Through our PaaS, clinical testing labs will be able to scale up their enterprise infrastructures for analyzing and managing DNA data. We provide a configurable API-based platform that allows users to move their analysis pipelines into the cloud, where they can utilize their own algorithms as well as industry-recognized tools and resources to create customized workflows in a secure and compliant environment.

One of our early clinical adopters, cancer researcher Boris Bastian from the University of California, San Francisco School of Medicine, said in a statement: “Working with the DNAnexus team has been invaluable for us as we deploy our data analysis pipeline to the cloud and work toward a production-grade clinical test. The DNAnexus platform is well-suited for rapid pipeline development and enterprise-readiness. We have relied heavily on their expertise in cloud-based solutions and benefited from their experience in managing data in a clinically appropriate manner.”

As part of this offering, we have ensured that our platform meets HIPAA, CLIA, and many other regulatory requirements for users working with sensitive medical information.

 

Keep Your HIPAA-Protected Data Safer with Cloud Computing

hipaa complianceIf you’ve been considering the implications of cloud computing when it comes to HIPAA compliance, a new article in Healthcare IT News is worth a read.

The article, penned by our own general counsel Lee Bendekgey, is entitled “Cloud computing reduces HIPAA compliance risk in managing genomic data.” In it, Lee looks at the massive computational infrastructure required for handling new health data, such as genome sequences. “The resources required to process, analyze, and manage petabytes of genomic information represent a huge burden for even the largest academic research facility or healthcare institution,” Lee writes.

While it may seem counterintuitive, he adds, moving data to a cloud environment can actually improve data security. Lee considers HIPAA requirements and historic breaches of HIPAA-secured data, looking at what factors may have improved security in those situations where personal health information was put at risk.

Breaches tend to occur on items that are portable — flash drives and laptops, for instance — so keeping data in the cloud means that sensitive data never actually lives on one of these easily stolen or lost devices. Cloud computing providers routinely encrypt data while it’s in transit and at rest, adding to high-grade security. Medical organizations considering this route should ensure that a cloud provider guarantees security audits, certifications, and assessments associated with HIPAA compliance.

“By using a cloud-based service with an appropriate security and compliance infrastructure, an organization can significantly reduce its compliance risk,” Lee writes.