The NIH Genomic Data Sharing (GDS) Policy is getting an update to ensure human genomic data in controlled-access repositories, like dbGaP, is managed securely and responsibly. These changes apply to all NIH-funded mechanisms (grants, contracts, intramural research, etc.) supporting genomic data repositories or developer activities.
Starting January 26, 2025, two major changes will affect how authorized users can download and analyze this data:
Updated Security Standards:
- Repositories storing genomic data must meet stricter security guidelines, like NIST SP 800-53 Moderate or equivalent standards (e.g., FedRAMP or FISMA Moderate).
- Approved users must confirm that their IT systems or third-party cloud services comply with NIST SP 800-171, covering all computers used to work with this data. This applies to all computers that are used to the download and analyze controlled-access data.
- International users can meet comparable standards like ISO/IEC 27001 instead.
New Rules for Developers:
- Developers (e.g., tool designers, platform maintainers) working with NIH-controlled genomic data must follow a newly defined Developer Code of Conduct, similar to the Genomic Data User Code of Conduct.
- They must also submit a Developer Use Statement (DUS) explaining their purpose, security compliance, and institutional responsibilities.
- Access will be reviewed by a specialized group called the Developer Data Access Committee (Developer DAC).
Good News for Researchers
The Seven Bridges platform is already doing the hard work for you! Seven Bridges meets these compliance standards, so you can focus on your research without worrying about complex security updates. By working in the cloud, you ensure your projects are both secure and aligned with NIH requirements.
Take advantage of a platform that’s ahead of the curve—move your work to the cloud with Seven Bridges!
Contact us for more information by emailing Support @ Velsera.com
Let’s keep pushing the boundaries of genomics while protecting the privacy and security of participant data! 🔬🧬
