Updates to Data Management and Access Practices Under the NIH Genomic Data Sharing Policy

NIH has issued an implementation update for data management and access practices under the Genomic Data Sharing (GDS) Policy (see Guide Notice NOT-OD-24-157) which introduces updated security standards for Approved Users of controlled-access data shared under the NIH GDS Policy (NOT-OD-14-124) and for repositories and/or systems storing or providing access to these data. The updates will take effect on January 25, 2025.

In summary:

• NIH is making the following changes to modernize the security standards provided for NIH controlled-access data in the NIH Security Best Practices for Controlled-Access Data Subject to the NIH GDS Policy that Approved Users adhere to as a part of terms and conditions of access:
  • Approved U.S. and non-U.S. users will be required to attest to NIH that their institution and any third-party system or Cloud Service Providers involved in data analysis or storage comply with NIST SP 800-171 or an equivalent IT security standard.
  • Adherence to the new standard will be included in new or renewed Data Use Certifications or similar agreements.

• NIH is establishing security standards for NIH controlled-access data repositories requiring the adoption of the NIST SP 800-53 Moderate IT security standard. These security standards will apply to NIH controlled-access data repositories and access systems supported by NIH funding to provide long-term storage for, or control access to, human genomic data generated and shared under the GDS Policy.

• NIH is establishing minimum expectations for developers provided access to controlled-access human genomic data under the GDS Policy. Developers will be expected to submit a request containing a Developer Use Statement to a NIH Developer Data Access Committee (DAC) for review. If the DAC approves, the NIH controlled-access data repository can use existing technical capabilities to grant developer access.

To help the research community prepare for these changes, a new NIH Security Best Practices page with references to relevant policy documents and guidance is now available on the NIH Scientific Data Sharing site. Additional information on scientific and genomic data sharing is available through these FAQs and questions about the Guide Notice can be submitted to [email protected].