N3C DYNAMIC WORKSPACES FOR NCATS

Axle Informatics, Llc, North Bethesda MD

Investigators

Abstract

The National Institutes of Health (NIH) is the Nation's leading Medical Research Agency and the primary Federal Agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and apply that knowledge to enhance health, lengthen life, and reduce illness and disability by supporting and making medical discoveries. The National Center for Advancing Translational Science (NCATS) at the NIH focuses on all aspects of the translation of research with an innovative pipeline of treatment discoveries for all diseases. NCATS' mission is to improve health through smarter science that results in better treatments faster for all diseases, rare or common. The National Clinical Cohort Collaborative (N3C) began as a collaborative vision for a national data resource that turned real-world evidence into the knowledge urgently needed to address the pandemic. It systematically collected data derived from electronic health records (EHRs) and other important repositories from different institutions and harmonized these data in a centralized resource available for collaborative research. The program has since expanded beyond its initial focus to encompass multiple Enclaves, focusing on various diseases. Building upon this successful foundation, N3C is now ready for its next evolutionary step: a transition to a more scalable, flexible, and secure Dynamic Workspaces Model. This new model enhances collaboration and facilitates more impactful translational research across disparate disease areas by creating secure, project-specific analytical workspaces—or Dynamic Workspaces—that provide approved researchers with access only to the data necessary for their study. This transition preserves the core principles of centralized data harmonization and a secure analytical environment while granting institutions more granular control over the use of their data through a transparent opt-out mechanism. This work will also ensure the platform achieves full compliance with new, stringent government requirements for Controlled-Access Data Repositories (CADR), reinforcing N3C as a leader in responsible data stewardship. Together with the Data Collect Once Use Numerous TimeS (COUNTS) Initiative, N3C will form the foundational infrastructure of the NIH Real World Data Network (RWDN). The RWDN will integrate vast amounts of real-world data from electronic health records (EHRs), insurance claims, pharmacies, and other sources. Building on prior NIH-funded efforts, the RWDN will eliminate redundancies from data collection, linkage, and analysis infrastructures, and will dramatically reduce administrative overhead by relying on a unified set of data use and governance agreements. It will provide direct access to advanced computational resources to support cutting-edge artificial intelligence/machine learning (AI/ML) modeling, petabyte-scale storage/compute, and high-throughput analytics. The Data COUNTS initiative serves as a foundational EHR data collection engine that ensures full provenance, traceability, and minimal data loss from health systems. Data COUNTS provides federated collection of EHR and other clinical data, as well as data and transmission architecture based on open-industry data and interoperability standards. It supports a broad array of use cases across HHS with appropriate adherence to data privacy, security, and data access policies. The overarching objective of this work is to transition N3C to a Dynamic Workspaces architecture while ensuring operational continuity, enhancing data utility for the research community, and achieving full compliance with all CADR requirements. To accomplish this, NCATS has identified objectives across eleven core and five optional workstreams that will need to be run by the Awardee.