PRIMED-AI: Validation Center (U54 Clinical Trial Not Allowed)

The National Institutes of Health (NIH), under the U.S. Department of Health and Human Services, is preparing to release a Notice of Funding Opportunity (NOFO) for a cooperative agreement titled "PRIMED-AI: Validation Center." This initiative is part of the broader Precision Medicine with Artificial Intelligence - Integrating Imaging with Multimodal Data (PRIMED-AI) program, which aims to accelerate the development and deployment of advanced AI-based clinical decision support (CDS) tools. These tools are intended to integrate imaging data with various other health data sources to improve the personalization of care for individuals with chronic and other complex health conditions. The funding announcement is currently a forecast, with applications expected to open on July 1, 2025, and due by November 1, 2025. The PRIMED-AI Validation Center will operate as an independent third-party hub, focusing on validating and verifying AI-driven CDS tools. Its primary function will be the rigorous retesting and harmonization of tools developed under the PRIMED-AI program to evaluate their reliability, performance, and uncertainty measures. This role is critical for ensuring these AI applications can be trusted for use in clinical environments. Validation tasks include the assessment of failure modes and confidence intervals associated with AI predictions, helping to standardize how these technologies are implemented and monitored across clinical settings. The NIH Common Fund is coordinating this effort with support from various NIH Institutes and Centers. The U54 cooperative agreement mechanism will be used, signifying substantial involvement from NIH staff in project oversight and progress. As a forecasted opportunity, the notice is being released well in advance to allow applicants ample time to build collaborative teams and craft thorough, scientifically sound proposals. Entities with prior experience in validating complex AI systems and assessing multimodal health data integration are encouraged to consider participation. While funding limits per award have not yet been specified, the total program funding available is projected at $3.9 million, with multiple awards expected. Applications that include robust methodologies for external validation and uncertainty quantification, along with demonstrated technical and collaborative capabilities, will likely be favored. Specific evaluation criteria will be detailed in the full NOFO when published. Eligible applicants for this opportunity include a wide array of institutions such as public and private higher education institutions, independent school districts, county governments, federally recognized and non-federally recognized tribal entities, small and large for-profit businesses, and nonprofit organizations with 501(c)(3) status. This broad eligibility spectrum is intended to encourage diverse participation from academia, industry, and community-based institutions. The anticipated award date is September 1, 2026, with the same date set for project initiation. No cost sharing or matching funds are required. Questions related to the opportunity can be directed to Dr. Sahana N. Kukke at the Office of the Director, NIH Common Fund, via phone at 301-402-3756 or by email at ODPRIMED-AI@od.nih.gov.

Applicants are encouraged to begin forming collaborations and projects early, particularly those with relevant expertise in AI validation and CDS tool analysis.