AMIA Supports NIH Data Governance Modernization, Offers Recommendations for Harmonized Implementation

AMIA's comments on NIH's Draft Controlled-Access Data Policy and revised Genomic Data Sharing Policy call for a flexible, risk-based framework that moves beyond rigid data-type categorizations. Key recommendations include harmonizing NIH data policies, investing in repository infrastructure and workforce capacity, avoiding prescriptive security standards that burden under-resourced institutions, and enabling responsible international collaboration. We also urge NIH to explicitly support reproducible AI development within controlled-access environments.