Hospital data could unlock faster approvals. The infrastructure to use it safely did not exist. Until now.

Every day, hospitals generate outcomes data, safety signals, and real-world performance records that could support regulatory submissions. That evidence already exists. But privacy regulations, liability concerns, and IT constraints have made it nearly impossible to access. Approvals stall. Costs climb. Evidence that was there all along goes unused.

For rare disease sponsors, the stakes are even higher. Patient populations are small and scattered across institutions. Randomized trials are often impractical or impossible. Real-world evidence is not just helpful in these cases. It is frequently the only path forward. Federated infrastructure makes it possible to reach those patients without asking any single hospital to hand over their data.

In December 2025, the FDA issued final guidance removing the requirement for identifiable patient-level data in real-world evidence submissions. De-identified, distributed datasets may now be considered for device regulatory decisions. This is a meaningful shift for sponsors who have long been locked out of this data. NexusRWE was built specifically for this moment.

Note: The December 2025 guidance applies to medical devices. On December 15, 2025, FDA also issued a press release stating it will accept RWE without requiring identifiable patient data for drugs and biologics as well.