FDA issues RFI on patient-level data access for real-world evidence submissions

What happened

The Food and Drug Administration announced a request for information (RFI) to gather perspectives on patient-level data access for real-world evidence in drug and biologic submissions. The RFI seeks input from regulated industry, health‑IT vendors, academic medical centers, patient advocates and others. Comments are due by 2027-01-11.

Why it matters for trust and compliance

• Its status is published. It is enacted but may not be in force yet. Check the effective date before planning around it.
• The RFI could shape future FDA requirements on handling patient‑level health data, impacting privacy and security practices.

Who is affected

Recommended actions

1. Check that privacy notices describe the practices this addresses.
2. Map the security requirements to existing controls and close gaps.
3. Confirm handling of sensitive data categories meets the stricter rules.