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HR 6117119th CongressIn Committee
Patient Device Data Access Act of 2025
Introduced: Nov 18, 2025
Sponsor: Rep. Sherrill, Mikie [D-NJ-11] (D-New Jersey)
Standard Summary
Comprehensive overview in 1-2 paragraphs
The Patient Device Data Access Act of 2025 amends the Federal Food, Drug, and Cosmetic Act to authorize the FDA to require manufacturers of covered medical devices to disclose patient-specific data to patients upon request. The bill establishes requirements for data disclosure, public reporting, and patient notification, while providing exceptions for data that is inaccessible or requires system redesign.
Key Points
- 1Authorizes FDA to require patient data disclosure by device manufacturers
- 2Covers implanted devices that record or transmit patient data
- 3Requires public disclosure of data types and access methods
- 4Mandates patient notification of recalls and software updates
- 5Includes exceptions for inaccessible data and system redesign
- 6Amends civil penalties for non-compliance
Impact Areas
Medical device regulationPatient data rightsHealth information privacyFDA enforcement authority
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