Patient Device Data Access Act of 2025

This bill amends the Federal Food, Drug, and Cosmetic Act to empower the Secretary to mandate that manufacturers of certain medical devices share patient-specific data with patients. Specifically, it authorizes the Secretary to require manufacturers of covered devices —electronic devices that are implanted, used for remote monitoring, and capable of recording or transmitting patient data—to disclose all patient-specific data accessible to them upon a patient's request. These requirements would be established through regulations, which must consider existing FDA guidance on sharing patient information. The regulations may specify that data be disclosed in an understandable and, if practicable, patient-preferred format. Manufacturers could also be required to publish on their websites information about the types of data collected, how they utilize it, and the process for patients to request their data. Importantly, the bill includes exceptions, ensuring manufacturers are not compelled to redesign devices or disclose data that is genuinely inaccessible to them, while also providing for civil penalties for non-compliance.