H.R. 6117 — Patient Device Data Access Act of 2025

This section authorizes the Secretary of HHS, by regulation and applicable to all manufacturers, to require manufacturers of covered devices—implantable electronic devices intended for diagnosing, curing, mitigating, treating, or preventing disease that enable remote monitoring and record or transmit patient data—to disclose patient-specific data (e.g., usage, alarms, outputs, pulse oximetry, heart electrical activity, or pacemaker rhythm data) to requesting patients, including in understandable or patient-preferred formats where possible; to publish on their websites whether the device is covered, types of data recorded/transmitted and accessible to the manufacturer, and data utilization methods (excluding proprietary information); and to publicize data request methods and notify patients of data access, recalls, software updates, or error messages. Regulations must consider FDA's October 2017 guidance titled “Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients Upon Request,” with exceptions for data inaccessible to manufacturers, closed systems, or redesign requirements. This section also amends civil penalty provisions at 21 U.S.C. 333(f)(1)(A) to explicitly cover violations of requirements under new section 524C.