To amend the Federal Food, Drug, and Cosmetic Act to authorize requiring the manufacturers of a covered device to disclose to a patient all patient-specific data that is recorded or transmitted by the device and accessible to the manufacturer, and for other purposes.
About This Bill
Committee
Latest Action · December 12, 2024
Referred to the House Committee on Energy and Commerce.
The Patient Device Data Access Act of 2024 would require medical device manufacturers to share patient data with their users upon request. The bill applies to electronic devices that are implanted in patients' bodies, used for remote monitoring, or capable of recording and transmitting health information, such as pacemakers and glucose monitors. When a patient asks for their data, manufacturers would need to disclose all patient-specific information that the device records and that is accessible to the company, potentially in formats the patient prefers. Manufacturers would also be required to publish information on their websites about what data their devices collect and how patients can request access to their own information. The legislation includes exceptions for data stored in closed systems that manufacturers cannot access, and it does not require companies to redesign devices to enable data sharing.
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