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.

Bill 118 hr 10406, also known as the Patient Data Access Act, aims to amend the Federal Food, Drug, and Cosmetic Act to allow for the disclosure of patient-specific data recorded or transmitted by medical devices to the patients themselves. This bill would require manufacturers of covered devices to provide patients with access to any data that is accessible to the manufacturer.

The purpose of this legislation is to empower patients by giving them more control over their own health information. By allowing patients to access the data collected by their medical devices, they can better understand their own health conditions and make more informed decisions about their care.

The bill does not specify which devices would be considered "covered devices," but it is likely to include a wide range of medical devices that collect and transmit patient data, such as pacemakers, insulin pumps, and continuous glucose monitors. Overall, the Patient Data Access Act seeks to promote transparency and patient autonomy in healthcare by ensuring that patients have access to the data generated by their own medical devices.