This bill would add a new section to the Federal Food, Drug, and Cosmetic Act that lets the Secretary of Health and Human Services require manufacturers of certain electronic medical devices to give patients their own device data on request. The rule could require manufacturers to disclose data that the device records or transmits and that the manufacturer can access. The Secretary would issue regulations, consider the FDA's October 2017 guidance, and may require manufacturers to provide data in understandable or preferred formats, post on their websites what data the device records or the manufacturer can access, explain how they use patient data (excluding proprietary details), publish how patients can request data, and notify patients about data access, recalls, software updates, or device error messages. The bill adds exceptions: manufacturers would not be required to disclose data that is in a closed system and inaccessible to them, to redesign devices to enable disclosure, or to disclose data that is inaccessible to the manufacturer. It defines "covered device" as an electronic device intended for diagnosis, cure, mitigation, treatment, or prevention of disease that is implanted, used for remote monitoring, and capable of recording or transmitting patient data. It defines "patient-specific data" and lists examples such as usage, alarms, pulse oximetry, and heart electrical activity. The bill also amends the civil penalties provision to allow penalties for violations of any requirement under the new section.
No publicly available information on federal costs, compliance costs to manufacturers, or other expenses is included in the bill text or metadata.
No publicly available information on proponents' statements or supporting arguments is included in the bill text or metadata.
No publicly available information on opponents' statements or objections is included in the bill text or metadata.