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.
The proposed legislation would have significant implications for patient rights in the healthcare system. By requiring device manufacturers to provide access to personal health data, the bill champions patient autonomy in understanding and managing their health. It is expected that this increased data access may facilitate better patient-provider relationships and improve health outcomes since patients can be better informed about their health conditions and the performance of their devices.
House Bill 10406, titled the 'Patient Device Data Access Act of 2024,' seeks to amend the Federal Food, Drug, and Cosmetic Act to mandate that manufacturers of covered medical devices disclose all patient-specific data recorded or transmitted by those devices, upon request by the patient. This legislation underscores the importance of patient access to their own data, aiming to enhance transparency and empower patients regarding their medical information. Provisions of the bill would require that the disclosure be in a format understandable to patients and allow requests for data in preferred formats where practicable.
While the bill is primarily aimed at enhancing transparency, it is anticipated that it may generate debate among stakeholders in the healthcare industry. Concerns may arise from manufacturers regarding the logistics and potential risks involved in disclosing sensitive patient data, including privacy issues and the implications of data mismanagement. Additionally, discussions may focus on how such requirements might impact the innovation in device manufacturing and the overall cost of medical care. The balance between patient access to information and the protection of proprietary device data could lead to further scrutiny and potential amendments to the bill.