Patient Device Data Access Act of 2025
Summary
The Patient Device Data Access Act of 2025 aims to amend the Federal Food, Drug, and Cosmetic Act. It seeks to authorize the Secretary to require manufacturers of covered devices to disclose patient-specific data recorded or transmitted by their devices directly to patients. This bill focuses on enhancing patient access to their health information generated by implanted or remote monitoring devices.
Expected Effects
If enacted, the bill would mandate device manufacturers to share specific data with patients upon request, provided the data is accessible to the manufacturer. This includes usage information, alarms, outputs, and data like pulse oximetry and heart activity. The Act also outlines exceptions for data in closed systems inaccessible to the manufacturer and prevents requirements to redesign devices.
Potential Benefits
- Empowers patients with greater control over their health data.
- Enhances transparency regarding device functionality and data collection.
- Facilitates better-informed healthcare decisions by patients and providers.
- May lead to improved patient engagement in managing their health conditions.
- Could drive innovation in device design to improve data accessibility.
Potential Disadvantages
- Potential for increased costs for manufacturers to comply with data disclosure requirements.
- Risk of misinterpretation of complex data by patients without medical expertise.
- Concerns about data security and privacy during transmission and storage.
- Possible burden on manufacturers to provide data in understandable formats.
- May create legal liabilities for manufacturers regarding data accuracy and interpretation.
Most Disadvantaged Areas:
Constitutional Alignment
The bill aligns with the spirit of promoting the general welfare, as stated in the Preamble of the US Constitution, by enhancing patient access to health information. It does not appear to infringe upon any specific constitutional rights or provisions. The authority granted to the Secretary falls under the Commerce Clause (Article I, Section 8), which allows Congress to regulate interstate commerce, including the manufacturing and distribution of medical devices.
Impact Assessment: Things You Care About ⓘ
This action has been evaluated across 19 key areas that matter to you. Scores range from 1 (highly disadvantageous) to 5 (highly beneficial).