Sponsor
Mikie Sherrill
Representative · D-NJ
Representative · D-NJ
The bill increases patient safety, transparency, and enforceable access to device-recorded health data, but raises costs for manufacturers, technical and digital-access barriers that may delay or limit real-world benefit, and potential legal disputes over disclosures.
Patients, especially those with chronic conditions, gain the explicit right to request and receive device-recorded health data about themselves, improving their ability to manage care and engage clinicians.
Patients and care teams will receive timely notifications about device recalls, software updates, and errors that affect safety, enabling faster corrective action and risk reduction.
Members of the public and device users (including people with disabilities) get clearer disclosures about what data devices record and how manufacturers use it, increasing privacy accountability and informed choice.
Manufacturers may face substantial compliance costs to extract, format, and deliver patient data in usable forms, costs that could be passed on to buyers, insurers, or patients.
Some device data reside in technically inaccessible or closed systems, creating disputes over what must be released and causing potential delays that hinder patient access and clinical decision-making.
Requiring online posting or electronic notifications risks leaving patients without internet access or digital literacy (including many in rural areas and some people with disabilities) unable to obtain or act on their data and safety notices.
Based on analysis of 2 sections of legislative text.
Requires FDA regulations to let patients obtain device-recorded patient-specific data that manufacturers can access, with limits for inaccessible or proprietary data.
Official title: 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.
Introduced November 18, 2025 by Mikie Sherrill · Last progress November 18, 2025
Requires the FDA to write regulations that let patients obtain all device-recorded or device-transmitted, patient-specific data that the manufacturer can access, on request. Regulations may require user‑friendly formats, public disclosures about covered devices and data types, online request procedures, and notifications about recalls or updates, while protecting truly inaccessible or proprietary information. Defines covered devices and patient-specific data, preserves exceptions for closed systems and data the manufacturer cannot access, and directs the FDA to consider its 2017 guidance when issuing rules. The bill also makes a conforming change to civil penalty language in the FD&C Act.