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The bill strengthens patients' enforceable access to device-collected health data and transparency about data use—improving safety and accountability—but creates compliance costs, technical and equity barriers to access, and potential legal disputes for manufacturers.
Patients with chronic conditions gain an enforceable right to obtain device-recorded health data and receive timely safety notifications (recalls, software updates, device errors), improving personal health management and safety.
People (including those with disabilities) benefit from public disclosures about what data devices collect and how manufacturers use it, increasing transparency and privacy accountability.
A uniform regulatory requirement (rather than guidance) creates predictable, enforceable patient access rights across manufacturers, improving consistency and government accountability.
Some device data may be technically inaccessible or stored in closed systems, creating disputes and delays in patient access and potentially slowing safety responses.
Manufacturers face new compliance costs to produce and deliver patient data in readable formats; those costs may be passed to buyers, insurers, or reduce device availability.
Patients without internet access or sufficient digital literacy (including people with disabilities and rural residents) may still struggle to obtain posted data or notifications, worsening inequities in access.
Based on analysis of 2 sections of legislative text.
Requires FDA rules so patients can request and receive patient-specific data that their covered medical device recorded or transmitted and that manufacturers can access, with limited exceptions.
Introduced November 18, 2025 by Mikie Sherrill · Last progress November 18, 2025
Requires the FDA to adopt regulations letting patients request and obtain all patient-specific data that their medical device recorded or transmitted and that the device manufacturer can access, subject to limited exceptions. Regulations may set standards for understandable or patient-preferred formats, public disclosures about covered devices and data types, online request procedures, and notifications about recalls or software updates while protecting truly inaccessible or proprietary information.