Patient Device Data Access Act of 2025
Sponsored By: Representative Sherrill
Introduced
Summary
Patient access to device data would be the central right this bill creates. It would authorize the Secretary of Health and Human Services to require device manufacturers, on a patient's request, to disclose all patient-specific data the manufacturer can access.
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- Patients: Patients could request and receive the patient-specific data recorded or transmitted by their covered device that the manufacturer can access. The data must be provided in an understandable format and, where practicable, in the patient's preferred format, and patients may be notified about recalls, software updates, or device error messages.
- Manufacturers: Manufacturers would need to publish on their public website that a device is covered, list the types of patient-specific data they record or receive, describe how they use the data (excluding proprietary details), and post how patients may request their data. Noncompliance could trigger civil penalties under the Food, Drug, and Cosmetic Act.
- Regulations and limits: The Secretary would issue implementing regulations and must consider the FDA's October 2017 guidance when doing so. The bill does not force redesign of devices or require disclosure of data the manufacturer cannot access or data kept in closed systems.
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Bill Overview
Analyzed Economic Effects
2 provisions identified: 1 benefits, 0 costs, 1 mixed.
Get your medical device data
This bill would let the Secretary set rules so makers must give you your own device data if they can access it. The data would need to be in a clear format and, when possible, your preferred format. Makers would need to post what data they collect, how to request it, and, where possible, how to access it. They would also need to alert you to recalls, software updates, or device error messages. Not following these rules could lead to civil penalties. The Secretary would consider FDA’s 2017 guidance when writing the rules.
Limits on what device makers share
If enacted, the bill would set which devices and data are covered: implanted, remote‑monitoring medical devices that record or send patient data. Patient‑specific data would include things like usage logs, alarms, outputs, pulse oximetry, heart electrical activity, and pacemaker rhythm data. It would only require sharing data the maker can reasonably access. Makers would not have to redesign devices, and data kept in closed systems that the maker cannot access would not have to be shared.
Sponsors & CoSponsors
Sponsor
Sherrill
NJ • D
Cosponsors
There are no cosponsors for this bill.
Roll Call Votes
No roll call votes available for this bill.
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