HR 6117
Patient Device Data Access Act of 2025
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Bill overview
The Patient Device Data Access Act of 2025 would require manufacturers of certain medical devices – including implanted devices and those used for remote monitoring – to share patient-specific data with patients upon request. This data, such as usage information and vital signs, would need to be provided in a patient-friendly format and in a way that aligns with the patient’s preferences. Manufacturers would also be required to disclose information about the data they collect and how they use it on their websites and to notify patients of recalls or updates.
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Primary sponsor
Mikie Sherrill
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119th CONGRESS — 1st Session
H. R. 6117
IN THE HOUSE OF REPRESENTATIVES
A BILL
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.
This Act may be cited as the Patient Device Data Access Act of 2025
.
The Secretary may require the manufacturer of a covered device, at the request of a patient who is using or has used such covered device, to disclose all patient-specific data that is—
recorded or transmitted by such device; and
accessible to the manufacturer.
Any requirement imposed on manufacturers under subsection (a) shall be by regulation.
Any requirement imposed under subsection (a) shall be applicable with respect to all manufacturers of covered devices.
Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients Upon Request.
If the Secretary issues regulations under paragraph (1), the Secretary may include in such regulations provisions requiring the manufacturer of a covered device to do the following:
At the request of a patient, disclose patient-specific data referred to in subsection (a), where possible—
in a format that is understandable to the patient; and
Publish on the public website of the manufacturer of a covered device—
what types of patient-specific data, if any, are—
being recorded or transmitted by the covered device; and
accessible to the manufacturer; and
Make publicly available, by posting on the manufacturer’s website, the method by which patients who are using or have used the covered device may request their own patient-specific data described in subsection (a).
Notify, where possible, patients who are using or have used the covered device about how they can access patient-specific data described in subsection (a).
This section does not authorize the Secretary to require the manufacturer of a covered device—
recorded, transmitted, and retained in a closed system; and
inaccessible to the manufacturer;
to redesign the covered device to enable disclosure of patient-specific data; or
to disclose patient-specific data that is inaccessible to the manufacturer.
In this section:
intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease;
implanted into a patient’s body;
used for the purposes of remote monitoring; and
capable of recording or transmitting patient data.
The term patient-specific data—
means data unique to an individual patient or unique to the patient’s treatment or diagnosis that is recorded or transmitted by a covered device;
shall include—
information recorded by a covered device regarding usage, alarms, or outputs; and
pulse oximetry data, heart electrical activity data, and data on rhythms as monitored by a pace maker.
, including any such requirement under section 524C,after
a requirement of this Act which relates to devices.