Bill Summary
The "Patient Device Data Access Act of 2025" aims to enhance patient access to data generated by medical devices. It amends the Federal Food, Drug, and Cosmetic Act to require manufacturers of covered devices—such as those used for diagnosis or monitoring that can record and transmit data—to disclose all patient-specific information upon the patient's request. This includes data related to the patient's treatment and device usage.
Key provisions include:
1. **Patient Requests**: Patients can request their specific data from manufacturers, which must be provided in an understandable format and, if possible, in the patient's preferred format.
2. **Manufacturer Responsibilities**: Manufacturers must publicly share information about the types of data their devices collect, how that data is used, and how patients can access their data.
3. **Patient Notifications**: Manufacturers are required to notify patients about device recalls, software updates, or any errors that occur.
4. **Exceptions**: The law does not require manufacturers to disclose data that is inaccessible or contained within a closed system.
Overall, this legislation seeks to empower patients by ensuring they have access to important health data from their medical devices, thereby enhancing transparency and patient engagement in their healthcare.
Possible Impacts
The "Patient Device Data Access Act of 2025" has several potential impacts on individuals. Here are three examples:
1. **Enhanced Patient Empowerment and Knowledge**: The legislation allows patients to request and receive all patient-specific data recorded or transmitted by covered devices. This access empowers patients to better understand their health conditions, treatment progress, and the functionality of their devices. As a result, patients may take a more active role in managing their healthcare, leading to improved health outcomes and satisfaction.
2. **Increased Transparency from Manufacturers**: The requirement for manufacturers to publicly disclose what types of patient-specific data are recorded and how that data is utilized promotes transparency in the medical device industry. Patients will have a clearer understanding of how their data is used and can make informed decisions about their health. This transparency can also enhance trust between patients and manufacturers.
3. **Timely Notifications for Safety and Updates**: The legislation mandates that manufacturers notify patients about important information regarding their covered devices, such as recalls, software updates, or error messages. This ensures that patients are kept informed about any critical issues that could affect their health and safety, allowing them to take necessary actions promptly, which could prevent adverse health events linked to device malfunctions or outdated technology.
[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6117 Introduced in House (IH)]
<DOC>
119th CONGRESS
1st Session
H. R. 6117
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.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
November 18, 2025
Ms. Sherrill introduced the following bill; which was referred to the
Committee on Energy and Commerce
_______________________________________________________________________
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.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Patient Device Data Access Act of
2025''.
SEC. 2. SHARING OF PATIENT-SPECIFIC DATA BY DEVICE MANUFACTURERS.
(a) In General.--Subchapter A of chapter V of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by adding at
the end the following:
``SEC. 524C. SHARING OF PATIENT-SPECIFIC DATA BY DEVICE MANUFACTURERS.
``(a) Requirement Authorized.--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--
``(1) recorded or transmitted by such device; and
``(2) accessible to the manufacturer.
``(b) Regulations.--
``(1) Issuance.--Any requirement imposed on manufacturers
under subsection (a) shall be by regulation.
``(2) Applicability to all manufacturers of covered
devices.--Any requirement imposed under subsection (a) shall be
applicable with respect to all manufacturers of covered
devices.
``(3) Consideration.--In issuing any regulation under
paragraph (1), the Secretary shall take into consideration the
guidance issued in October 2017 by the Food and Drug
Administration titled `Manufacturers Sharing Patient-Specific
Information from Medical Devices with Patients Upon Request'.
``(4) Contents.--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:
``(A) At the request of a patient, disclose
patient-specific data referred to in subsection (a),
where possible--
``(i) in a format that is understandable to
the patient; and
``(ii) to the extent practicable, in a
format preferred by the patient.
``(B) Publish on the public website of the
manufacturer of a covered device--
``(i) an indication that such device is a
covered device subject to regulation under this
section;
``(ii) what types of patient-specific data,
if any, are--
``(I) being recorded or transmitted
by the covered device; and
``(II) accessible to the
manufacturer; and
``(iii) whether and how the manufacturer
utilizes patient data, not including any
proprietary information of the manufacturer.
``(C) 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).
``(D) 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).
``(E) Notify patients if their covered device is
subject to a recall, has a software update, or has
generated an error message.
``(c) Exceptions.--This section does not authorize the Secretary to
require the manufacturer of a covered device--
``(1) to disclose data that is--
``(A) recorded, transmitted, and retained in a
closed system; and
``(B) inaccessible to the manufacturer;
``(2) to redesign the covered device to enable disclosure
of patient-specific data; or
``(3) to disclose patient-specific data that is
inaccessible to the manufacturer.
``(d) Definitions.--In this section:
``(1) The term `covered device' means any electronic device
that is--
``(A) intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of disease;
``(B) implanted into a patient's body;
``(C) used for the purposes of remote monitoring;
and
``(D) capable of recording or transmitting patient
data.
``(2) The term `patient-specific data'--
``(A) 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;
``(B) includes data described in subparagraph (A)
irrespective of whether such data, absent regulation
under this section, would otherwise be required by law
to be disclosed to the patient or their physician; and
``(C) shall include--
``(i) information recorded by a covered
device regarding usage, alarms, or outputs; and
``(ii) pulse oximetry data, heart
electrical activity data, and data on rhythms
as monitored by a pace maker.
``(3) The term `inaccessible to the manufacturer' means
data that is not reasonably accessible.''.
(b) Civil Penalties.--Section 303(f)(1)(A) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 333(f)(1)(A)) is amended by inserting
``, including any such requirement under section 524C,'' after ``a
requirement of this Act which relates to devices''.
<all>