H.R. 6117 – Patient Device Data Access Act of 2025

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Updated December 4, 2025 at 3:52 PM UTC

The Patient Device Data Access Act of 2025 would let the FDA require makers of certain electronic medical devices to give patients any personal health data the device records or transmits and that the maker can access. It also obliges manufacturers to publicly disclose what data their devices collect, how patients can request it, and to notify users of recalls or updates. The law defines “covered devices” and “patient‑specific data,” sets limits on what must be shared, and adds civil penalties for non‑compliance.

Key Provisions

The FDA Secretary may issue regulations that require manufacturers of “covered devices” to give patients, on request, all data the device records or transmits that the manufacturer can access.
Manufacturers must, where possible, provide the data in a format the patient can understand and preferably in the patient’s chosen format.
Manufacturers must post on their public website that the device is covered, describe what patient‑specific data the device records/transmits, explain how the data is used (excluding proprietary info), and give clear instructions for patients to request their data.
Manufacturers must notify patients using the device about how to access their data, and also inform them of recalls, software updates, or error messages when applicable.
The rule does not force manufacturers to redesign devices, disclose data stored in closed systems that they cannot access, or share data that is otherwise inaccessible to them.
The bill adds a civil‑penalty provision so that failure to comply with any such requirement can be penalized under existing FD&C Act penalties.

Legislative Activity

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1 earlier action

HouseIntro Referral Latest Action

Referred to the House Committee on Energy and Commerce.

Energy and Commerce Committee

November 18, 2025

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HouseIntro Referral

Introduced in House

November 18, 2025

HouseIntro Referral

Referred to the House Committee on Energy and Commerce.

Energy and Commerce Committee

November 18, 2025

Bill Text

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Introduced in HouseIssued November 18, 2025

I

119th CONGRESS

1st Session

H. R. 6117

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.

1.

Short title

This Act may be cited as the Patient Device Data Access Act of 2025.

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:

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.