Patient Device Data Access Act of 2025

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6117 Introduced in House (IH)]

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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''.
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