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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 10406 Introduced in House (IH)]

<DOC>

118th CONGRESS
  2d Session
                               H. R. 10406

    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

                           December 12, 2024

 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 
2024''.

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) Disclose patient-specific data referred to in 
                subsection (a), where possible, in a format that is--
                            ``(i) understandable to the patient; and
                            ``(ii) at the request of the patient, to 
                        the extent practicable, in a preferred format, 
                        including an industry standard data format.
                    ``(B) Receive and consider patient requests to 
                disclose patient-specific data in a preferred format 
                described in subparagraph (A).
                    ``(C) 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;
                            ``(iii) whether the covered device operates 
                        in a closed system or otherwise collects 
                        patient-specific data that is inaccessible to 
                        the manufacturer; and
                            ``(iv) whether and how the manufacturer 
                        utilizes patient data.
                    ``(D) 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).
                    ``(E) 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).
                    ``(F) 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) data a health care provider inputs 
                        into a covered device to record the status, and 
                        ongoing treatment, of a patient;
                            ``(ii) information recorded by a covered 
                        device regarding usage, alarms, or outputs; and
                            ``(iii) 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 after ``a 
requirement of this Act which relates to devices'' by inserting ``, 
including any such requirement under section 524C,''.
                                 <all>
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