No official summary available for this bill.
[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>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
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