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 DE-
VICE 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 regu-
lation. 
‘‘(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 regula-
tion under paragraph (1), the Secretary shall take 
into consideration the guidance issued in October 
2017 by the Food and Drug Administration titled 
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‘Manufacturers Sharing Patient-Specific Information 
from Medical Devices with Patients Upon Request’. 
‘‘(4) CONTENTS.—If the Secretary issues regu-
lations under paragraph (1), the Secretary may in-
clude 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 understand-
able 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 trans-
mitted by the covered device; and 
‘‘(II) accessible to the manufac-
turer; and 
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‘‘(iii) whether and how the manufac-
turer utilizes patient data, not including 
any proprietary information of the manu-
facturer. 
‘‘(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 de-
scribed 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 de-
vice— 
‘‘(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 
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‘‘(3) to disclose patient-specific data that is in-
accessible to the manufacturer. 
‘‘(d) DEFINITIONS.—In this section: 
‘‘(1) The term ‘covered device’ means any elec-
tronic 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 moni-
toring; 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 subpara-
graph (A) irrespective of whether such data, ab-
sent regulation under this section, would other-
wise be required by law to be disclosed to the 
patient or their physician; and 
‘‘(C) shall include— 
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‘‘(i) information recorded by a covered 
device regarding usage, alarms, or outputs; 
and 
‘‘(ii) pulse oximetry data, heart elec-
trical activity data, and data on rhythms 
as monitored by a pace maker. 
‘‘(3) The term ‘inaccessible to the manufac-
turer’ means data that is not reasonably acces-
sible.’’. 
(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 require-
ment of this Act which relates to devices’’. 
Æ 
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