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) 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 for-
mat, 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— 
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‘‘(I) being recorded or trans-
mitted by the covered device; and 
‘‘(II) accessible to the manufac-
turer; 
‘‘(iii) whether the covered device oper-
ates in a closed system or otherwise col-
lects patient-specific data that is inacces-
sible to the manufacturer; and 
‘‘(iv) whether and how the manufac-
turer 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 de-
scribed 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 de-
vice— 
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‘‘(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 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; 
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‘‘(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— 
‘‘(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 cov-
ered device regarding usage, alarms, or 
outputs; and 
‘‘(iii) 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 after ‘‘a requirement of this Act 
which relates to devices’’ by inserting ‘‘, including any 
such requirement under section 524C,’’. 
Æ 
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