I
118THCONGRESS
1
STSESSION H. R. 1557
To require the Secretary of Health and Human Services to submit a report
on the interoperability of medical devices.
IN THE HOUSE OF REPRESENTATIVES
MARCH10, 2023
Mrs. M
ILLER-MEEKS(for herself, Ms. CRAIG, Mr. MURPHY, and Ms.
S
CHRIER) introduced the following bill; which was referred to the Com-
mittee on Energy and Commerce
A BILL
To require the Secretary of Health and Human Services
to submit a report on the interoperability of medical devices.
Be it enacted by the Senate and House of Representa-1
tives of the United States of America in Congress assembled, 2
SECTION 1. SHORT TITLE. 3
This Act may be cited as the ‘‘Better Interoperability 4
for Devices Act of 2023’’ or the ‘‘BID Act of 2023’’. 5
SEC. 2. REPORT ON THE INTEROPERABILITY OF MEDICAL 6
DEVICES. 7
(a) I
NGENERAL.—Not later than 1 year after the 8
date of the enactment of this Act, the Secretary of Health 9
and Human Services (in this section referred to as the 10
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‘‘Secretary’’), acting through the Commissioner of Food 1
and Drugs and in consultation with the National Coordi-2
nator for Health Information Technology, shall prepare 3
and submit to the Committee on Energy and Commerce 4
of the House of Representatives and the Committee on 5
Health, Education, Labor, and Pensions of the Senate, 6
and make publicly available (including through posting on 7
the website of the Food and Drug Administration), a re-8
port on the state of interoperability of medical devices and 9
the implications of such state for the safety and effective-10
ness of such medical devices. 11
(b) C
ONTENTS.—The report described in subsection 12
(a) shall include— 13
(1) a review of existing medical device inter-14
operability standards and the extent to which such 15
standards have been adopted, including— 16
(A) whether medical device interoperability 17
standards included in the Recognized Con-18
sensus Standards Database of the Food and 19
Drug Administration were widely adopted by 20
the medical device industry upon inclusion in 21
the Database; 22
(B) a discussion of how adoption of inter-23
operability standards for medical devices sup-24
port patient access to data, home-based care, 25
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telemedicine, and data sharing among devices 1
used in the clinical setting; 2
(C) a comparison of the standards used for 3
device interoperability with the standards used 4
for other aspects of clinical care, such as stand-5
ards to ensure the security of health informa-6
tion and standards to support interoperability 7
among electronic health record systems; 8
(D) an assessment of the ability of patients 9
to obtain standard data from the devices they 10
use, and the associated standards used to facili-11
tate access to such data; and 12
(E) an analysis of the cost burden on 13
health care providers, the medical device indus-14
try, and other entities associated with the adop-15
tion of medical device interoperability stand-16
ards; 17
(2) recommendations to improve adoption of de-18
vice interoperability standards, including any needed 19
guidance, regulatory or statutory changes, or incen-20
tives for such adoption; and 21
(3) a summary of recommendations or informa-22
tion submitted to the Secretary by stakeholders 23
under subsection (c). 24
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(c) STAKEHOLDER COMMENT.—Not later than 180 1
days prior to the submission of the report under sub-2
section (a), the Secretary, acting through the Commis-3
sioner of Food and Drugs, shall consult with representa-4
tives of regulated industry groups, patient groups, aca-5
demia, and other interested parties to obtain recommenda-6
tions or information relevant to the report. 7
Æ
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