I
119THCONGRESS
1
STSESSION H. R. 661
To require the Secretary of Health and Human Services, in consultation
with the Secretary of Commerce, the Council for Technology and Innova-
tion of the Centers for Medicare & Medicaid Services, and the Commis-
sioner of Food and Drugs, to carry out a program to facilitate and
coordinate efforts between the United States and Israel to expand and
enhance collaboration on the development and delivery of health care
products and services.
IN THE HOUSE OF REPRESENTATIVES
JANUARY23, 2025
Mr. B
UCHANAN(for himself, Mr. SOTO, and Mrs. MILLER-MEEKS) introduced
the following bill; which was referred to the Committee on Energy and
Commerce
A BILL
To require the Secretary of Health and Human Services,
in consultation with the Secretary of Commerce, the
Council for Technology and Innovation of the Centers
for Medicare & Medicaid Services, and the Commissioner
of Food and Drugs, to carry out a program to facilitate
and coordinate efforts between the United States and
Israel to expand and enhance collaboration on the devel-
opment and delivery of health care products and services.
Be it enacted by the Senate and House of Representa-1
tives of the United States of America in Congress assembled, 2
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•HR 661 IH
SECTION 1. SHORT TITLE. 1
This Act may be cited as the ‘‘Maximizing Israel-U.S. 2
Research Advancement and Collaborative Leadership in 3
Emerging Medical Technology Act of 2025’’ or the ‘‘MIR-4
ACLE Medical Technology Act of 2025’’. 5
SEC. 2. PROGRAM FOR FACILITATION AND COORDINATION 6
OF UNITED STATES-ISRAEL EFFORTS ON THE 7
DEVELOPMENT AND DELIVERY OF HEALTH 8
CARE PRODUCTS AND SERVICES. 9
(a) I
NGENERAL.—Subject to the availability of ap-10
propriations, the Secretary of Health and Human Serv-11
ices, in consultation with the Secretary of Commerce, the 12
Council for Technology and Innovation of the Centers for 13
Medicare & Medicaid Services, and the Commissioner of 14
Food and Drugs, shall carry out a program to facilitate 15
and coordinate efforts between the United States and 16
Israel to expand and enhance collaboration on— 17
(1) the development of health care products and 18
services; and 19
(2) the delivery of such products and services to 20
those in need. 21
(b) P
ROGRAMCOMPONENTS.—The program under 22
subsection (a) shall include facilitation and coordination 23
of efforts including each of the following: 24
(1) R
ESEARCH AND DEVELOPMENT .— 25
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(A) Joint research projects between United 1
States and Israeli institutions and companies. 2
(B) Promoting collaboration in areas such 3
as medical device technology, pharmaceuticals 4
(including biological products, genomics, and in-5
novative digital health care solutions), and 6
health care systems management, including a 7
special focus on early-stage clinical trials. 8
(C) With respect to biological products, 9
supporting— 10
(i) innovation; 11
(ii) process optimization; and 12
(iii) the development of advanced 13
manufacturing techniques that can en-14
hance productivity, reduce costs, and im-15
prove product quality. 16
(D) Work toward developing a framework 17
for sharing health data for research purposes 18
with the Ministry of Health of Israel. 19
(2) I
NNOVATION AND START -UP ECOSYSTEM.— 20
(A) Fostering collaboration between United 21
States and Israeli start-up and other companies 22
in the health care sector. 23
(B) Facilitating innovative technology ac-24
ceptance by the marketplace. 25
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(C) Facilitating mechanisms for technology 1
transfer and joint venture opportunities. 2
(D) Supporting innovation hubs to accel-3
erate the development and commercialization of 4
United States health care technologies in the 5
Israeli market, including by encouraging cyber-6
security standards for sharing data, promoting 7
patient privacy, and encouraging research. 8
(3) R
EGULATORY HARMONIZATION AND INTEL -9
LECTUAL PROPERTY PROTECTION .—Establishing 10
joint efforts— 11
(A) to ensure intellectual property protec-12
tion; 13
(B) to increase regulatory harmonization, 14
including with respect to regulatory data pro-15
tection for biological products; 16
(C) to formulate plans for a commer-17
cialization framework for medical device tech-18
nologies; 19
(D) to encourage a potential mutual rec-20
ognition agreement for pharmaceutical good 21
manufacturing Practices between the Food and 22
Drug Administration and Israeli regulators; 23
(E) to strengthen and reaffirm the con-24
fidentiality commitment with the Food and 25
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Drug Administration and the Pharmaceutical 1
Division, the Medical Devices Department, and 2
the National Food Services and Nutrition Divi-3
sion of the Ministry of Health of Israel; 4
(F) to encourage Israel’s participation in 5
regulatory harmonization and cooperation orga-6
nizations; and 7
(G) to expand international collaboration 8
under Project Orbis for concurrent submission 9
and review of oncology products. 10
(4) H
EALTH CARE SYSTEM STRENGTHENING .— 11
Facilitating the sharing of best practices, knowledge, 12
and skills in areas such as clinical care and health 13
care management. 14
(5) T
ELEMEDICINE AND DIGITAL HEALTH CO -15
OPERATION.—Establishing initiatives— 16
(A) to enhance telemedicine infrastructure; 17
(B) to promote interoperability between 18
United States and Israeli health care systems; 19
and 20
(C) to facilitate collaboration on digital 21
health technologies, data analytics, and cyberse-22
curity. 23
(6) D
ISEASE PREVENTION INITIATIVES .—Col-24
laborating in disease prevention, including joint ef-25
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forts to combat infectious diseases, develop vaccines, 1
and share epidemiological data. 2
(7) B
IOLOGICAL PRODUCT MANUFACTURING .— 3
(A) Promoting biological product manufac-4
turing. 5
(B) Establishing joint manufacturing fa-6
cilities for biological products in facilities in the 7
United States that leverage the strengths and 8
expertise of both countries. 9
(C) Pursuing accelerated development of 10
life-saving treatments and new sources of nutri-11
tion that are both healthier and more available 12
at an affordable cost. 13
(D) Workforce training and skill develop-14
ment, including promoting exchange programs 15
and training initiatives to develop a skilled 16
workforce in biological product manufacturing. 17
(E) Supply chain resilience through stra-18
tegic collaboration to identify and develop con-19
tingency plans to mitigate biological product 20
supply disruptions. 21
(F) Facilitating public-private partnerships 22
to support the development and scale-up of bio-23
logical product manufacturing capabilities. 24
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(c) UNITEDSTATES-ISRAELHEALTHCARECOL-1
LABORATIONCENTER.—In carrying out the program 2
under subsection (a), the Secretary of Health and Human 3
Services may establish a joint United States-Israel Health 4
Care Collaboration Center in the United States leveraging 5
the experience, knowledge, and expertise of institutions of 6
higher education, national laboratories, entities in the pri-7
vate sector, and others in the development and delivery 8
of health care products and services. 9
(d) C
OMMENCEMENT OF IMPLEMENTATION.—Not 10
later than 6 months after the date of enactment of this 11
Act, the Secretary of Health and Human Services shall 12
commence implementation of the program under this sec-13
tion. 14
(e) A
UTHORIZATION OFAPPROPRIATIONS.—To carry 15
out this Act, there is authorized to be appropriated 16
$8,000,000 for each of fiscal years 2026 through 2030. 17
Æ
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