[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8299 Introduced in House (IH)]
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118th CONGRESS
2d Session
H. R. 8299
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 development and delivery of health
care products and services.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
May 8, 2024
Mr. Buchanan (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 development and delivery of health
care products and services.
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 ``Maximizing Israel-U.S. Research
Advancement and Collaborative Leadership in Emerging Medical Technology
Act of 2024'' or the ``MIRACLE Medical Technology Act of 2024''.
SEC. 2. PROGRAM FOR FACILITATION AND COORDINATION OF UNITED STATES-
ISRAEL EFFORTS ON THE DEVELOPMENT AND DELIVERY OF HEALTH
CARE PRODUCTS AND SERVICES.
(a) In General.--Subject to the availability of appropriations, 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, shall carry out a program to facilitate and coordinate
efforts between the United States and Israel to expand and enhance
collaboration on--
(1) the development of health care products and services;
and
(2) the delivery of such products and services to those in
need.
(b) Program Components.--The program under subsection (a) shall
include facilitation and coordination of efforts including each of the
following:
(1) Research and development.--
(A) Joint research projects between United States
and Israeli institutions and companies.
(B) Promoting collaboration in areas such as
medical device technology, pharmaceuticals including
biological products, genomics, and innovative digital
health care solutions and health care systems
management, including a special focus on early-stage
clinical trials.
(C) With respect to biological products,
supporting--
(i) innovation;
(ii) process optimization; and
(iii) the development of advanced
manufacturing techniques that can enhance
productivity, reduce costs, and improve product
quality.
(D) Work toward developing a framework for sharing
health data for research purposes with the Ministry of
Health of Israel.
(2) Innovation and start-up ecosystem.--
(A) Fostering collaboration between United States
and Israeli start-up and other companies in the health
care sector.
(B) Facilitating innovative technology acceptance
by the marketplace.
(C) Facilitating mechanisms for technology transfer
and joint venture opportunities.
(D) Supporting innovation hubs to accelerate the
development and commercialization of United States
health care technologies in the Israeli market,
including by encouraging cybersecurity standards for
sharing data, promoting patient privacy, and
encouraging research.
(3) Regulatory harmonization and intellectual property
protection.--Establishing joint efforts--
(A) to ensure intellectual property protection;
(B) to increase regulatory harmonization, including
with respect to regulatory data protection for
biological products;
(C) to formulate plans for a commercialization
framework for medical device technologies;
(D) to encourage a potential mutual recognition
agreement for pharmaceutical good manufacturing
Practices between the Food and Drug Administration and
Israeli regulators;
(E) to strengthen and reaffirm the confidentiality
commitment with the Food and Drug Administration and
the Pharmaceutical Division, the Medical Devices
Department, and the National Food Services and
Nutrition Division of the Ministry of Health of Israel;
(F) to encourage Israel's participation in
regulatory harmonization and cooperation organizations;
and
(G) to expand international collaboration under
Project Orbis for concurrent submission and review of
oncology products.
(4) Health care system strengthening.--Facilitating the
sharing of best practices, knowledge, and skills in areas such
as clinical care and health care management.
(5) Telemedicine and digital health cooperation.--
Establishing initiatives--
(A) to enhance telemedicine infrastructure;
(B) to promote interoperability between United
States and Israeli health care systems; and
(C) to facilitate collaboration on digital health
technologies, data analytics, and cybersecurity.
(6) Disease prevention initiatives.--Collaborating in
disease prevention, including joint efforts to combat
infectious diseases, develop vaccines, and share
epidemiological data.
(7) Biological product manufacturing.--
(A) Promoting biological product manufacturing.
(B) Establishing joint manufacturing facilities for
biological products in facilities in the United States
that leverage the strengths and expertise of both
countries.
(C) Pursuing accelerated development of life-saving
treatments and new sources of nutrition that are both
healthier and more available at an affordable cost.
(D) Workforce training and skill development,
including promoting exchange programs and training
initiatives to develop a skilled workforce in
biological product manufacturing.
(E) Supply chain resilience through strategic
collaboration to identify and develop contingency plans
to mitigate biological product supply disruptions.
(F) Facilitating public-private partnerships to
support the development and scale-up of biological
product manufacturing capabilities.
(c) United States-Israel Health Care Collaboration Center.--In
carrying out the program under subsection (a), the Secretary of Health
and Human Services may establish a joint United States-Israel Health
Care Collaboration Center in the United States leveraging the
experience, knowledge, and expertise of institutions of higher
education, national laboratories, entities in the private sector, and
others in the development and delivery of health care products and
services.
(d) Commencement of Implementation.--Not later than 6 months after
the date of enactment of this Act, the Secretary of Health and Human
Services shall commence implementation of the program under this
section.
(e) Authorization of Appropriations.--To carry out this Act, there
is authorized to be appropriated $8,000,000 for each of fiscal years
2025 through 2029.
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