[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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