I 118th CONGRESS 2d Session H. R. 8299 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.

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 . 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.