MIRACLE Medical Technology Act of 2025
The MIRACLE Medical Technology Act of 2025 would require the Secretary of Health and Human Services (HHS), in consultation with the Secretary of Commerce, the Centers for Medicare & Medicaid Services’ Council for Technology and Innovation, and the FDA Commissioner, to establish a program to boost collaboration between the United States and Israel on developing and delivering health care products and services. The program covers joint research and development, innovation ecosystems, regulatory and IP cooperation, health care system strengthening, telemedicine and digital health, disease prevention, and manufacturing of biological products, including joint facilities and workforce training. The bill also authorizes the creation of a US-Israel Health Care Collaboration Center and requires implementation within six months of enactment, with funding authorized at $8 million annually for fiscal years 2026–2030 (subject to appropriations).
Key Points
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- 2Purpose and leadership: Establish a cross-border program led by HHS, with participation from the Secretary of Commerce, the CMS Council for Technology and Innovation, and the FDA Commissioner to expand US-Israel collaboration on health care products and services.
- 3Program components (R&D and innovation): Joint US-Israel research projects, collaboration in medical devices, pharmaceuticals (including biology and genomics), health care systems management, and emphasis on early-stage clinical trials; support for innovation in manufacturing processes for biological products.
- 4Regulatory harmonization and IP: Efforts to protect IP, harmonize regulatory data protections for biologics, plan commercialization frameworks for medical devices, explore mutual recognition with FDA and Israeli regulators for good manufacturing practices (GMP), strengthen confidentiality with Israeli health authorities, and expand collaboration through initiatives like Project Orbis for oncology.
- 5Health care system and digital health: Sharing best practices in clinical care and management; telemedicine infrastructure, system interoperability, data analytics, cybersecurity, and digital health technology collaboration.
- 6Manufacturing and workforce: Joint manufacturing facilities in the US for biological products, accelerated development of life-saving treatments and affordable nutrition, workforce training and exchange programs, supply chain resilience, public-private partnerships to scale manufacturing.
- 7Center and timeline: The Secretary may establish a US-Israel Health Care Collaboration Center to leverage academic, national lab, and private-sector expertise. Implementation must begin within 6 months of enactment.
- 8Funding: Authorization of $8 million per fiscal year from 2026 through 2030, subject to appropriations and availability of funds.