MIRACLE Medical Technology Act of 2025
- Bill Number
- H.R. 661
- Origin Chamber
- House
- Congress
- 119th Congress, Session 1
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2025-01-23: Referred to the House Committee on Energy and Commerce.
- Last Updated
- 2026-04-08T17:33:35Z
AI-Generated Summary
Purpose
The legislation aims to strengthen collaboration between the United States and Israel in developing and delivering health care products and services. It requires the Secretary of Health and Human Services (HHS) to establish a program that coordinates efforts between the two countries to advance medical technology, innovation, and health care systems, ultimately improving access to innovative treatments and services.
Key Provisions
- Program Establishment: HHS must implement a program, in consultation with the Secretary of Commerce, the Centers for Medicare & Medicaid Services (CMS) Council for Technology and Innovation, and the Food and Drug Administration (FDA) Commissioner, to facilitate U.S.-Israel collaboration on health care development and delivery. The program is subject to available funding.
- Core Components:
- Research and Development: Supports joint projects between U.S. and Israeli institutions/companies, focusing on medical devices, pharmaceuticals (including biologics, genomics, and digital health), early-stage clinical trials, innovation in biologics manufacturing, and a framework for sharing health data for research with Israel's Ministry of Health.
- Innovation and Start-Up Ecosystem: Promotes partnerships between start-ups and companies, technology transfer, joint ventures, and innovation hubs to commercialize U.S. technologies in Israel, including cybersecurity and patient privacy standards.
- Regulatory Harmonization and Intellectual Property (IP) Protection: Encourages joint efforts on IP safeguards, aligning regulations (e.g., data protection for biologics), commercialization frameworks for medical devices, mutual recognition of manufacturing standards, confidentiality agreements, Israel's involvement in global regulatory groups, and expanded oncology product reviews under Project Orbis.
- Health Care System Strengthening: Shares best practices in clinical care and management.
- Telemedicine and Digital Health: Builds infrastructure, promotes system interoperability, and collaborates on data analytics and cybersecurity.
- Disease Prevention: Joint work on infectious diseases, vaccines, and epidemiological data sharing.
- Biological Product Manufacturing: Advances manufacturing, establishes joint facilities in the U.S., accelerates life-saving treatments and nutrition sources, provides workforce training/exchanges, enhances supply chain resilience, and fosters public-private partnerships.
- Collaboration Center: HHS may create a joint U.S.-Israel Health Care Collaboration Center in the U.S., drawing on expertise from universities, national labs, and private entities.
- Implementation Timeline: The program must begin within 6 months of enactment.
- Funding: Authorizes $8 million annually for fiscal years 2026 through 2030.
Significant Changes to Existing Law
This bill introduces a new, dedicated program for U.S.-Israel health care collaboration, which does not appear to amend or reference specific prior laws. It builds on existing bilateral ties (e.g., confidentiality agreements with Israel's health regulators and Project Orbis) by formalizing and expanding them into a comprehensive framework, without altering broader U.S. health regulations.
Potential Impacts
- Government Agencies: HHS, FDA, CMS, and the Department of Commerce will need to coordinate new international efforts, potentially increasing administrative workload but leveraging existing resources like Project Orbis. This could streamline regulatory processes and reduce duplication in approvals.
- Citizens: U.S. and Israeli residents may benefit from faster access to innovative health products, such as advanced biologics, vaccines, and digital health tools, leading to improved treatments, lower costs, and better disease prevention. Enhanced supply chains could mitigate shortages of critical medicines.
- International Relations: Strengthens U.S.-Israel strategic partnership in health technology, fostering goodwill and positioning both nations as leaders in global medical innovation. It may indirectly influence relations with other countries through shared standards in international regulatory bodies.
Main Stakeholders Affected
- U.S. Government Entities: HHS, FDA, CMS, and Department of Commerce, responsible for program execution.
- Israeli Government Entities: Ministry of Health (including its Pharmaceutical, Medical Devices, and Nutrition divisions), as key partners in collaboration.
- Private Sector: U.S. and Israeli health care companies, start-ups, and manufacturers, gaining opportunities for joint ventures, technology transfer, and market access.
- Research and Academic Institutions: Universities, national labs, and research organizations in both countries, involved in joint projects and data sharing.
- Health Care Providers and Workforce: Clinicians, telemedicine operators, and workers in biologics manufacturing, benefiting from training, best practices, and infrastructure improvements.
- Citizens and Patients: Individuals in the U.S. and Israel seeking affordable, innovative health care solutions.
Notable Legal, Constitutional, or Political Implications
- Legal: Emphasizes IP protection and regulatory alignment, which could simplify cross-border approvals but requires careful handling of data privacy (e.g., under U.S. laws like HIPAA) and confidentiality to avoid breaches. The bill reaffirms existing agreements, reducing legal risks in data sharing.
- Constitutional: No direct challenges; it aligns with Congress's authority to regulate foreign commerce and health policy under the Commerce Clause, promoting international cooperation without infringing on individual rights.
- Political: Highlights bipartisan support (introduced by representatives from both parties) and underscores U.S. commitment to allies like Israel amid global health challenges. It may face scrutiny over funding priorities or foreign aid perceptions but promotes mutual benefits without mandating expenditures beyond authorizations.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Cosponsors (3)
Rep. Soto, Darren [D-FL-9], Rep. Miller-Meeks, Mariannette [R-IA-1], Rep. Suozzi, Thomas R. [D-NY-3]
Recent Actions
- 2025-01-23: Referred to the House Committee on Energy and Commerce.
- 2025-01-23: Introduced in House
- 2025-01-23: Introduced in House
Bill Versions
- Maximizing Israel-U.S. Research Advancement and Collaborative Leadership in Emerging Medical Technology Act of 2025 — issued 2025-01-23 — PDF (7 pages)