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ALLISON HOBBS GILESPreviously held: Vice President of Global Government Affairs
Graduate Medical Education (GME): -"Resident Physician Shortage Reduction Act of 2025" (H.R. 4731) which would increase GME positions in rural areas; -the "Public Health and Bio-Preparedness Workforce Loan Repayment Reauthorization Act of 2025" (H.R. 4445) FDA Modernization: -Modeling non-animal studies for medtech -Biotechnology: reduce regulatory barriers; align public-private investment -Medical Device Electronic Labeling Act (IFU) bill (FDA issue) (H.R. 1539) FDA Reform: -Medical device shortage reporting; domestic production of medical products; use of real-world data (RWD) and real-world evidence (RWE) Nursing Workforce Shortage Artificial Intelligence (AI): -Presidential E.O. 14179 setting forth national policy framework for AI and Congressional action to provide preemption of conflicting state requirements, safe and efficient adoption of AI. Right-to-Repair provision in House NDAA (H.R.4784/H.R. 8800) broadly would impact FDA regulated medical devices
Tax incentives to promote U.S. manufacturing; construction of workforce housing; new market tax credit (H.R. 1103)
USDA Sec. 502 low-income, rural areas in need of affordable housing proposals for workforce development
Workforce Development
Tariffs levied by the Administration; Dept. of Commerce Bureau of Industry and Security: Request for Comments on Section 232 Investigation of Imports of Personal Protective Equipment, Medical Consumables, and Medical Equipment, Including Devices Tariff Trade Act of 2025 (S. 1272/H.R.2665) U.S.-China Board of Trade
Name, Image and Likeness (NIL) issue: "SCORE Act" (H.R. 4312)
Medicare Reimbursement: Medicare Coverage of Breakthrough Technologies (S. 1717/H.R. 5343); Transitional Coverage for Emerging Technologies (TCET)/Medicare Coverage for Innovative Technology (MCIT); supplies and services incident to a physician's services reimbursement. Medicare coverage of telehealth flexibilities CMS NPRM IPPS proposal to repeal New Technology Add on Payment (NTAP) and Transitional Pass-Through pathway for FDA Breakthrough Devices; proposal for adoption of unique device identifier (UDI) capture measure under the Medicare Promoting Interoperability Program. Medicare payment for FTE residents training in rural areas, "Rural Physician Workforce Production Act of 2025" (H.R. 1153) Medicare Program: Regulatory Alignment for Predictable and Immediate Device Coverage Pathway (RAPID) Proposed Coverage Pathway proposal by CMS
PFAS issues: Fluoro Polymers [Per- and polyfluoroalkyl] (PFAS) type(s) of substances used in medical devices