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Bethany J. Hills

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Education

  • State University of New York - Buffalo (MPH)
  • State University of New York - Buffalo (JD, cum laude)
  • State University of New York - Geneseo (BA, summa cum laude)

Bar Admissions

  • New York

Bethany is Chair of the firm's FDA practice and leverages deep FDA regulatory experience and exceptional knowledge of the health care delivery system to help international and domestic health technology companies enter and navigate the US health care market. Bethany helps companies manage the full range of FDA regulation issues, from inspections and investigations through complex regulatory challenges affecting everything from product approvals and product labeling to collaborative research, supply, and distribution agreements. She focuses on mission critical strategic engagements, including all aspects of FDA communications. She regularly devises unique regulatory strategies that are then implemented through FDA submissions and complex interactions with the FDA, including post-approval compliance and enforcement.

Bethany has represented the full breadth of health care provider businesses — hospitals, physicians, accountable care organizations, developmental disability specialists, and others — in a broad range of regulatory, reimbursement, and US and international compliance matters.

Through that extensive representation, she has developed an understanding of compliance issues and of the US health care reimbursement system that far surpasses that of most FDA lawyers. She uses her strengths in these areas to provide clients with insight on regulatory policy, reimbursement issues, and pricing to shape innovation, and helps them use that knowledge to develop viable value propositions. She advises clients on laws applying to referral relationships, clinical trial compliance, licensure, and security and privacy issues as well as on the ins and outs of government and third-party reimbursement. Clients rely on Bethany’s practical guidance to help them invest and collaborate strategically, by identifying technologies that are likely to complement the health care delivery system, clear FDA regulatory hurdles, and provide a healthy return on investment.

Before joining Mintz Levin, Bethany served as the co-leader of the FDA and medical technology services team in the New York office of another law firm. She works with academic centers to educate future business leaders on relevant health care regulatory issues, and is frequently invited to speak on issues concerning FDA regulations, health care reimbursement, and pricing.  

Websites

MintzEdge

Recognitions & Awards

  • Lexology and the ILO: Client Choice Award
  • New York Super Lawyers: Rising Star - Food and Drugs, Health Care, and Technology Transactions (2015 - 2016)
  • Chambers USA: “Up-and-Coming” lawyer,  New York Healthcare category (2012 ‒ 2014)
  • American Bar Association and Bureau of National Affairs: Excellence in Health Law (2005)
  • Environment and Society Institute, Lester Milbrath fellowship

Professional & Community Involvement

  • Member, executive committee, Food, Drug, and Cosmetic Law Section, New York State Bar Association
  • Member, Editorial Advisory Board, BNA Medical Devices Law & Industry Report
  • Member, Regulatory Affairs Professional Society
  • Member, American Health Lawyers Association
  • Executive committee, Kevin Guest House for Patient Families, Buffalo, NY (until 2012)
  • Board of directors, MedTech (2014 ‒ 2015)
  • Board of directors, NY Data Protection Review Board (2010 ‒ 2013)