Bethany J. HillsPartner
Bethany Hills focuses her practice on life science and health care. She advises life sciences and health tech industry clients on the full range of regulatory compliance issues, bringing together FDA regulatory, healthcare regulatory and life science compliance expertise. Bethany helps her clients manage complex, multi-faceted regulatory compliance issues in product development, product launch, ongoing market compliance and defends private and government enforcement actions. She provides practical, strategic guidance for investment, strategic collaborations and long-term commercial success.
Bethany helps companies manage strategic and critical regulatory compliance issues impacting product development and classification, governmental inspections and investigations, and complex regulatory business challenges such as product approvals and labeling, and collaborative research, supply and distribution. She provides risk assessments, develops operational procedures and compliance programs, manages medical-legal-regulatory approval processes, structures commercial licensing and collaboration arrangements, and develops strong government agency engagement strategies for product and reimbursement submissions.
Bethany has deep expertise in digital health issues and experience in artificial intelligence and software solutions in the life science and health care industry. She manages complex GXP issues for regulated companies and manages agency engagement and product correction and recall strategies when issues are identified. Bethany has expertise in the intersection of FDA and healthcare regulatory, including pharmacy regulation, DEA, CLIA, state licensure, clinical trial compliance and innovation, and corporate practice of medicine issues.
Bethany is an Advisory Board Member for the University at Buffalo Innovation Hub, Seed Fund.
- M.P.H., State University of New York at Buffalo
- J.D., State University of New York at Buffalo School of Law
B.A., State University of New York at Geneseo
- LMG, FDA/Medical Devices, 2021
- Chambers USA, Healthcare Law, 2012-2014
- American Bar Association and Bureau of National Affairs, "Excellence in Health Law," 2005
- "Food and Drug Administration’s Final Food Traceability Rule: What It Says and What It Means for the Future," The Journal of Federal Agency Action, Vol. 1, No. 2, pp. 91–103, March-April 2023
- Speaker, "Trends in Diagnostic Regulation: What's Upcoming for FDA and Industry," FDLI Annual Conference, June 15, 2022
- Quoted, "Medicare's new proposal to cover medical devices draws a mixed reaction," Statnews, June 30, 2023
Memberships And Affiliations
- Member, editorial advisory board, Bloomberg BNA's Medical Devices Law and Industry Report, 2013-present
- Vice chair, Food Drug & Cosmetic Law Section, New York State Bar Association, 2011-2012
- Chair, Food Drug & Cosmetic Law Section, New York State Bar Association, 2012-2014
- Member, Data Protection Review Board, 2010-2014
- Member, executive committee, Kevin Guest House for Patient Families, Buffalo, New York, 2007-2012
- Board member, Innovation Hub Investment Advisory Board, New York University at Buffalo, 2019-present
- Limited partner, LaunchNY Seed Fund I, 2019-present
- Invitation only member, Chief (a powerful women’s organization), 2020-present
My latest insights
FDA reveals key details about plan to bolster controversial oversight of LDTs
7 November 2023 .12 minute read