Bethany J. HillsPartner
As Vice Chair of the firm’s FDA practice, Bethany Hills advises life sciences and health tech industry clients on complex pre- and post-market product and distribution issues. Her clients span the full range of FDA regulated companies, including medical device and digital health, drug, combination product, diagnostic and biologic, as well as regenerative medicine, cosmetic, dietary supplement and food industry businesses. She also represents investor groups that focus on innovation in these industries.
Bethany helps companies manage strategic and critical FDA regulation issues including product development and classification, governmental inspections and investigations, and complex regulatory challenges such as product approvals and labeling and collaborative research, supply and distribution agreements.
In addition, Bethany has deep expertise in healthcare delivery systems, referral relationships, clinical trial compliance, licensure and security and privacy issues, as well as the intricacies of government and third-party reimbursement. Bethany’s practical guidance helps clients invest and collaborate strategically by identifying technologies that are likely to thrive within the healthcare delivery system, clear FDA regulatory hurdles and realize long term commercial success.
- 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
- Chambers USA, Healthcare Law, 2012-2014
- American Bar Association and Bureau of National Affairs, "Excellence in Health Law," 2005
- LMG, FDA/Medical Devices, 2021
- Co-author, "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
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
- Digital health advisor, Evolution Road, 2019-present
- 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