Bethany J. Hills

Partner, New York

Biography

Overview

Bethany Hills focuses her practice on regulatory compliance issues for the life science and health care industry. She advises clients on the full range of regulatory, compliance and policy 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 telemedicine, pharmacy regulation, DEA, CLIA, HIPAA, 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, a Mentor to innovative companies through the NYS Biodefense Commercialization Fund and Springboard Enterprises, and serves on the Editorial Board of the peer reviewed journal, AI in Precision Oncology.

Bars and Courts
New York
New Jersey
Education
MPH
State University of New York at Buffalo
JD
State University of New York at Buffalo School of Law
BA
State University of New York at Buffalo School of Law
Languages
English

Experience

Speaking Engagements

Speaker, "Trends in Diagnostic Regulation: What's Upcoming for FDA and Industry," FDLI Annual Conference, June 15, 2022

Panelist, "Building a Compliance Program for 2023 and Beyond", American Health Law Association webinar, October 2023

Speaker, "Disruptive Technologies: How Companies can Navigate Regulatory and Legal Complexities" Association of Corporate Counsel, Life Science 2021

Panelist, "AI and Digital Health: The Bottom Line for Patients", BioNJ AI & Digital Health Day 2023

Speaker, "Ethics of AI in Precision Oncology" AI Precision Oncology, 2023 State of AI in Precision Oncology Summit

Speaker, "510(k) and DeNovo Program" FDLI Annual Conference, 2019

Speaker, "Trends in Diagnostic Regulation" FDLI Annual Conference 2022

Panelist, "Due Diligence: Ensuring Regulatory Compliance and Control Post Transaction" FDLI Annual Conference 2023

Speaker "Regulation of Digital Health Products: An Introduction" FDLI Introduction to Medical Device Law and Regulation 2023

Publications

"Ethics and Regulation of AI in Precision Oncology" AI in Precision Oncology, Vol. 1, No. 5, 2025

"Artificial Intelligence in Pharma: Adoption and Innovation Despite US Legal and Regulatory Framework" Pharma Network Magazine, Aug. 2019

Promotion of FDA Regulated Products, co-author, Regulatory Affairs Professional Society (Book)

Awards and Recognition

LMG, FDA/Medical Devices, 2021

Chambers USA, Healthcare Law, 2012-2014

American Bar Association and Bureau of National Affairs, "Excellence in Health Law," 2005