Bethany J. Hills

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.