“ I’m passionate about the innovative technologies and services my clients offer, and I bring a practical, full life cycle approach to my counsel that includes not just core FDA regulatory compliance, but also a deep understanding of product reimbursement and the healthcare systems the products will be used in.
As co-lead of the FDA Regulatory & Compliance practice, Bethany J. Hills advises her life sciences and health tech industry clients on both pre- and post-market issues, including everything from FDA submissions and communication strategies to post-approval FDA and healthcare compliance and reimbursement issues. Her clients span the full range of FDA and healthcare regulated companies, including medical device and health tech, drug, combination product, diagnostic, biologic, and regenerative medicine, cosmetic, dietary supplement, and food industry businesses, and the investor groups focusing on innovation in these industries.
Bethany leverages her deep FDA regulatory experience and exceptional knowledge of the healthcare delivery system to help both domestic and international life sciences and healthcare technology clients enter and navigate the U.S. market. She helps companies manage the full range of FDA regulation issues, from product development and classification, to inspections and investigations through complex regulatory challenges, affecting everything from product approvals and labeling to collaborative research, supply, and distribution agreements. Her work for clients regularly spans the full scope of pre-market and post-market issues, from devising unique regulatory strategies that are then implemented through FDA submissions, including post-approval FDA and healthcare compliance and enforcement.
Through her extensive representation of healthcare technology and virtual care businesses, she has an understanding of healthcare compliance issues that far surpasses most other FDA lawyers and is invaluable to the success of product launch and sustainable growth. Bethany uses her strengths in these areas to advise clients on regulations applying to referral relationships, clinical trial compliance, licensure, and security and privacy issues, as well as the intricacies 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 healthcare delivery system, clear FDA regulatory hurdles, and realize commercial success. With her focus on exceptional service, one client recently noted that “Bethany provides both deep knowledge and a practical perspective that has been very valuable to [our] success in achieving key legal and business goals. Bethany has worked with us to meet our needs and continues to deliver quality work product on very fast-paced and demanding projects.”
Bethany works globally with academic centers to educate future business leaders on relevant regulatory issues and is a frequent author and speaker on topics concerning FDA regulations, healthcare reimbursement, and life sciences compliance. She is also an angel investor in life sciences and health tech companies and an active member of Biocom California’s Regulatory Affairs Committee.
Bethany has in-depth knowledge of health care regulation to assist clients with government audits and investigations, M&A and financing transactions, and corporate compliance activities. She also provides strategic advice to traditional health care providers, investors, and start-ups on telehealth initiatives as well as the traditional practice of medicine across multiple states. Bethany has experience counseling on telehealth, HIPAA, and the corporate practice of medicine. She specializes in providing regulatory and strategic advice to health care providers and payors of all types, including hospitals, managed care organizations, long-term care facilities, pharmacies, pharmaceutical and device manufacturers, telemedicine providers, and urgent care and retail health clinics. She also represents companies doing business with, and investing in, health care providers.
Bethany also provides complex fraud and abuse regulatory advice to companies across the healthcare and life sciences industry, spanning the federal anti-kickback statute, state statutes prohibiting kickbacks and self-referrals, the Stark law, Medicare and Medicaid program requirements, the federal Physician Payments Sunshine Act, state licensure laws, and the Clinical Laboratory Improvement Amendments of 1988 (CLIA). She works closely with clients to design and institutionalize compliance programs in preparation for product launch or in response to external inquiries (federal and state investigations of false claims or insurance fraud, regulator surveys, or licensure actions). She also helps clients oversee internal investigations, and advises on the practical and legal fraud and abuse implications of business structures and sales and marketing practices. She frequently advises on self-disclosure and overpayment requirements. Bethany also represents clients in the complex overlap of FDA advertising and marketing rules as they intersect with fraud and abuse legal frameworks, helping clients proactively prepare for commercial success or reactively defend against fraud and abuse allegations.
In addition, she advises clients on how to deploy telemedicine and internet based health initiatives, electronic health records, and how to address HIPAA privacy and security matters.Show More