Beth A. Stanfield

Beth’s experience includes the following:

• Providing core compliance counsel regarding state and federal laws governing referrals and financial arrangements, including the federal Anti-Kickback Statute (AKS), Stark law, Eliminating Kickbacks in Recovery Act of 2018 (EKRA), False Claims Act, federal fraud and abuse regulations, and state self-referral and fee-splitting laws
• Developing and negotiating compliant structures and contracts for a myriad of health-related transactions, including mergers and acquisitions, joint ventures, physician compensation agreements, vendor and consulting agreements, research agreements, business associate agreements, and a litany of commercial contracts arising in the fast-paced digital health setting
• Counseling practice owners and investors in the full scope of start-up and ongoing operational compliance, including providing the foundational documents needed to build a complaint, successful practice from the ground floor, including management structures and safe harbor agreements, provider compensation and employment agreements, and other core documents essential to comply with state and federal health and employment regulations, state board rules and corporate practice of medicine doctrines, and provider licensing, practice, and insurance reimbursement requirements
• Developing state and federal enforcement risk mitigation strategies, including identification and resolution of potential areas of noncompliance, implementation, and integration of effective compliance plans, and (when necessary) counsel relating to OIG, DOJ, and state Attorney General agency investigations, subpoenas, and audits, including negotiation and implementation of Corporate Integrity Agreements
• Providing counsel on a wide range of health data security and privacy issues under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the Health Information Technology for Economic and Clinical Health Act (HITECH), and the HIPAA Omnibus Final Rule, including counsel on privacy and security compliance and managing providers’ security incident response, breach notification evaluation, remediation, and potential breach reporting
• Performing due diligence for buyers, sellers, and investors, including counsel relating to digital health security and HIPAA compliance, evaluation of financial arrangements and business structures, and compliance relating to the overlapping employment and health regulatory environment
• Developing strategies for leveraging and implementing emerging health care delivery systems, including telemedicine/telehealth, personalized medicine, digital health, mobile health, and direct-to-consumer models
• Providing legal support for research, innovation, and development in a multitude of health care settings (provider, innovator, investor, technology/integration, AI, digital health, EMR/EHR) with an emphasis on protecting and monetizing intellectual property, analytics, and health-related data

Beth began her legal career in 2005 as a federal judicial clerk to the Honorable Henry Coke Morgan, Jr., Senior United States District Court Judge for the Eastern District of Virginia. Following her clerkship, Beth relocated to Charlotte, North Carolina where she practiced for fourteen years. In 2019, Beth and her family relocated to the Cape Fear region to enjoy the beach life, clean air, and more time with her family, where they still reside.