Telehealth in the Hot Seat: Proactive Compliance in the Face of Heightened Enforcement

James A. Cannatti III advises healthcare, technology, and life sciences organizations on complex regulatory, compliance, and enforcement matters at the forefront of the evolving healthcare ecosystem. His practice spans digital health and health information technology (IT) policy, fraud and abuse compliance, and emerging regulatory risk areas, including in the diagnostics, life sciences services, research, pharmacy, and distribution space.

James counsels healthcare providers, diagnostics companies, health IT developers, and life sciences services and research companies on compliance with federal healthcare requirements, including the Anti-Kickback Statute, Stark Law, and EKRA. He also represents clients in internal investigations and enforcement matters, drawing on his deep experience with government expectations and enforcement priorities to provide practical, regulator-informed guidance on navigating enforcement risk and regulatory change.

James’s advisory work frequently addresses cutting-edge regulatory topics and developments, including:

• Fraud and abuse risk and enforcement trends involving healthcare providers, diagnostics, laboratory services, and life sciences companies
• Internal investigations and responses to government inquiries involving the US Department of Justice and the US Department of Health and Human Services’ Office of Inspector General (OIG)
• Compliance with the Anti-Kickback Statute, Stark Law, and the Eliminating Kickbacks in Recovery Act of 2018 in complex commercial arrangements
• Digital health enforcement and compliance risks, including remote patient monitoring and telehealth
• Information blocking and interoperability requirements under the 21st Century Cures Act
• Health IT certification, APIs, and data-sharing obligations

Before entering private practice, James spent more than a decade at the OIG, where he held a range of roles, including serving as its first Senior Counselor for Health Information Technology. In that role, he worked on the development, interpretation, and enforcement of federal healthcare policy affecting providers, health IT developers, and other industry stakeholders.

While in law school, James served as a managing editor of the Ohio State Journal on Dispute Resolution.

Focused on compliance, transactions and sector-specific counseling, Amanda Enyeart works with her clients to deploy digital health technology in compliance with a wide range of health law regulations. She is particularly concentrated on telehealth, fraud and abuse, information technology, data strategies and digital health matters. She provides counsel on all aspects of telehealth and other healthcare delivery modalities, advising on the complex patchwork of state-by-state regulatory issues, including practitioner licensure, Medicare and Medicaid reimbursement, compliance with the federal Stark Law and Anti-Kickback Statute, and state fraud and abuse laws.

Amanda advises healthcare industry clients, including hospitals and health systems, digital health companies, telehealth providers and retail health clinics, on all aspects of software licenses, as well as other agreements, for the acquisition of electronic health record (EHR) systems and other mission critical health information technology. Amanda also counsels healthcare clients, including covered entities and business associates, regarding compliance with the Health Insurance Portability and Accountability Act (HIPAA) and other federal and state privacy, security and breach notification laws.

On the transactional front, Amanda is a valuable resource to companies as they structure business deals and negotiate technology agreements. She is experienced acting on behalf of both technology providers and the healthcare organizations that are their customers. She also conducts specialized due diligence in various health industry areas, including hospitals and health systems, and digital health companies and telehealth companies. In addition, Amanda also regularly acts as counsel in healthcare IT transactional matters concerning telehealth and other mission-critical health information and data-centered technologies.