From Data to Delivery: The New Healthcare Continuum

Stacey Callaghan counsels digital health organizations, healthcare entities, and private equity clients as they navigate regulatory, compliance, and transactional issues. She focuses on assisting clients in developing telemedicine strategies and documenting multi-state telehealth arrangements given the evolving digital health regulatory landscape. As co-head of our Women’s Digital Health Initiative, Stacey focuses on aiding digital health providers of women’s health services navigate issues unique to the industry and works to help these clients successfully advance their efforts. Stacey also assists clients in matters including data privacy and protection requirements under HIPAA and other privacy laws, data breach investigations and compliance, and data sharing, licensing, and de-identification arrangements.

Stacey is experienced in executing healthcare transactions, and routinely guides clients through joint ventures, mergers and acquisitions and strategic collaborations. She counsels on governance matters and regulatory issues, including compliance with federal and state fraud and abuse laws.

Prior to joining the firm, Stacey was a healthcare associate at a large US-based law firm. She is a frequent author on a variety of healthcare legal issues, primarily those issues impacting providers in the digital health space. During law school, Stacey served as the executive notes editor for the Journal of Legislation.

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.