McDermott Will & Schulte, a global law firm

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.

Kristian (Krist) Werling is the global head of McDermott’s Health & Life Sciences practice, which provides regulatory and transactional counsel to health and life sciences industry leaders, changemakers, and investors.

Krist and the McDermott Health & Life Sciences team lead the most significant transactions, critical regulatory issues, and litigation matters that shape the health and life sciences industry. In his own practice, Krist represents life sciences companies, health service providers, private equity firms, and venture capital investors in a wide variety of transactional and regulatory matters. He has led cutting-edge industry transactions that have introduced cancer and gene therapy products to the global market, expanded access to fertility services, increased the availability of cost-effective outpatient surgical services, and transformed the delivery of physician services in a broad range of specialties.

Krist's decades of experience on the buy-side and sell-side of health and life sciences dealmaking spans the healthcare and life sciences landscape. He leads cross-disciplinary teams and delivers business-focused legal guidance to help clients pursue their most innovative strategies, working across borders and health and life sciences subsectors to connect and advise industry stakeholders. Krist is also skilled at developing creative transaction structures, conducting sector-specific due diligence, and providing forward-looking counsel to mitigate issues that can derail transactions or stunt long-term growth. His deep understanding of sector-specific regulatory nuances allows him to efficiently close transactions and maximize client outcomes.

Representative PE clients include Ampersand Capital Partners (buy-side and sell-side); Amulet Capital Partners (buy-side and sell-side); Windrose Health Investors (buy-side and sell-side M&A, and joint venture matters); Iron Path Capital (investments, carve-out acquisitions and new platform formations), Quad-C (new platform formation and investment and sell-side), PPC (buy-side).

Representative healthcare and life sciences companies include Baxter International and Vanda Pharmaceuticals (cross-border sales and acquisitions; licensing); REGENXBIO (strategic partnership with AbbVie); Cleveland Clinic, Hospital for Special Surgery and Northwestern Medicine (strategic innovation investments and joint ventures); numerous founder-owned businesses in strategic transactions with investors.