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.

Advises healthcare providers, from startups to established market leaders, on complex federal and state regulatory and reimbursement matters

Serves as a national authority on the 340B Drug Pricing Program

Counsels clients on fraud and abuse laws, Medicare provider-based and co-location rules, pharmacy laws and licensure, graduate medical education, rural providers, and federally qualified health centers

Advises on the development of innovative healthcare delivery models

Leads the defense of M&A and joint ventures before the DOJ, FTC, and international competition authorities

Counsels customers, suppliers, and competitors adversely affected by proposed transactions

Advises on antitrust litigation, including Sherman Act and Clayton Act Section 7 matters

Counsels clients on distribution issues, contracting arrangements, and other competition-related matters

Daniel F. Gottlieb counsels a wide range of healthcare industry clients, including healthcare providers, health plans, health information technology vendors, life sciences companies and data aggregators. He is sought out for his legal knowledge and practical approach on data protection, interoperability, and complex data and software licensing transactions, collaborations and strategic initiatives.

Daniel counsels healthcare clients regarding compliance with US federal and state and international privacy, security, breach notification and information blocking laws, including the Health Insurance Portability and Accountability Act (HIPAA), 21st Century Cures Act, California Consumer Privacy Act (CCPA), Telephone Consumer Protection Act, CAN-SPAM and EU General Data Protection Regulation (GDPR). He offers guidance on the intersection of privacy and security requirements with information blocking prohibitions under the 21st Century Cures Act and Medicare rules impacting the deployment of health information technology.

Daniel has deep experience regarding requirements for de-identification, anonymization and other secondary uses of health information under HIPAA, CCPA and GDPR. Daniel regularly advises clients regarding their response to cyberattacks and other security breaches, and defends against subsequent investigations by state regulators and the US Department of Health and Human Services Office for Civil Rights.

He advises healthcare clients on all aspects of data and software licenses and other agreements for the acquisition of electronic health record (EHR) systems and other mission-critical health IT and health content. He drafts and negotiates hosting, cloud computing and IT service agreements, as well as license agreements for health data and other health content.

Daniel assists with compliance program implementations, compliance audits, and government program overpayment and refund matters, including drafting billing compliance policies and procedures. He also counsels clients on compliance with Medicare and Medicaid reimbursement, fraud and abuse laws; the PhRMA Code on Interactions with Health Care Professionals; and the AdvaMed Code of Ethics on Interactions with Health Care Professionals.

Counsels healthcare and life sciences clients on government investigations, regulatory compliance, and compliance program development  

Represents clients in False Claims Act qui tam matters, government audits, civil monetary penalty and exclusion investigations, and CMS suspension and revocation actions  

Advises on the Anti-Kickback Statute and Stark Law, and on Medicare and Medicaid coverage and payment rules  

Negotiates and implements corporate integrity agreements and makes government self-disclosures 

Advises clients on telehealth, remote patient monitoring, AI-enabled tools, consumer wellness and other virtual care or digital health companies on product development, compliance, commercialization, and reimbursement strategies

Guides clients on structuring compliant care delivery models, navigating multi-state licensure, and advising on fraud and abuse, data privacy, cybersecurity, and other key areas

Advises mail order, retail and other types of pharmacies, suppliers and manufacturers on partnerships with healthcare companies and related compliance considerations

Develops compliance frameworks for consumer wellness programs and mobile health solutions

Leads retailers, tech companies and other non-healthcare companies through their development and launch of healthcare products or offerings

Structures provider networks and strategic collaborations among hospitals, health centers, and physicians

Counsels investors on healthcare trends, reimbursement opportunities and changes in laws to assist with designing their investment strategies

Drew Elizabeth McCormick is a seasoned healthcare regulatory lawyer whose practice spans the full spectrum of federal and state regulatory oversight of the health industry. She is particularly known for her sophisticated command of fraud and abuse laws — including the Anti-Kickback Statute, the Stark Law, the False Claims Act, and state fraud and abuse analogues — as well as Medicare and Medicaid program rules, reimbursement rules and policy, and enrollment, licensing, and certification requirements. She also has extensive experience in various emerging areas of healthcare regulation, including surprise billing regulation and state transaction notice laws.

Drew regularly leverages this deep regulatory knowledge in government audits, civil investigative demands, and internal investigations, helping clients assess exposure, craft defensible responses, and navigate complex interactions with enforcement agencies. Her work also extends to the transactional arena, where she identifies regulatory risks, structures compliant arrangements, and supports diligence and post-closing integration for strategic transactions.

In addition, Drew provides strategic, day-to-day counseling to healthcare providers, payors, and emerging companies, guiding them through operational questions, policy changes, and compliance program design to support both business objectives and regulatory integrity.

Defends clients across industry sectors in privacy-related litigation and regulatory investigations including involving data breaches, website tracking, ambient recording and biometric data 

Counsels clients on data privacy, cybersecurity, and compliance matters across the full data lifecycle, providing a litigator’s perspective on compliance and incident response 

Assists clients with privacy and cybersecurity due diligence in corporate transactions and private equity investments 

Counsels clients on privacy risks raised by artificial intelligence (AI) tools and ambient recording technologies and defends them in related litigations

Steven J. Schnelle is a trusted advisor to investors, executives, general counsel, and business operators in the healthcare and life sciences sectors, delivering actionable strategies to help them achieve market leadership, drive transformative growth, and navigate complex regulatory landscapes. With a national reputation for his transactional acumen and regulatory insights, Steven brings clarity and alignment to multifaceted arrangements, empowering organizations to excel in today’s dynamic healthcare environment.

Steven is a recognized authority in national reimbursement strategy, enabling clients to maximize the value of healthcare services and products. His counsel is particularly sought after by executive leadership teams and general counsel in hospital systems, as well as by professional groups; pharmacy service providers; clinical laboratories; and manufacturers of pharmaceuticals, medical devices, and durable medical equipment. He has extensive experience in advising on cutting-edge regulatory developments and innovative business models, ensuring his clients remain competitive and compliant.

Core Areas of Experience:

• Healthcare Mergers and Acquisitions (M&A). Guiding transactions involving changes of ownership and control with a focus on seamless regulatory coordination
• Federal Healthcare Oversight. Managing audits, investigations, and compliance with federal programs
• Third-Party Payer and Reimbursement. Addressing challenges and opportunities in payer participation and payment structures
• Medicare Administrative Appeals. Driving favorable outcomes in high-stakes appeals
• Sector-Specific Regulations. Navigating the nuanced regulatory requirements of health facilities, corporate practice, pharmacy, clinical laboratories, hospice care, and pharmaceutical/device manufacturing
• Pharmacy Matters. Counseling pharmacies on state and federal regulatory frameworks, Medicare enrollment disputes, and revocations

Steven has also cultivated a niche practice in navigating the complexities of the 340B Drug Pricing Program, providing tailored guidance on program development, audit response, manufacturer repayments, and litigation. His ability to resolve intricate issues relating to duplicate discounts and alleged diversion has earned him accolades from healthcare providers and pharmacy services providers alike.

Thought Leadership

Steven’s thought leadership has been widely recognized, with accolades from Chambers USA and other prestigious legal directories. He is a sought-after speaker at industry conferences, addressing topics ranging from healthcare M&A trends to reimbursement innovation. His insights have also been featured in leading publications, and he frequently mentors the next generation of legal talent in the healthcare sector.

Monica A. Wallace focuses her practice on complex regulatory and transactional counseling to healthcare organizations, including health systems, hospitals, ambulatory surgery centers, physician groups, dental providers, behavioral health clients, integrated delivery systems, academic medical centers, DMEPOS and pharmaceutical manufacturers and suppliers, home health agencies, and venture capital and private equity firms and their health-related portfolio companies. Monica is a practice area leader for the Healthcare Regulatory & Compliance practice.

Monica concentrates her regulatory practice on healthcare fraud and abuse, Medicare and Medicaid enrollment, reimbursement and billing, legal assessments and audits, compliance programs, and other general regulatory matters including licensure, survey/certification and accreditation. Her transactional practice includes mergers, acquisitions and affiliations, divestitures, hospital/physician joint ventures and corporate reorganization.

Previously, Monica worked with hospital executive management at the University of Iowa Hospitals and Clinics on strategic academic medical center issues.

Leads regulatory and transactional matters that shape the health and life sciences landscape

Represents private capital investors across buy-side and sell-side dealmaking in the sector

Helps clients structure innovative strategies with business-focused guidance across borders, and across health and life sciences subsectors

Stephen Wu is a nationally recognized antitrust lawyer with more than twenty-five years’ experience defending clients against antitrust litigation and government investigations into mergers and acquisitions and business practices. Stephen is also a trusted strategic advisor who counsels clients on antitrust compliance issues.

Stephen has successfully defended clients in class actions and other complex litigation brought by purchasers, competitors, and employees alleging unlawful price-fixing, wage-fixing, exclusive dealing, group boycott, market allocation, tying, and monopolization claims in federal courts around the country. In addition, Stephen has successfully defended numerous mergers and acquisitions and clients’ business practices from Federal Trade Commission (FTC), Department of Justice, and State Attorneys General investigations. He also regularly advises clients on pricing, distribution, and joint venture matters.

Stephen represents clients in a wide variety of industries, ranging from consumer goods to healthcare to packaging. He is co-head of the Firm’s Health Antitrust Practice Group.

Stephen has been recognized as a leading antitrust lawyer by The Best Lawyers in America, BTI Consulting, Chambers USA, Global Competition Review, Lawyers of Color, The Legal 500 USA, LMG Life Sciences, The National Law Journal, Super Lawyers, and Thomson Reuters Stand-Out Lawyers.

Prior to joining the Firm, Stephen was an attorney for the FTC, where he received its Award for Meritorious Service. At the Firm, Stephen received McDermott’s Pro Bono and Community Service Award for his pro bono efforts.

Sam Siegfried is a trusted advisor on emerging healthcare technology matters, with a particular focus on data privacy and security, artificial intelligence (AI), clinical research, and complex technology transactions. He helps healthcare and life sciences companies navigate evolving regulations, maximize data-driven opportunities, and implement innovative technologies. He also conducts privacy and research diligence and negotiates transition services agreements for mergers and acquisitions, strategic investments, and joint ventures.

With extensive experience in key privacy frameworks, including the Health Insurance Portability and Accountability Act (HIPAA), the California Consumer Privacy Act (CCPA), Washington’s My Health My Data Act (MHMDA), the General Data Protection Regulation (GDPR), and other evolving US and global data protection frameworks, Sam provides critical data strategy guidance to digital health platforms, genomic sequencing providers, health systems, biotech firms, and other health and life sciences organizations.

As AI reshapes healthcare delivery and innovation, Sam works closely with AI developers and deployers on AI governance programs, generative AI use, and consumer protection risks. In the clinical research space, he advises on federal and state research regulations, research compliance program development, research informed consent, and Institutional Review Board (IRB) requirements.

Beyond his regulatory practice, Sam structures and negotiates complex commercial transactions, including data licensing agreements, software as a service (SaaS) and other technology platform agreements, AI development partnerships, research collaborations, and clinical trial agreements.

Before joining McDermott, Sam served as in-house counsel at an academic medical center and a precision medicine startup, handling complex privacy, research, and healthcare regulatory challenges. This frontline experience informs his pragmatic approach, allowing him to deliver solutions that seamlessly integrate compliance with business objectives.

Leads complex patent litigation disputes, with an emphasis on high-stakes trial work

Represents clients in pharmaceutical and life sciences patent matters, including Hatch-Waxman disputes

Handles patent disputes across a broad range of technologies, including medical devices and consumer products

Leads the defense of M&A and joint ventures before the DOJ, FTC, and international competition authorities

Counsels customers, suppliers, and competitors adversely affected by proposed transactions

Advises on antitrust litigation, including Sherman Act and Clayton Act Section 7 matters

Counsels clients on distribution issues, contracting arrangements, and other competition-related matters

Assists in the design, deployment, and ongoing implementation of innovative care delivery models for life sciences, healthcare, and informatics clients

Regularly advises companies pivoting to healthcare vertical offerings based on legacy technology and strategic assets

Advises clients on AI governance, public trust, and AI deployment

Advises clients on HIE participation, data sharing and compliance

Counsels clients on the development of data and biospecimen registries, real-world evidence platforms, and biobanking programs

Abigail M. Kagan is an experienced labor and employment advisor on matters ranging from day-to-day human resources (HR) counseling to complex transaction strategy. Abigail’s practice balances  regulatory compliance with tangible short- and long-term goals. This includes internal investigations, executive contracts, Family and Medical Leave Act (FMLA)  and Americans with Disabilities Act (ADA) disability accommodations, discrimination and harassment, industry-tailored personnel policies, wage and hour audits, reductions in force, workplace health and safety, workplace violence, employee mobility and non-compete enforcement, gig workers, and workforce integration and rebadging.

Clients turn to Abigail for her practical recommendations and simple yet elegant solutions. Abigail holds a master’s in public health, and her decades of working alongside healthcare leaders make her particularly attuned to the unique challenges facing healthcare employers.

Abigail is a member of McDermott Will & Schulte’s Pro Bono Committee and the Gender Diversity Committee.

Sarah Kitchell focuses her practice on transactional and regulatory matters affecting a wide range of clients in the health care industry, including nonprofit and for-profit health systems, academic medical centers, community hospitals, drug and device manufacturers, contract research organizations, and post-acute and sub-acute providers such as home health and hospice providers, therapy providers, behavioral health providers and senior living facilities.

Sarah concentrates her transactional practice on strategic affiliations, mergers and acquisitions, physician-hospital alignments, venture capital investments and complex contractual arrangements. She also represents research sites, sponsors and contract research organizations with all aspects of clinical research contraction and formation of research networks. She also has provided assistance to medical centers and other research participants involving compliance matters, including internal compliance audits and revisions to policies and procedures involving topics such as research misconduct.

While in law school, Sarah was editor in chief of the Boston University Law Review and served as a summer associate at the Firm. Prior to law school, she worked for the National Cancer Institute’s Cancer Information Service at the University of Iowa Hospitals & Clinics and at a rural health clinic in Tennessee.

Sarah is a member of the Firm’s Associate Development Committee, Associate Recruiting Committee, and Pro Bono and Community Service Committee. She focuses her pro bono efforts on representation of small nonprofit arts organizations and matters for the Medical-Legal Partnership of Boston.

Provides multijurisdictional counsel on IP portfolio strategy, including patent prosecution, transactions, and disputes

Focuses on biomedical engineering and life sciences technologies

Handles transactional IP matters, including transaction structuring; portfolio due diligence; and negotiation of collaboration, license, and joint venture agreements

Supports transatlantic disputes, including US district court cases, PTAB proceedings, reexaminations, EPO oppositions, and UPC litigation

Lisa P. Rumin focuses her practice on antitrust, regulatory and litigation matters. She assists clients across a variety of industries and has represented numerous clients in the healthcare, pharmaceutical, and biotechnology industries. Lisa advises clients on mergers and acquisitions, including obtaining clearance from the Federal Trade Commission (FTC) and Department of Justice (DOJ), as well as counsels clients on issues regarding antitrust compliance, pricing, and distribution. She also counsels clients on cartel prosecutions and defenses, including government investigations and the initiation and defense of civil class action litigation. Lisa is experienced in areas of e-discovery, document review and production for investigations before the FTC, DOJ and state attorneys general office.

In addition to her antitrust and competition work, Lisa maintains an active pro bono practice. She has represented clients in asylum, sexual harassment and employment discrimination matters, as well as assisted Lawyers Without Borders on projects aimed at strengthening legal training and enforcement in various countries.

While in law school, Lisa was the notes and comments editor for the Wake Forest Law Review. She served as a judicial intern to the Honorable Calvin E. Murphy in the North Carolina Business Court.

Stephen Wu is a nationally recognized antitrust lawyer with more than twenty-five years’ experience defending clients against antitrust litigation and government investigations into mergers and acquisitions and business practices. Stephen is also a trusted strategic advisor who counsels clients on antitrust compliance issues.

Stephen has successfully defended clients in class actions and other complex litigation brought by purchasers, competitors, and employees alleging unlawful price-fixing, wage-fixing, exclusive dealing, group boycott, market allocation, tying, and monopolization claims in federal courts around the country. In addition, Stephen has successfully defended numerous mergers and acquisitions and clients’ business practices from Federal Trade Commission (FTC), Department of Justice, and State Attorneys General investigations. He also regularly advises clients on pricing, distribution, and joint venture matters.

Stephen represents clients in a wide variety of industries, ranging from consumer goods to healthcare to packaging. He is co-head of the Firm’s Health Antitrust Practice Group.

Stephen has been recognized as a leading antitrust lawyer by The Best Lawyers in America, BTI Consulting, Chambers USA, Global Competition Review, Lawyers of Color, The Legal 500 USA, LMG Life Sciences, The National Law Journal, Super Lawyers, and Thomson Reuters Stand-Out Lawyers.

Prior to joining the Firm, Stephen was an attorney for the FTC, where he received its Award for Meritorious Service. At the Firm, Stephen received McDermott’s Pro Bono and Community Service Award for his pro bono efforts.