McDermott Will & Schulte, a global law firm

Stephen W. Bernstein specializes in e-health, “big data”, data engineering, deployment of digital health tools and solutions and health-related matters affected by the internet and the Health Insurance Portability and Accountability Act (HIPAA), as well as private equity investments, mergers, acquisitions, affiliations and joint ventures involving technology, digital health companies, hospitals and physicians. Stephen co-leads the Firm’s Digital Health Practice, which brings together McDermott lawyers from within and outside the Health Industry Advisory Practice Group to develop thought leadership, share information and collaborate on best practices. Stephen served as global head of the Firm’s Health Practice from 2009-2018, and as the Health Practice’s Partner-in-Charge of Health Practice Operations during 2023 and 2024. He has also served on the Firm’s Management, Compensation, Executive and Finance Committees.

Stephen has particular experience working with private equity funds, venture funds, as well as pharmaceutical, biotech and device companies concerning uses of health information for clinical and database research, product/disease registries and marketing matters, electronic health record development and implementation, including the ways these endeavors relate to personalized medicine.

Representative clients include the Best Buy Health, OMERS Private Equity, Modernizing Medicine, Nuance Communications, American Society of Clinical Oncology (ASCO), Stanford University, Physicians’ Organization at Children’s Hospital (Boston), Cape Cod Healthcare, Summit Partners and Caisse de dépôt et placement du Québec (CDPQ).

Stephen has practiced health law since 1988 in Boston, Massachusetts, and in Palo Alto, California. In Palo Alto, he provided on-site counsel to Stanford University Medical Center. Among other accomplishments at Stanford, Stephen participated in the negotiations for the affiliation between Stanford Health Services and Lucile Salter Packard Children’s Hospital. He lectures extensively on healthcare technology privacy/HIPAA and related security matters, digital health, collaborative transformations, data mining, clinical research and product/disease registries as well as electronic health record implementation. Stephen has been featured on National Public Radio’s syndicated program Here and Now and has been quoted by The Wall Street Journal and The Washington Post on medical privacy issues.

Charles (Charlie) R. Buck advises healthcare enterprises on complex transactions and regulatory compliance. He represents a wide range of clients, including proprietary and tax-exempt hospital systems, academic medical centers and faculty practice groups, accountable care organizations, and health maintenance organizations (HMOs) and other health insurers. Charlie is partner-in-charge of the Firm’s Boston Health Industry Advisory Practice Group and Co-Leader of its Hospitals and Health Systems practice.

Charlie provides legal counsel and solutions in connection with mergers and acquisitions, joint ventures, strategic affiliations, conversions to tax-exempt status, and other transactional matters. His practice focuses on provide strategic and transactional advice to hospitals and health systems, academic medical centers, and other organizations in the healthcare sector. Charlie has extensive experience with federal fraud and abuse laws (including the Stark Law) and certain state regulatory matters.

After earning his law degree, Charlie clerked for the Honorable Charles R. Breyer of the US District Court for the Northern District of California. Prior to law school, Charlie served on the professional staff of the United States Senate Finance Committee for Senator Daniel Patrick Moynihan, where he concentrated on health reform and Medicare Part A. He also worked as a policy analyst at the Jackson Hole Group, where he focused on rural healthcare and purchasing cooperatives.

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.

Jiayan Chen is an industry leader on matters relating to health data, technology and research. She represents clients on regulatory and compliance matters, commercial transactions, and investments and acquisitions that require deep knowledge of privacy, data strategies, artificial intelligence (AI) and other healthcare technologies, or research compliance. Clients turn to Jiayan for her practical, industry-informed guidance as they seek to develop, improve, deploy, or acquire solutions or businesses that harness the power of data or technology. Jiayan has extensive experience advising on investments and acquisitions in the life sciences sector, particularly with respect to businesses that conduct clinical research or offer solutions designed to accelerate research or research recruitment. Her practice includes working with patient safety organizations (PSOs) on listing applications, compliance, and strategies for appropriately creating and sharing patient safety work product.

Jiayan’s subject matter and industry insights come from advising a broad range of clients, including AI and other healthcare technology companies; data companies; hospitals and health systems; academic medical centers; genetics companies; digital health companies; PSOs; drug, device, and biotech companies; private equity funds; and platform companies.

Jiayan regularly counsels clients on data privacy requirements under US federal and state privacy law, including the Health Insurance Portability and Accountability Act (HIPAA) and various state genetic, health information, and consumer privacy laws. She works with clients on mapping and implementing data use and sharing strategies with appropriate data governance and programmatic safeguards. Well before the proliferation of generative AI, Jiayan was working with AI developers and deployers on compliance with privacy and research laws, efforts to leverage data to train and validate AI tools, and transactions involving the licensing of AI tools and AI-enabled platforms. These days, Jiayan also guides clients in developing AI governance and advises on proposed regulatory and legislative changes impacting AI.

Jiayan represents clients on a wide array of matters related to biomedical research, including negotiating the full range of agreements impacting research, building research compliance infrastructure, preparing protocols and informed consent and authorizations, and conducting transactions involving research site networks, providers of research solutions and other stakeholders in the biomedical research space. Jiayan’s regulatory practice includes counseling clients on state and federal “sunshine” and gift ban laws. She analyzes proposed arrangements and corporate organizational structures to identify and inform reporting obligations, and helps clients develop compliance mechanisms for managing their reporting obligations.

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.

Marshall E. Jackson, Jr. focuses his practice on transactional and regulatory counseling for clients in the healthcare and life sciences industries. Leveraging his transactional background and deep healthcare regulatory experience, Marshall provides practical and comprehensive counsel on the complex strategic and operational issues facing healthcare and life sciences companies and their investors.

He advises investors, including private equity, growth equity, venture capital firms, and their portfolio companies, on mergers and acquisitions, joint ventures, and strategic affiliations, as well as on a wide range of corporate, regulatory, and governance matters. Marshall is also deeply experienced on the company side, representing physician practices and other health organizations in their corporate, regulatory compliance, and governance needs.

Additionally, Marshall is particularly experienced in the digital health and health tech space — the intersection of healthcare and life sciences, software, analytics, technology, AI, and electronic data. He advises investors, healthcare and life sciences companies, and technology companies across the full scope of their transactional opportunities and complex legal, regulatory and compliance issues.

Sharon Lamb focuses her practice on transactional and regulatory advice in the health and life sciences sector and leads McDermott’s UK Health and Life Sciences Practice Group.

Sharon advises on global transactional mandates, including mergers and acquisitions and joint ventures in health services, pharma and life sciences, digital health and health technologies. Sharon also provides strategic, regulatory and commercial support to UK and international clients on UK health and life sciences with a focus on health services, pharmaceuticals, medical devices, digital health and health data.

Sharon is widely recognized for her expertise on NHS and public law procurement, regulatory and contracting matters, including payment and reimbursement and market access. She has particular experience advising strategic and private equity investors in transactions and investments in health and life sciences.

Sharon is also well-versed in health care services governance and regulatory matters, NHS public private partnerships, procurements, joint ventures and shared working arrangements, mergers, acquisitions, health data and competition issues.

Sharon has practiced health and life sciences law in the UK since 2002 and is recognized in Chambers and Legal 500. Sharon has written and lectures widely on health and life sciences issues and has a wealth of experience with NHS law and policy, having worked on a 4-year part time secondment with the NHS and national health bodies in London.

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

Kate McDonald represents clients across the healthcare industry on complex regulatory matters and high-stakes mergers and acquisitions, affiliations and other investments. She delivers strategic advice on federal and state laws applicable to health insurers and HMOs, including the downstream implications for their provider organizations and vendors, as well as the reimbursement landscape of federal healthcare programs.

Kate’s clients rely on her extensive experience navigating the Medicare Advantage, Medicare Part D and Medicaid managed care programs. She partners with health plans, provider organizations, technology start-ups, private equity funds and retailers to benchmark risks, solve regulatory challenges and structure transactions, particularly those that involve federal and state healthcare programs. As payors and providers continue to realign in today’s market, Kate offers nuanced insights into the unique obstacles and opportunities facing companies at the intersection of these two worlds. She helps innovative companies navigate state risk-bearing regulations, drafts and negotiates agreements with complex reimbursement structures and regulatory implications, and advises healthcare companies and private equity funds on investments in highly regulated segments of the healthcare market.

Kate’s healthcare regulatory experience also includes deep insights into DC certificate of need (CON) laws. She helps providers obtain CON approval for the introduction and expansion of healthcare services, changes in ownership, capital expenditures, and closure of healthcare services or facilities in Washington, DC.

Kate is a contributing author to Regulation of Medicare Part D Plans (Thomson Reuters, 2019 edition) and Thomson Reuters Health Law Handbook (2017 edition). She speaks regularly at healthcare industry events, including the Wall Street Journal Health Forum, American Health Lawyers Association Institute for Health Plan Counsel, Blue Cross Blue Shield National Summit, Health Care Compliance Association Managed Care Compliance Conference, and Medicaid Managed Care Congress. Kate was the first recipient of the McDermott Will & Emery Client Service Award (2019).

Sarah G. Raaii devotes her practice to issues impacting group health and welfare benefit plans by counseling employers, digital health and point solution clients, plan administrators, insurers, consultants and other health plan service providers.

Sarah advises her clients on healthcare reform issues; consumer-driven health benefits; self-funded and fully insured health plans; data privacy and the Health Insurance Portability and Accountability Act (HIPAA); wellness programs; cafeteria plans; and regulatory, sub-regulatory and legal compliance. She provides guidance on the Affordable Care Act (ACA); the Employee Retirement Income Security Act (ERISA); health plan transparency; mental health parity; the No Surprises Act; the Consolidated Omnibus Budget Reconciliation Act (COBRA); flexible benefit plans; health reimbursement accounts (HRAs); health savings accounts (HSAs); plan network design; multiple employer welfare arrangements (MEWAs); association health plans; captive insurance arrangements; and other health benefits issues.

Sarah drafts and negotiates complex agreements between employers, health plans, third-party administrators, pharmacy benefit managers, carriers, consultants and other health plan service providers. She also counsels digital health, telehealth and point solution entities; third-party administrators; pharmacy benefit managers; and other benefit administrators on partnering with employers, group health plans and insurers. As co-chair of the Firm’s Post-Roe Working Group – a multidisciplinary team of lawyers providing clients with reproductive health guidance – Sarah has advised hundreds of health plans and benefit administrators on health benefits following the end of Roe v. Wade.

Additionally, Sarah routinely analyzes frequently changing health benefits laws and regulations and recommends risk mitigation strategies. She provides strategic due diligence and health benefits design, implementation and transition advice on issues arising from corporate and private equity mergers, acquisitions and other transactions.

Sarah frequently publishes and presents on health benefits trends and developments and has been quoted on health plan issues in prominent media outlets, including The New York Times, The Wall Street Journal, Bloomberg Law and Law360.

Prior to joining the firm, Sarah worked at the White House for the National Economic Council, where she implemented the ACA with leaders from the Executive Office of the President, the US Department of Labor, the US Department of Health and Human Services, and the US Department of the Treasury. She previously collaborated with in-house lawyers and federal and state government relations professionals in the leadership development program of a Fortune 500 global insurance and financial services corporation.

Caroline Reignley provides strategic legal, regulatory and compliance counsel to for-profit and nonprofit hospitals, health systems, other healthcare providers, life sciences and technology companies.

Fraud and Abuse

Caroline counsels clients on interpretation and risk mitigation under the Anti-Kickback Statute, Stark Law and EKRA. She also advises on internal and government investigations related to the False Claims Act, Stark Law and Anti-Kickback Statute. Her extensive experience navigating civil and criminal investigations within the healthcare space informs her strategic approach to risk management in transactions and the development of robust compliance programs.

Digital Health

Caroline advises clients involved in digital health—the intersection of health software applications, analytical tools, medical technology and electronic data assets enabled by the internet and mobile devices—on the applicable legal and regulatory infrastructure, with a particular focus on remote patient monitoring programs. She offers nuanced insights into fraud and abuse issues that arise in novel partnerships and other relationships between digital health companies and established healthcare providers. Her broad experience allows her to deliver practical, forward-thinking compliance and revenue strategies that help her clients thrive in today’s complex and still-evolving digital health regulatory landscape.

Medicare Reimbursement and Healthcare Compliance Matters

Caroline advises Medicare providers, consultants and vendors on a wide range of business, legal and regulatory issues. Caroline has extensive experience advising clients on Medicare and Medicaid fee-for-service reimbursement, billing and coding. She also advises clients on professional licensure, scope of practice, physician and health care professional clinician relationships and supervision, together with overall corporate compliance.

Prior to joining the Firm, Caroline served as a health law fellow for a regional nonprofit health system and as a law clerk at the US Department of Health and Human Services. Her background gives her a deep understanding of legal issues from both the regulator and provider perspectives.

Michael (Mike) Ryan advises manufacturers, healthcare providers, and investors on the legal, regulatory, and reimbursement/market access issues that arise during the development and commercialization of medical devices, clinical laboratory testing services, biological products, and drugs. He helps clinical laboratories and life sciences companies maintain regulatory compliance and evaluate, develop, and implement strategies to optimize coding, coverage, and payment for novel technologies.

Additionally, Mike helps innovative companies identify and navigate applicable Food and Drug Administration (FDA) regulatory requirements for new technologies, particularly in vitro diagnostics and digital health products. He regularly advises clients on the FDA’s evolving requirements for laboratory developed tests (LDTs) and reviews promotional and marketing materials for FDA-regulated medical products.

Mike also counsels clinical laboratories on state and federal compliance issues, including those under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), state laboratory licensure laws, and billing and reimbursement rules.

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.

Guides development and launch of digital health products and AI-enabled products and services

Structures data use, disclosure, and commercialization strategies for health technology clients

Leads full scale ransomware and other cybersecurity incident remediation and response for private and public companies

Manages government investigations related to privacy, cybersecurity, and consumer protection issues

Advises on HIPAA, HITECH, and health information privacy compliance

Counsels on website and mobile app tracking technologies and wiretapping risk

Patrick Zanayed represents private equity funds, digital health companies, strategic investors, ambulatory surgery centers, behavioral health facilities, senior care facilities, physician practices, and dental practices in a variety of transactional and regulatory matters. He also has deep experience advising on pharma services, clinical research, and health technology transactions.

Patrick has assisted clients in connection with numerous transactions, including mergers, acquisitions, dissolutions, and management and professional service arrangements, as well as the creation of multi-state physician practice management and telehealth structures. He also regularly advises clients with respect to corporate practice of medicine laws, state and federal telehealth laws, pharmacy laws, the fraud and abuse laws including the Anti-Kickback Statute, Beneficiary Inducements Civil Monetary Penalty Law, the Stark law and other federal and state legal, regulatory and business issues affecting healthcare providers and facilities.