McDermott Will & Schulte, a global law firm

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.

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.

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

Mimi Alexandre counsels clients across the healthcare industry with a particular focus on entities in the managed care arena. Mimi routinely works with health plans, health maintenance organizations, private equity funds and vendors, helping them navigate complex regulatory schemes and facilitate business objectives.

Mimi has deep familiarity with and significant experience in government programs, including Medicare Advantage and Part D. She leverages this knowledge to provide risk assessments and practical advice. Mimi also routinely negotiates complex agreements with providers, pharmaceutical benefits managers and risk adjustment vendors. As the managed care landscape shifts, Mimi has gained significant experience evaluating the need for risk-bearing licenses and assisting in the formation of value-based contracting arrangements.

Mimi regularly brings her regulatory knowledge to bear on transactions involving plans, providers, intermediaries and vendors. In this capacity, Mimi evaluates regulatory and business risks for buyers and investors and negotiates deal documents accordingly.

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.

Grayson I. Dimick provides strategic regulatory counseling for a wide variety of healthcare industry members. She delivers creative and practical legal solutions for digital health initiatives that comply with the constantly evolving regulatory landscape.

Grayson counsels healthcare providers, health systems, private equity firms and their portfolio companies, and technology companies on regulatory, transactional and compliance matters. She advises on professional and facility licensure, corporate practice of medicine requirements, professional scope of practice and supervision, prescribing and reimbursement. She also assists clients with the development and implementation of telehealth programs.

Grayson is a member of the Firm’s Gender Diversity Subcommittee and maintains an active pro bono practice.

While in law school, Grayson was a law fellow for Georgetown University Law Center’s first-year legal research and writing program and a senior staff editor for the Food & Drug Law Journal. Prior to law school, she worked for a health policy research center and a behavioral health organization.

Edward (Ted) Diskant is a former federal prosecutor and the co-head of McDermott Will & Schulte’s global white-collar and government investigations practice. Ted leverages his background overseeing some of the most high-profile criminal matters brought by the US Attorney’s Office for the Southern District of New York to help companies and individuals navigate a wide range of white-collar, litigation, and regulatory enforcement matters. Recognized as a leading white-collar practitioner by Chambers USA, Ted is “super responsive and practical” in approaching clients’ most sensitive and complex issues. He is routinely hired to lead sensitive internal investigations and respond to government inquiries, with a particular focus on matters involving the False Claims Act (FCA), the Foreign Corrupt Practices Act (FCPA) and other anti-bribery laws, wire fraud, healthcare fraud, money laundering, and the Bank Secrecy Act (BSA).

An experienced trial lawyer, Ted also regularly takes complex civil and criminal cases to trial. Recognized as part of McDermott’s globally ranked team, Global Investigations Review (GIR) highlights that Ted “brings lots of trial experience to the table,” and clients rely on Ted’s extensive courtroom experience at all stages of litigation. Ted also frequently consults on compliance matters and helps clients design, implement, and audit compliance programs consistent with US Justice Department (DOJ) and other applicable guidance.

Prior to joining McDermott Will & Schulte, Ted spent nine years at the US Attorney’s Office for the Southern District of New York, most recently serving as Chief of the Public Corruption Unit. In that capacity, Ted supervised a team of approximately twenty senior prosecutors, overseeing some of the Office’s most sensitive and high-profile matters. Ted also led investigations and prosecutions of financial institutions related to compliance with the BSA, as well as US sanctions and AML requirements.

As part of his pro bono practice, Ted serves on the Criminal Justice Act (CJA) Panel for the Southern District of New York, representing defendants in federal criminal matters, appeals, and in habeas proceedings. Ted co-founded the LGBT White-Collar Working Group and serves on the Firm’s Diversity Committee.

Prior to joining the US Attorney’s Office, Ted clerked for the Hon. Debra Ann Livingston, Chief Judge, United States Court of Appeals for the Second Circuit, and for the Hon. Sidney H. Stein, United States District Court, Southern District of New York.

Pankit J. Doshi serves as the Office Managing Partner for the Firm’s San Francisco and Silicon Valley Office.

Pankit focuses his practice on preventative counseling and representing employers in both state and federal courts up through trial and appeal. Pankit serves as lead counsel on cases involving issues related to prosecution and defense of unfair business competition claims, including trade secret misappropriation and restrictive covenant enforcement, independent contractor misclassification, whistleblower complaints, wage and hour disputes and individual claims for wrongful termination, sexual harassment, discrimination, retaliation and breach of contract claims. Pankit also regularly defends employers in complex wage and hour class action and representative actions around the country.

Pankit provides advice and counseling to employers of all sizes, ranging from Fortune 100 companies to startups, on a full-spectrum of labor and employment issues, among them structuring of restrictive covenants, advising on employment compliance strategies, evaluating independent contractor and exempt status relationships, preparing executive employment agreements and protecting intellectual property. He has also assisted companies with nationwide wage and hour and misclassification audits, as well as highly sensitive workplace harassment investigations.

Pankit is experienced in handling employment matters across numerous industries, including automotive, construction, consulting, entertainment, financial services, healthcare, hospitality, manufacturing, pharmaceuticals, retail, security, technology, telecommunications and transportation.

Pankit represents employers at trial, administrative hearings and during investigations by various state and federal agencies, including the US Department of Labor, the US Equal Employment Opportunity Commission, the California Department of Fair Employment and Housing and the California Department of Industrial Relations - Division of Labor Standards Enforcement.

Pankit frequently lectures at annual meetings on employment law issues around the country.

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.

With a practice focused primarily on the development, delivery and implementation of digital health solutions, data and research, Jennifer S. Geetter works closely with both adopters and developers to bring their innovative healthcare solutions to patients and providers. In order to design and deploy digital health technologies effectively, Jenn offers valuable guidance on key issues, like patient on-boarding, provider implementation, privacy and regulatory issues. She advises global life sciences, healthcare and informatics clients on legal issues attendant to digital health, biomedical innovation, research compliance, global privacy and data security laws, and financial relationship management. Jennifer represents a broad range of clients, including the following:

• Mobile app, mHealth, and other digital health technology companies and platform providers
• Informatics, data broker and data aggregator companies
• Pharmaceutical, device and biologics companies
• Health plan, institutional healthcare provider and other enterprises
• Research institutes

Clients seek Jennifer out for her knowledge on the development of data and biospecimen registries and real-world evidence (RWE). She advises healthcare and life sciences stakeholders in considering the complex regulatory and implementation challenges that arise when developing these registries and other digital care solutions, including research, compliance, privacy, interoperability, and data governance, access and curation. Jenn also considers a range of other issues that impact how registries are built, including data governance strategies and application. She has built a strong reputation for counseling clients through registry development, with special emphasis on navigating the unique legal nuances around genetic information, biospecimens, sensitive data and other special use cases. Jennifer assists these clients with a range of projects, including the following:

• Health Insurance Portability and Accountability Act (HIPAA), Federal Trade Commission (FTC), and state and federal privacy, security and breach response preparedness and response
• Development and implementation of data-sharing strategies and platforms to achieve business objectives, particularly in connection with biomedical innovation, healthcare reform, electronic health record implementation and quality assurance requirements
• Data privacy, data mapping and data use strategies for mobile apps and other mHealth and digital technologies
• Research compliance, research program structure, and operational and compliance infrastructure
• Complex research affiliation agreements and arrangements
• Scientific review and research misconduct proceedings and investigations (internal and with government involvement)
• Biobanking and registry development and compliance, including emerging issues in the future, unspecified use of biospecimens and genomic data

In her work with digital health clients on strategic and compliance counseling, Jennifer is especially knowledgeable on interoperable, comprehensive data collaborations and data webs, and human subject research compliance. Her forward-thinking and strategic vision have benefited clients in the development of comprehensive data strategies concerning areas such as privacy, security, data mapping, secondary data use, availability and interoperability.

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.

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.

Tony Maida counsels health care and life sciences clients on government investigations, regulatory compliance and compliance program development. Having served as a government official, Tony has extensive experience in health care fraud and abuse and compliance issues, including the federal and state Anti-Kickback and Stark Laws and Medicare and Medicaid coverage and payment rules. Tony is a practice area leader for the Healthcare Regulatory & Compliance practice.

He represents clients in False Claims Act (FCA) qui tam matters, government audits, civil monetary penalty and exclusion investigations, and Centers for Medicare and Medicaid Services (CMS) suspension, and revocation actions, negotiating and implementing corporate integrity agreements, and making government self-disclosures. Tony also draws on his background in government investigations to assist clients in evaluating, developing and implementing corporate compliance programs.

Tony previously served as deputy chief of the Administrative and Civil Remedies Branch of the US Department of Health and Human Services (HHS) Office of Inspector General (OIG), where he represented the agency on investigating FCA and civil monetary penalty cases, negotiating and monitoring corporate integrity agreements, and defending exclusion appeals. While serving at HHS, Tony was a principal author of the OIG's current Self-Disclosure Protocol. He also has advised CMS on policy issues, including the Medicare Overpayment Rule and the creation of the Self-Referral Disclosure Protocol.

Tony represents a wide variety of clients, including

• Hospitals and health systems
• Professional services organizations and physician practice management companies, such as anesthesia, dentistry, dermatology, emergency medicine, oncology, primary care, radiology and wellness practices
• Pharmaceutical and medical device manufacturers and distributors
• Long-term care, home health, hospice and other post/sub-acute providers
• Pharmacies and pharmacy benefit managers
• Dialysis providers
• Laboratories
• Ambulance companies
• Health plans
• Electronic health records and revenue cycle management vendors
• Investors and other financial institutions that invest in and/or support the health care and life science industries

Tony writes and speaks frequently on health care regulatory topics and has lectured on health care fraud and abuse issues at Boston University School of Law and American University Washington College of Law.

Prior to his government service, Tony represented hospitals and physician practices on health care regulatory and corporate compliance issues. During law school, Tony was the editor of the 2001 Symposium issues of the American Journal of Law and Medicine.

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

Advises clients on trademark and copyright counseling, licensing, prosecution, and enforcement

Helps companies register, maintain, protect, and license trademarks, service marks, domain names, and other brand assets worldwide

Supports business-focused IP planning for transactions, including strategic alliances, joint ventures, M&A, and complex IP license structures

Advises on data-licensing issues, including for clients operating in the digital health space

Michael S. Nadel is a first-chair trial lawyer, litigator, and advisor to businesses and ultra-high-net-worth families. He solves clients’ most difficult and sensitive problems.

Michael has won jury trials and arbitrations involving breach of contract, trade secret misappropriation, fraud, breach of fiduciary duty, patent and trademark infringement, the False Claims Act, unfair competition, defamation, and deceptive trade practices. He won the first jury verdict obtained by any litigant under the Defend Trade Secrets Act, the federal trade secret statute. Recently, Michael won mission-critical victories for clients in the fields of technology, healthcare, and heath data licensing. He also engineers successful outcomes in contentious intrafamily and intrabusiness disputes and has won guardianship, conservatorship, and trust battles.

Beyond the courtroom, Michael leverages his quarter century at McDermott to marshal the firm’s global resources for transactions, criminal and internal investigations, and crisis management efforts.

Kristen O’Brien is an accomplished healthcare executive with a deep understanding of regulatory advocacy and healthcare policy efforts.

Kristen offers a strong background and a keen eye for solutions to barriers and challenges impacting healthcare clients. With more than 10 years of experience, her work focuses on implementing new laws through the rulemaking process, as well as working with relevant agency officials to develop and improve agency guidance.

Kristen recently served as Principal of the Health Industry Policy and Regulatory Practice Group at a law and lobbying firm where she provided representation for hospital systems, physician practices, medical device companies, digital health companies and trade associations. She has extensive experience in providing analysis and counsel related to government healthcare payment programs under Medicare and Medicaid. She also has extensive knowledge of navigating the Centers for Medicare & Medicaid Services (CMS), the Office of the National Coordinator for Health Information Technology (ONC) and others.

Previously, Kristen provided legislative and regulatory legal analysis as a senior attorney for the American Medical Association. Additionally, Kristen served on the staff of former Senator Max Baucus (D-MT), focusing on health and environmental issues, as well as financial reform.

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.

Sagar K. Ravi brings nearly a decade of experience as a federal prosecutor and seasoned trial lawyer to advise clients facing a wide range of white-collar and regulatory enforcement matters and high-stakes disputes. His practice focuses on cutting-edge issues at the intersection of law and technology, including digital assets, privacy and cybersecurity, healthcare fraud, false advertising, and artificial intelligence (AI). Leveraging his extensive engagement with US Department of Justice (DOJ) components, state attorneys general, and civil regulators, Sagar helps companies and individuals navigate complex, consequential investigations involving multiple government agencies and stakeholders and any ensuing litigation.

Before joining the firm, Sagar served as chief of the Complex Frauds and Cybercrime Unit at the US Attorney’s Office for the Southern District of New York (SDNY), where he led a team of 20 senior prosecutors handling the most sophisticated fraud and cyber cases in the country, many of which were international in scope. He oversaw groundbreaking investigations, including some of the first US criminal investigations involving AI.

As a prosecutor, Sagar led and supervised cases and cross-border investigations involving healthcare fraud, the False Claims Act (FCA), securities and investment fraud, intellectual property and trade secrets theft, consumer fraud, tax offenses, sanctions, the Foreign Corrupt Practices Act (FCPA), and money laundering and the Bank Secrecy Act (BSA). During his time at SDNY, Sagar tried and supervised 23 federal criminal trials to verdict and handled 10 appeals before the US Court of Appeals for the Second Circuit. In addition to the DOJ, through his extensive experience with joint and parallel investigations, Sagar has had regular engagement with multiple civil regulators, including the US Securities and Exchange Commission (SEC), the US Commodity Futures Trading Commission and the Federal Trade Commission, among others.

Recognized nationally for his experience handling novel, high-profile criminal cyber and national security matters, Sagar provides strategic counsel to clients facing sensitive cross-border cybersecurity incidents, ransomware attacks, and AI-related risks. He also advises clients on the full spectrum of digital asset issues, including cryptocurrency theft and investment fraud, smart contract manipulation, fraud in non-fungible token (NFT) offerings, and crypto-enabled money laundering.

Earlier in his career, Sagar clerked for the Honorable Kiyo A. Matsumoto of the US District Court for the Eastern District of New York and practiced at an international law firm representing corporate and individual clients in a variety of white-collar matters.

James (Jamie) Ravitz is the co-head of the firm’s Life Sciences industry practice and head of the Food and Drug Administration (FDA) practice. He works alongside clients across the entire spectrum of life sciences and healthcare law, including regulatory counsel, compliance, and investigations and government enforcement. He is particularly focused on Food and Drug Administration (FDA) regulatory counseling. Jamie works in partnership with companies and investors across the complete ecosystem of FDA-regulated products — drugs, devices, health technologies, biologics, food, cosmetics and cannabis — to help them achieve their business goals.

Jamie works with manufacturers and distributors of FDA-regulated products, with deep experience on novel drugs, biologics, and cutting-edge products, from the product concept stage through to post-market and product marketing to facilitate market success and reduce enforcement risk. Jamie is a valuable addition to healthcare and life sciences transaction matters, assisting clients with FDA-related due diligence to maximize value and minimize risk and roadblocks during the transaction.

When compliance or enforcement matters arise, Jamie takes a proactive, business-focused approach to address the issues with minimal business disruption. He also works with clients on the regulatory components of internal investigations, enforcement activity, and consumer protection litigation when they arise. He has worked with clients on numerous internal investigations and responses to Office of Inspector General (OIG) and US Department of Justice (DOJ) subpoenas and has assisted in the defense and settlement of qui tam whistleblower suits alleging violations of the False Claims Act.

Jamie is a recognized thought leader in the health law and medical device spaces. He is a regular speaker at health and life sciences industry conferences and has served as an advisory board member to bio-innovation centers and trade media editorial boards.

Prior to joining McDermott Will & Schulte, Jamie served as leader of the FDA, healthcare, and consumer products compliance practice at a large international law firm.

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.

Stephen Reynolds (CIPP/US, CISSP) advises some of the largest companies in the world on complex data security and privacy matters.

A former computer programmer and IT analyst, Stephen is uniquely able to use his computer background to the advantage of his clients in matters involving data security, privacy, artificial intelligence and computer forensic investigations. He assists with responding to cybersecurity incidents, such as ransomware attacks, fund transfer fraud, data breaches and business email compromise matters. This work includes helping companies comply with regulatory obligations in the event of these incidents—including Securities and Exchange Commission (SEC) filings for publicly traded companies. Having litigated data security and privacy cases from the trial court level and through the highest levels of appeals, Stephen also represents clients in litigation and regulatory investigations regarding data security, privacy and technology matters.

Stephen has advised multiple publicly traded companies, including technology companies, professional services firms and consumer facing organizations, on compliance with the SEC’s recently adopted requirements for disclosing cybersecurity incidents, risk management and governance within 10-K annual reports. This guidance has included helping clients draft language for SEC reporting obligations and craft internal policies related to SEC disclosure obligations. Additionally, Stephen has helped clients with evaluating the potential need for and in making disclosures of material cybersecurity incidents on Form 8-Ks.

Stephen frequently educates others on data security and privacy at industry conferences and other forums. He is on the board of the International Association of Privacy Professionals (IAPP) and an instructor of the IAPP’s CIPP/US certification. In addition, Stephen is an instructor for the CISSP certification through the ISC(2). He also lectures on Data Security and Privacy Law at Indiana University Robert H. McKinney School of Law.

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.