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.

Caitlyn M. Campbell, a former US Securities & Exchange Commission (SEC) Enforcement Attorney, co-leads the firm's SEC enforcement practice. She represents clients in SEC investigations, securities class action and derivative litigation and compliance matters. With more than two decades of experience in public service and private practice, Caitlyn advises on complex issues involving alleged violations of federal securities laws, including accounting fraud, disclosure and internal controls-related violations, regulatory violations by investment advisers and broker-dealers, insider trading, market abuse, anti-corruption and Foreign Corrupt Practices Act (FCPA) violations and whistleblower claims. She also assists companies in developing training programs and compliance policies and procedures.

Before joining McDermott Will & Schulte, Caitlyn served eight years at the SEC, including as Senior Counsel to the Directors of Enforcement, assisting with the management of the Commission’s largest division. At the SEC, Caitlyn led all aspects of investigations involving accounting fraud, complex insider trading schemes, market abuse, market manipulation, misappropriation of investor funds, investment adviser fraud and the Immigrant Investor Program. She also coordinated complex, cross-border investigations with foreign regulators. In addition to her investigative work, Caitlyn co-chaired the New England region committee that focused on proactively identifying accounting and disclosure fraud and served as liaison to both the SEC's national Financial Reporting and Audit Group and the Boston FBI.

Caitlyn has conducted numerous internal investigations for major public companies, their boards of directors, and board committees.  She has represented public companies, audit firms, senior executives, registered investment advisers, hedge funds and private equity firms in matters before the SEC, US Department of Justice (DOJ), and the Financial Industry Regulatory Authority (FINRA). Her litigation experience includes representing corporations, directors, and officers in securities class actions and shareholder derivative suits. She has also advised clients in Special Purpose Acquisition Company (SPAC)-related litigation and SEC investigations.

A frequent speaker on enforcement, accounting fraud, and internal investigations, Caitlyn is recognized for her deep understanding of the intersection between regulatory expectations and corporate governance.

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.

Paul Helms helps clients navigate their most serious securities and fraud-related challenges, acting as both a trusted counselor and steady advocate. A former senior attorney at the Securities and Exchange Commission (SEC), where he served as counsel to the Director of Enforcement, Paul draws on his government experience to defend clients in SEC enforcement matters, internal investigations, and private securities litigation.

As the co-lead of McDermott Will & Schulte’s SEC enforcement practice, Paul represents public companies, investment advisers, accounting firms, and corporate leaders nationwide. He knows that investigations and lawsuits are not just legal matters – they can be personally and professionally disruptive. Paul’s approach centers on clear communication, practical strategy, and securing the best possible outcome while minimizing the impact on clients’ lives and businesses.

With experience on both sides of the table, Paul has handled the full spectrum of SEC matters: accounting and disclosure issues, investment adviser and broker-dealer compliance, offering fraud, market manipulation, public finance, Foreign Corrupt Practices Act (FCPA), insider trading, and professional liability. He has led high-profile internal investigations into complex fraud and compliance problems and successfully defended clients in shareholder derivative suits and securities class actions, achieving dismissals and favorable settlements.

Paul also dedicates time to pro bono work. He serves as external general counsel of Episcopal Charities in Chicago and has led fraud-related investigations for nonprofit organizations. Earlier in his career, Paul clerked for Judge James H. Michael Jr. of the US District Court for the Western District of Virginia and served as editor in chief of the Vanderbilt Law Review. He is a Chartered Alternative Investment Analyst (CAIA) and a Certified Fraud Examiner (CFE).

Jeremy White represents a wide range of clients in complex litigation matters in the wage and hour, employment discrimination and public accommodation areas.

Jeremy has specific experience in collective and class actions under Title VII of the Civil Rights Act of 1964, the Equal Pay Act (EPA), the Americans with Disabilities Act (ADA), the Fair Labor Standards Act (FLSA) and other federal and state statutes concerning employment-related claims. He has defended employers before federal, state and local agencies, courts and courts of appeals.

Jeremy counsels employers on a full spectrum of workplace issues, including personnel policies and practices, employee classifications, separations, terminations and layoffs, performance management, internal complaints and investigations, restrictive covenants and dispute resolution measures.

Jeremy also has experience defending companies against lawsuits brought under Title III of the ADA, California’s Unruh Civil Rights Act, the Florida Civil Rights Act, New York State Civil Rights Law and other similar state laws. These matters have involved a broad range of accessibility issues, including but not limited to architectural barriers, mobility devices, websites, service animals and communication technologies.

Jeremy maintains an active pro bono practice, and has represented clients, including disability rights organizations, in various matters.

Richard B. Smith focuses his practice on representation of life sciences companies and related transactions. He has served as counsel to public, private and emerging life sciences companies, advising those companies on strategic business transactions such as licensing, joint ventures, and collaborations involving research, development, marketing, supply, clinical development and co-promotion of pharmaceutical, diagnostic and medical device products.

Richard also advises companies on other corporate issues common to life sciences companies, including corporate formation of new ventures, venture capital, private equity, venture philanthropy and other forms of financing, mergers and acquisitions, as well as university and institutional licensing and intellectual property strategies.