Digital Health Forum 2023

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.

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.

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

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.

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.

David Quinn (Dave) Gacioch focuses his practice on litigation and enforcement defense, primarily related to the US healthcare sector.  Dave counsels hospitals, health systems, physician practices, and other providers, along with payors, private equity sponsors, pharmaceutical and medical device manufacturers, and others involved in the US healthcare system, on compliance and risk mitigation issues.  He conducts internal investigations for clients, and represents them in government investigations, enforcement actions, and civil and criminal litigation, including class actions.

Dave has deep experience across a number of key substantive issues, including:

• False Claims Act matters pursued by whistleblowers (qui tam cases) or government authorities;
• Fraud and abuse issues arising under the Anti-Kickback Statute, the Stark Law, and other laws governing federal healthcare programs such as Medicare and Medicaid—especially fair market value (business valuation and professional services compensation) issues;
• Federal and state oversight of controlled substance laws, including defending Drug Enforcement Administration (DEA) investigations;
• Information privacy, cybersecurity and data breach response issues arising under the Health Insurance Portability and Accountability Act (HIPAA), 42 C.F.R. Part 2, and other US federal and state laws;
• Website and mobile application user tracking technologies and potential regulatory and litigation challenges to their deployment, including under wiretapping/eavesdropping statutes;
• Conscience and religious freedom-based investigations of providers by the US Department of Health & Human Services, Office for Civil Rights (HHS-OCR);
• Negotiation of, and compliance with, corporate integrity agreements (CIAs) and corrective action plans (CAPs);
• Response to sentinel events, such as allegations of provider staff abuse of patients— including compliance with real-time administrative and criminal reporting obligations while planning for potential investigative, civil litigation, and community relations impacts downstream;
• Compliance with and investigation preparation/defense regarding COVID-19 pandemic relief programs such as the CARES Act Provider Relief Fund and advance/accelerated Medicare payments; and
• Response to civil investigative demands (CIDs) and subpoenas.

Dave works closely with McDermott’s best-in-class Health Industry Advisory team to provide litigation and enforcement defense representation informed by leading-edge thinking on complex healthcare regulatory issues.  As a recent example, Dave co-leads the Firm's Post-Dobbs Resource Center - a joint healthcare, regulatory, privacy and litigation team that counsels clients on how to navigate the challenging legal landscape around abortion and other reproductive health care in the wake of the US Supreme Court's  Dobbs v. Jackson Women’s Health Org. decision in 2022.

Additionally, Dave is working closely with McDermott’s best-in-class Health Information Privacy and Privacy/Cybersecurity teams to provide comprehensive, strategic counseling and representation to clients around website and mobile application user tracking and marketing technologies (AdTech)—including defending multiple class action cases brought against clients under wiretapping/eavesdropping statutes.

Dave is one of the leading lawyers in the United States in the area of responding to HHS-OCR investigations, whether based upon HIPAA or upon conscience and religious freedom laws, and negotiating favorable resolutions when such investigations result in allegations of non-compliance by covered entities or business associates. Notably, Dave served as lead counsel in the successful defense of a health system against the first attempt by the HHS-OCR and the Department of Justice Civil Rights Division to take conscience-based enforcement action against a provider—securing a dismissal of the DOJ lawsuit and a reversal of HHS-OCR’s notice of violation.

As a former advanced emergency medical technician and ambulance service officer, Dave brings a provider’s perspective to the practicalities of healthcare compliance and risk mitigation, which allows him to grasp issues quickly and to communicate them effectively both to and on behalf of providers.

Dave’s practice also includes commercial litigation and dispute resolution on behalf of a variety of clients inside and beyond health care, including a leading alcohol beverages brand.  Additionally, Dave serves as national coordinating counsel for a building products manufacturer in the asbestos product liability litigation.

Dave regularly writes and lectures on the issues referenced above. Dave also has significant trial, hearing, and arbitration experience, and has performed extensive pro bono work.

Previously, Dave served as law clerk to the Honorable Ernest C. Torres, Chief Judge of the US District Court for the District of Rhode Island.

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

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.

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.

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.

Amy C. Pimentel (CIPM) advises clients on the legal, regulatory, and governance challenges that arise at the intersection of privacy, cybersecurity, and technology. She helps organizations navigate evolving global requirements while developing practical strategies that enable innovation, manage risk, and support business growth. Amy is particularly skilled at translating complex legal and regulatory frameworks into operational solutions that work across jurisdictions, products, and business functions.

Amy serves as a strategic advisor to companies developing, deploying, and scaling technology-driven products and services. She counsels clients on artificial intelligence (AI) governance, data strategy, privacy compliance, cybersecurity, and digital product development, helping them harness emerging technologies responsibly and effectively. Working across industries — including health care and life sciences, technology, financial services, media/social media, and consumer products — Amy partners with legal, product, engineering, and executive teams to embed privacy, security, and responsible AI principles throughout the product lifecycle. Her practical, business-focused approach helps clients bring innovative products to market while navigating an increasingly complex regulatory environment.

In addition to regulatory and product counseling, Amy advises on technology, data, and cybersecurity issues in commercial transactions, outsourcing arrangements, strategic partnerships, and corporate transactions. She drafts and negotiates complex technology and data agreements, conducts privacy and cyber due diligence, and counsels clients on third-party risk management, data commercialization, security incidents, and regulatory investigations. By combining deep regulatory knowledge with a strong understanding of emerging technologies, Amy helps clients address today's challenges while preparing for the risks and opportunities of tomorrow.

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.

Aroma Sharma focuses her practice on a wide range of corporate and transactional matters, acting predominantly for private and emerging companies. Aroma has advised clients on mergers and acquisitions, debt and equity financing, corporate and equity restructuring and recapitalizations and joint ventures in various industries, including technology and health and life sciences. She also advises clients regularly on general corporate and corporate governance matters. Aroma also has experience working on cross-border transactions, including business’ international expansion into new territories.

Aroma regularly serves as primary outside counsel for clients. She understands the importance of knowing a client’s business, and completed a secondment with a large, multi-national accounting and advisory firm, assisting with drafting and negotiating commercial transactional agreements.

Aroma was also a fellow in Entrepreneurship, Social Entrepreneurship & Innovation at NYU School of Law and has a special interest in working with social enterprises and sustainable businesses.

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.