Monica R. Chmielewski, Partner | Foley & Lardner

Monica R. Chmielewski is a partner at Foley & Lardner LLP and vice chair of the firm’s Health Care Practice Group. She concentrates her practice exclusively on health care and life sciences matters, representing health systems, hospitals, academic medical centers, pharmaceutical, biotech, and medical device companies, as well as pharmacies. Monica advises clients across the full life cycle of medical research, development, and commercialization, including regulatory compliance, clinical trials (including decentralized trials), FDA submissions, manufacturing, supply chain matters, and complex health care transactions.

• Education & Credentials
  • Monica earned her Juris Doctor, cum laude, from Wayne State University, where she was inducted into the Order of the Coif. She received her undergraduate degree in Government and Ancient History and Archaeology from Franklin and Marshall College. She is admitted to practice law in Illinois and Michigan.
• Recognition & Leadership
  • Monica has been recognized by Chambers USA: America’s Leading Business Lawyers in Healthcare: Pharmaceutical/Medical Products Regulatory from 2020 through 2025. She has also been named a Thomson Reuters Stand-out Lawyer for 2023–2024 and has been recognized in The Legal 500 for her work in Life Sciences.
• Professional Involvement
  • Monica is a frequent author and contributor to Health Care Law Today, where she writes on emerging FDA guidance, clinical trial considerations, digital health technologies, and life sciences regulatory developments. She is also an experienced speaker, presenting topics such as research misconduct proceedings, FDA regulatory updates, and digital health compliance issues.
• Experience
  • Monica provides ongoing counsel to health care providers and life sciences companies on regulatory compliance matters governing clinical research, including Institutional Review Board issues, investigations of research misconduct, and adherence to good clinical practice standards. She advises clients on FDA submissions, 510(k) applications, pharmaceutical product promotion — including off-label considerations — and the regulation of software and mobile applications as medical devices.

• • Her practice also includes advising on drug and device supply chain regulation, pharmacy and PBM contracting, group purchasing organization negotiations, and federal and state compliance obligations. Monica represents clients in government investigations and audits and counsels on compliance matters involving the False Claims Act, Stark Law, Anti-Kickback Statute, HIPAA, and related laws. In addition, she serves as transactional counsel in mergers, acquisitions, joint ventures, and other complex health care and life sciences transactions, and advises clients on structuring and regulatory issues related to telemedicine and telehealth services.

Melissa K. Bianchi, Partner | Hogan Lovells

Melissa K. Bianchi is a partner in the Washington, D.C. office of Hogan Lovells and leads the firm’s digital health initiative. She brings a cross-disciplinary approach to digital health products, including mobile applications, wearable technologies, and other health IT solutions. Well versed in health privacy law, she advises pharmaceutical and biotechnology companies, health plans, hospitals, and academic medical centers on complex health data issues arising under the Health Insurance Portability and Accountability Act (HIPAA) and other U.S. privacy and regulatory frameworks. Her practice spans digital health innovation, clinical research compliance, health information exchange, and prescription drug coverage issues under Medicare Part D, Medicaid expansion, and broader health reform initiatives.

• Education & Credentials
  • Melissa earned her Juris Doctor from Stanford Law School and her A.B., magna cum laude, from Harvard University. She is admitted to practice in the District of Columbia and in California.
• Recognition & Leadership
  • Melissa has been recognized by The Legal 500 US for her work in Healthcare: Health Insurers and Technology: Data Protection and Privacy. She was also named one of Nightingale’s Outstanding Young Healthcare Lawyers.
• Professional Involvement
  • Melissa is a frequent speaker and thought leader on digital health, prescription drug coverage, and health reform developments. She regularly advises trade associations, pharmaceutical companies, and health plans on evolving Medicare Part D and Medicaid prescription drug coverage issues and broader regulatory changes affecting the life sciences industry.
• Experience
  • Melissa advises pharmaceutical, biotechnology, digital health, and health information technology companies, as well as hospitals and academic medical centers, on privacy, data governance, and clinical research compliance. She counsels clients on structuring research activities under HIPAA, managing health information exchange and meaningful use requirements, and addressing genetic information and data repository issues.

• • Her experience includes serving as outside privacy counsel on clinical trial recruitment initiatives, advising on the use of mobile technologies in clinical trials and patient support programs, conducting privacy assessments, and guiding clients through data breach response and compliance obligations. She also
    represents pharmaceutical companies and health plans in matters involving Medicare prescription drug coverage and health reform implementation.

Khaled Mowad, Counsel | Hogan Lovells

Khaled Mowad is counsel in the New York office of Hogan Lovells, where he advises clients across industries — including technology, health care, sports, media, and financial services — on the legal, regulatory, and commercial issues surrounding data, innovation, and risk. Drawing on deep experience with U.S. federal and state privacy and consumer protection laws, including HIPAA, the California Consumer Privacy Act (CCPA), the FTC Act, the General Data Protection Regulation (GDPR), and the Gramm-Leach-Bliley Act (GLBA), he helps organizations navigate complex compliance obligations, structure data-sharing arrangements, and negotiate commercial agreements involving sensitive information and emerging technologies. His practice frequently involves high-stakes business partnerships, mergers and acquisitions, strategic procurement, and large-scale data transactions, particularly in highly regulated sectors such as health care.

• Education & Credentials
  • Khaled earned his J.D. from Harvard Law School and his B.A. from Rutgers, The State University of New Jersey. He is admitted to practice in New York and New Jersey.
• Recognition & Leadership
  • Khaled has advised clients on complex, high-value transactions and strategic collaborations across regulated industries, including matters involving multinational organizations and data-driven business models.
• Professional Involvement
  • Khaled regularly contributes to client advisories and thought leadership addressing emerging developments in data protection, AI, and regulatory risk management.
• Experience
  • Khaled draws on deep experience with U.S. federal and state privacy and consumer protection laws, including HIPAA, the California Consumer Privacy Act (CCPA), the FTC Act, the General Data Protection Regulation (GDPR), and the Gramm-Leach-Bliley Act (GLBA). He regularly counsels clients — from start-ups and emerging companies to established multinational organizations and investors — on structuring data-sharing arrangements, negotiating commercial agreements involving sensitive information and emerging technologies, and mitigating regulatory and transactional risks.

• • With a particular focus on health care and other highly regulated industries, Khaled supports clients as they deploy digital solutions, leverage data as a strategic business asset, and navigate compliance considerations in complex transactions and innovation-driven initiatives.

I. Transfer and Treatment of Medical Records in Healthcare Transactions | 1:00pm – 2:00pm

This session will review and discuss legal and regulatory considerations associated with the transfer of medical records and information in various healthcare transactions, including mergers, affiliations, joint ventures, and asset sales. We will examine, in relation to specific transaction structures, the different models of record transfer and the regulatory and compliance considerations associated with each, including the applicability and interplay of HIPAA and state privacy and records retention laws, as well as patient access rights and issues related to record valuation.

In addition, the session will address practical compliance planning and risk mitigation considerations that arise when health information changes custody or control. Participants will explore how transaction structure impacts data ownership, custodianship, and ongoing compliance obligations; how to allocate responsibility for legacy records, electronic health record (EHR) systems, and archived data; and how to anticipate and manage continuing regulatory obligations following closing. The discussion will also consider emerging issues involving digital health platforms, decentralized record systems, and cross-state data transfers, providing attendees with actionable guidance for structuring compliant record transfer frameworks in complex healthcare transactions.

Break | 2:00pm – 2:10pm

II. Data Risk and Regulatory Scrutiny in Healthcare M&A: Diligence, Deal Structure, and Successor Liability | 2:10pm – 3:10pm

Healthcare transactions present uniquely complex data protection and privacy challenges that extend well beyond traditional deal diligence. In addition to evaluating financial and operational risk, buyers and sellers must assess compliance with the Health Insurance Portability and Accountability Act (HIPAA), evolving consumer health data statutes, and heightened regulatory scrutiny from agencies including the FTC, attorneys general, and U.S. Department of Health and Human Services (HHS).

This session will examine how medical records, patient data flows, AI-enabled tools, vendor ecosystems, and breach history impact valuation, deal structure, representations and warranties, and post-closing integration. The session will provide practical guidance on current market standards for allocating risk, conducting effective diligence, and avoiding successor liability in healthcare M&A. Specific topics to be covered include the impact of consumer health privacy laws, data breach and ransomware considerations, medical record transfer considerations, data protection considerations related to transition services arrangements.