Linda Malek

In the health care context, Linda is particularly focused on regulatory compliance issues related to clinical research and clinical trials. She creates and implements comprehensive policies governing the conduct of research involving human subjects and advises clients on human subject research compliance issues. Linda also counsels on legal issues related to conducting secondary research on existing data repositories and tissue banks, including on data privacy and informed consent issues related to the ability to conduct future research. She has experience advising clients on a wide variety of research areas, including biologics, pharmacogenomics, translational research, secondary research, tissue banking, and data repositories. Linda also counsels digital health and biotech companies developing AI tools in the complex and evolving federal and state regulatory landscape, balancing the priorities of oversight authorities with issues related to data privacy and security as well as business goals. She also advises clients on general health care matters related to fraud and abuse, including issues under the Stark laws and federal and state anti-kickback statutes. Her work includes structuring complex transactions in compliance with such laws, assisting in the creation of internal compliance programs, and advising on issues related to the False Claims Act.

Linda’s privacy and cybersecurity practice involves advising clients in both the private and public sectors regarding the complex interaction of, and compliance with, various state, federal, and international data privacy laws, including the Health Insurance Portability and Accountability Act, the Gramm-Leach-Bliley Act, the Children's Online Privacy Protection Act, the Health Information Technology for Economic and Clinical Health Act, the Family Educational Rights and Privacy Act, federal law regarding the protection of human research subjects, the European Union’s General Data Privacy Regulations, and the FTC and state enforcement activities. She counsels clients on both transactional and regulatory issues across industries on issues related to the use of personal data.

Linda advises on issues relevant to the collection, storage, protection, and authorized use of personally identifiable information (PII). Her work includes performing compliance audits, structuring transactions, and drafting agreements, and, when needed, assisting clients in conducting internal investigations.

Linda began her legal career in government and served as an attorney for the Office of the Corporation Counsel, Division of Legal Counsel, where she focused on health policy issues and was named Outstanding Assistant Corporation Counsel by the Association of the Bar of the City of New York.

Linda is a respected leader in the field, recognized by top legal publications. She was recognized in The Best Lawyers in America® for 2022 through 2024, included in the list of Notable Women in Law by Crain’s New York Business in 2020, and honored by New York Metro Super Lawyers in seven consecutive editions. In 2024, Linda was listed in Chambers USA as up and coming in health care.