Full Name
Linda Malek
Job Title
Partner
Company
Moses Singer
Speaker Bio
Linda A. Malek is a partner at Moses Singer, Chair of the firm's Healthcare & Life Sciences practice group and Leader of the Healthcare Privacy & Cybersecurity practice. She focuses on regulatory, technology and business matters in the healthcare industry. Linda has been recognized in The Best Lawyers in America® for 2022, has been named in the list of Notable Women in Law by Crain’s New York Business in 2020, and New York Metro Super Lawyers has recognized Linda in six consecutive editions as a leader in the healthcare field.In addition, Chambers USA describes Linda as "well versed in transactional and regulatory matters, with particular insight into privacy issues relating to electronic and personal health records.” She has authored articles and lectured extensively on legal topics relating to ever-changing compliance obligations prompted by state, federal and international authorities’ scrutiny of privacy issues involving electronic and personal health records, mobile applications and digital media.

Linda counsels a wide range of organizations and institutions including national and regional managed care organizations, financial institutions, IRBs, government agencies, hospitals and hospital systems, genetics and biotechnology companies, medical device companies, international scientific organizations, pharmaceutical companies, and research foundations. Her extensive knowledge in the application of Federal and state healthcare laws and regulations comprises a focal point of Linda's practice. She works closely with her clients’ businesses, providing advice regarding compliance with health care fraud and abuse, Medicare/Medicaid regulations, False Claims Act, regulations governing human subject research and genetic testing, Affordable Care Act initiatives and other regulatory matters. Linda’s competency in transactional matters includes advice regarding mergers and acquisitions, organizing start-up ventures, joint ventures, and negotiating complex agreements among various industry stakeholders.

In the life sciences context, Linda advises clients on cutting-edge legal issues with respect to translational and biomedical research and technology, genomics and gene studies, genetic privacy, regenerative medicine, clinical trials and tissue banking. Her work has also included strategizing and implementing clinical research policies and programs, and drafting and negotiating complex and time-sensitive grant and clinical research agreements.

In the privacy and cybersecurity contexts, Linda advises clients on compliance with federal, state and international privacy and security laws. This includes analyzing privacy and security practices under the variety of state laws, federal laws such as the Health Insurance Portability and Accountability Act (HIPAA) and the Health Information Technology for Economic and Clinical Health Act (HITECH), and international laws such as the General Data Protection Regulation (GDPR) legislation.

Linda earned her J.D. from University of Virginia School of Law, and her B.A., cum laude, from Walla Walla College. Linda has been elected as one of the new class of NewYorkBIO Board of Directors for 2022, and also serves as a member of the Education Advisory Board of the International Association of Privacy Professionals. In recognition of Linda’s national proficiency in healthcare privacy law, the ABA Health Law Section nominated her for appointment to the Founding Board of the National Board of Health Lawyers, the newest division of the National Board of Trial Advocacy. She also serves as a member of the Healthcare Reform Task Force of the American Bar Association.
Linda Malek