Linda A. Malek is a partner at Moses & Singer and chair of the firm’s Healthcare and Privacy and Cybersecurity departments. She concentrates on regulatory, technological and business matters in the healthcare industry. Recognized by Super Lawyers and Chambers USA as a leader in her field, the highly-regarded ranking describes Linda as “well versed in transactional and regulatory matters, with particular insight into privacy issues relating to electronic and personal health records.”
Linda counsels healthcare organizations and financial institutions on transactional matters in the healthcare industry including mergers and acquisitions, healthcare privacy issues, risk arrangements involving large health maintenance organizations, and contractual issues relevant to academic medical centers concerning human subject research.
As a part of the life sciences practice at the firm, Linda advises clients on cutting-edge issues with respect to translational research, genomics, regenerative medicine, genetic privacy and tissue banking. She also represents and counsels academic medical centers, biotechnology companies, pharmaceutical companies, biorepositories, scientific research consortia and research foundations.
Healthcare laws and regulations comprise the focal point of Linda’s practice. She has extensive knowledge of privacy and technology issues affecting protected health information, pharmaceutical marketing activities, clinical research involving human subjects and transparency in clinical research. Her practice area also covers access to healthcare for the uninsured as well as changes to the Medicare and Medicaid programs impacting both providers and managed care plans.
Linda advises clients on compliance with federal, state and international privacy and security laws concerning the transfer of identifiable health information, the provision of health care and medical research. This includes analyzing their privacy and security practices as well as their compliance plans under the Health Insurance Portability and Accountability Act (“HIPAA”) and under the Health Information Technology for Economic and Clinical Health Act (“HITECH”).
Linda has significant experience advising in the context of qui tam actions and the False Claims Act. She works with payors, providers and pharmaceutical companies on issues concerning clinical research compliance and fraud and abuse under federal and state laws.
Linda’s healthcare expertise also includes insurance issues. She regularly advises on Medicare and Medicaid reimbursement matters that impact hospitals, long-term care facilities, managed care providers, mental healthcare providers and New York City agencies.
Committed to advancing the quality of healthcare in the United States through innovations in information technology, Linda has been appointed by the Markle Foundation to their Health Information Exchange (HIE) Advisory Committee. The Committee is part of the “Markle Connecting for Health” public-private collaboration to enable secure and private information sharing. As an active member of the Committee, Linda is the author of Key Laws and Regulations: Changes Relevant to the Markle Common Framework, a survey of recent changes to federal policy and security laws since the policies of the Framework were released in 2006.
Prior to joining Moses & Singer, Linda spent nearly six years as a healthcare attorney for the Office of the Corporation Counsel, Division of Legal Counsel, where she was named Outstanding Assistant Corporation Counsel by the Association of the Bar of the City of New York.
Linda has been recognized as a Super Lawyer for four consecutive years in the edition of New York Metro Super Lawyers®.