Profile

Linda Malek is a partner at New York City law firm Moses & Singer LLP. Her areas of practice include Healthcare and Privacy.

Overview

Linda A. Malek is a partner at Moses & Singer and chair of the firm’s Healthcare and Privacy practice areas. Linda’s practice focuses on transactions, technology, and regulatory matters in the healthcare industry.

She advises a variety of healthcare entities on emerging laws and regulations affecting the healthcare industry such as issues relevant to privacy in the context of protected health information; pharmaceutical marketing activities; clinical research involving human subjects; transparency in clinical research; access to healthcare for the uninsured; and changes to the Medicare and Medicaid programs affecting both providers and managed care plans. Recognized by Chambers USA as a leader in her field, the highly-regarded ranking described 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, risk arrangements involving large health maintenance organizations, and contractual issues relevant to academic medical centers concerning human subject research. She also assists clients on compliance issues related to federal, state and international privacy laws, such as the Health Insurance Portability and Accountability Act ("HIPAA"). Linda counsels payors, providers and pharmaceutical companies on a variety of regulatory compliance issues that include clinical research compliance and fraud and abuse under federal and state laws.

In addition to assisting clients in establishing internal compliance programs, Linda has extensive experience advising in the context of qui tam actions and the False Claims Act. Her proficiency in a wide range of healthcare issues includes advising clients 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 practicing 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.

Honours Achieved

• Chambers USA , 01/2010-12/2010

Professional Memberships

• New York State Bar Association, Public Health Committee , -
• Healthcare Association of New York State, Medicaid Fraud Task Force , -
• American Health Lawyers Association , -
• Former Board Member, Women in Health Management , -
• American Health Information Community, Privacy and Security Workgroup , -
• Recipient, New York Women's Agenda Galaxy Award , -
• Board Member, William Alanson White Institute of Psychiatry, Psychoanalysis & Psychology, -
• Vice Chair, United Hospital Fund, New Leadership Group , -
• Vice Chair, American Bar Association, Health Law Section, eHealth, Privacy & Security Interest Group , -

Publications & Presentations

• “Complying with Health Care Privacy Laws. Effective Implementation of Privacy Compliance Programs” , Inside the Minds, Contributing Author, 10/2008
• "The Children's Health Insurance Program Reauthorization Act of 2009" , Moses & Singer Client Alert, 02/2009
• "Stimulus Bill Makes Sweeping Changes to Federal Health Care Privacy Laws" , Moses & Singer Client Alert, 03/2009
• "Health Care Privacy and Security Law Reform in the American Recovery and Reinvestment Act: Sweeping Changes for the Health Care Sector" , Bloomberg Law Reports®: Privacy & Information, 04/2009
• "New Rules for Investigational Drugs Effective October 13, 2009" , Moses & Singer Client Alert, 08/2009
• "The Fraud Enforcement and Recovery Act of 2009: Significant Amendments Made to the False Claims Act" , Moses & Singer Client Alert, 10/2009
• "Security Breach Notification Rules Announced by HHS and FTC" , Moses & Singer Client Alert, 11/2009
• "Healthcare Reform Law May Impact Clinical Trial Billing and Contract Negotiations" , Moses & Singer Client Alert, 05/2010
• "Why Should Banks Care About Healthcare Reform?" , ABA Bank Compliance, 07/2010
• "Proposed Revisions by HHS Would Facilitate Research" , Moses & Singer Client Alert, 08/2010
• "FDA Publishes Revised Informed Consent Regulations" , Moses & Singer Client Alert, 01/2011
• "Pharmacy Joint Venture Raises Anti-Kickback Concerns" , Moses & Singer Client Alert, 05/2011
• "The Preliminary FTC Staff Report: Implications for Health Care Businesses" , BNA’s Health Law Reporter, 09/2011
• "What Was the Most Significant Health Law Development of 2011?" , Bloomberg Law Reports®: Health Law, BLAW Q&A, 01/2012
• "Comments Due on Consumer Data Privacy Codes" , Moses & Singer Client Alert, 03/2012
• "Wireless Medical Devices: Potential Risks to Patient Safety and Privacy", Moses & Singer Client Alert, 05/2012

Colleges Attended

• University of Virginia School of Law, J.D.,
• Walla Walla College, B.A.,

Languages Spoken

• English