Linda A. Malek

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 five consecutive years in the edition of  New York Metro Super Lawyers®.

• Healthcare
• Fraud and Abuse
• Healthcare Privacy and HIPAA Rules
• Institutional Providers
• Life Sciences
• Long-Term and Home Health Care
• Managed Care
• Pharmaceutical Industry
• Regulatory Compliance
• Privacy

• University of Virginia School of Law (J.D.)
• Walla Walla College (B.A., cum laude)

• Moses & Singer Attorneys Achieve Top Women Super Lawyers Status
• Linda Malek Appointed to National Board of Health Lawyers
• Super Lawyers Honors 41 Moses & Singer Attorneys in 2015 New York Metro Edition
• Super Lawyers Honors 36 Moses & Singer Attorneys in 2014 New York Metro Edition
• Linda Malek Appointed to Leadership Position at ABA Health Law Section
• Moses & Singer Women Attorneys Featured in New York Times Magazine
• Linda Malek Speaks on the "Rising Cost of Cancer Drugs and Cancer Research" at NYC Bar Association
• Linda Malek Leads Panel on “Personalized Medicine” for the American Bar Association.
• Super Lawyers Announces List of Winning Moses & Singer Attorneys
• Moses & Singer Celebrates Its Alumni
• Chambers USA Lists Moses & Singer Partners

• The Use of Data in Transforming Research and Digital Health
• Serval Ventures Healthtech NY
• Mobile Health: The Power of Wearables, Sensors, and Apps to Transform Clinical Trials
• Pennsylvania Bar Institute: Research Law and Compliance Forum
• Big Data, Big Potential: Privacy in Genetics Research and Analysis
• Washington Health Law Summit - Privacy in Clinical Research: Ethical and Legal Challenges and Opportunities
• Legal and Ethical Challenges in the Use of Genetic Information in Clinical Research
• Pilot Health Tech NYC
• The Rising Cost of Cancer Drugs and Cancer Research
• Developments in Personalized Medicine and Associated Legal Challenges and Opportunities
• Partnering for Cures
• CEO Breakfast (Sponsor)
• Emerging Legal Risks in Clinical Trials
• The New Standard for Breach Under the Final Rule: Addressing and Identifying Incidents, Protections, Obligations and Liabilities
• Life Sciences Summit
• The Critical Legal and Business Guide to HIPAA and HITECH in the Era of Health Information Technology
• Emerging Issues in Health Information Exchanges
• Key Laws and Regulations: Changes Relevant to the Markle Common Framework
• Assessing, Investigating, and Responding to Data Breaches
• The Impact of HITECH on Financial Institutions: A Checkup for Your Institution
• HITECH and HIPAA Fundamentals
• Bridge-the-Gap II for Newly Admitted Attorneys
• Meaningful Privacy and Security
• HIPAA Fundamentals
• Integrating GINA Privacy Rules into HIPAA Compliance Programs
• Demystifying Privacy and Security Regulations: Ensuring Thorough Data Collection While Abiding by Foreign and Domestic Privacy Laws
• Clinical Research Issues
• Metropolitan New York Chapter: Compliance - What You Don't Know CAN Hurt You!
• Foreign Corrupt Practices Act
• Clinical Trials Registries: Panacea or Pablum?
• Access to Data: Avoiding Privacy and Security Violations and Examining the Curent Secondary Research Landscape
• Global Conference & Exhibition
• HCCA 2007 Research Compliance Conference
• The Practical Privacy Series: Pharma/Healthcare
• AMC Security & Privacy: Kick It Up A Notch

• HHS Issues Guidance on HIPAA Privacy Rule
• Fraud and Abuse in 'E-Health' Arena
• HIPAA Privacy Rules Impact Employers
• Patient Health Data Goes On-Line
• HIPAA: Essentials for Effective Compliance
• Health and Financial Privacy Rules May Link Up: The Proposed Medical Financial Privacy Protection Act
• Privacy in Medical Research: How the informed Consent Requirement Will Change Under HIPAA
• E-Sign on the Dotted E-Line
• HIPAA's Lack of Private Right to Sue Not a Total Bar
• Confidentiality of E-healthcare Information: Emerging Issues for Employers Under HIPAA
• Significant Changes for Wyoming Genetic Privacy Law; More May Be on the Horizon for New York, Arizona, and New Hampshire
• WannaCry and Petya: Why Attention Should be Devoted to IT Security in Corporate Due Diligence
• The 21st Century Cures Act: Its Impact on Health Information Privacy and Security Protections
• FDA Releases Draft Guidance for Creating FDA-Approved Public Genomic Databases
• Data Privacy, Cybersecurity, And Health IT Legal Issues In Emerging Mobile Health Technologies
• EU-US Safe Harbor Framework Ruled Invalid by EU Court of Justice
• CMS May Use Self-Audits as Evidence of Noncompliance
• Solutions to Recently Raised Concerns About Data-Sharing between Foundations and Universities
• Genetic Privacy Concerns May Trigger Informed Consent Changes
• Certain Barriers to Research Removed by HHS
• Final Omnibus Rule Removes Barriers to Research
• Genomic Privacy Report Recommends Changes to Informed Consent Process
• Genomic Privacy Policy Recommendations May Affect Non-Profit Research Organizations and Patient Advocacy Groups
• HITECH Audit Protocols Released by OCR
• Wireless Medical Devices: Potential Risks to Patient Safety and Privacy
• Comments Due on Consumer Data Privacy Codes
• What Was the Most Significant Health Law Development of 2011?
• The Preliminary FTC Staff Report: Implications for Health Care Businesses
• Pharmacy Joint Venture Raises Anti-Kickback Concerns
• FDA Publishes Revised Informed Consent Regulations
• Proposed Revisions by HHS Would Facilitate Research
• Why Should Banks Care About Healthcare Reform?
• Healthcare Reform Law May Impact Clinical Trial Billing and Contract Negotiations
• Security Breach Notification Rules Announced by HHS and FTC
• The Fraud Enforcement and Recovery Act of 2009: Significant Amendments Made to the False Claims Act
• New Rules for Investigational Drugs Effective October 13, 2009
• Health Care Privacy and Security Law Reform in the American Recovery and Reinvestment Act: Sweeping Changes for the Health Care Sector
• Stimulus Bill Makes Sweeping Changes to Federal Health Care Privacy Laws
• The Children's Health Insurance Program Reauthorization Act of 2009
• Foreign Corrupt Practices Act
• The Privacy and Security Challenges of Electronic and Personal Health Records: Is Your Business Prepared?
• GINA May Affect Informed Consent Forms
• Electronic and Personal Health Records: The Risks and Benefits for Providers
• Sponsors Beware: FDAAA Creates Compliance Challenges for Drug and Medical Device Clinical Trials
• Medicare Extension Act
• New Developments in Electronic Health Records and Personal Health Records
• California Expands the Scope of Its Security Notification Law and Medical Privacy Law
• The Consolidated Appropriations Act, 2008
• The Food and Drug Administration Amendments Act of 2007
• The Changing Landscape of Medicaid Fraud Compliance
• Privacy and Security Bulletin
• Employment Matters
• Scientific Misconduct: Risks to Biotechnology
• HIPAA: Enforcement for Violations by Covered, Noncovered Entities
• Disclosure of Protected Health Information for Legal Proceedings
• Implementing the HHS Office of Inspector Generals Final Compliance Guidance for Pharmaceutical Manufacturers
• HIPAA's Security Rule Becomes Effective in 2005
• The Potential Impact of Sarbanes-Oxley on the Health Care Industry
• Identifying Your Organization's Business Associates
• Proposed Amendments to the HIPAA Privacy Rule
• The HIPAA Privacy Rule's Impact on Employers
• The Administrative Simplification Compliance Act: Postponing the inevitable
• Why Employers Have to Pay Attention to the HIPAA Privacy Rule