Linda A. Malek

Linda A. Malek is a partner at Moses & Singer and Chair of the firm’s Healthcare and Privacy & Cybersecurity practice groups.  Her practice concentrates on regulatory, technology and business matters in the healthcare industry. Recognized by New York Metro Super Lawyers® in five consecutive editions, and by Chambers USA as a leader in her field, the Chambers 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 a wide range of organizations and financial institutions on health law, such as national and regional managed care organizations, financial institutions, IRBs, government agencies, hospitals and hospital systems, genetic and biotechnology companies, medical device companies, international scientific organizations, pharmaceutical companies, and research foundations.  Providing expertise in the application of Federal and state healthcare laws and regulations to her clients’ businesses comprise a focal point of Linda’s practice.  She works closely with them to ensure compliance with health care anti-fraud, state, national and international privacy laws, Medicare/Medicaid regulations, False Claims Act, human subject research, genetic testing, Affordable Care Act initiatives and other regulatory matters.  The depth of her expertise 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 counseling on privacy and security issues, strategizing and implementing clinical research policies and programs, and drafting and negotiating complex and time-sensitive grant and clinical research agreements.

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 under state laws, federal laws such as the Health Insurance Portability and Accountability Act ("HIPAA") and under the Health Information Technology for Economic and Clinical Health Act (“HITECH”)., and international laws such as the recently enacted General Data Protection Regulation (GDPR) legislation.

Linda serves as Chair of the Health Law and Policy Coordinating Committee of the Health Law Section of the American Bar Association.  She has also been appointed to the Founding Board of the newest division of the NBTA (National Board of Trial Advocacy), called the National Board of Health Lawyers. She was nominated from the ABA Health Law Section based on her nationally recognized expertise in healthcare privacy law.

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.

• 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 & Cybersecurity

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

• New York

• French

• Linda A. Malek Selected For Inclusion In Crain’s 2020 Notable Women in Law
• Linda A. Malek Quoted in ModernHealthcare.com
• Linda A. Malek Quoted in BloombergLaw.com
• Linda Malek Quoted in Cybersecurity Law360
• 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

• Linda A. Malek To Speak At 2020 NewYorkBIO Annual Meeting
• Linda Malek & Nora L. Schmitt Present At The NYSBA Committee on Medical Research and Biotechnology
• Linda Malek To Moderate At NYBIO Annual Business Meeting
• 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
• FDA Issues Important Guidance Related to Conduct of Clinical Trials
• HHS Waiver of Certain HIPAA Privacy Rule Sanctions and Penalties, and Existing HIPAA PHI Use Exceptions Help Facilitate COVID-19 Response
• Proposed Privacy Laws Put Genetic Testing Cos. In Hot Seat
• Washington State Proposes New DTC Genetic Privacy Legislation
• HHS Anti-Kickback Plan Could Boost Patient Engagement
• Rapid Expansion of Telehealth Comes With New Challenges
• Third-Party Data Breaches Highlight the Importance of Vetting Vendors in Compliance With GDPR and CCPA
• Final CMS Wage Index Rule May Seriously Impact Urban Hospitals
• HHS OIG Releases Guidance on Self-Disclosure for Federal Grants and Contracts
• SHIELD Act to Expand New York’s Data Breach Notification Requirements
• INSIGHT: Modernizing the Approach to Regulating Software as a Medical Device
• European Commission Releases New Guidance on the Free Flow of Non-Personal Data in the European Union, Clarifying Relationship with GDPR
• Connecting the Dots on the Regulation of Connected Medical Devices
• Recent FTC Blog Post Has Broad Implications for Organizations Engaged in Genetic Testing
• Federal and State Lawmakers Move to Increase Access to Telehealth Services, But Numerous Obstacles Remain
• 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