Moses & Singer LLP

Practices & Industries

Education

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

Bar/Court Admissions

  • New York

Foreign Languages

  • French

Linda A. Malek

Partner

Contact Me

T(212) 554-7814

F(917) 206-4314

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 six 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.

Publications
Presentations
  • NewYorkBio Annual Conference, 2018
  • Academic Medical Center, Security & Privacy Conference, 2007, 2010
  • American Bar Association, 2005, 2010, 2012, 2013
  • American Conference Institute, 2007-2013
  • American Health Lawyers Association, 2009
  • Annual HIMSS Conference & Exhibition, 2012
  • Association of Clinical Research Professionals Global Conference, 2008
  • Association of the Bar of the City of New York, 2002-2006
  • Barnett International Web Conference 2005
  • Centers for Medicare and Medicaid Services in conjunction with the Health Care Compliance Association 2005
  • Drug Information Association, 2009
  • Fraud and Compliance Forum, 2009
  • Greater New York Hospital Association, 2008, 2010
  • Health Care Compliance Association, Research Compliance Institute Conference, 2003-2007
  • Healthcare Financial Management Association, 2010
  • International Association of Privacy Professionals, 2003, 2004, 2007
  • LIfe Sciences Summit, 2013
  • Milken Institute, 2013
  • National Automated Clearing House Association, 2010
  • National Health Care Payer Summit, 2005
  • National Medicare Prescription Drug Congress, 2004
  • New York Biotechnology Association, 2013
  • New York State Bar Association, 2005, 2009, 2011, 2013
  • Pediatric Clinical Trials Conference, 2004
  • Practicing Law Institute, 2010
  • Society of Corporate Compliance and Ethics, 2005
Professional Affiliations
  • Founding Board, National Board of Health Lawyers, a division of NBTA (National Board of Trial Advocacy)
  • Vice Chair, American Bar Association, Health Law Section, eHealth, Privacy & Security Interest Group
  • Vice Chair, United Hospital Fund, New Leadership Group
  • Board Member, William Alanson White Institute of Psychiatry, Psychoanalysis & Psychology
  • Recipient, New York Women's Agenda Galaxy Award
  • American Health Information Community, Privacy and Security Workgroup
  • Former Board Member, Women in Health Management
  • American Health Lawyers Association
  • Healthcare Association of New York State, Medicaid Fraud Task Force
  • New York State Bar Association, Public Health Committee
Law School Activities/Honors
  • Recipient, Mary Claiborne and Roy H. Ritter Award, University of Virginia School of Law
  • Editorial Board, Journal of Law and Politics, University of Virginia School of Law
  • Founding Member, Journal of Social Policy and the Law, University of Virginia School of Law
Videos

 

Related News

Related Events

Related Articles

Videos

Linda Malek & Marisa Cruz discuss the future of Home Testing on NewYorkBIO's #VirtualBreakfastSeries

Yves Duroseau, Gil Addo, & Linda Malek discuss the future of access on the #VirtualBreakfastSeries

Biography

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 six 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.

Publications
Presentations
  • NewYorkBio Annual Conference, 2018
  • Academic Medical Center, Security & Privacy Conference, 2007, 2010
  • American Bar Association, 2005, 2010, 2012, 2013
  • American Conference Institute, 2007-2013
  • American Health Lawyers Association, 2009
  • Annual HIMSS Conference & Exhibition, 2012
  • Association of Clinical Research Professionals Global Conference, 2008
  • Association of the Bar of the City of New York, 2002-2006
  • Barnett International Web Conference 2005
  • Centers for Medicare and Medicaid Services in conjunction with the Health Care Compliance Association 2005
  • Drug Information Association, 2009
  • Fraud and Compliance Forum, 2009
  • Greater New York Hospital Association, 2008, 2010
  • Health Care Compliance Association, Research Compliance Institute Conference, 2003-2007
  • Healthcare Financial Management Association, 2010
  • International Association of Privacy Professionals, 2003, 2004, 2007
  • LIfe Sciences Summit, 2013
  • Milken Institute, 2013
  • National Automated Clearing House Association, 2010
  • National Health Care Payer Summit, 2005
  • National Medicare Prescription Drug Congress, 2004
  • New York Biotechnology Association, 2013
  • New York State Bar Association, 2005, 2009, 2011, 2013
  • Pediatric Clinical Trials Conference, 2004
  • Practicing Law Institute, 2010
  • Society of Corporate Compliance and Ethics, 2005
Professional Affiliations
  • Founding Board, National Board of Health Lawyers, a division of NBTA (National Board of Trial Advocacy)
  • Vice Chair, American Bar Association, Health Law Section, eHealth, Privacy & Security Interest Group
  • Vice Chair, United Hospital Fund, New Leadership Group
  • Board Member, William Alanson White Institute of Psychiatry, Psychoanalysis & Psychology
  • Recipient, New York Women's Agenda Galaxy Award
  • American Health Information Community, Privacy and Security Workgroup
  • Former Board Member, Women in Health Management
  • American Health Lawyers Association
  • Healthcare Association of New York State, Medicaid Fraud Task Force
  • New York State Bar Association, Public Health Committee
Law School Activities/Honors
  • Recipient, Mary Claiborne and Roy H. Ritter Award, University of Virginia School of Law
  • Editorial Board, Journal of Law and Politics, University of Virginia School of Law
  • Founding Member, Journal of Social Policy and the Law, University of Virginia School of Law
Videos

 

Practices & Industries
Education
  • University of Virginia School of Law (J.D.)
  • Walla Walla College (B.A., cum laude)
Bar/Court Admissions
  • New York
Foreign Languages
  • French
Related News
Related Events
Related Articles
Videos

 

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