• Healthcare
  • Privacy
  •   Linda A. Malek
    Partner

    lmalek@mosessinger.com
    T: (212) 554-7814
    F: (917) 206-4314

    Linda A. Malek, a partner at Moses & Singer, chair of the Healthcare practice and co-chair of the Privacy practice, focuses her practice on healthcare transactions, healthcare technology, and regulatory matters concerning the healthcare industry. Her work at the firm has included advising a variety of healthcare entities on healthcare transactions, including the emerging laws and regulations affecting the health insurance industry, the impact of the Medicare Modernization Act, counseling healthcare organizations on compliance issues related to federal, state and international privacy laws, including the Health Insurance Portability and Accountability Act ("HIPAA"), drafting risk agreements for ventures involving large health maintenance organizations, structuring arrangements involving human subjects research, representing both for-profit and not-for-profit healthcare entities, and counseling payors, providers and pharmaceutical companies on a variety of regulatory compliance issues, including privacy, clinical research compliance, and fraud and abuse under federal and state laws.

    Prior to joining Moses & Singer, Ms. Malek 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. Her expertise in a wide range of health care issues has included advising many types of clients on Medicare and Medicaid reimbursement issues which impact hospitals, managed care providers, mental health care providers and New York City agencies.

    Ms. Malek also has extensive experience in advising clients on issues of corporate governance and ethics in the healthcare environment, in counseling clients in the context of qui tam actions and the False Claims Act, and in assisting clients in establishing internal compliance programs.

    EDUCATION
  • University of Virginia Law School, J.D., 1993
  • Walla Walla College, B.A., cum laude, 1989

    LAW SCHOOL ACTIVITIES / HONORS
  • 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

    ARTICLES
  • "The Privacy and Security Challenges of Electronic and Personal Health Records: Is Your Business Prepared?," Bloomberg Law Reports®: Privacy & Information, June 2008.
  • "Electronic and Personal Health Records: The Risks and Benefits for Providers," BNA‘s Health Law Reporter, April 2008.
  • "Sponsors Beware: FDAAA Creates Compliance Challenges for Drug and Medical Device Clinical Trials," Bloomberg Law Reports®: Health Law, March 2008.
  • "The Changing Landscape of Medicaid Fraud Compliance," New York Law Journal, October 2006.
  • "Privacy and Security Bulletin," Moses & Singer Newsletter, May 2006.
  • "Employment Matters," Moses & Singer, LLP Newsletter, April 2006.
  • "Scientific Misconduct: Risks to Biotechnology," Genetic Engineering News, February 2006.
  • "HIPAA: Enforcement for Violations by Covered, Noncovered Entities," New York Law Journal, October 2005.
  • "Disclosure of Protected Health Information for Legal Proceedings," New York Law Journal, April 2004.
  • "Implementing the HHS Office of Inspector Generals Final Compliance Guidance for Pharmaceutical Manufacturers," BNA's Pharmaceutical Law & Industry Report, July 2003.
  • "HIPAA's Security Rule Becomes Effective in 2005," The National Law Journal, March 2003.
  • "The Potential Impact of Sarbanes-Oxley on the Health Care Industry," New York Law Journal, March 2003.
  • "Identifying Your Organization's Business Associates," Healthleaders.com, July 2002.
  • "Proposed Amendments to the HIPAA Privacy Rule," Healthleaders.com, May 2002.
  • "The HIPAA Privacy Rule's Impact on Employers," HealthLeaders.com, March 2002.
  • "The Administrative Simplification Compliance Act: Postponing the inevitable," HealthLeaders.com, January 2002.
  • "Why Employers Have to Pay Attention to the HIPAA Privacy Rule," VentureReporter.net, October 2001.
  • "HHS Issues Guidance on HIPAA Privacy Rule," iHealthcare Weekly, July 2001.
  • "Fraud and Abuse in 'E-Health' Arena," New York Law Journal-E-Commerce Section, May 2001.
  • "HIPAA Privacy Rules Impact Employers," New York Law Journal-Corporate Counsel Section, May 2001.
  • "Patient Health Data Goes On-Line," New York Law Journal, November 2000.
  • "HIPAA: Essentials for Effective Compliance," CCH Healthcare Compliance Guide, November 2000.
  • "Health and Financial Privacy Rules May Link Up: The Proposed Medical Financial Privacy Protection Act," iHealthcare Weekly, September 2000.
  • "Privacy in Medical Research: How the informed Consent Requirement Will Change Under HIPAA," iHealthcare Weekly, July 2000.
  • "E-Sign on the Dotted E-Line," iHealthcare Weekly, July 2000.
  • "HIPAA's Lack of Private Right to Sue Not a Total Bar," The National Law Journal, June 2000.
  • "Confidentiality of E-healthcare Information: Emerging Issues for Employers Under HIPAA," iHealthcare Weekly, June 2000.

    PROFESSIONAL AFFILIATIONS
  • Vice Chair, United Hospital Fund, New Leadership Group
  • Vice Chair, Website Interest Group, American Bar Association
  • Board Member, William Alanson White Institute of Psychiatry, Psychoanalysis & Psychology
  • 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

    PRESENTATIONS
  • American Conference Institute, 2007
  • International Association of Privacy Professionals, 2007
  • Academic Medical Center, Security & Privacy Conference 2007
  • Health Care Compliance Association, 2006 Research Compliance Institute Conference
  • The Centers for Medicare and Medicaid Services in conjunction with the Health Care Compliance Association 2005
  • Barnett International Web Conference 2005
  • National Health Care Payer Summit, 2005
  • American Bar Association, 2005
  • New York State Bar Association, 2005
  • Association of the Bar of the City of New York, 2002, 2003, 2004, 2006
  • Health Care Compliance Association, 2003, 2004, 2005
  • Society of Corporate Compliance and Ethics, 2005
  • Pediatric Clinical Trials Conference, 2004
  • International Association of Privacy Professionals, 2003, 2004
  • National Medicare Prescription Drug Congress, 2004