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lmalek@mosessinger.com
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 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.
EDUCATION
- University of Virginia School of Law, J.D.
- Walla Walla College, B.A., cum laude
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
ARTICLES
- "Comments Due on Consumer Data Privacy Codes," Moses & Singer Client Alert, March 2012.
- "What Was the Most Significant Health Law Development of 2011?," Bloomberg Law Reports®: Health Law, BLAW Q&A, January 2012.
- "The Preliminary FTC Staff Report: Implications for Health Care Businesses," BNA’s Health Law Reporter
, September 2011.
- "Pharmacy Joint Venture Raises Anti-Kickback Concerns," Moses & Singer Client Alert, May 2011.
- "FDA Publishes Revised Informed Consent Regulations," Moses & Singer Client Alert, January 2011.
- "Proposed Revisions by HHS Would Facilitate Research," Moses & Singer Client Alert, August 2010.
- "Why Should Banks Care About Healthcare Reform?," ABA Bank Compliance, July 2010.
- "Healthcare Reform Law May Impact Clinical Trial Billing and Contract Negotiations," Moses & Singer Client Alert, May 2010.
- "Security Breach Notification Rules Announced by HHS and FTC," Moses & Singer Client Alert, November 2009.
- "The Fraud Enforcement and Recovery Act of 2009: Significant Amendments Made to the False Claims Act," Moses & Singer Client Alert, October 2009.
- "New Rules for Investigational Drugs Effective October 13, 2009," Moses & Singer Client Alert, August 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, April 2009.
- "Stimulus Bill Makes Sweeping Changes to Federal Health Care Privacy Laws," Moses & Singer Client Alert, March 2009.
- "The Children's Health Insurance Program Reauthorization Act of 2009," Moses & Singer Client Alert, February 2009.
- "Foreign Corrupt Practices Act," Moses & Singer Client Alert, December 2008.
- "The Privacy and Security Challenges of Electronic and Personal Health Records: Is Your Business Prepared?," Bloomberg Law Reports®: Privacy & Information, June 2008.
- "GINA May Affect Informed Consent Forms," Moses & Singer Client Alert, 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.
- "Medicare Extension Act," Moses & Singer Client Alert, March 2008.
- "New Developments in Electronic Health Records and Personal Health Records," Moses & Singer Client Alert, March 2008.
- "California Expands the Scope of Its Security Notification Law and Medical Privacy Law," Moses & Singer Client Alert, January 2008.
- "The Consolidated Appropriations Act, 2008," Moses & Singer Client Alert, January 2008.
- "The Food and Drug Administration Amendments Act of 2007," Moses & Singer Client Alert, October 2007.
- "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 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.
PUBLICATIONS
PRESENTATIONS
- Annual HIMSS Conference & Exhibition, 2012
- The National Automated Clearing House Association, 2010
- Practising Law Institute, 2010
- Healthcare Financial Management Association, 2010
- Fraud and Compliance Forum, 2009
- American Health Lawyers Association, 2009
- Drug Information Association, 2009
- Greater New York Hospital Association, 2008, 2010
- Association of Clinical Research Professionals Global Conference, 2008
- American Conference Institute, 2007-2010
- International Association of Privacy Professionals, 2007
- Academic Medical Center, Security & Privacy Conference, 2007, 2010
- Health Care Compliance Association, Research Compliance Institute Conference, 2006, 2007
- 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, 2010, 2012
- New York State Bar Association, 2005, 2009, 2011
- Association of the Bar of the City of New York, 2002, 2003, 2004, 2006
- Health Care Compliance Association, 2003-2007
- 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
PROFESSIONAL AFFILIATIONS
- 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
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