Linda Malek

Partner & CHS Managing Director

Overview

Linda Malek is a partner in Crowell’s Health Care and Privacy & Cybersecurity Groups, where she advises a broad array of health care and life sciences clients on compliance with federal, state, and international law governing clinical research, data privacy, cybersecurity, and fraud and abuse. Her clients include national hospitals systems and academic medical centers, genetic and biotechnology companies, pharmaceutical companies, medical device companies, financial institutions involved in healthcare services, research foundations and international scientific organizations.

In the healthcare context, Linda is particularly focused on regulatory compliance issues related to clinical research and clinical trials. She creates and implements comprehensive policies governing the conduct of research involving human subjects, and advises clients on human subject research compliance issues. Linda also counsels on legal issues related to conducting secondary research on existing data repositories and tissue banks, including on data privacy and informed consent issues related to the ability to conduct future research. She has experience advising clients on a wide variety of research areas, including biologics, pharmacogenomics, translational research, secondary research, tissue banking, and data repositories. Linda also advises clients in general health care matters related to fraud and abuse, including issues under the Stark laws and federal and state anti-kickback statutes. Her work includes structuring complex transactions in compliance with such laws, assisting in the creation of internal compliance programs, and advising on issues related to the False Claims Act.

Linda’s privacy and cybersecurity practice involves advising clients in both the private and public sectors regarding the complex interaction of, and compliance with, various state, federal, and international data privacy laws, including the Health Insurance Portability and Accountability Act (HIPAA), the Gramm-Leach-Bliley Act, the Children's Online Privacy Protection Act (COPPA), the Health Information Technology for Economic and Clinical Health Act (HITECH), the Family Educational Rights and Privacy Act (FERPA), federal law regarding the protection of human research subjects, the European Union’s General Data Privacy Regulations (GDPR), and the FTC and state enforcement activities. She counsels clients on both transactional and regulatory issues across industries on issues related to the use of personal data.

Linda advises on issues relevant to the collection, storage, protection and authorized use of personally identifiable information (PII). Her work includes performing compliance audits, structuring transactions and drafting agreements, and, when needed, assisting clients in the conduct of internal investigations.

Linda began her legal career in government and served as an attorney for the Office of the Corporation Counsel, Division of Legal Counsel, where she focused on health policy issues and was named Outstanding Assistant Corporation Counsel by the Association of the Bar of the City of New York.

Linda is a respected leader in the field, recognized by top legal publications. She was recognized in The Best Lawyers in America® for 2022 through 2024, included in the list of Notable Women in Law by Crain’s New York Business in 2020, and honored by New York Metro Super Lawyers in seven consecutive editions.

Career & Education

|
    • New York
      Office of the Corporation Counsel, Division of Legal Counsel
    • New York
      Office of the Corporation Counsel, Division of Legal Counsel
    • Walla Walla University, B.A., cum laude
    • University of Virginia School of Law, J.D.,

      Editorial Board Member, Journal of Law and Politics


      Recipient, Mary Claiborne and Roy H. Ritter Award, The University of Virginia School of Law
    • Walla Walla University, B.A., cum laude
    • University of Virginia School of Law, J.D.,

      Editorial Board Member, Journal of Law and Politics


      Recipient, Mary Claiborne and Roy H. Ritter Award, The University of Virginia School of Law
    • New York
    • New York
    • Board Member, NYBIO
    • Trustee, Lucy B. Moses Foundation
    • Former member of Educational Advisory Board, International Association of Privacy Professionals
    • Founding Board, National Board of Health Lawyers, a division of NBTA (National Board of Trial Advocacy)
    • American Bar Association, Health Reform Task Force
    • American Health Lawyers Association
    • Board Member, NYBIO
    • Trustee, Lucy B. Moses Foundation
    • Former member of Educational Advisory Board, International Association of Privacy Professionals
    • Founding Board, National Board of Health Lawyers, a division of NBTA (National Board of Trial Advocacy)
    • American Bar Association, Health Reform Task Force
    • American Health Lawyers Association
    • French
    • French

Linda's Insights

Client Alert | 2 min read | 04.24.24

FTC Continues Focus on Tracking Technologies and Personal Health Data

The Federal Trade Commission (FTC) recently entered into a settlement with Monument, Inc., an alcohol addiction treatment service, for allegedly disclosing users’ personal health data to third-party advertising platforms without consumer consent and violating their own website claims to consumers with respect to the disclosure of such data. The action follows other settlements by the FTC focused on tracking technologies collecting sensitive health information through web pages and web portals. “This action continues the FTC’s work to ensure strict limits on how firms handle sensitive health data, rather than putting the onus on consumers to protect themselves,” said Samuel Levine, Director of the FTC’s Bureau of Consumer Protection. “Following on the heels of actions against GoodRx, BetterHelp, and Premom, the market should be getting the message that consumer health data should be handled with extreme caution.”...

Recognition

 

  • Best Lawyers in America: 2022 - 2024
  • Super Lawyers: 2013 - 2024

Linda's Insights

Client Alert | 2 min read | 04.24.24

FTC Continues Focus on Tracking Technologies and Personal Health Data

The Federal Trade Commission (FTC) recently entered into a settlement with Monument, Inc., an alcohol addiction treatment service, for allegedly disclosing users’ personal health data to third-party advertising platforms without consumer consent and violating their own website claims to consumers with respect to the disclosure of such data. The action follows other settlements by the FTC focused on tracking technologies collecting sensitive health information through web pages and web portals. “This action continues the FTC’s work to ensure strict limits on how firms handle sensitive health data, rather than putting the onus on consumers to protect themselves,” said Samuel Levine, Director of the FTC’s Bureau of Consumer Protection. “Following on the heels of actions against GoodRx, BetterHelp, and Premom, the market should be getting the message that consumer health data should be handled with extreme caution.”...

Insights

Speaking Engagement | 03.13.24

"Best Practices in Recruiting for Health Equity: Designing a Successful Protocol for Recruitment," Clinical Trials Masterclass, New York, NY
|
    • How Health Cos. Can Brace For Tracking Tech Scrutiny

      |

      08.24.23

      Law360

    • Theories of AI Liability: It’s Still About the Human Element

      |

      09.20.22

      Reuters

    • Data Privacy and Artificial Intelligence in Health Care

      |

      03.17.22

      Reuters

    • Government Oversight in Managing Risks of AI in Health Care

      |

      01.12.22

      Reuters

    • Significance of FTC Guidance on Artificial Intelligence in Health Care

      |

      11.24.21

      Reuters Legal

    • INSIGHT: Advice for Digital Health Developers During Covid-19

      |

      05.05.20

      Bloomberg Law

    • Proposed Privacy Laws Put Genetic Testing Cos. In Hot Seat

      |

      02.24.20

      Law360

    • INSIGHT: Modernizing the Approach to Regulating Software as a Medical Device

      |

      06.10.19

      Bloomberg Law

    • Genetic Testing Is On FTC's Radar

      |

      04.18.19

      Law360

    • "Best Practices in Recruiting for Health Equity: Designing a Successful Protocol for Recruitment," Clinical Trials Masterclass, New York, NY

      |

      03.13.24

    • "Future of Clinical Trials," Clinical Trials Masterclass, New York, NY

      |

      03.13.24

    • "Presentation of Attendee Clinical Trial Site Checklist: Feedback from Professionals," Clinical Trials Masterclass, New York, NY

      |

      03.13.24

    • Protecting AI in Healthcare: Addressing Algorithmic Bias, Data Privacy, Security

      |

      07.18.22

      Healthcare Strategies 

    • 2022 Expert Predictions Part Two: Digital Health Solutions, Security Trends

      |

      01.10.22

      Healthcare Strategies

    • DOJ Official Calls Uber Security Chief Conviction An 'Outlier'

      |

      12.09.22

      Law360

    • Why FDA's Medical Device Cyber Recommendations 'Have Teeth'

      |

      05.27.22

      Healthcare Info Security 

    • 3 Key Details To Watch As Congress Mulls Breach Report Law

      |

      12.24.21

      Law360

    • Top Healthcare Cybersecurity Predictions For Next Year

      |

      12.16.21

      Healthcare Info Security 

    • Feds Will Weigh Whether Cyber Best Practices Were Followed When Assessing HIPAA Fines

      |

      01.11.21

      SC Magazine

    • The Virus Shot Goes in Your Arm, but Where Does Your Data Go?

      |

      09.23.20

      Bloomberg Law

    • Apps Checking Covid-19 Symptoms Pose Data Collection Risks

      |

      03.24.20

      Bloomberg Law 

Linda's Insights

Client Alert | 2 min read | 04.24.24

FTC Continues Focus on Tracking Technologies and Personal Health Data

The Federal Trade Commission (FTC) recently entered into a settlement with Monument, Inc., an alcohol addiction treatment service, for allegedly disclosing users’ personal health data to third-party advertising platforms without consumer consent and violating their own website claims to consumers with respect to the disclosure of such data. The action follows other settlements by the FTC focused on tracking technologies collecting sensitive health information through web pages and web portals. “This action continues the FTC’s work to ensure strict limits on how firms handle sensitive health data, rather than putting the onus on consumers to protect themselves,” said Samuel Levine, Director of the FTC’s Bureau of Consumer Protection. “Following on the heels of actions against GoodRx, BetterHelp, and Premom, the market should be getting the message that consumer health data should be handled with extreme caution.”...