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Linda Malek

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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.

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On February 28, the Department of Health and Human Services (HHS) announced that it was rescinding the Richardson Waiver, a policy in place since 1971 which said HHS would provide notice of proposed rulemaking in certain cases where it was not otherwise required to do so by law. This announcement signals a policy shift for the agency and suggests that where permitted by law, HHS will generally now issue rules relating to “agency management or personnel or to public property, loans, grants, benefits, or contracts” without providing notice and comment to stakeholders, and may otherwise find good cause to forego notice and comment procedures.Continue Reading HHS Suggests It Will Provide Less Notice and Opportunity for Comment on Grant and Contract Rules

On January 7, 2025, in the last weeks of the Biden Administration and before President Trump returned to the White House, the Food and Drug Administration (FDA) issued draft guidance, entitled “Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products.” This guidance provides recommendations on the use of AI intended to support a regulatory decision about a drug or biological product’s safety, effectiveness, or quality. The guidance discusses the use of AI models in the nonclinical, clinical, post-marketing, and manufacturing phases of the drug product life cycle. This is the first time FDA has proposed draft guidance on the use of AI for the development of drug and biological products and may provide insight on how AI models in medical product regulation should be assessed. The FDA is seeking public comment on the proposed guidance by April 7, 2025.     Continue Reading FDA Proposes Framework to Assess AI Model Output Credibility to Support Regulatory Decision-Making