News & Analysis as of

Sensitive Personal Information Clinical Trials

Knobbe Martens

FDA Announces Review of New Clinical Trials That Export Americans’ Biological Samples to Hostile Countries

Knobbe Martens on

On June 18, 2025, the U.S. Food and Drug Administration (FDA) announced that it will review new clinical trials that involve sending biological samples to “hostile countries,” to prevent exploitation of Americans’ sensitive...more

Katten Muchin Rosenman LLP

FDA Scrutinizes Clinical Trials Exporting U.S. Genetic Material

On June 18, 2025, the U.S. Food and Drug Administration (“FDA”) announced an immediate review of new clinical trials that export American citizens’ biological materials to countries of concern, such as China, for genetic...more

Gardner Law

New DOJ Rule Restricts Deidentified Data Transfer

Gardner Law on

No Safe Harbor: New DOJ Data Export Rule Restricts Deidentified Data Transfer - This article outlines new requirements from the Department of Justice regarding “bulk sensitive data”, including de-identified, anonymized,...more

Goodwin

Life Sciences Companies Must Navigate the DOJ Data Rule

Goodwin on

Life sciences companies have long been outside the scope of US national security regulations and benefited from significant exemptions under US privacy laws. ...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q2 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Polsinelli

California Privacy Rights Act: Latest Update, Impact and Next Steps

Polsinelli on

The California Privacy Rights Act (CPRA) is a ballot initiative that, if passed in November, will significantly amend the California Consumer Privacy Act (CCPA)....more

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