NIH Follows in FDA’s Footsteps and Adopts “Bulk Sensitive Data” Policy That Goes Beyond DOJ Rule Requirements

Lexology October 28, 2025
Morrison Foerster LLP

The National Institutes of Health (“NIH”) has become the latest federal agency to impose obligations that go beyond those required by the watershed U.S. Department of Justice (“DOJ”) data security program (“DSP”) with its new Policy on Enhancing Security Measures for Human Biospecimens (“NIH Policy”). The NIH Policy comes on the heels of the additional restrictions on clinical trials that the U.S. Food and Drug Administration (“FDA”) announced this summer in a press release.

While these updates are relevant to the life sciences industry in particular, they may signal a broader regulatory trend that merits attention across all industries.

Even companies outside of the life sciences industry should take note of these policy developments as they may foreshadow a broader...

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