Beating Others to the Punch, DHS Proposes CUI Changes to Acquisition Regulations
Client Alert | 1 min read | 02.07.17
On the last full day of the Obama Administration, the Department of Homeland Security (DHS) published a proposed rule that would make several amendments to the Homeland Security Acquisition Regulation (HSAR) regarding Controlled Unclassified Information (CUI). Despite recent developments, the proposed rule is open for comment until March 20, 2017, and seeks to impose several obligations, including: (1) contractors handling CUI under a contract must be in compliance with a bevy of DHS policies and procedures at the time of contract award; (2) contractors operating federal information systems must meet numerous information security obligations prior to handling CUI on those systems; (3) contractors must report known or suspected incidents affecting CUI within one to eight hours, depending on the type of CUI at issue; and (4) contractors must adhere to specific breach notification and credit monitoring requirements in response to incidents affecting personally identifiable information (PII), a subset of CUI.
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Client Alert | 3 min read | 06.26.25
FDA Targets Gene Editing Clinical Trials in China and other “Hostile Countries”
In a somewhat ambiguous press release on Wednesday, June 18, 2025, the Food and Drug Administration (FDA) announced a halt and “immediate review” of new clinical trials where American patients’ cells are sent to China or other “hostile countries” for genetic engineering with the expectation that the cells will be infused back into U.S. patients.[1] A subsequent podcast published by the agency also said that therapies that involved cells that were sent to China for genetic engineering and intended for subsequent infusion into U.S. patients would not be approved going forward. The announcement said that there is “mounting evidence” that some clinical researchers failed to obtain informed consent from trial participants about the international transfer and manipulation of biological material.
Client Alert | 3 min read | 06.26.25
Client Alert | 4 min read | 06.26.25
Ninth Circuit Affirms that CIPA Only Applies to Third-Party Eavesdropping
Client Alert | 4 min read | 06.24.25
CBP Issues First Comprehensive Guide to Modifying a Withhold Release Order (WRO)