As Epstein Becker Green previously reported, the National Security Division of the U.S. Department of Justice (“DOJ”) issued a final rule, effective on April 8, 2025, called the Bulk Sensitive Data Rule (“BSD Rule”) (codified at 28 C.F.R. Part 202).

The BSD Rule prohibits and/or restricts U.S. persons and/or companies from engaging in certain transactions involving certain categories of government-related data and sensitive personal data with covered persons or six countries of concern, including China (including Hong Kong and Macau), Russia, Iran, North Korea, Cuba, and Venezuela.

This final rule implemented the Biden administration’s Executive Order 14117, dated February 28, 2024 – entitled “Preventing Access to Americans’ Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern.” In addition to safeguarding sensitive data, the BSD Rule allows for the DOJ to investigate non-compliance with its requirements and enforce civil and criminal penalties when non-compliance is discovered. Implementation of the BSD Rule is a result of a heightened interest in ensuring the security of data, especially in cross-border data sharing arrangements.

Even though the BSD Rule took effect in April, the DOJ implemented a 90-day safe harbor period during which time companies were encouraged to become compliant with the rule before the July 2025 enforcement date. Now, almost six months since the DOJ began enforcement, and as the BSD Rule’s reporting requirements take effect in 2026, it is vital that companies assess their business relationships and data to ensure compliance with this complex rule that imposes new requirements on both U.S. organizations and persons.

For instance, impacted relationships that companies should be aware of may include those held with:

  • Data brokerage transactions (licensing, sale of data, data exchanged in a commercial transaction);
  • Employment agreements and/or board service involving foreign persons or companies;
  • Vendor agreements (for goods or services other than employment); and
  • Investment agreements (providing direct or indirect ownership in U.S. real estate or legal entities).

Even business relationships and transactions with foreign countries not among the six countries of concern should be evaluated to assess whether the non-country of concern recipients still receive bulk U.S. sensitive personal data. If so, companies must ensure that the appropriate downstream data protection language is included in all relevant contracts and appropriate diligence of those transactions is routinely performed.

Accordingly, U.S. organizations across all industries – including health care/life sciences, finance, technology, research – must “know their data.”  This includes an assessment of the following:

  • their business relationships and employment agreements to know and understand the entities or persons with which they transact (including where they are located and/or physically store data);
  • the volume and type of personal data collected to determine whether the data is considered “sensitive personal data” within the rule’s prescribed thresholds or could be deemed government-related data also subject to the BSD Rule;
  • how the organization uses the data in business transactions and/or data sharing arrangements; and
  • whether an exemption applies.

If an organization handles human genomic data, human biometric data, precise geolocation data, personal health data, and/or personal financial data, then further analysis should be done to determine compliance with the BSD Rule.

The instruction to “know your data” is one that even the DOJ has directed U.S. companies and persons to be aware of in light of this new rule, especially if the company regularly conducts business with, or is affiliated with a country of concern. At a minimum, due diligence into the nature and extent of those relationships is essential to determine if any reporting is required pursuant to the rule in 2026.

For additional information about the issues discussed in this Insight, please contact the attorney(s) listed on this page.

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