17 April 2025
Since April 8, 2025, new requirements for international data transfers apply in the US via the Final Rule to Executive Order 14117 ("Bulk Data Rule"). The Bulk Data Rule aims to protect sensitive personal data of US citizens and government-related data from access by so-called "countries of concern" - currently China (including Hong Kong and Macau), Russia, Iran, North Korea, Venezuela and Cuba. The Bulk Data Rule impacts data transfers from the US through which such sensitive data could be accessed or used by foreign individuals or entities with connections to the aforementioned "countries of concern".
European companies with relations to the US - for example through subsidiaries, customers or contractual partners - may be indirectly affected by the new requirements and should review their data processing and contractual practices now.
The requirements affect data transfers by US companies to foreign individuals or entities that are directly or indirectly associated with a "country of concern". This includes:
In addition, the National Security Division ("NSD") can classify other persons - including US citizens - as "designated covered persons" if they meet certain control criteria. These persons are then included an official "covered persons list" which will be published.
Important: As part of their compliance program, US companies are obliged to check whether partners fall under the above categories.
Typical processes affected are
Important: It is sufficient that data access is theoretically possible - actual access is not necessary.
From certain data volumes ("bulk"), the following data is protected by the requirements:
Personal identifiers (e.g. IP addresses, user IDs) |
From 100,000 persons |
---|---|
Precise location data (e.g. GPS data with <1,000 m accuracy) |
From 1,000 persons or devices |
Biometric data (e.g. facial recognition, fingerprint, voice) |
From 1,000 persons |
Human genetic data (DNA sequences, genetic analyses) |
From 100 persons |
Health data (e.g. diagnoses, treatments, vaccination statuses) |
From 10,000 people |
Financial data (e.g. account data, credit reports, payment histories) |
From 10,000 people |
When combining different data categories |
lowest applicable number |
Regardless of the data volume, the Final Rule also covers so-called "government-related data":
Important: Anonymized, pseudonymized, encrypted, de-identified or aggregated data is also covered if it exceeds the specified quantity thresholds. The decisive factor is not the form of processing, but rather the risk that such data can be used for re-identification - for example through traceability or cross-comparisons - and evaluated in a security-relevant manner.
There are a number of generally prohibited data transfers ("prohibited transactions") (with individual exceptions), e.g.:
There are also certain "restricted transactions". These are only permitted if certain security standards are met. “Restricted transactions” include contracts with service providers or suppliers, employment or investment contracts with critical countries.
If the US companies subject to the Bulk Data Rule do not meet the required security standards (implementation of CISA guidelines on IT security, verifiable risk assessment and logging of data transfers), their ”restricted transactions” are also deemed to be prohibited.
There are two notable instances where this may be the case:
International data flows therefore remain permitted in principle - but companies must be vigilant to avoid unintentional breaches or liability risks.
Even if your company is based exclusively in the EU, you may be affected - for example by:
We would recommend taking the following steps:
The Bulk Data Rule came into force on April 8, 2025. Since then, the basic restrictions on certain international data transactions apply - particularly with regard to access by countries of concern or covered persons.
However, the US Department of Justice (DOJ) provides for a transition period until July 8, 2025: During this period, civil enforcement actions will be waived if a company can prove that it is working on implementing suitable compliance measures.
Some key obligations for restricted transactions - in particular, regarding due diligence, documentation, auditing and reporting - will not come into force until October 5, 2025. US companies therefore have a limited preparation window to adapt processes, contracts and internal responsibilities to the new requirements. During this time, companies are likely to approach their partners abroad.
by Dr. Gregor Schmid, LL.M. (Cambridge) and Wiebke Reuter, LL.M. (London)