Datentransaktionen: Auswirkungen der endgültigen Regelung des US-Justizministeriums auf akademische medizinische Zentren mit klinischen Forschungsprogrammen

The Department of Justice (DOJ) published its Final Rule to implement Executive Order 14117 on January 8, 2025, with a correcting amendment issued April 18, 2025. Executive Order 14117, issued on February 28, 2024, titled “Preventing Access to Americans’ Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern,” instructed the Attorney General to create regulations that ban or limit U.S. persons from participating in transactions involving property in which a foreign country or its nationals have an interest. Transactions are banned or limited if they involve U.S. government-related data or bulk sensitive personal data (as defined by the final implementing rules), fall into categories deemed by the Attorney General to pose a national security risk (with such security risk arising from potential access to data by identified countries of concern or related individuals), and meet additional criteria outlined in the Executive Order.

The Final Rule outlines categories of transactions that are either banned or limited; designates specific countries and types of individuals or entities with whom transactions involving government-related or bulk U.S. sensitive personal data are restricted; creates a system for granting, modifying, or revoking licenses for otherwise restricted activities and for issuing advisory opinions; and sets requirements for transaction recordkeeping and reporting requirements to support the DOJ’s investigations, enforcement, and regulatory actions in relation to the Executive Order. 

Academic Medical Centers (AMCs) and similar entities engaged in clinical research and international collaborations need to be aware of and determine the applicability of the regulatory requirements imposed by the Final Rule. Research partnerships involving biometric identifiers, personal health information, or genomic data may be deemed restricted or prohibited transactions if the partnerships include entities from designated countries of concern.

Zusammenfassung

The Final Rule is aimed at preventing certain U.S. foreign adversaries — including China, Russia, Iran, North Korea, Cuba, and Venezuela — from accessing sensitive U.S. personal data and government-related information. 

Key Definitions. The Final Rule authorizes the DOJ to regulate and enforce restrictions on data transactions with designated “Countries of Concern” and “Covered Persons.” 

• “Country of Concern” is defined to mean: 

any foreign government that, as determined by the Attorney General with the concurrence of the Secretary of State and the Secretary of Commerce, (1) has engaged in a long-term pattern or serious instances of conduct significantly adverse to the national security of the United States or security and safety of United States persons, and (2) poses a significant risk of exploiting government-related data or bulk U.S. sensitive personal data to the detriment of the national security of the United States or security and safety of U.S. persons. 

• “Covered Person” is defined to include: (1) foreign entities that (a) are fifty percent or more owned, directly or indirectly, by countries of concern or another covered persons; or (b) are organized under the law of, or have their principal place of business in, a Country of Concern; (2) foreign entities that are fifty percent or more owned, directly or indirectly, by Covered Persons, either individuals or entities; (3) foreign individuals who are non-U.S. residents working as employees or contractors of a Country of Concern; (4) foreign individuals primarily residing in Countries of Concern; and (5) other entities or individuals as reasonably determined by the Attorney General based on certain criteria. 

Categories of Covered Data. The Final Rule targets eight categories of “Covered Data,” including biometric identifiers, genomic data, health and financial data, precise geolocation information, and personal identifiers that can be linked to other sensitive data. It also includes certain government-related information, such as data tied to U.S. government personnel or the geolocation of sensitive facilities. Notably, the regulations apply regardless of data processing volume when government-related information is involved. 

Primary Types of Restricted Transactions. The DOJ identifies three primary types of restricted transactions: employment, investment, and vendor agreements. U.S. businesses must ensure foreign employees, investors, and service providers — especially those linked to Countries of Concern — do not gain access to Covered Data unless strict security protocols are met. This affects a wide range of commercial activities, from hiring and corporate deals to cloud services and software subscriptions, and likely impacts AMCs engaging in clinical research when data is shared with certain employees. Research sponsors, investors and service providers. Prohibitions and restrictions of the Final Rule, however, only apply to Covered Data Transactions with a Country of Concern or Covered Person that involve access by a Country of Concern or Covered Person to government-related data or bulk U.S. sensitive personal data. The Final Rule does not regulate transactions that do not implicate access to government-related data or bulk U.S. sensitive personal data by a Country of Concern or a Covered Person.

Prohibited Transactions. Notably, under the Final Rule certain transactions are absolutely prohibited, such as those involving the sale or licensing of Covered Data to foreign entities in data brokerage arrangements, or those involving biometric data or biospecimens. 

Penalties for Non-Compliance. Violations of the Final Rule carry significant fines and penalties. Civil fines can reach the greater of US$368,136 or twice the transaction amount. Willful violations may result in criminal penalties of up to US$1 million and up to 20 years in prison.

The Bottom Line for Clinical Research. To comply with the Final Rule, AMCs must engage in rigorous and thorough diligence on proposed, and existing research activities, collaborations and operations, including on their partners, clients, employees/contractors, and data recipients, to determine if a proposed or existing transaction falls within the ambit of the Final Rule.  The scope and penalties for violations of and non-compliance with the Final Rule are a clear indicator that a process to determine and ensure compliance with the Final Rule will be critical for AMCs, and businesses across industries, that engage in activities and transactions involving personal or government-related data.

Implications for Academic Medical Centers with Clinical Research Programs

The Final Rule adds a new layer of regulatory compliance complexity for AMCs and similar entities engaged in clinical research and international collaborations. 

• Research studies and activities, including research collaborations and partnerships involving biometric identifiers, personal health information or genomic data, may be deemed restricted or prohibited transactions if the partnerships include entities from designated Countries of Concern and/or Covered Persons. 
• Existing and proposed multi-national studies and data-sharing initiatives must be reviewed to determine if the Final Rule is applicable to the study or activity, and if so, to ensure compliance. 
• Additionally, AMCs must also ensure that vendors, including cloud and AI service providers, are not affiliated with Countries of Concern and that all data processing activities meet stringent new security and compliance standards. As noted above, ensuring compliance with the Final Rule will necessitate a thorough review of the AMC’s vendor contracts. 
• Further, the Final Rule necessitates a reassessment by AMCs, of their data-sharing policies and multi-site protocols, and will likely require the incorporation of national security-focused compliance clauses in certain data sharing agreements (such as data use agreements) and the enhancement of institutional data governance frameworks, which frameworks should be designed to avoid and mitigate any legal and regulatory exposure, and ensure that the institution is able to maintain eligibility for receipt of federal funding.

Nächste Schritte

This Final Rule prescribes significant categorical rules that prevent U.S. persons from providing government-related data or U.S. citizens’ bulk, sensitive personal data, including through commercial data-brokerage transactions, to Countries of Concern or Covered Persons. Compliance with the Final Rule specifically necessitates that AMCs and institution implement security measures when engaging in investment transactions, employment agreements, and vendor contracts, that involve either government-related data or large-scale collections of sensitive personal data — such as health records, biometric identifiers, or financial information. 

The requirements of the Final Rule are intended to prevent foreign adversaries from indirectly accessing this data through commercial relationships. By identifying these specific transaction types, the Final Rule seeks to address perceived national security gaps and provides clear, enforceable standards that define when and how data-related dealings with foreign actors are restricted.

Failure to comply with these new requirements could result in fines and penalties, regulatory scrutiny, loss of federal funding, and enforcement actions, making compliance with the Final Rule, when and as applicable to a transaction and activity, a critical compliance priority for AMCs and institutions handling large volumes of sensitive personal data.

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