Today my colleagues and I will discuss recent developments in the US trade regulatory space.
We’re almost 100 days into the new administration, which stepped into a dynamic US trade regulatory environment, including new...more
4/23/2025
/ Biden Administration ,
China ,
Compliance ,
Department of Justice (DOJ) ,
Deregulation ,
Enforcement Priorities ,
Foreign Corrupt Practices Act (FCPA) ,
Foreign Investment ,
National Security ,
Tariffs ,
Trump Administration ,
US Trade Policies
Life sciences companies have long been outside the scope of US national security regulations and benefited from significant exemptions under US privacy laws. ...more
4/15/2025
/ CFIUS ,
China ,
Clinical Trials ,
Cybersecurity Information Sharing Act (CISA) ,
Data Privacy ,
Data Protection ,
Department of Justice (DOJ) ,
Foreign Investment ,
Life Sciences ,
National Security ,
Personal Data ,
Regulatory Requirements ,
Sensitive Personal Information
On April 8, 2025, a sweeping rule issued by the US Department of Justice (DOJ) will take effect. The rule imposes restrictions—and in some cases, outright prohibitions—on US companies in connection with certain types of data...more
4/7/2025
/ China ,
Corporate Counsel ,
Cuba ,
Cybersecurity ,
Cybersecurity Information Sharing Act (CISA) ,
Data Privacy ,
Data Security ,
Department of Justice (DOJ) ,
Foreign Investment ,
International Data Transfers ,
Iran ,
New Rules ,
North Korea ,
Personal Data ,
Personal Information ,
Regulatory Requirements ,
Russia ,
Sensitive Personal Information ,
Third-Party Risk ,
Third-Party Service Provider ,
Venezuela
On December 27, 2024, the US Department of Justice (DOJ) issued a final rule establishing a new national security program to prevent access to Americans’ bulk sensitive personal data and government-related data by China...more
On November 21, 2024, the US Department of the Treasury’s Office of Foreign Assets Control (OFAC) placed Gazprombank – Russia’s largest remaining non-designated bank – and more than 50 other Russian banks on its Specially...more
On October 28, 2024, the US Department of the Treasury issued final regulations governing certain outbound investments in the semiconductor, quantum computing, and artificial intelligence (AI) sectors of the People’s Republic...more
11/7/2024
/ Advanced Notice of Proposed Rulemaking (ANPRM) ,
Artificial Intelligence ,
Biden Administration ,
China ,
Executive Orders ,
Foreign Investment ,
National Security ,
Outbound Transactions ,
Popular ,
Regulatory Requirements ,
Semiconductors ,
Technology Sector ,
U.S. Treasury
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
4/1/2024
/ Advanced Notice of Proposed Rulemaking (ANPRM) ,
Biden Administration ,
Biologics ,
Centers for Medicare & Medicaid Services (CMS) ,
Clinical Laboratory Testing ,
Clinical Trials ,
Cybersecurity ,
Drug Pricing ,
EU ,
Executive Orders ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
Medical Technology Companies ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
NIST ,
Pharmaceutical Industry ,
Proposed Legislation ,
Proposed Rules ,
Regulatory Reform ,
Research and Development ,
Sensitive Personal Information ,
UK
In a sweeping, coordinated effort across federal agencies, the US government has taken a giant leap forward to prevent access to data that could be exploited to the detriment of national security. On February 28, 2024,...more
3/8/2024
/ Advanced Notice of Proposed Rulemaking (ANPRM) ,
Biden Administration ,
Bureau of Industry and Security (BIS) ,
CFIUS ,
China ,
Covered Person ,
Covered Transactions ,
Cuba ,
Data Protection ,
Data Security ,
Department of Justice (DOJ) ,
Executive Orders ,
International Data Transfers ,
Iran ,
North Korea ,
Office of Foreign Assets Control (OFAC) ,
Personal Data ,
Prohibited Transactions ,
Russia ,
Sensitive Personal Information ,
Venezuela
Proposed federal legislation known as the BIOSECURE Act is being considered in both the U.S. House of Representatives and the U.S. Senate....more
3/6/2024
/ Advanced Notice of Proposed Rulemaking (ANPRM) ,
Biotechnology ,
Bureau of Industry and Security (BIS) ,
China ,
Cuba ,
Data Collection ,
Department of Justice (DOJ) ,
Entity List ,
Export Controls ,
Federal Acquisition Regulations (FAR) ,
Federal Contractors ,
Federal Funding ,
Iran ,
National Security ,
NDAA ,
North Korea ,
Pharmaceutical Industry ,
Popular ,
Proposed Legislation ,
Russia ,
Technology Sector
After months of speculation, the US government took steps to regulate outbound investment in specific foreign industries of concern. President Biden on August 9, 2023, issued Executive Order 14105 directing the Department of...more
8/16/2023
/ Advanced Notice of Proposed Rulemaking (ANPRM) ,
Artificial Intelligence ,
Biden Administration ,
China ,
Electronics ,
Executive Orders ,
Foreign Investment ,
Hong Kong ,
Macau ,
National Security ,
Notice Requirements ,
Office of Foreign Assets Control (OFAC) ,
Outbound Transactions ,
Popular ,
Prohibited Transactions ,
Semiconductors ,
Technology Sector ,
U.S. Treasury
As Russia’s invasion of Ukraine continues, the White House countered with another wave of sanctions and export controls.
Building on the restrictions discussed in our Phase I and Phase II alerts, these new measures further...more
3/7/2022
/ Belarus ,
Bureau of Industry and Security (BIS) ,
Commerce Control List ,
Defense Sector ,
Economic Sanctions ,
Entity List ,
Export Administration Regulations (EAR) ,
Export Controls ,
Exports ,
Financial Institutions ,
Foreign Direct Product Rule ,
General Licenses ,
Military End Use ,
Office of Foreign Assets Control (OFAC) ,
Oil & Gas ,
Russia ,
SDN List ,
Software Developers ,
Source Code ,
U.S. Commerce Department
Earlier this week, following Russia’s aggressive incursion into Ukraine, we reported on the imposition of U.S. sanctions in response — a modest response that reserved the heavier sanctions that have been anticipated.
On...more
2/25/2022
/ Banking Sector ,
Belarus ,
Bureau of Industry and Security (BIS) ,
CAPTA List ,
Commerce Control List ,
Economic Sanctions ,
End-Users ,
Export Administration Regulations (EAR) ,
Export Controls ,
Financial Institutions ,
Foreign Direct Product Rule ,
General Licenses ,
Military End Use ,
Office of Foreign Assets Control (OFAC) ,
Prohibited Transactions ,
Russia ,
SDN List
The U.S. Department of Commerce, Bureau of Industry & Security (BIS) has added 33 China-based companies to its Unverified List, which now includes more than 100 entities located in China. A listing of these companies is...more
Much has been reported in the media about the efforts of the Committee on Foreign Investment in the United States (CFIUS) to investigate — and, where appropriate, mitigate, or even divest — transactions that the parties did...more
On January 19, 2021, the U.S. Department of Commerce published an interim final rule (the “ICTS Rule”) under former President Trump’s Information and Communications Technology and Services Executive Order issued in May 2019....more
On September 15, 2020, the U.S. Department of the Treasury issued a final rule modifying the mandatory filing requirements associated with reviews conducted by the Committee on Foreign Investment in the United States (CFIUS)...more
9/23/2020
/ CFIUS ,
Critical Infrastructure Sectors ,
Exceptions ,
Export Administration Regulations (EAR) ,
Export Controls ,
Exports ,
Filing Requirements ,
Final Rules ,
Foreign Investment ,
Technology Sector ,
U.S. Treasury
On June 29, 2020, the U.S. Departments of State and Commerce announced stricter controls on exports to Hong Kong, withdrawing Hong Kong’s preferential treatment as an autonomous territory. The regulatory changes follow...more
On May 20, 2020, the U.S. Department of the Treasury issued a proposed rule modifying the mandatory filing requirements associated with certain foreign investments in U.S. businesses that deal with “critical technologies.”...more
In a final rule issued April 28, 2020, the U.S. Commerce Department’s Bureau of Industry and Security (BIS) announced new export control requirements relating to China, Russia, and Venezuela.
Effective June 29, 2020, BIS...more
On April 27, 2020, the U.S. Department of the Treasury published an interim rule requiring the payment of a filing fee to the Committee on Foreign Investment in the United States (CFIUS) in connection with CFIUS’s review of...more
In This Issue. The Consumer Financial Protection Bureau (CFPB) released a policy statement outlining framework that the CFPB will immediately begin to apply in matters of supervision and enforcement regarding the “abusive”...more
1/31/2020
/ Abusive Acts ,
Consumer Financial Protection Bureau (CFPB) ,
Cybersecurity ,
Digital Currency ,
FDIC ,
FIRRMA ,
Foreign Investment ,
ISDA ,
Libor ,
MD&A Statements ,
OCC ,
OCIE ,
Securities and Exchange Commission (SEC) ,
UK
On January 17, 2020, the U.S. Department of the Treasury published long-awaited regulations that substantially implement the balance of new authorities under which the Committee on Foreign Investment in the United States...more
The Department of Justice announced that the United States and the United Kingdom have reached a bilateral agreement under the CLOUD Act that would permit service providers to disclose data in response to requests issued...more
On September 17, 2019, the U.S. Department of the Treasury unveiled proposed regulations that would expand the jurisdiction of the Committee on Foreign Investment in the United States (CFIUS) to cover certain real estate...more
On December 6, 2018, the Bureau of Consumer Financial Protection (“CFPB”) announced that two days earlier it had filed a complain?t and stipulated final judgment and order against a Nevada-based non-bank mortgage company in...more