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
On December 4, 2018, one of the nation’s largest debt buyers and its subsidiaries reached a settlement with 42 states and the District of Columbia (see, e.g., announcements here and here). The settlement closes the states’...more
On November 19, 2018, the Department of Commerce published an Advanced Notice of Proposed Rulemaking (ANPR) seeking public comment on how to identify certain “emerging technologies” that are essential to U.S. national...more
Editor's Note -
In This Issue. The Securities and Exchange Commission (SEC) granted no-action relief for fund boards; the Financial Stability Oversight Council (FSOC) announced the rescission of the “systemically important...more
10/18/2018
/ ATDS ,
Bank Secrecy Act ,
Banking Sector ,
Consumer Financial Protection Bureau (CFPB) ,
Dodd-Frank ,
Excessive Fees ,
Financial Services Industry ,
FinTech ,
FSOC ,
Investment ,
Joint Statements ,
No-Action Relief ,
Securities and Exchange Commission (SEC) ,
TCPA ,
Virtual Currency
On Wednesday, October 10, 2018, the Department of the Treasury exercised its authority under the recently passed Foreign Investment Risk Review Modernization Act (FIRRMA) to implement a Pilot Program that expands the...more
On September 13, 2018, the Consumer Financial Protection Bureau (“CFPB”) announced that it filed a complaint against a lender, its president, and related entities (“Defendants”) for allegedly making small-dollar loans in...more
New legislation addressing foreign investment in the United States is expected to become law in the next several weeks. The Foreign Investment Risk Review Modernization Act (FIRRMA) promises important changes to the powers...more