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
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