With the demise of the proposed federal moratorium on state-level AI regulations, which Congress eliminated at the last moment from the “One Big, Beautiful Bill” last week, state AI legislation takes center stage. The AI...more
On July 1, 2025, in a near-unanimous, 99-1 vote, the U.S. Senate stripped the AI moratorium provisions originally included in the “One Big Beautiful Bill Act." The AI moratorium, which we previously covered here, would have...more
California Assembly Bill 2013 (AB 2013), known as the Generative Artificial Intelligence: Training Data Transparency Act, was signed into law on September 28, 2024, and is set to take effect on January 1, 2026. ...more
6/11/2025
/ Artificial Intelligence ,
California Privacy Protection Agency (CPPA) ,
Copyright ,
Data Collection ,
Data Privacy ,
Disclosure Requirements ,
New Legislation ,
Regulatory Requirements ,
Software Developers ,
Technology Sector ,
Trade Secrets ,
Transparency
The artificial intelligence (AI) landscape is evolving at a dizzying pace. Just as organizations were adapting to generative AI and its capabilities for creating content, a new paradigm has emerged. ...more
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
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
4/1/2025
/ Department of Health and Human Services (HHS) ,
Diagnostic Tests ,
Electronic Protected Health Information (ePHI) ,
Food and Drug Administration (FDA) ,
Government Shutdown ,
Life Sciences ,
Medical Devices ,
New Regulations ,
Pharmaceutical Industry ,
Proposed Rules ,
Regulatory Requirements ,
Tariffs ,
Trump Administration ,
US Trade Policies
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
The EU Parliament’s committees for internal market and civil liberties overwhelmingly adopted the final text of the Artificial Intelligence Act (AI Act). The European Parliament will now vote on the AI Act in a formality that...more
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
10/2/2023
/ Biologics ,
Clinical Trials ,
Compliance ,
Diagnostic Tests ,
Draft Guidance ,
EU ,
European Medicines Agency (EMA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Manufacturers ,
Marketing ,
Medical Devices ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
PDUFA ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Legislation ,
Public Consultations ,
Regulatory Oversight ,
Regulatory Requirements ,
UK