On July 23, 2025, the White House released “Winning the Race: America’s AI Action Plan” (Action Plan), which describes itself as a strategic roadmap intended to foster US leadership in AI and “articulate policy...more
The European Commission published its General-Purpose AI Code of Practice (Code) on July 10, 2025, after a long drafting process that was originally intended to conclude in May 2025. The development of the code was...more
Introduction -
In our June 2024 white paper, Legal red teaming: A systematic approach to assessing legal risk of generative AI models, we presented legal red teaming, a methodology aimed at helping organizations that...more
Artificial intelligence (AI) technology is advancing rapidly. A key development is the emergence of “agentic” AI structures, which operate with a greater autonomy compared to traditional AI systems. These powerful agents...more
New guidance emphasizes risk-based governance, requires “impact assessments” - On April 7, 2025, the White House Office of Management and Budget (OMB) released two memoranda, outlining its latest guidance for federal...more
The first compliance deadline set out in the European Union (EU)’s Regulation (EU) 2024/1689, or the EU AI Act, took effect on February 2, 2025. ...more
2/4/2025
/ Artificial Intelligence ,
Cooperative Compliance Regime ,
Data Privacy ,
Data Protection ,
Deadlines ,
EU ,
European Commission ,
Infrastructure ,
Innovative Technology ,
Machine Learning ,
Regulatory Agenda ,
Regulatory Reform ,
Regulatory Requirements ,
Risk Management
During its last week before the inauguration, the Biden Administration issued significant and complex new export controls on semiconductors and related technology for artificial intelligence (AI) applications worldwide. These...more
1/27/2025
/ Artificial Intelligence ,
Biden Administration ,
Export Controls ,
Final Rules ,
Interim Final Rules (IFR) ,
Machine Learning ,
National Security ,
Regulatory Agenda ,
Regulatory Requirements ,
Semiconductors ,
Supply Chain ,
Trump Administration ,
U.S. Commerce Department
The US Food and Drug Administration (FDA) recently issued its draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, on January 6, 2025. ...more
1/24/2025
/ Artificial Intelligence ,
Clinical Trials ,
Comment Period ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
Pharmaceutical Industry ,
Regulatory Requirements ,
Risk Management
The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations on January 7, 2025....more
1/16/2025
/ Artificial Intelligence ,
Cybersecurity ,
Data Privacy ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Healthcare ,
Machine Learning ,
Medical Devices ,
Regulatory Requirements ,
Risk Management ,
Software ,
Transparency
On September 28, 2024, California enacted SB 1120, which regulates the use of artificial intelligence (AI), an algorithm, or “other software tool” in utilization review and utilization management (UR/UM) functions by...more