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
The US Food and Drug Administration (FDA) recently issued its draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, on January 6, 2025.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Draft Guidance ,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The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations on January 7, 2025....more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Draft Guidance ,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
Artificial intelligence (AI) technology is advancing at an unprecedented rate, increasing in complexity while driving significant innovation across sectors. In response to the rapid development of AI, myriad compliance...more
11/6/2024
/ Algorithms ,
Artificial Intelligence ,
Automation Systems ,
Compliance ,
Corporate Governance ,
Cybersecurity ,
Data Security ,
Innovative Technology ,
Legislative Agendas ,
Machine Learning ,
Regulatory Agenda ,
Regulatory Reform ,
Risk Assessment ,
Risk Management ,
Technology Sector
New directives would have implications across a range of federal agencies - On October 24, 2024, the White House released the “first-ever” National Security Memorandum (NSM) on artificial intelligence (AI). The NSM directs...more
More than ever, artificial intelligence (AI) is being implemented as a powerful tool to improve our lives and businesses. But with its benefits comes a host of risks – and regulators are homing in on its use as a tool for...more
10/15/2024
/ Artificial Intelligence ,
Bribery ,
Chief Compliance Officers ,
Compliance ,
Corporate Crimes ,
Cyber Threats ,
Cybersecurity ,
Data Protection ,
Department of Justice (DOJ) ,
Enforcement Priorities ,
Fraud ,
Machine Learning ,
Price-Fixing ,
Regulatory Oversight ,
Risk Management