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 proxy statement has become an integral component of a public company’s preparation for its annual meeting of shareholders. The rules and regulations under the Securities and Exchange Act of 1934 (the Exchange Act),...more
3/28/2025
/ Board of Directors ,
Corporate Governance ,
Disclosure Requirements ,
Environmental Social & Governance (ESG) ,
Executive Compensation ,
Insider Trading ,
Proxy Statements ,
Regulation S-K ,
Securities and Exchange Commission (SEC) ,
Securities Exchange Act of 1934 ,
Securities Regulation ,
Shareholders
Key takeaways from the US Copyright Office’s Copyrightability Report and the DC Circuit’s March 2025 Thaler decision - On January 29, 2025, the US Copyright Office issued Copyright and Artificial Intelligence, Part 2:...more
Senator Amy Klobuchar (D-MN) and eight Senate co-sponsors reintroduced “The Preventing Algorithmic Collusion Act” – formerly Senate Bill 3686 – as Senate Bill 232 (S. 232) on January 23, 2025. S. 232 makes no substantive...more
The US District Court for the District of Minnesota has ruled that plaintiffs may proceed in a putative class action lawsuit brought against a Medicare Advantage organization (MAO) to challenge its alleged use of an...more
2/25/2025
/ Algorithms ,
Artificial Intelligence ,
Breach of Contract ,
Class Action ,
Insurance Claims ,
Insurance Industry ,
Insurance Litigation ,
Medicare ,
Medicare Advantage ,
Medicare Advantage Organizations (MAOs) ,
Putative Class Actions
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
On January 23, 2025, President Donald Trump signed the Executive Order (EO) Removing Barriers to American Leadership in Artificial Intelligence. The artificial intelligence (AI)- focused EO is anticipated by the White House...more
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
The bipartisan task force on artificial intelligence (AI) in the US House of Representatives on December 17, 2024 released its highly anticipated report providing guiding principles, recommendations, and policy proposals to...more
The US Commodity Futures Trading Commission (CFTC) issued a nonbinding staff advisory, CFT Letter No. 24-17, to all CFTC-registered entities and registrants concerning the use of artificial intelligence (AI) in CFTC-regulated...more
On November 14, 2024, the EU AI Office published a first draft of the General-Purpose AI Code of Practice (draft Code), the first of four drafting rounds that will conclude in April 2025....more
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
In September 2024, government officials and private industry leaders announced that Three Mile Island, the Pennsylvania power plant that was the site of the nation’s most severe commercial nuclear accident, will be reopened...more
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
Over the course of September, more than 30 artificial intelligence (AI)-focused bills crossed California Governor Gavin Newsom’s desk. The bills proposed a broad set of rules, ranging from mandatory disclosure of information...more
On September 23, 2024, Principal Deputy Assistant Attorney General Nicole M. Argentieri announced much-anticipated revisions to the US Department of Justice (DOJ)’s Evaluation of Corporate Compliance Programs (Revised ECCP)...more
On September 9, 2024, China’s National Technical Committee 260 on Cybersecurity released the first version of its AI Safety Governance Framework (the Framework), which was formulated to implement the Global AI Governance...more
9/13/2024
/ Artificial Intelligence ,
China ,
Cybersecurity ,
Data Collection ,
Ethics ,
Innovative Technology ,
Machine Learning ,
Regulatory Oversight ,
Risk Assessment ,
Risk Mitigation ,
Technology Sector ,
Transparency