The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations on January 7, 2025. The draft guidance provides insights on how FDA

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Time is running out for Corporate Transparency Act (CTA) compliance. The law, which became effective on January 1, 2024, requires certain entities – or “reporting companies” – to disclose information about their beneficial ownership to

Continue Reading ‘Tis the season and past time for a ho-ho-hum approach to Corporate Transparency Act reporting deadline

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 healthcare service plans (HCSPs)

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On September 19, 2024, the US Court of Appeals for the Second Circuit issued a summary order in which it held that the “safe harbor” provision of Section 546(e) of the Bankruptcy Code preempted a

Continue Reading Second Circuit rules Bankruptcy Code’s “safe harbor” provision preempts state law fraudulent transfer claims