Expert Analysis

• 10 Practical Takeaways From FDA's Biopharma AI Guidance

  

  Recent guidance from the U.S. Food and Drug Administration provides much-needed guidance on the usage of artificial intelligence in producing information to support regulatory decision-making regarding drug safety, with implications ranging from life cycle maintenance to AI tool acquisition, say attorneys at Covington.

• Making The Opportunity Zones Program Great At Last

  

  As the opportunity zone program approaches its expiration, the Republican-led government could take specific steps to extend and improve the program, address its structural flaws, encourage broader participation and enable it to live up to its promised outcomes, say attorneys at Pillsbury.

• What Rodney Hood's OCC Stint Could Mean For Banking

  

  Acting Comptroller of the Currency Rodney Hood's time at the helm of the OCC, while temporary, is likely to feature clarity for financial institutions navigating regulations, the development of fintech innovation, and clearer expectations for counsel advising on related matters, say attorneys at Vedder Price.

• Opinion

  We Must Allow Judges To Use Their Independent Judgment

  

  As two recent cases show, the ability of judges to access their independent judgment crucially enables courts to exercise the discretion needed to reach the right outcome based on the unique facts within the law, says John Siffert at Lankler Siffert & Wohl.

• 4 Actions For Cos. As SEC Rebrands Cyber Enforcement Units

  

  As the U.S. Securities and Exchange Commission signals its changing enforcement priorities by retooling a Biden-era crypto-asset and cybersecurity enforcement unit into a task force against artificial-intelligence-powered hacks and online investing fraud, financial institutions and technology companies should adapt by considering four key points, say attorneys at Troutman.

• High Court Water Permit Ruling Lacks Specificity

  

  The enforcement impact of the U.S. Supreme Court’s recent decision in San Francisco v. U.S. Environmental Protection Agency may not be significant, because while the ruling makes clear that certain water permit provisions must instruct permittees on how to achieve stated goals, it doesn’t clarify the level of necessary instruction, says Daniel Deeb at ArentFox Schiff.

• Deportation Flights May End Up A Legal And Strategic Error

  

  Officials in the Trump administration could face criminal contempt charges if a D.C. judge finds that they flouted his orders last weekend to halt deportation flights to El Salvador, which could ultimately make mass deportations more difficult — and proving noncompliance a self-defeating strategy, says Ethan Greenberg at Anderson Kill.

• Mitigating The Risk Of Interacting With A Designated Cartel

  

  There are steps companies doing business in Latin America should take to mitigate risks associated with the Trump administration's designation of several cartels as foreign terrorist organizations and the terrorism statute's material-support provisions, which may render seemingly legitimate transactions criminal, say attorneys at Covington.

• How Health Cos. Can Navigate Data Security Regulation Limbo

  

  Despite the Trump administration's freeze on proposed updates to the Health Insurance Portability and Accountability Act security rule, there are critical cybersecurity steps healthcare organizations can take now without clear federal guidance, says William Li at Axiom.

• Opinion

  Firms Must Speak Up After Trump Orders: An Associate's View

  

  Rachel Cohen at Skadden discusses why she is helping to organize a movement of BigLaw associates urging their firms to stand up for the rule of law after the Trump administration’s moves against Covington, Perkins Coie and Paul Weiss.

• Preparing For Tariffs On Canadian Power In The Northeast

  

  The on-again, off-again risk of import and export tariffs on energy transactions between the U.S. and Canada may have repercussions for U.S. energy stakeholders in the ISO New England and New York Independent System Operator electricity markets — but there are options that could help reduce cost impacts, say attorneys at Husch Blackwell.

• How Calif.'s Wildfire Insurance Crisis Might Affect Texas

  

  Attorneys at Munsch Hardt examine the implications of California's wildfire insurance crisis for Texas, including potential shifts in coverage availability, regulatory differences and how the insurers in the second-largest U.S. state may react to a major wildfire event.

• New SEC Guidance May Change How Investors, Cos. Talk

  

  The U.S. Securities and Exchange Commission's recent updates to the Schedules 13D and G compliance and disclosure interpretations may mean large institutional investors substantially curtail the feedback they provide companies about their voting intentions in connection with shareholder meetings, which could result in negative voting outcomes for companies, say attorneys at Cleary.

• 4 Key Payments Trends For White Collar Attys

  

  As the payments landscape continues to innovate and the new administration looks to expand the role of digital currency in the American economy, white collar practitioners should be aware of several key issues in this space, say attorneys at Jenner & Block.

• Calif. Antitrust Bill Could Alter Enforcement Landscape

  

  If enacted, a recently proposed California bill that would strengthen the state’s antitrust law could signal a notable shift in the U.S. enforcement environment, but questions remain about the types of cases the state could pursue, whether other states will follow suit and more, say attorneys at DLA Piper.