Expert Analysis

• Analyzing FDA Draft Guidance On Clinical Trial Diversity

  

  In light of the U.S. Food and Drug Administration's draft guidance on clinical trial diversity action plans, there are several important considerations for sponsors and clinical researchers to keep in mind to prevent delay in a drug or device application, say attorneys at Crowell & Moring.

• Justices' Criminal Law Decisions: The Term In Review

  

  Each of the 11 criminal decisions issued in the U.S. Supreme Court’s recently concluded term is independently important, but taken together, they reveal trends in the court’s broader approach to criminal law, presenting both pitfalls and opportunities for defendants and their counsel, says Kenneth Notter at MoloLamken.

• What's New In The AI Healthcare Regulatory Space

  

  Attorneys at Hogan Lovells review the current legal and regulatory landscape for artificial intelligence applications in healthcare, touching on policies around safety, transparency, nondiscrimination and reimbursement, and what to expect in the future.

• Biden Policy Gives Employers New Ways To Help Dreamers

  

  A new Biden administration immigration policy makes the process more predictable for Deferred Action for Childhood Arrivals recipients to seek employment visas, and, given uncertainties surrounding DACA’s future, employers should immediately determine which of their employees may be eligible, says Jennifer Kim at Moore & Van Allen.

• 25 Years Of OECD's Anti-Bribery Convention

  

  Marking its 25th anniversary this year, the Organization for Economic Cooperation and Development's anti-bribery convention has advanced legislative reforms and reshaped corporate conduct in dozens of countries amid the persistent challenges of uneven enforcement and political pressure, say attorneys at Debevoise.

• Despite Calif. Delays, Climate Disclosure Rules Are Coming

  

  Progress continues on state, federal and international climate disclosure regimes, making compliance a key concern for companies — but the timeline for implementation of California's disclosure laws remains unclear due to funding and timing disputes, says David Smith at Manatt Phelps.

• Series

  After Chevron: Bid Protest Litigation Will Hold Steady For Now

  

  Though the substantive holding of Loper Bright is unlikely to affect bid protests because questions of statutory interpretation are rare, the spirit of the U.S. Supreme Court's decision may signal a general trend away from agency deference even on the complex technical issues that often arise, say Kayleigh Scalzo and Andrew Guy at Covington.

• Challenging Prosecutors' Use Of Defendants' Jail Phone Calls

  

  Although it’s an uphill battle under current case law, counsel for pretrial detainees may be able to challenge prosecutors’ use of jail-recorded phone calls between the defendant and their attorney by taking certain advance measures, say Jim McLoughlin and Fielding Huseth at Moore & Van Allen.

• 1 Year At The UPC: Implications For Transatlantic Disputes

  

  In its first year, the Unified Patent Court has issued important decisions on procedures like provisional measures, but complexities remain when it comes to coordinating proceedings across jurisdictions like the U.S. due to differences in timelines and discovery practices, say attorneys at McDermott.

• Opinion

  H-2 Visas Offer Humane, Economic Solution To Border Crisis

  

  Congress should leverage the H-2 agricultural and temporary worker visa programs to match qualified migrants with employers facing shortages of workers — a nonpolitical solution to a highly divisive humanitarian issue, say Ashley Dees and Jeffrey Joseph at BAL.

• PAGA Reforms Encourage Proactive Employer Compliance

  

  Recently enacted reforms to California's Private Attorneys General Act should make litigation under the law less burdensome for employers, presenting a valuable opportunity to streamline compliance and reduce litigation risks by proactively addressing many of the issues that have historically attracted PAGA claims, say attorneys at Mintz.

• Opinion

  Now More Than Ever, Lawyers Must Exhibit Professionalism

  

  As society becomes increasingly fractured and workplace incivility is on the rise, attorneys must champion professionalism and lead by example, demonstrating how lawyers can respectfully disagree without being disagreeable, says Edward Casmere at Norton Rose.

• Series

  After Chevron: Piercing FEMA Authority Is Not Insurmountable

  

  While the Federal Emergency Management Agency's discretionary authority continues to provide significant protection from claims under the Administrative Procedure Act, Loper Bright is a blow to the argument that Congress gave FEMA unfettered discretion to administer its own programs, says Wendy Huff Ellard at Baker Donelson.

• What Happens After Hawaii Kids' Historic Climate Deal

  

  Implications of the Hawaii Department of Transportation's first-of-its-kind settlement with youth plaintiffs over constitutional climate claims may be limited, but it could incite similar claims, says J. Michael Showalter and Robert Middleton at ArentFox Schiff.

• How Tech Trackers May Implicate HIPAA After Hospital Ruling

  

  A recent Texas federal court order in American Hospital Association v. Becerra adds a legal protection on key data, clarifying when tracking technologies implicate the Health Insurance Portability and Accountability Act, so organizations should ensure all technology used is known and accounted for, say John Howard and Myriah Jaworski at Clark Hill.