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• Analyzing FDA Draft Guidance On Clinical Trial Diversity

  

  In light of the U.S. Food and Drug Administration's draft guidance on clinical trial diversity action plans, there are several important considerations for sponsors and clinical researchers to keep in mind to prevent delay in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 are 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.

• Takeaways From EU's Initial Findings On Apple's App Store

  

  A deep dive into the European Commission's recent preliminary findings that Apple's App Store rules are in breach of the Digital Markets Act reveal that enforcement of the EU's Big Tech law might go beyond the literal text of the regulation and more toward the spirit of compliance, say William Dolan and Pratik Agarwal at Rule Garza.

• 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.

• How To Comply With Chicago's New Paid Leave Ordinance

  

  Chicago's new Paid Leave and Paid Sick and Safe Leave Ordinance went into effect earlier this month, so employers subject to the new rules should update leave policies, train supervisors and deliver notice as they seek compliance, say Alison Crane and Sarah Gasperini at Jackson Lewis.

• Cyber Incident Response Checklist For SEC Compliance

  

  In light of recent guidance from the U.S. Securities and Exchange Commission, which clarified the distinction between two types of cybersecurity incident disclosures, companies should align their materiality assessment, incident response and disclosure control processes to bolster compliance and provide a measure of protection, say attorneys at Troutman Pepper.

• Expect CFPB To Enforce Warning Against 'Coercive' Fine Print

  

  The recent Consumer Financial Protection Bureau warning against unenforceable terms "deceptively" slipped into the fine print of contracts will likely be challenged in court, but until then, companies should expect the agency to treat its guidance as law and must carefully scrutinize their consumer contracts, say attorneys at Ballard Spahr.

• Loss Causation Ruling Departs From Usual Securities Cases

  

  A California federal court recently dismissed Ramos v. Comerica, finding that the allegations failed to establish loss causation, but the reasoning is in tension with the pleading-stage approaches generally followed by both courts and economists in securities fraud litigation, say Jesse Jensen and Aasiya Glover at Bernstein Litowitz.

• 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.

• 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.

• 'Outsourcing' Ruling, 5 Years On: A Warning, Not A Watershed

  

  A New York federal court’s 2019 ruling in U.S. v. Connolly, holding that the government improperly outsourced an investigation to Deutsche Bank, has not undercut corporate cooperation incentives as feared — but companies should not completely ignore the lessons of the case, say Temidayo Aganga-Williams and Anna Nabutovsky at Selendy Gay.

• Series

  Serving In The National Guard Makes Me A Better Lawyer

  

  My ongoing military experience as a judge advocate general in the National Guard has shaped me as a person and a lawyer, teaching me the importance of embracing confidence, balance and teamwork in both my Army and civilian roles, says Danielle Aymond at Baker Donelson.

• Big Business May Come To Rue The Post-Administrative State

  

  Many have framed the U.S. Supreme Court’s recent decisions overturning Chevron deference and extending the window to challenge regulations as big wins for big business, but sand in the gears of agency rulemaking may be a double-edged sword, creating prolonged uncertainty that impedes businesses’ ability to plan for the future, says Todd Baker at Columbia University.