Expert Analysis

• Trans Care Enforcement Landscape Is Evolving Quickly

  

  The recent coordinated federal effort to reshape pediatric gender-affirming care through enforcement and funding pressure has created a rapidly evolving regulatory environment marked by shifting risk assessments and potential downstream market effects for healthcare institutions and life sciences companies, say attorneys at Arnall Golden.

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  Playing Piano Makes Me A Better Lawyer

  

  Playing piano and practicing law share many parallels relating to managing complexity: Just as hearing an entire musical passage in my head allows me to reliably deliver the message, thinking about the audience's impression helps me create a legal narrative that keeps the reader engaged, says Michael Shepherd at Fish & Richardson.

• 3 Cases Highlight SEC Distinction Between Exec, Co. Liability

  

  Three recent enforcement actions against Spero Therapeutics, Lottery.com and Archer-Daniels-Midland demonstrate that while public companies are subject to liability for misrepresentations, the U.S. Securities and Exchange Commission is focused on individual liability when disclosure violations involve so-called half-truths, say attorneys at Cooley.

• AI-Generated Doc Ruling Guides Attys On Privilege Risks

  

  A New York federal court's ruling, in U.S. v. Heppner, that documents created by a defendant using an artificial intelligence tool were not privileged, can serve as a guide to attorneys for retaining attorney-client or work-product privilege over client documents created with AI, say attorneys at Sher Tremonte.

• The Law Firm Merger Diaries: Leadership Strategy After Day 1

  

  For law firm leaders, ensuring a newly combined law firm lives up to its promise, both in its first days of operation and well after, includes tough decisions, clear and specific communication, and cheerleading, says Peter Michaud at Ballard Spahr.

• Record FCA Recoveries Signal Intensified Healthcare Focus

  

  In its recently released False Claims Act statistics, the U.S. government's emphasis on record healthcare recoveries and government-initiated healthcare matters last year indicates robust enforcement ahead, though the administration's focus on current policy objectives also extends beyond the healthcare sector, say attorneys at Epstein Becker.

• Fed. Circ. In Jan.: On The Validity Of Expert Testimony

  

  The Federal Circuit's recent decision in Barry v. DePuy, addressing whether expert testimony is admissible even if it does not strictly adhere to the court's claim construction, suggests that exclusion via a Daubert motion is appropriate only when the line to improper testimony is clearly crossed, say attorneys at Knobbe Martens.

• Calif.'s Civility Push Shows Why Professionalism Is Vital

  

  The California Bar’s campaign against discourteous behavior by attorneys, including a newly required annual civility oath, reflects a growing concern among states that professionalism in law needs shoring up — and recognizes that maintaining composure even when stressed is key to both succeeding professionally and maintaining faith in the legal system, says Lucy Wang at Hinshaw.

• A Potential Shift In FDA's Approach To Drug Trial Design

  

  Recent guidance released by the U.S. Food and Drug Administration clarifying how Bayesian approaches — which combine prior knowledge with new data — may be used in clinical trials reflects the agency's continued interest in innovative trial designs that may accelerate drug approvals, say attorneys at Alston & Bird.

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  Trivia Competition Makes Me A Better Lawyer

  

  Playing trivia taught me to quickly absorb information and recognize when I've learned what I'm expected to know, training me in the crucial skills needed to be a good attorney, and reminding me to be gracious in defeat, says Jonah Knobler at Patterson Belknap.

• What FDA Guidance Means For Future Of Health Software

  

  Two significant final guidance documents released by the U.S. Food and Drug Administration last month reflect a targeted effort to ease innovation friction around specific areas, including singular clinical decision support recommendations and sensor-based wearables, while maintaining established regulatory boundaries, say attorneys at Covington.

• Opinion

  Federal Preemption In AI And Robotics Is Essential

  

  Federal preemption offers a unified front at a decisive moment that is essential for safeguarding America's economic edge in artificial intelligence and robotics against global rivals, harnessing trillions of dollars in potential, securing high-skilled jobs through human augmentation, and defending technological sovereignty, says Steven Weisburd at Shook Hardy.

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  Law School's Missed Lessons: What Cross-Selling Truly Takes

  

  Early-career attorneys may struggle to introduce clients to practitioners in other specialties, but cross-selling becomes easier once they know why it’s vital to their first years of practice, which mistakes to avoid and how to anticipate clients' needs, say attorneys at Moses & Singer.

• Drafting Tech Patents After USPTO's Eligibility Memos

  

  Two recent U.S. Patent and Trademark Office memos on subject matter eligibility declarations provide an evidentiary playbook for artificial intelligence and software patent applications, highlighting how targeted, stand‑alone SMEDs that present objective, claim‑anchored facts can improve patent application outcomes, say attorneys at Reed Smith.

• How State FCA Activity May Affect Civil Fraud Enforcement

  

  A growing trend of state attorneys general enforcing their False Claims Act analogues independently of the U.S. Department of Justice carries potential repercussions for civil fraud enforcement and qui tam litigation considerations, say Li Yu at Bernstein Litowitz, Ellen London at London & Naor and Gwen Stamper at Vogel Slade.