Expert Analysis

• 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.

• An Instructive Reminder On Appealing ITC Determinations

  

  A recent Federal Circuit decision, partially dismissing Crocs' appeal of a U.S. International Trade Commission verdict as untimely, offers a powerful reminder that the ITC is a creature of statute and that practitioners would do well to interpret those statutes conservatively, says Derrick Carman at Robins Kaplan.

• Ruling Puts Guardrails On FTC Merger Filing Rule Expansion

  

  A Texas federal court recently vacated the Federal Trade Commission's overhaul of the Hart-Scott-Rodino premerger notification form, in a significant setback for the antitrust agencies, say attorneys at Reed Smith.

• Opinion

  Bridging The Bench And Bars To Uphold The Rule Of Law

  

  In a moment when the judiciary faces unprecedented partisan attacks and public trust in our courts is fragile, and with the stakes being especially high for mass tort cases, attorneys on both sides of the bench have a responsibility to restore confidence in our justice system, say Bryan Aylstock at Aylstock Witkin and Kiley Grombacher at Bradley/Grombacher.

• State And Int'l Standards May Supplant EPA's GHG Rule

  

  The U.S. Environmental Protection agency's recent repeal of its 2009 finding that greenhouse gases endanger public health will likely increase regulatory uncertainty, as states attempt to fill the breach with their own regulatory regimes and some companies shift focus to international climate benchmarks instead, say attorneys at ArentFox Schiff.

• 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.

• Series

  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.

• What 'Precedential' Decisions Reveal About USPTO's Direction

  

  Significant procedural changes at the U.S. Patent and Trademark Office last year have reshaped patent litigation and business strategies and created uncertainty around the USPTO's governing rules, but an accounting of the decisions the office designated as precedential and informative sheds light on the agency's new approach, say attorneys at Sterne Kessler.

• OCC Mortgage Escrow Rules Add Fuel To Preemption Debate

  

  Two rules proposed in December by the Office of the Comptroller of the Currency, which would preempt state laws requiring national banks to pay interest on mortgage escrow accounts, are a bold new federal gambit in the debate over how much authority Congress intended to hand state regulators under the Dodd-Frank Act, says Christian Hancock at Bradley Arant.

• CFIUS Initiative May Smooth Way For Some Foreign Investors

  

  A new program that will allow certain foreign investors to be prevetted and admitted to fast-track approval by the Committee on Foreign Investment in the United States will likely have tangible benefits for investors participating in competitive M&A, say attorneys at Simpson Thacher.

• When Tokenized Real-World Assets Collide With Real World

  

  The city of Detroit's ongoing case against Real Token, alleging building code and safety violations across over 400 Detroit residential properties, highlights the brave new world we face when real estate assets are tokenized via blockchain technology — and what happens to the human tenants caught in the middle, say Biying Cheng and Cornell law professor David Reiss.

• 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 Lenders Can Be Ready For Disparate Impact Variabilities

  

  Amid state attorneys general's and regulators' mixed messaging around disparate impact liability, financial institutions can take several steps to minimize risk, including ensuring compliance management aligns with current law and avoiding decisions that impede growth in business and service, says Elena Babinecz at Baker Donelson.

• Wage-Based H-1B Rule Amplifies Lottery Risks For Law Firms

  

  Under the wage-based H-1B lottery rule taking effect Feb. 27, law firms planning to hire noncitizen law graduates awaiting bar admission should consider their options, as the work performed by such candidates may sit at the intersection of multiple occupational classifications with differing chances of success, says Jun Li at Reid & Wise.

• Series

  Judges On AI: Practical Use Cases In Chambers

  

  U.S. Magistrate Judge Allison Goddard in the Southern District of California discusses how she uses generative artificial intelligence tools in chambers to make work more efficient and effective — from editing jury instructions for clarity to summarizing key documents.