Expert Analysis

• FDA's Biosimilarity Guidance Holds Uncertain Implications

  

  The U.S. Food and Drug Administration's new draft guidance aimed at simplifying the biosimilarity demonstration process may not be enough to overcome the barriers that have historically constrained biosimilar competition, and could affect biosimilar access in unexpected ways, say analysts at Analysis Group.

• Unpacking Key Themes From NY's New Healthcare Strategy

  

  New York Gov. Kathy Hochul's 2026 State of the State agenda, read together with the state's fiscal year 2027 executive budget, reflect a clear framework to utilize Medicaid as the state's operating platform for healthcare reform, say attorneys at Sheppard.

• 5 Different AI Systems Raise Distinct Privilege Issues

  

  A New York federal court’s recent U.S. v. Heppner decision, holding that a defendant’s use of Claude was not privileged, only addressed one narrow artificial intelligence system, but lawyers must recognize that the spectrum of AI tools raises different confidentiality and privilege questions, says Heidi Nadel at HP.

• Health Co.'s 'Success Story' Misstep Holds HIPAA Lessons

  

  Cadia Healthcare Facilities' fall settlement with the U.S. Department of Health and Human Services for improperly disclosing patients' protected health information in online success stories is an instructive example of Health Insurance Portability and Accountability Act risks that can arise from digital marketing efforts, say attorneys at Woods Rogers.

• Opinion

  AI-Assisted Arbitration Needs Safeguards To Ensure Fairness

  

  As tribunals and arbitral institutions increasingly use artificial intelligence tools in their decision-making processes, ​​​​​​​clear disclosure standards and procedural safeguards are necessary to ensure that efficiency gains do not erode the fairness principles on which arbitration depends, says Alexander Lima at Wesco International.

• 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.

• Series

  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.

• 11th Circ. May Bring Tectonic Shift To FCA Qui Tam Actions

  

  The Eleventh Circuit's upcoming decision in Zafirov v. Florida Medical Associates, assessing whether the False Claims Act permits ordinary citizens to stand as officers of the federal government, could significantly limit private relators' ability to bring FCA actions, say attorneys at Saul Ewing.

• 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.

• To Survive FCA Actions, Small Cos. Must Take Offensive Steps

  

  A fumbled response to False Claims Act allegations can doom lower-middle-market businesses, and with FCA enforcement hitting record levels for two years, smaller companies must have offensive strategies ready that focus their limited resources on defeating civil qui tam and federal criminal actions, says Derrelle Janey at Olshan Frome.

• 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.

• How US Liability Law Is Becoming The Primary Regulator Of AI

  

  Comprehensive federal AI regulation remains fragmented and uncertain — but U.S. courts, applying long-standing doctrines of liability and responsibility, are actively shaping how AI systems are designed, deployed and governed, and companies are aligning their AI practices because courts may hold them accountable if they do not, says Alexander Lima at Wesco International.

• 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.

• Methods For Challenging State Civil Investigative Demands

  

  Ongoing challenges to enforcement actions underscore the uphill battle businesses face in arguing that a state investigation is prohibited by federal law, but when properly deployed, these arguments present a viable strategy to resist civil investigative demands issued by state attorneys general, say attorneys at Troutman Pepper.