Expert Analysis

• How HHS Discrimination Rule Affects Gender-Affirming Care

  

  The U.S. Department of Health and Human Services' new final rule, which reinterprets the Affordable Care Act's anti-discrimination provision, greatly clarifies protections for gender-affirming care and will require compliance considerations from sponsors and administrators of most group health plans, say attorneys at McDermott.

• Opinion

  'Natural Person' Or Not, AI-Made IP Deserves Protection

  

  The entire legal edifice rests on a determination that an artificial system is not a so-called natural person, and although this may appear to be straightforward on its face, rapid advances in technology may soon force us to revisit our understanding of a natural person, says Manav Das at McDonnell Boehnen.

• Lessons On Challenging Class Plaintiffs' Expert Testimony

  

  In class actions seeking damages, plaintiffs are increasingly using expert opinions to establish predominance, but several recent rulings from California federal courts shed light on how defendants can respond, say Jennifer Romano and Raija Horstman at Crowell & Moring.

• Exploring An Alternative Model Of Litigation Finance

  

  A new model of litigation finance, most aptly described as insurance-backed litigation funding, differs from traditional funding in two key ways, and the process of securing it involves three primary steps, say Bob Koneck, Christopher Le Neve Foster and Richard Butters at Atlantic Global Risk LLC.

• FTC Noncompete Rule's Impact On Healthcare Nonprofits

  

  Healthcare entities that are nonprofit or tax-exempt and thus outside of the pending Federal Trade Commission noncompete rule's reach should evaluate a number of potential risk factors and impacts, starting by assessing their own status, say Ben Shook and Tania Archer at Moore & Van Allen.

• Cell Therapy Cos. Must Beware Limits Of Patent Safe Harbors

  

  Though developers of gene and cell therapy products commonly assume that a legal safe harbor protects them from patent infringement suits, recent case law shows that not all preapproval uses of patented technology are necessarily protected, say Natasha Daughtrey and Joshua Weinger at Goodwin.

• Series

  Teaching Yoga Makes Me A Better Lawyer

  

  Being a yoga instructor has helped me develop my confidence and authenticity, as well as stress management and people skills — all of which have crossed over into my career as an attorney, says Laura Gongaware at Clyde & Co.

• How Clinical Trials Affect Patentability In US And Europe

  

  A comparison of recent U.S. and European patent decisions — concerning the effect of disclosures in clinical trials on the patentability of products — offers guidance on good practice for companies dealing with public use issues and prior art documents in these commercially important jurisdictions, say lawyers at Finnegan.

• Opinion

  State-Regulated Cannabis Can Thrive Without Section 280E

  

  Marijauna's reclassification as a Schedule III-controlled substance comes at a critical juncture, as removing marijuana from being subjected to Section 280E of the Internal Revenue Code is the only path forward for the state-regulated cannabis industry to survive and thrive, say Andrew Kline at Perkins Coie and Sammy Markland at FTI Consulting.

• Key Takeaways From FDA Final Rule On Lab-Developed Tests

  

  Michele Buenafe and Dennis Gucciardo at Morgan Lewis discuss potential consequences of the U.S. Food and Drug Administration's recently finalized rule regulating lab-developed tests as medical devices, and explain the rule's phaseout policy for enforcement discretion.

• Examining Illinois Genetic Privacy Law Amid Deluge Of Claims

  

  After a federal court certified an Illinois Genetic Information Privacy Act class action in August, claims under the law have skyrocketed, so employers, insurers and others that collect health and genetic information should ensure compliance with the act to limit litigation risk, say attorneys at Squire Patton.

• Assessing HHS' Stance On Rare Disease Patient Assistance

  

  The U.S. Department of Health and Human Services' recent advisory opinion, temporarily blessing manufacturer-supported copay funds for rare disease patients, carves a narrow path for single-donor funds, but charities and their donors may require additional assistance to navigate programs for such patients, says Mary Kohler at Kohler Health Law.

• Opinion

  Feds' Biotech Enforcement Efforts Are Too Heavy-Handed

  

  The U.S. Department of Justice's recent actions against biotech companies untether the Anti-Kickback Statute from its original legislative purpose, and threaten to stifle innovation and undermine patient quality of care, say attorneys at Ropes & Gray.

• Del. Ruling Highlights M&A Deal Adviser Conflict Disclosures

  

  The Delaware Supreme Court recently reversed the Court of Chancery's dismissal of challenges to Nordic Capital's acquisition of Inovalon, demonstrating the importance of full disclosure of financial adviser conflicts when a going-private merger seeks business judgment rule review, say attorneys at Debevoise.

• Action Steps To Address New Restrictions On Outbound Data

  

  Companies should immediately assess all their data-based operations so they can consider strategies to effectively mitigate new compliance risks brought on by recently implemented transaction restrictions, including a Justice Department proposal and landmark data legislation, say attorneys at Wiley.