Expert Analysis

• High Court Cert Spotlights Varying Tests For Federal Removal

  

  A recent decision by the U.S. Supreme Court to review Chevron v. Plaquemines Parish, a case involving the federal officer removal statute, highlights three other recent circuit court decisions raising federal removal questions, and serves as a reminder that defendants are the masters of removal actions, says Varun Aery at Hollingsworth.

• IRhythm IPR Denial Raises Key PTAB Discretion Questions

  

  By giving the passage of time a dispositive role in denying institution of five inter partes review petitions filed by iRhythm Technologies, the U.S. Patent and Trademark Office has upended the strategic considerations for filing and defending against IPRs, disclosing prior art during prosecution, and engaging in licensing negotiations, say attorneys at Dentons.

• Rising Enforcement Stakes For Pharma Telehealth Platforms

  

  Two pieces of legislation recently introduced in Congress could transform the structure and promotion of telehealth arrangements as legislators increasingly scrutinize direct-to-consumer advertising platforms, potentially paving the way for a new U.S. Food and Drug Administration policy with bipartisan support, say attorneys at Sheppard Mullin.

• Handling Revenue Cycle Management Disputes In The AI Age

  

  As healthcare providers and revenue cycle management vendors face an increasing use of artificial intelligence in claims adjudication, it's important for providers and their general counsel to plan in advance for potential disagreements with vendors and investigate the root causes behind any underperformance that arises, say consultants at AlixPartners.

• Prepare For Increased FDA Inspections Of Foreign Facilities

  

  In light of the U.S. Food and Drug Administration's recently announced plans to expand use of unannounced inspections of foreign drug manufacturing factories, foreign firms should implement best practices in anticipation of an imminent increase in enforcement activity, say attorneys at McGuireWoods.

• How Medical Practices Can Improve Privacy Compliance

  

  In light of recent high-profile patient privacy violations, health practices — especially in California — should better position themselves to comply with medical privacy laws by shoring up strategies ranging from mapping electronic protected health information to building a better compliance culture, says Suzanne Natbony at Aliant Law.

• 5 Open Questions About FDA's AI-Assisted Review Plans

  

  The U.S. Food and Drug Administration recently touted the completion of a generative artificial intelligence program for scientific reviewers and plans for agencywide deployment to speed up reviews of premarket applications, but there is considerable uncertainty surrounding the tools' ability to protect trade secrets, avoid bias and more, say attorneys at King & Spalding.

• 3 Takeaways From Recent Cyberattacks On Healthcare Cos.

  

  For the healthcare industry, the upward trend in styles of cyberattacks, costs, and entities targeted highlights the critical importance of proactive planning to help withstand the operational, legal and reputational turmoil that can follow a data breach, say attorneys at Troutman Pepper.

• How Focus On Menopause Care Is Fueling Innovation, Access

  

  Recent legislative developments concerning the growing field of menopause care are creating opportunities for increased investment and innovation in the space as they increase access to education and coverage, say attorneys at Kirkland.

• International Ramifications Of Canada's Health AI Moves

  

  Recent artificial intelligence developments in Canada's health industry are creating ripple effects for global investors, cross-border innovators and legal practitioners, and may create opportunities for U.S. companies rethinking their international strategies, says Atoussa Mahmoudpour at AMR Law.

• Maintaining Legal Compliance For GenAI In Life Sciences

  

  As companies continue to implement generative artificial intelligence to enhance all phases of drug discovery, they must remain mindful of legal, regulatory and practical considerations as best practices in this space emerge and evolve, say attorneys at Sullivan & Cromwell.

• 7 Considerations For Conducting Drug Clinical Trials Abroad

  

  With continuing cuts to U.S. Food and Drug Administration staffing motivating some pharmaceutical companies to consider developing drugs abroad, it's important to understand the additional risks and compliance requirements associated with conducting clinical studies in other countries, say attorneys at Morgan Lewis.

• Compliance Lessons From Warby Parker's HIPAA Fine

  

  The U.S. Department of Health and Human Services' civil money penalty against Warby Parker highlights the emerging challenges that consumer-facing brands encounter when expanding into healthcare-adjacent sectors, with Health Insurance Portability and Accountability Act compliance being a potential focus of regulatory attention, say attorneys at Saul Ewing.