Expert Analysis

• 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.

• A Look At AI Benefits And Risks In Global Development Efforts

  

  In areas like healthcare and law, artificial intelligence can play a transformative role in achieving the U.N.'s 2030 agenda for creating a more equitable, prosperous and sustainable world, but if not properly managed, AI could hinder global development efforts and widen existing gaps within society, say attorneys at Winston & Strawn.

• What's Next For Lab Test Regulation Without FDA Authority

  

  A recent Texas federal court decision vacating the U.S. Food and Drug Administration's final rule that would apply FDA regulations to laboratory-developed tests signals potential positive impacts in the diagnostic space, and could inspire more healthcare entities to litigate against the government, say attorneys at Hooper Lundy.

• 23andMe Case Highlights Privacy Complexities In Ch. 11

  

  Attorneys at Pryor Cashman discuss the interplay between a sale of personally identifiable information and bankruptcy law in light of genetics and health company 23andMe's recent filing for Chapter 11 relief.

• 10 Practical Takeaways From FDA's Biopharma AI Guidance

  

  Recent guidance from the U.S. Food and Drug Administration provides much-needed insight on the usage of artificial intelligence in producing information to support regulatory decision-making regarding drug safety, with implications ranging from life cycle maintenance to AI tool acquisition, say attorneys at Covington.