Digital Health & Technology

Expert Analysis

• Assessing FDA Pathways For Genome-Edited Plant Foods

  

  The U.S. Food and Drug Administration's recent clarification of the regulatory pathways for foods produced from genome-edited plants seeks to strike a balance between public health and innovation, and may hold broader significance for developers of novel human foods subject to voluntary notification programs, say Emily Marden and Diane McEnroe at Sidley Austin.

• Spartan Arbitration Tactics Against Well-Funded Opponents

  

  Like the ancient Spartans who held off a numerically superior Persian army at the Battle of Thermopylae, trial attorneys and clients faced with arbitration against an opponent with a bigger war chest can take a strategic approach to create a pass to victory, say Kostas Katsiris and Benjamin Argyle at Venable.

• How AI May Be Used In Fintech Fraud — And Fraud Detection

  

  Recent enforcement actions in the fintech and finance industries show that the government is increasingly pursuing fraud enabled by artificial intelligence — at the same time it’s using AI innovations to enforce regulations and investigate fraud, say attorneys at ArentFox Schiff.

• What Recent Study Shows About AI's Promise For Legal Tasks

  

  Amid both skepticism and excitement about the promise of generative artificial intelligence in legal contexts, the first randomized controlled trial studying its impact on basic lawyering tasks shows mixed but promising results, and underscores the need for attorneys to proactively engage with AI, says Daniel Schwarcz at University of Minnesota Law School.

• BIPA's Statutory Exemptions Post-Healthcare Ruling

  

  The Illinois Supreme Court's November opinion in Mosby v. Ingalls Memorial Hospital, which held that the Biometric Information Privacy Act's healthcare exemption also applies when information is collected from healthcare workers, is a major win for healthcare defendants that resolves an important question of statutory interpretation, say attorneys at Quinn Emanuel.

• What's New In FDA's Updated Data Monitoring Guidance

  

  The U.S. Food and Drug Administration's new guidance on the use of data monitoring committees in clinical trials is set to replace the agency's 2006 guidance on the topic, with notable updates including stronger language indicating a more stringent stance against financial conflicts of interest and adaptation to recent changes in DMC structure, say attorneys at Hogan Lovells.

• Keeping Up With Class Actions: Data Breach Litigation In Flux

  

  In this monthly look at notable class action decisions, Gerald Maatman at Duane Morris examines a recent mixed-bag data breach ruling from an Illinois federal court — in the context of case law developments over the last year — which illustrates the range of issues confronting litigants going forward.

• Inside The PTAB's Seagen Cancer Drug Patent Decision

  

  The Patent Trial and Appeal Board's recent finding that Seagen's claims for antibody-drug conjugate technology were unpatentable — for lack of enablement, lack of written description and anticipation — mark the latest chapter in the complex patent dispute as the case heads for director review, says Ryan Hagglund at Loeb & Loeb.

• Despite Risks, AI Is A Worthy Tool For Healthcare Industry

  

  Artificial intelligence appears to provide a productive path forward for the healthcare industry, improving economic and human health outcomes, though companies must continue to address certain technology and compliance pain points, says Sarah Abrams at Bowhead Specialty Underwriters.

• Potential Defendant Strategies Amid Calif. Privacy Questions

  

  Although the current case law surrounding the California Consumer Privacy Act is in its infancy, courts have begun addressing important issues related to the notice-and-cure provisions of the statute, and these decisions show defendant-businesses would be wise to assert their notice rights early and repeatedly, say Viola Trebicka and Dan Humphrey at Quinn Emanuel.

• Health Policy Legislative Landscape May Remain Frozen

  

  With Congress again delaying the full resolution of fiscal year 2024 federal spending legislation, there is now an additional window in which Congress could work through several priority issues for healthcare stakeholders, though these issues are unlikely to be resolved in time, say attorneys at Faegre Drinker.

• What Businesses Should Know About NJ Privacy Bill

  

  New Jersey’s recently passed comprehensive privacy bill S.B. 332 presents businesses with a nuanced framework and compliance obligations, including opt-in consent requirements for sensitive data, with recommendations for businesses to organize data, review consent requirements and more, says Trisha Sircar at Katten.

• Staying Ahead Of The AI Policymaking Curve

  

  With artificial intelligence poised to be the hottest legislative and regulatory topic in 2024, expect the AI policymaking toolbox to continue to expand and evolve as stakeholders in the U.S. and abroad develop, deploy, use and learn more about these technologies, say attorneys at Hogan Lovells.