Digital Health & Technology

Expert Analysis

• HHS' Updated Tracking Tech Guidance Offers Little Clarity

  

  The U.S. Department of Health and Human Services' Office for Civil Rights' updated guidance on the use of online tracking technologies appears more focused on legal issues raised in ongoing litigation with the American Hospital Association and less on practical guidance for covered entities, say attorneys at Sheppard Mullin.

• Contract Disputes Recap: Facts Differ But Same Rules Apply

  

  Zachary Jacobson and Sarah Barney at Seyfarth examine two decisions illustrating that reliance on a technicality may not save an otherwise untimely appeal, and that enforcement of commercial terms and conditions under a federal supply schedule contract may be possible.

• Hospitals Must Adapt To Growing Cybercrime Threats

  

  As the tide of cybersecurity attacks targeting the healthcare industry continues to grow, hospitals and healthcare providers must take steps to protect themselves, including by replacing legacy records systems and ensuring that business associate agreements address responsibility for breaches, says Christine Chasse at Spencer Fane.

• 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.