Expert Analysis

• Digging Into The Debate On FDA's Proposed Lab Test Rule

  

  A proposed 10-word amendment from the U.S. Food and Drug Administration represents a sea change in device regulation as it would summarily end decades of FDA enforcement discretion for laboratory developed tests, and the public comments offer some insight into the future of this long-running saga, say attorneys at Mintz.

• Opinion

  What Insurers Gain When Litigating Coverage Denials

  

  Lately, insurance companies have denied coverage for lawsuits alleging liability relating to the ordinary operations of highly regulated businesses, such as those in the pharmaceutical and energy sectors — demonstrating time and again how litigation can be a vehicle for carriers to mitigate their own costs, say attorneys at Reed Smith.

• Law Firm Strategies For Successfully Navigating 2024 Trends

  

  Though law firms face the dual challenge of external and internal pressures as they enter 2024, firms willing to pivot will be able to stand out by adapting to stakeholder needs and reimagining their infrastructure, says Shireen Hilal at Maior Consultants.

• 10 Privacy Compliance Areas To Focus On In 2024

  

  The fast pace of change in the cybersecurity realm means reactive approaches to new laws, regulations and enforcement actions are not effective ways to build or scale privacy programs, so companies should plan strategically and prepare for a few emerging risks and requirements in the first half of this year, says Sam Castic at Hintze Law.

• AI In Health Law: The Top Guest Articles Of 2023

  

  As the use of artificial intelligence accelerated this year, Expert Analysis writers examined AI's significant impact on the healthcare sector, ranging from key compliance considerations for companies utilizing AI tools to regulators' efforts to keep up with rapidly evolving technologies.

• The Most-Read Legal Industry Law360 Guest Articles Of 2023

  

  A range of legal industry topics drew readers' attention in Law360's Expert Analysis section this year, from associate retention strategies to ethical billing practices.

• Inside Higher Education's New FCA Liability Challenges

  

  As the educational sector expands its use of government funding, schools are at increased risk under the False Claims Act, but recent settlements offer valuable lessons about new theories of liability they may face and specific procedures to reduce their exposure, say James Zelenay and Jeremy Ochsenbein at Gibson Dunn.

• AI Executive Order's Life Science, Healthcare Industry Effects

  

  The recent White House executive order to manage risks associated with artificial intelligence includes provisions specific to healthcare and life sciences that merit special attention, including transparency, human oversight of AI output, and real world performance monitoring, say attorneys at Ropes & Gray.

• 5 Most Notable Class Action Standing Cases Of 2023

  

  Key appellate class action decisions this past year continued the trend of a more demanding approach to the threshold issue of standing during each phase of litigation, say attorneys at MoFo.

• HHS Advisory Highlights Free Product Inducement Risks

  

  A recent U.S. Department of Health and Human Services advisory opinion highlights concerns that valuable free products and other inducements may influence patients and providers to choose one manufacturer’s product over another, notwithstanding that such free healthcare products may be a benefit, say attorneys at Morgan Lewis.

• How SEC And NY Cyber Reporting Rules Affect Key Industries

  

  The new U.S. Securities and Exchange Commission and New York State Department of Financial Services cybersecurity disclosure requirements, and their competing obligations, reveal the increasing complexity for organizations evaluating and reacting to cybersecurity incidents — particularly those in the healthcare and financial services industries, say attorneys at Manatt.

• Trends Shaping The 2024 Consumer Packaged Goods Industry

  

  The better-for-you segment within the consumer packaged goods industry is poised for a significant evolution in 2024, and industry players must remain agile and adaptive through M&A activities, legal considerations, sustainability initiatives and changing technology, says Christopher Cain at Foley & Lardner.

• NY Wrongful Death Law Revamp Retains Original's Drawbacks

  

  If approved by New York Gov. Kathy Hochul, the Grieving Families Act will transform the landscape of wrongful death law in New York by increasing the potential for damages, raising insurance premiums, burdening hospitals and courts, stifling the economy and subjecting parties to the unsettling effects of retroactive legislation, say attorneys at Shaub Ahmuty.

• Attorneys' Busiest Times Can Be Business Opportunities

  

  Attorneys who resolve to grow their revenue and client base in 2024 should be careful not to abandon their goals when they get too busy with client work, because these periods of zero bandwidth can actually be a catalyst for future growth, says Amy Drysdale at Alchemy Consulting.

• 9th Circ. Scienter Ruling May Strengthen FDA's Leverage

  

  A recent Ninth Circuit decision in U.S. v. Marschall — regarding scienter and violations of the Federal Food Drug and Cosmetic Act — appears to give the U.S. Food and Drug Administration another arrow in its quiver to lob in the direction of any repeat offender, with potentially very broad applications, say Elena Quattrone and Zachary Taylor at Epstein Becker.