Expert Analysis

• A Primer On New Calif. Health Transaction Reporting Rules

  

  New California regulations regarding the reporting of certain transactions involving healthcare entities, which took effect on Jan. 1, address some industry feedback about overly broad requirements but still leave several areas of concern, says Andrew Demetriou at Husch Blackwell.

• Opinion

  Waiving COVID-19 IP Protections Would Harm US Industry

  

  President Joe Biden should turn down a World Trade Organization proposal to waive crucial intellectual property protections behind COVID-19 tests and diagnostics — protections that allow U.S. companies to sustain millions of jobs and develop life-saving treatments that benefit patients in every country, says former U.S. Circuit Judge Paul Michel, now at the Council for Innovation Promotion.

• Series

  In The CFPB Playbook: Rulemaking Rush Before Election Year

  

  In this quarterly Consumer Financial Protection Bureau activity recap by former bureau personnel, attorneys at McGuireWoods explain the regulator's recent push to finalize new rules about data aggregators, digital payment apps and more before the election-year Congressional Review Act window opens.

• What The Law Firm Of The Future Will Look Like

  

  As the legal landscape shifts, it’s become increasingly clear that the BigLaw business model must adapt in four key ways to remain viable, from fostering workplace flexibility to embracing technology, say Kevin Henderson and Eric Pacifici at SMB Law Group.

• 4 PR Pointers When Your Case Is In The News

  

  Media coverage of new lawsuits exploded last year, demonstrating why defense attorneys should devise a public relations plan that complements their legal strategy, incorporating several objectives to balance ethical obligations and advocacy, say Nathan Burchfiel at Pinkston and Ryan June at Castañeda + Heidelman.

• 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.