Expert Analysis

• A Primer On EU's Updated Human Substance Regulations

  

  The European Union's updated standards regarding quality and safety of substances of human origin meant for human application carry significant implications for companies that work with cells and tissues, and U.S. companies active in the EU market should pay particular attention to the import and export rules, say Geneviève Michaux and Georgios Symeonidis at King & Spalding.

• Opinion

  Prejudgment Interest Is A Game-Changer In Ill. Civil Suits

  

  Civil litigation can leave plaintiffs financially strained and desperate for any recovery, especially when defendants use delaying tactics — but the Illinois Legislature's move to allow prejudgment interest has helped bring litigants to the table earlier to resolve disputes, minimizing court expenses and benefiting all parties, says Benjamin Crane at Coplan + Crane.

• Series

  After Chevron: New Lines Of Attack For FCA Defense Bar

  

  Loper Bright has given defense counsel new avenues to overcome the False Claims Act elements of falsity and scienter, as any FCA claim based upon ambiguous statutory terms can no longer stand solely on agency regulations to establish the statute's meaning, which is itself necessary to satisfy the FCA's basic requirements, says Elisha Kobre at Bradley Arant.

• CFPB's Medical Debt Proposal May Have Side Effects

  

  The Consumer Financial Protection Bureau’s recent proposal to prevent medical debt information from appearing on consumer reports and creditors from basing lending decisions on such information may have initial benefits for some consumers, but there are potential negative consequences that should also be considered, say attorneys at Cooley.

• New NHTSA Fuel Economy Rule Adds Compliance Complexity

  

  The National Highway Traffic Safety Administration's recently announced final rule on new corporate average fuel economy standards for passenger cars and light trucks will create challenges for manufacturers, which must also comply with the EPA's multipollutant rule and California's zero-emission vehicle programs, say Joanne Rotondi and Hannah Graae at Hogan Lovells.

• Series

  Teaching Scuba Diving Makes Me A Better Lawyer

  

  As a master scuba instructor, I’ve learned how to prepare for the unexpected, overcome fears and practice patience, and each of these skills – among the many others I’ve developed – has profoundly enhanced my work as a lawyer, says Ron Raether at Troutman Pepper.

• 15 Areas That Would Change Under Health Data Rule Proposal

  

  If finalized, the Office of the National Coordinator for Health Information Technology's proposed rule will significantly progress its efforts to advance interoperability, respond to stakeholder concerns and clarify compliance with the health IT certification program, say attorneys at Ropes & Gray.

• The Road Ahead For Regulation Of Digital Twins In Healthcare

  

  Digital replicas of cells, organs and people — known as digital twins — can facilitate clinical trials for new drugs by reducing the number of patients required, but data limitations can create logistical hurdles and regulatory efforts addressing digital twins are still in early stages, say consultants at Keystone Strategy.

• A Guide To Long-Term, Part-Time Employee Determinations

  

  With final regulations under the Secure Act requiring 401(k) retirement benefits for long-term, part-time employees expected soon, Amy Sheridan and David Guadagnoli at Sullivan & Worcester look at how the proposed rules would shift the risk-reward calculus on excluding categories of employees, and what plan sponsors would need to consider when designing retirement plans.

• Series

  After Chevron: Delegation Of Authority And Tax Regulators

  

  The U.S. Department of the Treasury and the Internal Revenue Service will face higher standards following Loper Bright’s finding that courts should determine whether agency rules meet the best possible interpretation of the tax code, as well as the scope of the authority delegated by Congress, says Edward Froelich at McDermott.

• Lawyers Can Take Action To Honor The Voting Rights Act

  

  As the Voting Rights Act reaches its 59th anniversary Tuesday, it must urgently be reinforced against recent efforts to dismantle voter protections, and lawyers can pitch in immediately by volunteering and taking on pro bono work to directly help safeguard the right to vote, says Anna Chu at We The Action.

• Decoding CFPB Priorities Amid Ramp-Up In Nonbank Actions

  

  Based on recent Consumer Financial Protection Bureau enforcement actions and press releases about its supervisory activities, the agency appears poised to continue increasing its scrutiny over nonbank entities — particularly with respect to emerging financial products and services — into next year, say attorneys at Wiley.

• Series

  After Chevron: What Loper Bright Portends For The NLRB

  

  While the U.S. Supreme Court has a long history of deferring to the National Labor Relations Board's readings of federal labor law, the court's Loper Bright v. Raimondo decision forces courts to take a harder look at the judgment of an agency — and the NLRB will not be immune from such greater scrutiny, says Irving Geslewitz at Much Shelist.

• PE Firms Should Prepare For Increased False Claims Scrutiny

  

  The impact private equity firms may have over medical decisions and care is increasingly attracting potential liability under the False Claims Act and attention from states and the federal government, so investors should follow best practices including conducting due diligence both before and after acquisitions, say attorneys at K&L Gates.

• Series

  After Chevron: NRC Is Shielded From Loper Bright's Effects

  

  While the U.S. Supreme Court's recent Loper Bright v. Relentless decision brought an end to Chevron deference, Congress' unique delegation of discretionary authority to the Nuclear Regulatory Commission will likely insulate it from the additional judicial scrutiny that other federal agencies will face, say Ryan Lighty and Scott Clausen at Morgan Lewis.