Expert Analysis

• 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.

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  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.

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  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.

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  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.

• Opinion

  Unclear Intellectual Property Laws Are Stifling US Innovation

  

  U.S. intellectual property law’s lack of predictability means far less job-creating investments for companies that need patent protection to compete, and Congress must step in with legislation like the Patent Eligibility Restoration Act to help address the problem, says Michael Gulliford at Soryn IP Capital Management.

• Pros And Cons Of 2025 NDAA's Space Contracting Proposal

  

  The introduction of a Commercial Augmentation Space Reserve fleet in the pending 2025 National Defense Authorization Act presents a significant opportunity for space and satellite companies — despite outstanding questions, and potential risks, for operators, say attorneys at Wiley.

• How 3rd Circ. Raised Bar For Constitutional Case Injunctions

  

  The Third Circuit's decision in Delaware State Sportsmen's Association v. Delaware Department of Safety & Homeland Security, rejecting the relaxed preliminary injunction standards many courts have used when plaintiffs allege constitutional harms, could portend a shift in such cases in at least four ways, say attorneys at Gibson Dunn.

• New Russia Sanctions Law: Bank Compliance Insights

  

  Financial institutions must familiarize themselves with the new reporting obligations imposed by the Rebuilding Economic Prosperity and Opportunity for Ukrainians Act, a recent law that authorizes seizures of Russian sovereign assets under U.S. jurisdiction, say attorneys at Seward & Kissel.

• Opinion

  Dreamer Green Card Updates Offer Too Little For Too Few

  

  Despite the Biden administration’s good intentions in announcing a new pathway for college-educated Dreamers to receive green cards, the initiative ultimately does little to improve the status quo for most beneficiaries, and could even leave applicants in a worse position, says Adam Moses at Harris Beach.

• 3 Healthcare FCA Deals Provide Self-Disclosure Takeaways

  

  Several civil False Claims Act settlements of alleged healthcare fraud violations over the past year demonstrate that healthcare providers may benefit substantially from voluntarily disclosing potential misconduct to both the U.S. Department of Justice and the U.S. Department of Health and Human Services, say Brian Albritton and Raquel Ramirez Jefferson at Phelps Dunbar.

• Opinion

  Congress Must Increase Small Biz Ch. 11 Debt Cap

  

  Congress must act to reinstate Subchapter V, which recently sunsetted when the debt threshold to qualify reverted from $7.5 million to just over $3 million, meaning thousands of small businesses will no longer be able to use the means of reorganization, says Daniel Gielchinsky at DGIM Law.