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.

• 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.

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  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.

• 3 Ways To Lower Insider Trading Risk After First 10b5-1 Case

  

  In light of the U.S. Department of Justice's insider trading prosecution against the former CEO of Ontrack based on alleged abuse of a Rule 10b5-1 safe harbor plan — designed to allow executives to sell their companies' securities without liability — companies and individuals should take steps to avoid enacting similar plans in bad faith, say attorneys at Jenner & Block.

• 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.

• 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.

• 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.

• Series

  After Chevron: ERISA Challenges To Watch

  

  The end of Chevron deference makes the outcome of Employee Retirement Income Security Act regulatory challenges more uncertain as courts become final arbiters of pending lawsuits about ESG investments, the definition of a fiduciary, unallocated pension forfeitures and discrimination in healthcare plans, says Evelyn Haralampu at Burns & Levinson.

• Opinion

  Expert Witness Standards Must Consider Peer Review Crisis

  

  For nearly two decades, the so-called replication crisis has upended how the scientific community views the reliability of peer-reviewed studies, and it’s time for courts to reevaluate whether peer review is a trustworthy proxy for expert witness reliability, say Jeffrey Gross and Robert LaCroix at Reid Collins.

• Takeaways From High Court's Tribal Health Admin Cost Ruling

  

  The U.S. Supreme Court's recent determination that the government must reimburse two Native American tribes for administrative healthcare costs will help tribes maintain equal footing with the Indian Health Service when administering programs, and continues a pattern of how the current court aligns on tribal concerns, say attorneys at Lewis Roca.

• Justices' Intent Witness Ruling May Be Useful For Defense Bar

  

  At first glance, the U.S. Supreme Court’s recent Diaz v. U.S. decision, allowing experts to testify to the mental state of criminal defendants in federal court, gives prosecutors a new tool, but creative white collar defense counsel may be able to use the same tool to their own advantage, say Jack Sharman and Rachel Bragg at Lightfoot Franklin.

• Eye On Compliance: New Pregnancy And Nursing Protections

  

  With New York rolling out paid lactation breaks and extra leave for prenatal care, and recent federal legislative developments enhancing protection for pregnant and nursing workers, employers required to offer these complex new accommodations should take several steps to mitigate their compliance risks, says Madjeen Garcon-Bonneau at Wilson Elser.