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.

• 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.

• How To Grow Marketing, Biz Dev Teams In A Tight Market

  

  Faced with fierce competition and rising operating costs, firms are feeling the pressure to build a well-oiled marketing and business development team that supports strategic priorities, but they’ll need to be flexible and creative given a tight talent market, says Ben Curle at Ambition.

• FTC Focus: Private Equity Investments In Healthcare

  

  As the Federal Trade Commission is tightening its scrutiny of private equity investment in healthcare, the agency is finding novel grounds to challenge key focus areas, including rollup acquisitions, the flip-and-strip approach and minority investments in rival providers, say attorneys at Proskauer.

• High Court's Expert Ruling May Help Health Fraud Defendants

  

  The U.S. Supreme Court's decision in Diaz v. U.S. appears to give the government a powerful new tool in calling its own agents as expert witnesses, but it could also benefit defense counsel in criminal healthcare fraud and other white collar criminal cases that arise in complex legal or regulatory environments, say attorneys at Holland & Knight.

• Patent Lessons From 5 Federal Circuit Reversals In June

  

  A look at June cases where the Federal Circuit reversed or vacated decisions by the Patent Trial and Appeal Board or a federal district court highlights a potential path for branded drugmakers to sue generic-drug makers for off-label uses, potential downsides of violating a pretrial order offering testimony, and more, say Denise De Mory and Li Guo at Bunsow De Mory.

• Unpacking HHS' Opinion On Cell Therapy Refund Programs

  

  A recent advisory opinion from the U.S. Department of Health and Human Services, determining that a biopharma company's refund program for its cell therapy will not be penalized, indicates an encouraging willingness to engage, but the regulator's assumptions about the program's limited term warrant a closer look, says Mary Kohler at Kohler Health.