Expert Analysis

• FDA's Lab-Developed Test Rule May Bring Historic Challenges

  

  If finalized, the U.S. Food and Drug Administration's proposed rule for regulating laboratory-developed tests will provoke some of the most interesting legal challenges that the agency has faced in decades, with outcomes that will likely reverberate across the agency's product centers, says Stacy Amin at MoFo.

• Finding Focus: Strategies For Attorneys With ADHD

  

  Given the prevalence of ADHD among attorneys, it is imperative that the legal community gain a better understanding of how ADHD affects well-being, and that resources and strategies exist for attorneys with this disability to manage their symptoms and achieve success, say Casey Dixon at Dixon Life Coaching and Krista Larson at Stinson.

• A Look At DOJ's New Nationwide Investment Fraud Approach

  

  Investment fraud charges are increasingly being brought in unlikely venues across the country, and the rationale behind the U.S. Department of Justice's approach could well be the heightened legal standards in connection with prosecuting investment fraud, says Jonathan Porter at Husch Blackwell.

• AI Use May Trigger False Claims Act's Public Disclosure Bar

  

  The likely use of publicly available artificial intelligence tools to detect government fraud by combing through large data sets will raise complex questions about a False Claims Act provision that prohibits the filing of claims based on previously disclosed information, say Nick Peterson and Spencer Brooks at Wiley Rein.

• Beware Privacy Risks In Training AI Models With Health Data

  

  Because data used to train artificial intelligence models may be protected by the Health Insurance Portability and Accountability Act or other regulations, users of these models should conduct proper diligence to avoid costly compliance failures, say Neha Matta and Barbara Bennett at Frost Brown.

• Unpacking GAO's FY 2023 Bid Protest Report

  

  The U.S. Government Accountability Office's recent bid protest report reflects an increase in sustained protests, illustrating that disappointed offerors may see little reason to refrain from seeking corrective action — but there is more to the story, say Aron Beezley and Patrick Quigley at Bradley Arant.

• How Fla. Bankruptcy Ruling May Affect Equity Owners

  

  A Florida bankruptcy court’s recent ruling in Vital Pharmaceuticals — which rejected the Third Circuit’s Majestic Star decision that determined a bankrupt corporation’s flow-through status was not protected by the automatic stay — may significantly affect how equity owners can mitigate the impact of flow-through structures in bankruptcy, say Eric Behl-Remijan and Natasha Hwangpo at Ropes & Gray.

• Earnout Contract Considerations After NC Good Faith Ruling

  

  The North Carolina Supreme Court's recent Value Health Solutions v. Pharmaceutical Research decision, holding the implied covenant of good faith and fair dealing did not apply in an earnout dispute related to an asset sale, demonstrates the need for practitioners to pay careful attention to milestone concepts in M&A transactions, says Benjamin Hicks at Wagner Hicks.

• FDA's Off-Label Comms Guidance Is A Reluctant Step Forward

  

  The U.S. Food and Drug Administration's latest draft guidance expands its safe harbor for health care providers that communicate information about their products' off-label uses, but does not fully resolve the First Amendment disconnect between federal courts and the agency's regulatory goals, say Jeffrey Shapiro and Lisa Dwyer at King & Spalding.

• White House AI Order Balances Innovation And Regulation

  

  President Joe Biden’s recently issued executive order on artificial intelligence lays out a sprawling list of directives aimed at establishing standards for safety, security and privacy protection, and may help strike the balance between the freedom to innovate and the need to impose regulation in this rapidly evolving space, say Kristen Logan and Martin Zoltick at Rothwell Figg.

• How Biden's AI Order Stacks Up Against Calif. And G7 Activity

  

  Evaluating the federal AI executive order alongside the California AI executive order and the G7's Hiroshima AI Code of Conduct can offer a more robust picture of key risks and concerns companies should proactively work to mitigate as they build or integrate artificial intelligence tools into their products and services, say attorneys at Jenner & Block.

• Reading Between The Lines Of HHS' National Lab Opinion

  

  The U.S. Department of Health and Human Services' Office of Inspector General recently rejected a national laboratory's request to pay a referring lab to process specimens, but the request might have been an attempt to exploit the OIG's advisory opinion process for a competitive advantage, says Mary Kohler at Kohler Health Law.

• ITC Ban On Apple Watch Could Still Be Reversed

  

  The U.S. International Trade Commission's recent final decision that the Apple Watch infringed two patents owned by Masimo Corp. was a rare instance of a popular consumer product being hit with an absolute importation ban, but it's possible that President Joe Biden could assert his power to reverse the ITC decision, says Benjamin Horton at Marshall Gerstein.

• A Closer Look At Proposed HHS Research Misconduct Rule

  

  The U.S. Department of Health and Human Services' proposed updates to its policies on research misconduct codify many well-known best practices, but also contain some potential surprises for the research community and counsel, say attorneys at Hogan Lovells.

• Handling Religious Objections To Abortion-Related Job Duties

  

  While health care and pharmacy employee religious exemption requests concerning abortion-related procedures or drugs are not new, recent cases demonstrate why employer accommodation considerations should factor in the Title VII standard set forth by the U.S. Supreme Court’s 2023 Groff v. DeJoy ruling, as well as applicable federal, state and local laws, say attorneys at Epstein Becker.