Policy & Compliance

Expert Analysis

• A Look At Healthcare Timelines Set By Biden's AI Order

  

  President Joe Biden's artificial intelligence executive order establishes standards for using AI in the healthcare industry, including a number of staggered deadlines that should help coordinate a more unified federal approach to AI governance, say attorneys at Holland & Knight.

• A Look At Successful Bid Protests In FY 2023

  

  Attorneys at Sheppard Mullin look beyond the statistics in the U.S. Government Accountability Office’s recent annual report on bid protests, sharing their insights about nine categories of sustained protests, gained from reading every fiscal year 2023 decision in which the protester had a positive result.

• Navigating Discovery Of Generative AI Information

  

  As generative artificial intelligence tools become increasingly ubiquitous, companies must make sure to preserve generative AI data when there is reasonable expectation of litigation, and to include transcripts in litigation hold notices, as they may be relevant to discovery requests, say Nick Peterson and Corey Hauser at Wiley.

• 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.

• 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.

• 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.

• 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.

• 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.

• Why Hemp-Synthesized Intoxicants Need Uniform Regs

  

  State laws regulating hemp-synthesized intoxicants are a patchwork with little consistency between any given state, and without the adoption of a uniform regulatory framework, producers and consumers alike will need to be very cautious, say Dylan Anderson and Seth Goldberg at Duane Morris.