Policy & Compliance

Expert Analysis

• A New Regulatory Environment For PE In Calif. Healthcare

  

  The California Office of Health Care Affordability's proposed revisions to its cost and market impact review regulations, amid broader state scrutiny of private equity-backed healthcare arrangements, represent a qualitative shift in California's regulatory posture toward institutional healthcare investment, say attorneys at Ropes & Gray.

• FDA Moves Leave Peptides In A Legal Gray Zone

  

  While the U.S. Food and Drug Administration has taken a concrete step forward on reclassifying certain peptides, the practical consequence of their interim status cannot be overstated — these substances are no longer designated as posing a significant safety risk, but they have not been affirmatively authorized for compounding, say attorneys at Sheppard.

• NY Banking Brief: All The Notable Legal Updates In Q2

  

  The year's second quarter brought several notable banking law developments to New York, including a proposal to align state stablecoin rules with the federal Genius Act, fresh fair lending and cybersecurity guidance from state regulators, and a significant Second Circuit holding on preemption, say attorneys at Ashurst Perkins Coie.

• A New Defense For Medicaid Fraud Cases In Texas

  

  The Texas Supreme Court decision in LabCorp v. Texas last month, finding that the state's False Claims Act requires proof that an omission is material, is among the first to establish that the government's lack of reaction to the defendant's disclosures rendered alleged omissions immaterial, say attorneys at Sheppard.

• Pregnancy Bias Suits Highlight EEOC's Expanding Reach

  

  Recent U.S. Equal Employment Opportunity Commission suits show that enactment of the Pregnant Workers Fairness Act has drawn scrutiny to a wider range of employment decisions and an increasing focus on individual decisions as indicators of whether an employer's policies comply with evolving federal requirements, say attorneys at Krevolin Horst.

• Legal Risks Of Using AI To Screen Psychedelic Trial Patients

  

  Though using artificial intelligence to preemptively identify drug trial participants likely to experience placebo effects could produce clearer research results, sponsors will need to be ready for the new legal questions these methods raise about informed consent, accountability for algorithmically derived criteria, and potential bias in data training sets, says Kimberly Chew at Husch Blackwell.

• How 6th Circ. Tightened NLRB Injunction Standard

  

  The Sixth Circuit's recent ruling in Kerwin v. Trinity Health Grand Haven Hospital, dissolving a Section 10(j) injunction obtained by the National Labor Relations Board against an employer that refused to bargain, will make it harder for the NLRB to obtain injunctions while prosecuting unfair labor practice proceedings, say attorneys at Bass Berry.

• Md. Ruling Reflects Classic Administrative Law Principle

  

  A Maryland federal court's recent decision in Columbus v. Kennedy significantly limits how far the Centers for Medicare & Medicaid Services can go in reshaping the Affordable Care Act through regulation, highlighting a principle that will likely be applied in similar Administrative Procedure Act challenges, says Michael King at Brownstein Hyatt.

• Healthcare Orgs Should Prep For Greater Grant Oversight

  

  The U.S. Department of Health and Human Services' new Audit Enforcement and Risk Oversight initiative, and a proposed overhaul of the governmentwide framework for grants management, signal an aggressive and data-driven approach to federal grant enforcement, and could significantly expand the pathways leading to enforcement actions and private litigation, say attorneys at Norton Rose.

• 3rd Circ. Decision Sheds Light On BIPA Bank Exemption

  

  The Third Circuit's recent decision in McGoveran v. Amazon illuminates how courts are extending the Illinois Biometric Information Privacy Act's financial institution carveout beyond banks and insurers to technology vendors and other businesses handling biometric data, a defendant-friendly shift that still casts uncertainty around BIPA's enforcement, say attorneys at Dorsey & Whitney.

• Data Reveals Pivot In Feds' Financial Fraud Priorities

  

  Recent Justice Department data shows fraud prosecutions fell to their lowest rate in a decade in 2025, illustrating a move away from traditional financial cases and toward a targeted mix of healthcare, government program, consumer and sanctions matters, say Paul Hinton and Adrienna Huffman at The Brattle Group.

• New Timeline For Benefits Cases May Increase FCA Litigation

  

  Recent reforms designed to speed enforcers’ intervention decisions in False Claims Act suits involving state-administered benefits will likely encourage more qui tam relators to litigate cases without the government’s imprimatur, and increase defendants’ discovery burdens, defense costs and business disruptions, say attorneys at Morgan Lewis.

• FTC's Clinical Trial Requirement Threatens Food Claim Rules

  

  The Federal Trade Commission's general requirement for randomized controlled trials for most health-benefit claims, recently embraced by the National Advertising Review Board, lacks legal basis and endangers the existing statutory framework Congress created for marketing food and dietary supplements versus drugs, say attorneys at Keller & Heckman.