ArticleReturn Of The BIOSECURE Act: What Life Sciences Companies Need To KnowHouse advances BIOSECURE Act as part of NDAA legislation.United StatesFood, Drugs, Healthcare, Life SciencesPolsinelli PC
ArticleThe Hidden Risks Of AI Notetakers: What Organizations Need To Evaluate Before DeploymentOrganizations are rapidly deploying AI notetaking tools, creating new legal, privacy and security exposure.United StatesTechnologyPolsinelli PC
ArticleCMS Announces Period Of Enhanced Oversight For New Hospices In Arizona, California, Nevada, And TexasRecently the Centers for Medicare & Medicaid Services ("CMS") announced in a newly released MedLearn Matter (MLN7867599, July 2023) that effective as of July 13, 2021, any "new hospice agency" located...GlobalFood, Drugs, Healthcare, Life SciencesPolsinelli PC
ArticleAs States Expand Notice Requirements, Updated HSR Thresholds Remain Paramount2025 saw an increase in state interest in merger regulation, including two states, Colorado and Washington, joining the federal government in requiring pre-closing notice of mergers.United StatesAntitrust/Competition LawPolsinelli PC
ArticleHealth Care Companies Face Antitrust Risks In Responding to COVID-19 Staffing ChallengesAccording to published reports, the COVID-19 emergency has caused significant staffing challenges at hospitals, clinics, and nursing homes in many parts of the country. United StatesAntitrust/Competition LawPolsinelli PC
ArticleNew York City Expands Earned Safe And Sick Time AgainNew York City's Earned Safe and Sick Time Act (ESSTA) adds 32 hours of frontloaded unpaid safe/sick time...United StatesEmployment and HRPolsinelli PC
ArticleTax And Disclosure Considerations Related To Executive Security BenefitsAs individual executives are attracting increased attention for their roles in high-profile consumer-facing companies, their employers are establishing or expanding executive security programs.United StatesCorporate/Commercial LawPolsinelli PC
ArticleDEA Issues Second Temporary Rule Extending Controlled Substance Prescribing Flexibilities Through December 2024On October 6, 2023, the Drug Enforcement Agency (DEA) and the Department of Health and Human Services (HHS) issued a Second Temporary Rule further extending the ability to prescribe...United StatesFood, Drugs, Healthcare, Life SciencesPolsinelli PC
ArticleWho Would Have Predicted It? Polymarket Settles For Operating Unregistered Swap Execution FacilityOn January 3, 2022, the Commodity Futures Trading Commission (CFTC) announced an order against and settlement with Polymarket, a blockchain-enabled prediction market that allows users to "bet"...United StatesTechnologyPolsinelli PC
ArticleIs The EU AI Act Faltering?The EU AI Act is a far-reaching comprehensive set of rules and regulations for AI systems seemingly modeled after the EU's influential privacy legislation GDPR.GlobalTechnologyPolsinelli PC
ArticleThree COVID-19 Relief Packages Done — What Comes Next?Senate Majority Leader Mitch McConnell (R-KY) has also acknowledged there will be a fourth COVID-19 response bill, with health care a top priority. United StatesCoronavirus (COVID-19)Polsinelli PC
ArticleThe Corporate Transparency Act: What Fractional Executives Need To KnowA new federal law requires businesses to disclose personal information and photographs of their owners and control persons, including retained fractional executives.United StatesCorporate/Commercial LawPolsinelli PC
ArticleFDA Issues Exemptions From November 27, 2024 Compliance Deadline For Updated DSCSA RequirementsOn Wednesday, the Food and Drug Administration (FDA) issued a statement granting additional exemptions from its November 27, 2024 deadline for compliance with certain product transaction requirements. United StatesFood, Drugs, Healthcare, Life SciencesPolsinelli PC
ArticleUnderstanding How The Corporate Transparency Act Will Apply To The Delaware Statutory Trust StructureIn general terms, the Corporate Transparency Act (the "CTA") requires reporting to the U.S. Department of Treasury's Financial Crimes Enforcement Network ("FinCEN")...United StatesCorporate/Commercial LawPolsinelli PC
ArticleScam Alert – Misleading Communications Related To Trademark Registry And ServicesWe have seen a wave of fraudulent emails in which the sender tries to convince business owners that another party is about to register the recipient's brand name(s).United StatesIntellectual PropertyPolsinelli PC
ArticleFTC Settlement With Rite Aid Mandates AI System AssessmentIn July, we noted that the Federal Trade Commission was an early mover in shaping standards for generative AI, having just served OpenAI with a Civil Investigative Demand seeking detailed responses to almost two hundred data requests.United StatesPrivacyPolsinelli PC
ArticleReady Or Not: HRSA's 340B Rebate Pilot Model Takes Off Despite Questions On Readiness And AuthorityOn October 30, 2025 despite HRSA being impacted by the government shutdown, the agency approved 8 drug manufacturers / 9 drugs for participation in HRSA's 340B Rebate Model Pilot Program (340B Rebate Pilot).United StatesFood, Drugs, Healthcare, Life SciencesPolsinelli PC
ArticleCorporate Transparency Act Filing Obligations For Dissolved EntitiesFinCEN has now definitively weighed in on the reporting obligations of dissolved entities. It issued new FAQs on September 10, 2024, clarifying that reporting companies may not use dissolution... United StatesCorporate/Commercial LawPolsinelli PC
ArticleCMS Proposes Changes To Medicare Provider Enrollment RulesThe Centers for Medicare & Medicaid Services ("CMS") published proposed changes to the Medicare Provider Enrollment requirements in the 2024...United StatesFood, Drugs, Healthcare, Life SciencesPolsinelli PC