ArticleTCPA And COVID-19In 1991, the Telephone Consumer Protection Act ("TCPA") (47 U.S.C. § 227) was enacted to address unwanted telephone calls and faxes for marketing. United StatesConsumer ProtectionPolsinelli PC
ArticleData Centers In The Mid-Atlantic Face A New Legal Frontier: "Bring Your Own Generation"While BYOG could meaningfully shorten time-to-power, it cannot function under current law without significant changes to PJM's tariff, FERC oversight, and state utility and permitting regimesUnited StatesEnergy and Natural ResourcesPolsinelli PC
Article2026 Health Care Reimbursement Newsletter2026 is shaping up to be a pivotal year for health care reimbursement. From major CMS payment rules to evolving disclosure requirements, AI scrutiny, and mounting pressure on providers across the care continuum...United StatesFood, Drugs, Healthcare, Life SciencesPolsinelli PC
ArticleGovernor Newsom Embraces Tighter Requirements On Private Equity And Hedge Fund Investments In California Health Care By Signing AB 1415 And SB 351This month, Governor Newsom signed AB 1415 and SB 351 into law, two bills that will enhance the requirements on investments by private equity groups...United StatesFood, Drugs, Healthcare, Life SciencesPolsinelli PC
ArticleRethinking Examiner Interviews – A Data-Driven AnalysisExaminer interviews are a powerful but underutilized tool in patent prosecution. Last year, a whopping 75% of patent applications concluded without a single interview in their file history.United StatesIntellectual PropertyPolsinelli PC
ArticleCBP Guidance Regarding Section 232 Dutiable Metal Content ValuationCBP has informally outlined its position on how importers should calculate Section 232 duties for derivative goods made of steel, aluminum and copper.United StatesInternational LawPolsinelli PC
ArticleGenerative AI's 'Industry Standards' For Cybersecurity And Data Privacy Could Be Here Sooner Rather Than LaterAI may be both the most "powerful capability of our time" and the "most powerful weapon of our time." That's according to Jen Easterly, Director of the Cybersecurity and Infrastructure Security Agency...United StatesTechnologyPolsinelli PC
ArticleHHS OIG Releases Final Information Blocking Enforcement Rule Applicable To Non-Provider ActorsOn June 27, 2023, the U.S. Department of Health and Human Services ("HHS"), Office of Inspector General ("OIG") posted on its website a final rule implementing its civil money penalty ("CMPs")...United StatesFood, Drugs, Healthcare, Life SciencesPolsinelli PC
ArticleOffice Of Health Care Affordability Appears To Both Limit And Expand Scope Of Health Care Transaction Notice Requirements In Latest Draft RegulationsCalifornia's Office of Health Care Affordability ("OHCA") published updated draft regulations implementing SB 184's pre-transaction notice requirements.United StatesFood, Drugs, Healthcare, Life SciencesPolsinelli PC
ArticleNo Second-Guessing Required: First Circuit Limits FCA Liability For Clinical LabsReliance on Physician Orders: Clinical laboratories may generally rely on physician orders to establish medical necessity and are not required to independently reassess clinical judgment.United StatesFood, Drugs, Healthcare, Life SciencesPolsinelli PC
ArticleOffice Of Health Care Affordability Publishes Near-Final Regulations On Health Care Transaction Notice RequirementsOn Tuesday, November 28, 2023, California's Office of Health Care Affordability ("OHCA") published its latest version of the proposed regulations requiring advanced notice of certain...United StatesFood, Drugs, Healthcare, Life SciencesPolsinelli PC
ArticleCOVID-19 And PrivacyAs part of Polsinelli's COVID-19 guidance, below we summarize three commonly asked questions regarding COVID-19 and obligations under CCPA and GDPR. United StatesPrivacyPolsinelli PC
ArticleCPPA Board Adopts New Data Broker RegulationsThe California Privacy Protection Agency (CPPA) Board met on November 8th and voted to adopt new regulations for data broker registration requirements.United StatesPrivacyPolsinelli PC
ArticleFinCEN Publishes Updated FAQs To Assist In Reporting ComplianceThe Financial Crimes Enforcement Network ("FinCEN") recently published updates to its list of Frequently Asked Questions ("FAQs") to assist entities in complying...United StatesCorporate/Commercial LawPolsinelli PC
ArticleDon't Let The Stark Law Catch You Off Guard: Risk Remains Despite The LullCMS and DOJ activity related to the Stark Law has been notably quiet in recent years, with no material rule updates since 2023 and limited enforcement actions.United StatesFood, Drugs, Healthcare, Life SciencesPolsinelli PC
ArticleNew FDA Drug Reforms: Congress Extends Voucher Incentive, Clarifies Orphan Exclusivity And Provides Greater Transparency For Q1/Q2 Generic ApprovalsIn legislation enacted on Feb. 3, 2026, Congress reauthorized the rare pediatric disease priority review voucher program, clarified the scope of orphan drug exclusivity...United StatesFood, Drugs, Healthcare, Life SciencesPolsinelli PC
ArticleOIG's Latest Advisory Opinion: When Is A Discount A "Discount"?On December 18, the Office of Inspector General (OIG) published Advisory Opinion No. 25-11, which provides one of the most detailed OIG articulations to date of how the Anti-Kickback Statute (AKS) and the Discount Safe Harbor apply to a variety of discount and rebate arrangements.United StatesFood, Drugs, Healthcare, Life SciencesPolsinelli PC
ArticleDesign Patent vs. Trade Dress: Strategic Considerations For Protecting Product DesignsProduct designs often serve as the cornerstone of a brand's identity, evoking instant recognition and loyalty among consumers.United StatesIntellectual PropertyPolsinelli PC
ArticleBlockchain+ Bi-WeeklyThe Blockchain Bi-Weekly presented by the Polsinelli Blockchain+ team is a rundown of some of the key stories in the Web3, blockchain and crypto ecosystems curated by our attorneys...United StatesTechnologyPolsinelli PC