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Insights and Analysis

Q3/2024 Life Science Law Update – Key developments for pharma & device companies in EU

The Q1 and Q3 Life Science and Health Care Law Update covers key trends in the EU only while the other reports (on Q2 and Q4) cover key trends in the EU as well as in the Big Five (France,...

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Publicly Traded Life Sciences Companies and Artificial Intelligence: Disclosing Risk Factors

Although the rise of artificial intelligence (AI) has created many opportunities and breakthroughs for life sciences companies in preclinical and clinical development, risks associated with ...

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New California laws impact uses of AI by health care providers, insurers, and vendors

Recent actions by state and federal lawmakers are trending toward increased regulation and oversight of uses of AI in health care. From patient communications to medical necessity...

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CMS Issues Final Guidance on IRA 2027 Drug Price Negotiation Program, 2026-27 MFP Effectuation

On October 2, 2024, the Centers for Medicare & Medicaid Services (CMS) issued final guidance for initial price applicability year (IPAY) 2027 of the Drug Price Negotiation Program...

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CMS Issues Final Guidance on IRA 2027 Drug Price Negotiation Program, 2026-27 MFP Effectuation

On October 2, 2024, the Centers for Medicare & Medicaid Services (CMS) issued final guidance for initial price applicability year (IPAY) 2027 of the Drug Price Negotiation Program...

Insights and Analysis

Court finds False Claims Act whistleblower provisions unconstitutional

Since June 2023, the False Claims Act (FCA) bar has waited with baited breath for district courts to address Justice Thomas’s dissent in United States ex rel. Polansky v. Executive...

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Texas AG uses consumer protection law to enforce against B2B clinical health GenAI company

Texas Attorney (“AG”) General Ken Paxton announced a first-for-Texas settlement against a generative AI company using patient data and providing products to health care...

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CMS issues Final Rule adopting some but not all proposed changes to the Medicaid Drug Rebate Program

On September 20, 2024, the Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled: Misclassification of Drugs, Program Administration and Program Integrity Updates...

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Life Sciences Procurement Update: FY2025 NDAA would change rules of origin for drugs

In July, the Senate Armed Services Committee passed its version of the FY 2025 National Defense Authorization Act (NDAA), which would make substantial changes to the rules for determining...

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