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Ropes & Gray LLP

U.S. District Court Ruling Vacates HIPAA Final Rule that Strengthened Privacy Protections for Reproductive Health Information

Ropes & Gray LLP on

On June 18, 2025, the United States District Court for the Northern District of Texas Amarillo Division issued an opinion, Purl v. Department of Health and Human Services, declaring the U.S. Department of Health and Human...more

Epstein Becker & Green

Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®

Epstein Becker & Green on

On March 31, 2025, the U.S. District Court for the Eastern District of Texas ruled that the Food and Drug Administration (FDA) lacks the statutory authority to regulate laboratory-developed tests (LDTs). The court’s judgment...more

Jones Day

Judge Blocks FDA Regulation of Laboratory-Developed Tests

Jones Day on

On March 31, 2025, a judge in the Eastern District of Texas struck down a 2024 Final Rule (the "Final Rule") by the Food and Drug Administration ("FDA") that exerted jurisdiction over the regulation of laboratory-developed...more

Akin Gump Strauss Hauer & Feld LLP

District Court Vacates FDA LDT Rule; What’s Next for Regulation of Lab Testing?

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On March 31, 2025, Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas issued an opinion and judgment in American Clinical Laboratory Association v. FDA. Judge Jordan’s decision vacates and sets...more

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