LATEST ARTICLES
United States
Frankfurt Kurnit Klein & Selz
The Federal Trade Commission ("FTC") has announced finalized changes to the Health Breach Notification Rule ("HBNR").
Goodwin Procter LLP
On April 29, 2024, Accord BioPharma, Inc. announced that the U.S. Food and Drug Administration (FDA) approved HERCESSI (trastuzumab-strf).
Arnold & Porter
On April 24, 2024, the U.S. Food and Drug Administration (FDA) released a revised draft guidance entitled "Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products...
Holland & Knight
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector.
Outside GC
The U.S. Congress is currently considering legislation to prevent the governments of foreign adversaries from siphoning data and information from U.S. companies...
Kutak Rock LLP
On April 26, 2024, the Department of Health and Human Services ("HHS") published a Final Rule to amend the HIPAA regulations.
Kramer Levin Naftalis & Frankel LLP
President Biden signed the Inflation Reduction Act (IRA) into law on Aug. 16, 2022, with the goal of reducing health care costs for the government and participants...
Wiley Rein
Legislation aiming to reform the regulation of pharmacy benefit managers (PBMs) remains on the horizon on both the federal and state levels.
Foley & Lardner
Bees and insects face diseases similar to humans, and American foulbrood poses a significant threat to bee colonies.
Mintz
As part of its 2025 Medicare Advantage and Part D Final Rule (the Final Rule), the Centers for Medicare & Medicaid Services (CMS) made a number of enrollment changes impacting dual eligible special needs plans (DSNPs).
Holland & Knight
The U.S. Food and Drug Administration (FDA or Agency) announced on April 29, 2024, in a forthcoming and long-awaited final rule...
Greenberg Traurig, LLP
On April 24, the United States Supreme Court heard oral arguments in Idaho v. United States, a challenge to Idaho's abortion prohibition.
Duane Morris LLP
In the matter styled The Plastic Surgery Center, P.A., v. Cigna Health and Life Insurance, et al.,...
Mintz
Of Counsel Benjamin Zegarelli spoke with MD+DI on the FDA's updated regulations to classifying laboratory-developed tests (LDTs) as medical devices under the Federal Food, Drug, and Cosmetic Act...
Crowell & Moring LLP
In recent years, organizations have been developing and using predictive models, which are powered by artificial intelligence (AI) and machine learning (ML) technologies...
Wolf Popper
Consumers often are surprised by receiving large bills for medical testing from a laboratory when they believe the testing should have been covered by their health insurance.
Morris James LLP
In In re Carvana Co. S'holders Litig., ___ A.3d ___, 2024 WL 1300199 (Del. Ch. Mar. 27, 2024), the Delaware Court of Chancery granted a motion to dismiss filed by a special litigation committee...
Axinn Veltrop & Harkrider
Expanding the range of ways they can identify and investigate potential competition concerns in healthcare, DOJ, FTC, and HHS recently announced the introduction of HealthyCompetition.gov...
European Union
Arnold & Porter
The revised transparency rules governing the transparency of information submitted to the Clinical Trial Information System, as adopted by the European Medicines Agency on 5 October 2023...
Foley Hoag LLP
New License Exception MED under the Export Administration Regulations ("EAR") authorizes the export, reexport, and/or transfer of EAR99 "medical devices,"...
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