Health Law Highlights

HRSA has finalized the 340B Rebate Model Pilot Program with nine manufacturers approved to participate starting January 1, 2026. The approved manufacturers include Bristol Myers Squibb,…

Healthcare remains the sector with the costliest data breaches, with incidents averaging $7.42 million in damages and marking the 12th consecutive year the industry topped breach…

Insurance companies face lawsuits alleging AI algorithms denied patient care without human oversight. UnitedHealth Group, Cigna, and Humana are defending against claims that their AI programs…

Joint Commission and the Coalition for Health AI released the first national guidance for responsible AI implementation in U.S. healthcare systems. The guidance establishes policies for…

Health systems possess the expertise to monitor AI tools but lack the infrastructure to implement comprehensive governance at scale. The Joint Commission and Coalition for Health…

Texas Medical Board now requires physicians to obtain structured consent before providing complementary and alternative medicine therapies. Effective January 2025, the rules apply to any non-conventional…

Shadow AI tools used without IT oversight create security risks that cost healthcare organizations $200,000 more per data breach than sanctioned AI incidents. IBM’s 2025 Cost…

The FDA announced a crackdown on direct-to-consumer pharmaceutical advertising on September 9, following a presidential memorandum directing action against misleading advertising practices. The agency issued thousands…

The OIG issued a favorable advisory opinion for a grant-funded family-powered therapy arrangement. The Company’s mission is to provide care for individuals with a certain disorder,…

Hospital associations challenge new merger notification rules as burdensome and unnecessary. The Federal Trade Commission under Lina Khan adopted changes to Hart-Scott-Rodino premerger notification requirements that…