Regulatory & Compliance

Justice Department Sues OhioHealth for Antitrust Violations
Regulatory & Compliance Justice Department Sues OhioHealth for Antitrust Violations

Challenging Market Dominance in Columbus Healthcare The landscape of metropolitan healthcare is undergoing a seismic shift as federal regulators turn their focus toward regional systems that have quietly amassed unprecedented levels of control over local markets. In a move that signals a hardening

Trend Analysis: Medtech Regulatory Funding Negotiations
Regulatory & Compliance Trend Analysis: Medtech Regulatory Funding Negotiations

The future of medical device innovation currently hangs on a series of closed-door discussions that will determine how billions of dollars are allocated to the Food and Drug Administration over the coming years. These high-stakes negotiations for the sixth iteration of the Medical Device User Fee

Hospitals and Pharma Clash Over New 340B Reporting Rules
Regulatory & Compliance Hospitals and Pharma Clash Over New 340B Reporting Rules

James Maitland is a leading expert in the intersection of healthcare operations and pharmaceutical regulation, specializing in the nuances of the 340B Drug Pricing Program. With years of experience advising safety-net providers on compliance and technological integration, he has become a vocal

Kennedy Promotes Key Aides to Advance MAHA Health Agenda
Regulatory & Compliance Kennedy Promotes Key Aides to Advance MAHA Health Agenda

Strengthening Executive Oversight for a New Era of Public Health The strategic realignment recently enacted within the Department of Health and Human Services (HHS) marks a pivotal moment in the administration’s efforts to reshape American healthcare. By promoting four high-level officials into

Federal Officials Align TEFCA and Health Tech Ecosystem
Regulatory & Compliance Federal Officials Align TEFCA and Health Tech Ecosystem

The historical struggle to move patient records between competing hospital systems has long been a primary obstacle to delivering efficient medical care across the United States, yet the landscape in 2026 reflects a transformative shift toward seamless data mobility. Federal officials from the

FTC and Major PBMs Near Settlement Over Insulin Pricing
Regulatory & Compliance FTC and Major PBMs Near Settlement Over Insulin Pricing

The American healthcare landscape is currently witnessing a seismic shift as the Federal Trade Commission (FTC) nears a comprehensive resolution with the nation’s dominant pharmacy benefit managers (PBMs). At the heart of this movement is a concerted effort to dismantle pricing structures that have

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