Regulatory & Compliance

Is HHS Transparency at Risk Amid Kennedy's Workforce Cuts?
Regulatory & Compliance Is HHS Transparency at Risk Amid Kennedy's Workforce Cuts?

A Senate committee hearing with HHS Secretary Robert F. Kennedy Jr. has been postponed due to the required seven-day notice not being met. The hearing, initially scheduled for April 10, was set to discuss the restructuring of the health department that Kennedy ordered. This restructuring has led to

FTC Resumes Lawsuit Against PBMs Over Inflated Insulin Prices
Regulatory & Compliance FTC Resumes Lawsuit Against PBMs Over Inflated Insulin Prices

James Maitland is an expert in pharmaceutical litigation and regulatory affairs, with a specific focus on how Pharmacy Benefit Managers (PBMs) influence the U.S. prescription drug market. Today, he shares his insights into the recent decision by Andrew Ferguson to rejoin the FTC's lawsuit

The Role of Blockchain Technology in Healthtech Compliance.
Regulatory & Compliance The Role of Blockchain Technology in Healthtech Compliance.

Imagine a world where patient data isn't just protected but actively managed by the patients themselves, all the while adhering to the stringent compliance requirements of the healthcare industry. That world isn't far off—thanks to blockchain technology, healthTech compliance is seeing a r

Federal Court Overturns FDA Regulation on Lab Developed Tests
Regulatory & Compliance Federal Court Overturns FDA Regulation on Lab Developed Tests

In a landmark ruling, a Texas federal court recently overturned the Food and Drug Administration’s (FDA) regulation of laboratory-developed tests (LDTs) as medical devices. This decision, made by Judge Sean Jordan of the U.S. District Court for the Eastern District of Texas, vacates the FDA’s final

Are Trump's Public Health Cuts Threatening State Emergencies?
Regulatory & Compliance Are Trump's Public Health Cuts Threatening State Emergencies?

The recent lawsuit initiated by a coalition of 23 states and Washington, D.C., against the U.S. Department of Health and Human Services (HHS) is raising critical concerns about the potential impact of over $11 billion cuts to public health funding. These cuts, originally allocated during the

HHS Undergoes Massive Restructuring, Slashing 10,000 Jobs
Regulatory & Compliance HHS Undergoes Massive Restructuring, Slashing 10,000 Jobs

The U.S. Department of Health and Human Services (HHS) unveiled a massive restructuring plan early one morning, announcing the elimination of 10,000 full-time employees, reducing its number of divisions from 28 to 15, and halving the number of regional offices. This extensive overhaul is intended

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