R. Lewis Dark
Articles by R. Lewis Dark
Enjoy the LDT Court Victory, Yet Remain Vigilant
VICTORY IN COURT! FOR AN INDU…
White House Is Off to a Fast Start, So Pay Attention
We already see the second term of President Donald Trump…
Innovations in Lab Testing Arriving at Light Speed
TODAY, IT’S A CHALLENGE TO STAY UP WITH ALL THE NEW THINGS arriving in the lab testing marketplace. Novel assays are launched weekly. That is equally true for next-generation automation and lab analyzers, with vendors regularly announcing something new to their menu of products. The pace of innova…
Market Speaks to Pathologists: It’s About Data
ONE PRIMARY TREND IN THE U.S. HEALTHCARE SYSTEM over the past 20 years deals with how patient data is created and used. Ongoing advances in information technology and the Internet—now commonly called “the cloud”—have created capabilities for data sharing and data analysis today that were unim…
Labs: Why it Pays to Know Your Customers
WOULD IT SURPRISE YOU TO LEARN THAT THERE ARE DOCTORS WHO ARE SERI…
Using AI to Predict Outcomes in FDA LDT Lawsuits
Given the popular sentiment that artificial intelligence (A…
Lawsuits Challenge Business Practices of Health Plans
IT MAY BE THAT SEVERAL RECENT FEDERAL LAWS AND RULES ON TRANSPARENCY IN HEALTHCARE are allowing aggrieved parties to pull back the curtain on unsavory practices at certain health insurance companies. Both self-insured employers and the employees of these companies are filing lawsuits claiming that pa…
129,624 Genetic Tests in the United States
REGULATION OF LABORATORY DEVELOPED TESTS (LDTs) by the federal Food and Drug Administratio…
Getting Test Claims Paid & Class Action Lawsuits
When you crack open this issue of The Dark Repor…
Federal Prosecution of Lab Test Fraud & Abuse
SOMETHING NEW AND DIFFERENT IS HAPPENING WITH THE ENFORCEMENT OF FRAUD AND ABUSE LAWS by the federal Department of Justice (DOJ). The number of cases being filed has increased over recent years. In turn, that means an increase in press releases announcing criminal convictions, guilty…
CURRENT ISSUE
Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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