TAG:
final rule
Upcoming Executive War College to Cover Important Lab Trends
By Robert Michel | From the Volume XXXII, No. 4 – March 10, 2025 Issue
New developments now changing the landscape in health-care and the clinical laboratory market will be addressed at the upcoming 30th Annual Executive War College on Diagnostic, Clinical Laboratory, and Pathology Management that happens on April 29-30, 20…
Pathologist Asks ChatGPT, Google Notebook to Predict LDT Trial Outcome
By Robert Michel | From the Volume XXXII, No. 1 – January 6, 2025 Issue
On his blog last month, pathologist Bruce Quinn, MD, PhD, published the answers provided by two artificial intelligence chatbots after he asked each to analyze the legal briefs submitted to federal courts in Texas where lab plaintiffs are challenging the FDA’s laboratory developed test (LDT) final …
Using AI to Predict Outcomes in FDA LDT Lawsuits
By R. Lewis Dark | From the Volume XXXII, No. 1 – January 6, 2025 Issue
Given the popular sentiment that artificial intelligence (A…
Top 10 Lab Stories for 2024 Reflect Important Trends
By Robert Michel | From the Volume XXXI, No. 17 – December 16, 2024 Issue
CEO SUMMARY: Most clinical laboratory managers will agree that the Food and Drug Administration’s (FDA) final rule to regulate laboratory developed tests (LDTs) is the biggest lab industry story for 2024. Every laboratory performing LDTs must now devote money and time to comply with the…
Federal Court Issues Ban on FTC’s Noncompete Rule
By Robert Michel | From the Volume XXXI, No. 12 – September 3, 2024 Issue
BY NOW, MOST CLINICAL LAB MANAGERS AND PATHOLOGY PRACTICE ADMINISTROATORS ARE AWARE of the Federal T…
What’s a Big Headwind for Labs? It’s the LDT Rule!
By R. Lewis Dark | From the Volume XXXI, No. 10 – July 22, 2024 Issue
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Significant Developments Are Shaping Lab Market
By Robert Michel | From the Volume XXXI, No. 7 – May 20, 2024 Issue
CEO SUMMARY: With 140 speakers and 1,000+ attendees, this year’s Executive War College again provided a comprehensive picture of the specific forces reshaping the U.S. market for lab testing services. Presented here is a smorgasbord of information and innovation shared by different spea…
FDA Hosts Webinar to Explain Key Issues with Final LDT Rule
By Robert Michel | From the Volume XXXI, No. 7 – May 20, 2024 Issue
ON APRIL 29. THE US FOOD AND DRUG ADMINISTRATION (FDA) announc…
Labcorp, Quest Issue Q1 Earnings, Offer Comments on FDA’s LDT Rule
By Robert Michel | From the Volume XXXI, No. 7 – May 20, 2024 Issue
BOTH LABCORP, BURLINGTON, N.C., AND QUEST DIAGNOSTICS, SECAUCU…
New CISA Draft Rule Mandates Rapid Reporting of Cyberattacks
By Robert Michel | From the Volume XXXI, No. 7 – May 20, 2024 Issue
CEO SUMMARY: There is another federal rule that will require compliance by clinical labs. An agency of U.S. Dept. of Homeland Security published a draft rule on April 4 that requires certain organizations—including hospitals, clinical labs, and pathology groups—to report, within 72 ho…
CURRENT ISSUE

Volume XXXII, No. 4 – March 10, 2025
A bold new technology has entered the European lab marketplace, with the introduction of an autonomous robotic phlebotomy device, already in service at a Netherlands hospital. Also, The Dark Report announces its sale to LabX Media Group of Ontario Canada.
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