Since 1995, Reliable Business Intelligence for Clinical Laboratories, Pathology Groups and Laboratory Diagnostics

The Dark Report

Are Lab Leaders Ready for Artificial Intelligence?

Commentary and Opinion by R. Lewis Dark / By R. Lewis Dark

WITH ASTONISHING SWIFTNESS, ARTIFICIAL INTELLIGENCE (AI) HAS BECOME PROBABLY THE SINGLE MOST IMPORTANT TECHNOLOGY discussed in corporate boardrooms and management meetings today. This is as true for clinical labs and pathology groups as it is for Fortune 100 corporations. Almost daily, there are headlines about the inroads AI is making into different aspects of business …

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Lab Market Fragmenting, Creating New Opportunities

Laboratory Management / By Robert Michel

CEO SUMMARY: Even as consolidation continues in the ownership of hospitals, health systems, office-based physicians, and clinical laboratories, there is a powerful trend of fragmentation quietly transforming the way providers—including clinical labs and pathology groups—serve patients and consumers who want specialized expertise and choice. Today’s market for clinical laboratory testing services is fragmenting at a pace …

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FDA Issues Memo to Reclassify Many High Risk IVD Assays

Laboratory Compliance / By Robert Michel

WAS IT AN EXPECTED FLOOD OF APPLICATIONS TO REVIEW laboratory developed tests (LDTs) that motivated the federal Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) to declare its intention “to initiate the reclassification process for most IVDs that are currently class III (high risk) into class II (moderate risk)” in a …

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Walgreens to Close 60 VillageMD Locations

Clinical Laboratory Trends / By Robert Michel

CEO SUMMARY: Following substantial losses in fiscal 2023, Walgreens is working to cut costs and reduce overhead. One casualty in this effort will be the closure of 60 of the 360 primary care clinics in retail pharmacy stores built by Walgreens in recent years. These actions demonstrate that putting primary care clinics into drugs stores …

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April 8, 2024, Intelligence: Late-Breaking Lab News

Late Breaking Lab News / By Robert Michel

UnitedHealth Group stated that the cyberattack against Change Healthcare, a business unit of UnitedHealth’s Optum division, disrupted processing of approximately $14 billion in claims. The company discovered the cyberattack on Feb. 21 and said it disconnected the data systems targeted in the attack. UnitedHealth also stated that its software system for preparing medical claims, named …

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Final Rule on AI Transparency Can Benefit Clinical Labs

Laboratory Information Systems / By Robert Michel

ARTIFICIAL INTELLIGENCE (AI) AND MACHINE LEARNING are becoming ubiquitous in today’s modern hospital systems and clinical laboratories. In response to these developments, federal officials issued a new rule that has major implications on how healthcare providers use artificial intelligence. This article is the second part of a report by The Dark Report that discusses The …

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Change Healthcare Hit by Major Cyberattack

Clinical Laboratory Trends / By Robert Michel

CEO SUMMARY: It was a classic ransomware attack against Change Healthcare, the business unit of Optum that is itself a division of UnitedHealth Group. On Feb. 21, this cyberattack shut down critical systems at Change Healthcare, such as those involved in accepting and forwarding prescription drug orders to pharmacies and remitting reimbursement for those prescriptions. …

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Examining the Worldwide Pathologist Shortage

Pathology Trends / By Robert Michel

CEO SUMMARY: Demand for pathology services is growing faster than the number of pathologists available to meet that demand. This is true for the United States and most other nations. Consequently, efforts are underway to more accurately measure the number of pathologists practicing in each country. Early data support the claim of an inadequate number …

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Is Mobile Phlebotomy a Timely Service to Offer Health Plans?

Managed Care Contracts / By Virchow

EDITOR’S NOTE: Our column, Virchow, is written by anonymous insiders working within the managed care world. The column aims to help clients of The Dark Report better understand the decisions, policies, and actions of payers as they manage their laboratory networks, establish coverage guidelines, process lab test claims, and audit labs. CLINICAL LABORATORIES COULD …

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Genetics Company 23andMe Shares Update on Cyberattack

Clinical Laboratory / By Robert Michel

CONSUMER GENETICS HEALTHCARE AND BIOPHARMACEUTICAL COMPANY 23ANDME recently revealed that unauthorized access to millions of its customers’ personal information may have started earlier than the company previously reported. In its original U.S. Securities and Exchange Commission filing, 23andMe said it noticed a data breach in October 2023. But after a recent company investigation, the company …

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