Reliable Business Intelligence News About Clinical Laboratories, Pathology Groups, & Laboratory
Diagnostics Since 1995
The most complete archive of clinical and pathology lab industry news available, including issues from 1997 to the present.
Theranos COO Ramesh “Sunny” Balwani has been found guilty of 12 counts of conspiracy and wire fraud, and The Dark Report examines his trial and compares it to that of CEO Elizabeth Holmes. Also, there are several important court rulings that will impact the way labs do business, as well as pending federal legislation to consider.
UnitedHealth is now offering a new laboratory benefits management program that may expand health plans’ use of prior authorization. Also, Oracle, a major informatics company, has ambitious plans that could make diagnostic data more accessible and, at the same time, more valuable for clinical laboratories.
More changes are coming for the clinical lab industry, including the Department of Justice’s move to hold individuals accountable for lab fraud, even after company settlements have been reached. Also, integrated delivery networks are forming new mergers to create ever-larger business entities, all of which has implications for labs.
Better collection and use of clinical data was a prominent theme discussed by attendees at last month’s annual Executive War College Conference on Laboratory and Pathology Management in New Orleans. Also, an attorney warns that federal fraud investigators are targeting labs that did extensive COVID-19 testing during the height of the pandemic.
The Dark Report examines the lab staffing shortage crisis, including the causes and potential remedies. In other news, the Ramesh Balwani trial, like that of Elizabeth Holmes, is raising questions of who is responsible for lab problems — the lab director or company executives. Also, the DOJ contends in a court motion that EKRA governs lab sales and marketing commissions.
Federal healthcare law enforcement is turning its eye to new areas of healthcare activity, including COVID-19 testing and opioid prescribing. In other news, the state of California has terminated its contract with PerkinElmer to run the state COVID-19 testing lab, even as numerous questions about the lab’s compliance with health regulations remain.
In this issue of The Dark Report, learn how the latest clinical laboratory trends will be showcased in the upcoming Executive War College. Also, read how the Valencia Branch Lab has remained open despite dozens of deficiencies; how IoT technology helps labs track specimen collection; and details on physician settlements for allegedly offering kickbacks for lab test referrals.
Artificial intelligence is making strides in the clinical laboratory and pathology laboratory industry. In Europe and the United States, the first AI-powered solutions that automate digital pathology image analysis for primary diagnosis are obtaining regulatory clearance. This is highlighted by the investment by Sonic Healthcare in a thriving AI business. Also, AI is being used in lab coding, billing and collections.
In just three weeks, two major LIS vendors announced significant deals, raising important questions about what these moves mean for clinical laboratory directors and pathologists. These acquisitions may trigger significant shifts in the LIS products labs can buy, and demonstrate the value of healthcare data. Also, two large private practice pathology groups decide to sell to larger pathology superlabs.
XIFIN’s acquisition of pharmacy technology company OmniSYS is the latest evidence that retail pharmacies are preparing to become a new front door to healthcare for consumers. Also, there is more consolidation within the IVD industry.
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Volume XXXI, No. 5 – April 8, 2024
The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.
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