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Profitable Collaboration with Pharma Companies

CEO SUMMARY: Drug discovery efforts by pharmaceutical companies often need a boost from anatomic pathology practices and clinical laboratories. Forward-thinking lab leaders and pathologists can take advantage of their data and expertise to partner with pharma, setting the …

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Clinical Labs Battle Complex Claims Denials

CEO SUMMARY: While the number of denials is not going up, the reasons that private payers deny claims are becoming more complex and time-consuming to appeal. After reviewing noteworthy trends among payers, learn a three-level approach to appeals that may lead to greater su…

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For AI Regulation, Look to Data Laws, FDA Action

CEO SUMMARY: AI is creating legal uncertainty for clinical labs, especially around data privacy and FDA oversight of AI tools in diagnostics. Few court cases exist yet that interpret AI use within clinical settings, but labs must watch how HIPAA and state laws wield influence. Vendor soft…

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Workers Use AI More than Lab Leaders Think

CEO SUMMARY: In part one of an analysis about the state of AI in clinical laboratories, The Dark Report explores how frontline workers, especially younger ones, are using AI tools like ChatGPT far more than lab leaders. Recent reports elsewhere in the business world show e…

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Federal Court Reverses Conviction in AKS Case

CEO SUMMARY: A federal appeals court has overturned the conviction of an operator of a durable medical equipment company who was accused of violating the Anti-Kickback Statute. A marketing company’s lack of true influence over decision-making related to the case seemed t…

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Economic, Tech Changes Drive Lab Concerns

CEO SUMMARY: Uncertainty around tariffs, future regulations, and artificial intelligence (AI) defined the mood at the 2025 Executive War College, where nearly 1,000 lab leaders gathered. Speakers warned of how stagnant healthcare spending could trickle down to labs. Meanwh…

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With LDT Rule Vacated, Labs Await FDA Retort

CEO SUMMARY: In a major win for clinical laboratories, a federal judge vacated the FDA’s final rule on LDTs, writing in his decision that the agency overstepped its authority. For now, labs can develop and modify LDTs without FDA oversight, but future action in some form…

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Role of Price Transparency During Path Contract Talks

CEO SUMMARY: Pathology groups have a much better opportunity to turn the tables on payers and other third parties during contract negotiations if they come armed with the data and other information recommended by two well-respected pathology experts…

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The Dark Report Acquired by LabX Media Group

CEO SUMMARY: One of the clinical laboratory industry’s longest-running sources of business intelligence, market trends, and management developments has a new owner. LabX Media Group completed its purchase of The Dark Intelligence Group, Inc. (TDIG) on Feb. 28, 2025. This transaction pav…

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Mayo Clinic’s Ambitious Digital Pathology Initiative

CEO SUMMARY: It’s the latest example of an academic medical center moving to develop its own digital pathology solutions. This collaboration involves Mayo Clinic, Nvidia, and Aignostics. The three will work together to use digital pathology images and patient data from Mayo Clinic and C…

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