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More Signs of Shifting Sands in the Lab World

If you feel like the ground is shifting under y…

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Oracle Hopes to Sway Market with New AI-Assisted EHR

W hile it remains to be seen whether it truly pushes boundaries, Oracle Health got attention when recently announcing it had released an immersive, next-generation electronic health records (EHR) platform fueled by artificial intelligence (AI). The system is conv…

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Could AI Oversight in Labs Fall Under a CLIA Model?

CEO SUMMARY: Clinical AI is advancing faster than regulation, creating risk for medical labs. An expert discusses using CLIA to oversee development and ensure safety, performance, and accountability while complementing FDA oversight. Lab leaders face regulatory uncertainty…

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Deal Offers Signals about the Future of Digital Pathology

THE DIGITAL PATHOLOGY MARKET IS AT AN INFLECTION POINT, AND TEMPUS’ RECENT $81.25 MILLION ACQUISITION OF PAIGE underscores both the challenges and opportunities ahead. While the pandemic temporarily accelerated digital pathology adoption, with vendors raising large su…

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August 25, 2025, Intelligence: Late-Breaking Lab News

As we first reported in Dark Daily earlier this month, several states have taken initiative to regulate how artificial intelligence (AI) applies to clinical laboratory services. For example, a California law that went into effect earlier this year impacts providers who use gene…

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AI Hype in Labs: 6 Tips to Sniff Out the BS

CEO SUMMARY: In the final entry of our artificial intelligence series, the co-founders of Sample Healthcare discuss how clinical labs can evaluate AI vendors effectively, with an emphasis on assessing technical credentials and quick proofs of concept. Armed with the right …

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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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Using Sophisticated Schemes, Fraudsters Hit the Next Level

Investigators and fraudsters appear to be upping their game as the government seeks to punish those filing unscrupulous Medicare claims. These aspects were clear in the US Department of Justice’s (DOJ) announcement last month of the largest healthcare fraud takedown reportedly in US history. Cli…

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National Enforcement Trends Will Test Labs

This issue is strong on different flavors of enforcement that clinical laboratories, whether they want to or not, will need to contend with. Perhaps you saw news coverage recently when the US military dropped a dozen or so “bunker buster” bombs into underground Ir…

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For Lab Veterans, It’s Time to Step into AI’s Shadow

READING THROUGH THE FIRST INSTALLMENT OF THE DARK REPORT’S analysis about the state of artificial intelligence (AI) in clinical laboratories, this cantankerous observer found himself thinking about ChatGPT. Do I dare to use ChatGPT? Occasionally. …

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