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artificial intelligence
More Signs of Shifting Sands in the Lab World
By R. Lewis Dark | From the Volume XXXII, No. 15 – October 27, 2025 Issue
If you feel like the ground is shifting under y…
Oracle Hopes to Sway Market with New AI-Assisted EHR
By Jillia Schlingman | From the Volume XXXII, No. 15 – October 27, 2025 Issue
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…
Could AI Oversight in Labs Fall Under a CLIA Model?
By Scott Wallask | From the Volume XXXII, No. 14 – October 6, 2025 Issue
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…
Deal Offers Signals about the Future of Digital Pathology
By Janette Wider | From the Volume XXXII, No. 13 – September 15, 2025 Issue
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…
August 25, 2025, Intelligence: Late-Breaking Lab News
By Scott Wallask | From the Volume XXXII, No. 12 – August 25, 2025 Issue
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…
AI Hype in Labs: 6 Tips to Sniff Out the BS
By Scott Wallask | From the Volume XXXII, No. 11 – August 4, 2025 Issue
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 …
For AI Regulation, Look to Data Laws, FDA Action
By Scott Wallask | From the Volume XXXII, No. 10 – July 14, 2025 Issue
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…
Using Sophisticated Schemes, Fraudsters Hit the Next Level
By Jillia Schlingman | From the Volume XXXII, No. 10 – July 14, 2025 Issue
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…
National Enforcement Trends Will Test Labs
By R. Lewis Dark | From the Volume XXXII, No. 10 – July 14, 2025 Issue
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…
For Lab Veterans, It’s Time to Step into AI’s Shadow
By R. Lewis Dark | From the Volume XXXII, No. 9 – June 23, 2025 Issue
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. …
CURRENT ISSUE
Volume XXXIII, No. 1 – January 19, 2026
The Dark Report looks at the FDA’s move to reclassify Oncology companion diagnostics as Class II medical devices and considers how labs can benefit. Also, observers are concerned about the effect of PAMA cuts on rural clinical laboratories.
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