Profitable Collaboration with Pharma Companies

By Stephen Beale | From the Volume XXXII, No. 12 – August 25, 2025 Issue

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

By Stephen Beale | From the Volume XXXII, No. 11 – August 4, 2025 Issue

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

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…

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How Labs, Pathologists Should Prepare for Payer Audits

By Robert Michel | From the Volume XXXII, No. 7 – May 12, 2025 Issue

PAYER AUDITS ARE ON THE RISE, AND CLINICAL LABORATORIES AND PATHOLOGY PRACTICES THAT ARE NOT ADEQUATELY PREPARED could face millions of dollars in unexpected recoupment demands. That’s the word from Jane Pine Wood, JD, a healthcare attorney with McDonald Hop…

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HHS Revises HIPAA Privacy, Security Rule

By Robert Michel | From the Volume XXXII, No. 2 – January 27, 2025 Issue

CEO SUMMARY: Officials at the Department of Health and Human Services (HHS) are proposing significant changes in what observers are calling a major revision to HIPAA’s requirements for protected health information (PHI) and cybersecurity. HHS issued a statement that the objective of the…

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Epic Sued for Antitrust Violations by Small, Start-up Company

By Robert Michel | From the Volume XXXI, No. 14 – October 14, 2024 Issue

IT’S BEING CALLED A “DAVID VERSUS GOLIATH” SPAT. Last month, Particle Health of New York City filed an …

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New CISA Draft Rule Mandates Rapid Reporting of Cyberattacks

By Robert Michel | From the Volume XXXI, No. 7 – May 20, 2024 Issue

CEO SUMMARY: There is another federal rule that will require compliance by clinical labs. An agency of U.S. Dept. of Homeland Security published a draft rule on April 4 that requires certain organizations—including hospitals, clinical labs, and pathology groups—to report, within 72 ho…

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Change Healthcare Hit by Major Cyberattack

By Robert Michel | From the Volume XXXI, No. 4 – March 18, 2024 Issue

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 prescript…

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European Lab’s Data Breach Has Lessons for U.S. Clinical Labs

By Robert Michel | From the Volume XXXI, No. 2 – February 5, 2024 Issue

IN WHAT COULD BE A CAUTIONARY TALE FOR CLINICAL LABORATORIES, a cybersecurity researcher has reported the discovery of a medical laboratory database that publicly exposed COVID-19 test records containing people’s personal data, including their names, passport numbers, appointment details, and test …

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Cyberattack Victims Sue Enzo Biochem and Labcorp

By Scott Wallask | From the Volume XXX, No. 10 – July 10, 2023 Issue

CEO SUMMARY: It’s the latest reminder that clinical laboratories and anatomic pathology groups are at risk for two threats. One threat is a cyberattack that shuts down a lab’s IT system while stealing patient data. The other threat involves lawsui…

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