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Top 10 Lab Stories for 2024 Reflect Important Trends

CEO SUMMARY: Most clinical laboratory managers will agree that the Food and Drug Administration’s (FDA) final rule to regulate laboratory developed tests (LDTs) is the biggest lab industry story for 2024. Every laboratory performing LDTs must now devote money and time to comply with the…

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Change Healthcare Cyberattack Involved 100 Million Americans

AFTER EXPERIENCING WHAT MANY CYBERSECURITY EXPERTS consider to be one of the largest, most disruptive ransomware attacks ev…

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Why Ransomware Attacks Are a Threat to Your Lab

  Have you and your lab management team noticed the major…

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New CISA Draft Rule Mandates Rapid Reporting of Cyberattacks

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 Health Cyberattack Breaches PHI Here at TDR!

CEO SUMMARY: It was Feb. 21 when cybercriminals attacked Change Healthcare’s claims processing systems. On April 22, UnitedHealth Group issued a statement that PHI for “a substantial proportion of people in America” was breached. We believe the PHI of our employees and T…

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UnitedHealth Group Faces DOJ Antitrust Probe

CEO SUMMARY: Recent events have not been kind to UnitedHealth Group and its subsidiaries UnitedHealthcare and Optum. In February, just as UHG’s Change Healthcare division was hit with a major cyberattack that disrupted billions of dolla…

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March 18, 2024, Intelligence: Late-Breaking Lab News

In California last month, Quest Diagnostics entered into a settlement agreement with California Attorney General Rob Bonta and nine local district attorneys. KCRA News of Sacramento reported that the “settlement resolves allegations that the company unlawfully disposed of …

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

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

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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Expert Lists Strategies to Cope with Cyber Attacks

CEO SUMMARY: Class action lawsuits filed by patients whose protected health information (PHI) was breached during a cyber attack may be one additional unwelcome consequence for clinical laboratories and anatomic pathology groups hit by a ransomware or cyber attack. This is what happ…

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