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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Proposed Electronic Signature Rule Has Compliance Risks

By Scott Wallask | From the Volume XXX, No. 9 – June 19, 2023 Issue

CEO SUMMARY: Proposed HHS rule aims to define and standardize physician electronic signatures. For clinical laboratories, this is important because lab test claims require a signed requisition form. Given …

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Draft Rule Standardizes Electronic Signatures

By Robert Michel | From the Volume XXX, No. 6 – April 17, 2023 Issue

CEO SUMMARY: Every year, payers refuse laboratory test claims on grounds that the ordering provider’s signature is missing or illegible—a situation that costs clinical labs million of dollars in…

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March 6, 2023, Intelligence: Late-Breaking Lab News

By Scott Wallask | From the Volume XXX No. 4 – March 6, 2023 Issue

Since Congress did not include new regulations for laboratory-developed tests (LDTs) in a year-end spending budget, it appears the Food and Drug Administration (FDA) will take steps of its own to increase the agency’s oversight of LDTs. “We are moving forward with rulemaking,” said Eliza…

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Labs Must Audit Their Cybersecurity Measures

By Scott Wallask | From the Volume XXIX, No. 14 – October 10, 2022 Issue

CEO SUMMARY: While clinical laboratory managers and pathologists are aware of the risks of a data breach, they often assume that related protection measures are working as needed. That is a mistake. With the cost of healthcare data breaches on the rise, it is vitally important for l…

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U.K.-based CliniSys Acquires Nashville-based ApolloLIMS

By Robert Michel | From the Volume XXIX, No. 6 – April 25, 2022 Issue

CONSOLIDATION IN THE CLINICAL LABORATORY INFORMATICS INDUSTRY took another step forward with the announcement that CliniSys (the parent of Sunquest Information Systems) was acquiring Nashville-based ApolloLIMS. This move may also further muddy the line between classic laborato…

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Expert Lists Strategies to Cope with Cyber Attacks

By Robert Michel | From the Volume XXIX, No. 1 – January 10, 2022 Issue

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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In Theranos’ Trial, CLIA Laboratory Director Has a Starring Role

By Robert Michel | From the Volume XXVIII, No. 16 – November 29, 2021 Issue

CEO SUMMARY: Most clinical lab directors understand the risks that come with running a CLIA-licensed lab. Such risks are at the forefront of the criminal trial of Elizabeth Holmes, founder of now-defunct Theranos. During the trial, federal prosecutors and defense attorneys question…

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