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HIPAA

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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Proposed Electronic Signature Rule Has Compliance Risks

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

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

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

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

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

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

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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New Lab Revenue Source: COVID-19 Worker Screening

CLINICAL LABORATORIES have a new revenue-generating opportunity, as some states relax stay-at-home rules: Many employers are likely to seek COVID-19 screening tests for employees returning to work to detect the presence of the new coronavirus. This new source of lab specimens and revenue gi…

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