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What Labs with LDTs Must Do to Comply with the FDA’s LDT Rule

TDR Insider / By Robert Michel

Until the recently filed court challenge to the Food and Drug Administration’s LDT rule succeeds or Congress intervenes with new legislation, those clinical laboratories performing laboratory developed tests (LDTs) must comply with the requirements of the new rule. This compliance will require substantial staff time and costs that may outweigh the benefit to the lab …

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Clinical Labs Face New Consumer-Driven Trend

TDR Insider / By Robert Michel

THERE IS A NEW CLASS OF CLINICAL LABORATORIES THAT ARE BUILDING MOMENTUM in the United States today. These are labs serving what The Washington Post described as a “new world of DIY [do-it-yourself] testing.” The Dark Report relates an investigative report by The Post, which states, “A new world of DIY testing is changing the …

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ACLA Files Federal Court Challenge to FDA’s Final LDT Rule

TDR Insider / By Robert Michel

BATTLE LINES ARE NOW DRAWN ON WHAT IS PROBABLY THE BIGGEST CONFRONTATION between the clinical laboratory industry and federal regulators in the past 50 years. On May 29, the American Clinical Laboratory Association (ACLA) with co-plaintiff HealthTrackRx filed a major lawsuit against the federal Department of Health and Human Services (HHS) and Food and Drug …

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New CISA Proposed Rule Mandates Rapid Reporting of Cyberattacks

TDR Insider / By Robert Michel

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 hours, any cyberattack and the payment of any ransom payments associated with a cyberattack. The …

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Wisconsin Diagnostic Lab’s Alternative Staff Solutions

TDR Insider / By Robert Michel

Even as clinical laboratories and pathology groups around the nation cope with a sustained shortage of qualified staff, the team at Wisconsin Medical Laboratories has successfully kept staffing at 96% of authorized levels. One effective strategy they use is to go into the community to educate recent college graduates and high school students about the …

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Lab Market Is Fragmenting, Creating New Opportunities

TDR Insider / By Robert Michel

Even as consolidation continues in the ownership of hospitals, health systems, office-based physicians, and clinical laboratories, there is a powerful trend of fragmentation quietly transforming the way providers—including clinical labs and pathology groups—serve patients and consumers who want specialized expertise and choice. Today’s market for clinical laboratory testing services is fragmenting at a pace that …

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Labs and Path Groups Should Prepare for Arrival of ‘Perfect Storm’

TDR Insider / By Robert Michel

In the near future, clinical labs and pathology groups will need to address three major developments. One involves the FDA proposed LDT rule. A second is the adoption by payers of guidelines that require genetic test claims to have Z-Codes. The third centers around coming reforms and updates to the 1992 CLIA rules. This is …

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Machine Learning Is Ready to Give Clinical Labs New Capabilities

TDR Insider / By Robert Michel

In the second part of an exclusive Q&A with The Dark Report, Clinisys CEO Michael Simpson explains how new developments in digital technologies will expand the value and role of lab test data. He predicts that labs will use artificial Intelligence (AI)—rooted in machine learning, natural language processing, and neural networks—to create operational efficiencies while …

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Clinisys CEO Discusses Strategic Changes That Labs Need to Make

TDR Insider / By Robert Michel

In an exclusive Q&A with The Dark Report, Clinisys CEO Michael Simpson describes the main forces transforming healthcare here in the United States and abroad. He connects these trends with advances in cloud-based technology, artificial intelligence, and machine learning. Simpson became CEO and President at lab informatics provider Clinisys in 2017. Since then, he has …

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FDA Releases Proposed Rule to Further Regulate LDTs

TDR Insider / By Robert Michel

The U.S. Food and Drug Administration (FDA) has taken the first step to regulate laboratory developed tests (LDTs). Many in the clinical laboratory oppose the FDA on this point. Last week, the agency made the draft rule public, prior to its official publication this week. This move by the FDA—which picked up significant momentum over …

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