LDT Rule Is Now a Fact! What Will Be Consequences?

By R. Lewis Dark | From the Volume XXXI, No. 8 – June 10, 2024 Issue

TODAY, THE NEW RULE FOR REGULATION OF LABORATORY DEVELOPED TESTS …

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ACLA Files Court Challenge to FDA’s Final LDT Rule

By Robert Michel | From the Volume XXXI, No. 8 – June 10, 2024 Issue

CEO SUMMARY: Discussing the FDA’s final LDT rule, one pathologist tracking this matter wrote, “In many ways, the FDA’s plan [final LDT rule] is like the guy who gets three wishes from a genie, and he asks for unlimited wishes.” ACLA and HealthTrackRx are challenging the FDA’s �…

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ACLA President Van Meter Discusses LDT Lawsuit

By Robert Michel | From the Volume XXXI, No. 8 – June 10, 2024 Issue

CEO SUMMARY: On July 5, the final laboratory developed test (LDT) rule issued by the federal Food and Drug Administration (FDA) takes effect. In response, the American Clinical Laboratory Association (ACLA) filed a lawsuit in federal court in Texas to challenge the FDA’s actions. In thi…

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Attorneys Assess Impact of FDA’s Final LDT Rule

By Robert Michel | From the Volume XXXI, No. 8 – June 10, 2024 Issue

CEO SUMMARY: Publication of the Food and Drug Administration’s final rule on laboratory developed tests (LDTs) is already causing some labs to consider withdrawing their existing LDTs because of compliance costs. Two experienced lab industry attorneys discuss aspects of the LDT rule and…

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Final Rule on AI Transparency Can Benefit Clinical Labs

By Robert Michel | From the Volume XXXI, No. 5 – April 8, 2024 Issue

ARTIFICIAL INTELLIGENCE (AI) AND MACHINE LEARNING are becoming ubiquitous in today’s modern hospital systems and clinical laboratories. In response to these developments, federal officials issued a new rule that has major implications on how healthcare providers use artificial intelligence. T…

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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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HHS Publishes Final Rule for Health IT Interoperability

By Robert Michel | From the Volume XXXI, No. 3 – February 26, 2024 Issue

THERE IS A NEW FEDERAL RULE intended to improve interoperability and portability of patient information. This rule could be a significant benefit for clinical laboratories and anatomic pathology groups. In December, the US Department of Health and Human Services (HHS) Offi…

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FDA & CMS Issue Letter, Agree on LDT Oversight

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

CEO SUMMARY: With the release of a public statement about the oversight of LDTs on Jan. 24, 2024, officials at both the Food and Drug Adminstration and the Centers for Medicare and Medicaid Service went on record that both agencies are aligned in the spec…

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Feds Bar Elizabeth Holmes from Government Health Programs

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

ONCE AGAIN, ELIZABETH HOLMES, THE DISGRACED FORMER CEO OF THERANOS, is in the news. This time it is because the federal Department of Health and Human Services (HHS) Office of the Inspector General (OIG) announced in January that Elizabeth Holmes is …

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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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