TDR Insider
What Labs with LDTs Must Do to Comply with the FDA’s LDT Rule
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 subs...
Clinical Labs Face New Consumer-Driven Trend
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."...
ACLA Files Federal Court Challenge to FDA’s Final LDT Rule
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 ma...
New CISA Proposed Rule Mandates Rapid Reporting of Cyberattacks
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 ...
Wisconsin Diagnostic Lab’s Alternative Staff Solutions
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 ...
Lab Market Is Fragmenting, Creating New Opportunities
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 s...
Labs and Path Groups Should Prepare for Arrival of ‘Perfect Storm’
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 1...
Machine Learning Is Ready to Give Clinical Labs New Capabilities
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)...
Clinisys CEO Discusses Strategic Changes That Labs Need to Make
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 ...
FDA Releases Proposed Rule to Further Regulate LDTs
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....
Don’t Be at the Mercy of the Tumultuous Healthcare Revolution
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CURRENT ISSUE
Volume XXXI, No. 10 – July 22, 2024
An attorney widely experienced in clinical laboratory regulation has prepared guidelines for complying with the FDA’s new LDT rule, and The Dark Report offers them in their entirety to readers. Also, a House of Representatives bill includes language calling for the FDA to suspend its rule.
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