TAG:
Department of Health and Human Services
Pathologist Asks ChatGPT, Google Notebook to Predict LDT Trial Outcome
On his blog last month, pathologist Bruce Quinn, MD, PhD, published the answers provided by two artificial intelligence chatbots after he asked each to analyze the legal briefs submitted to federal courts in Texas where lab plaintiffs are challenging the FDA’s laboratory developed test (LDT) final …
Using AI to Predict Outcomes in FDA LDT Lawsuits
Given the popular sentiment that artificial intelligence (A…
Two Different LDT Lawsuits Combined in Federal Court
CEO SUMMARY: Different lawsuits challenging the FDA’s LDT rule were filed in recent months by the American Clinical Laboratory Association and the Association for Molecular Pathology. Both lawsuits were filed in the U.S. District Court for the Southern …
Four Health Systems Launch ‘Longitude Health’
CEO SUMMARY: For the second time in the past 16 months, respected health systems have taken steps to collaborate specifically to advance value-based care. Longitude Health joins Risant Health as the newest attempt to bring together different health systems and foster collaboration and inn…
HHS Issues Final Rule to Deal with Information Blocking
ANY HEALTHCARE PROVIDER DETERMINED TO HAVE COMMITTED “INFORMATION BLOCKING” can now be asse…
LDT Rule Is Now a Fact! What Will Be Consequences?
TODAY, THE NEW RULE FOR REGULATION OF LABORATORY DEVELOPED TESTS …
ACLA Files Court Challenge to FDA’s Final LDT Rule
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  
ACLA President Van Meter Discusses LDT Lawsuit
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…
Attorneys Assess Impact of FDA’s Final LDT Rule
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…
Change Healthcare Hit by Major Cyberattack
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…
CURRENT ISSUE
Volume XXXII, No. 1 – January 6, 2025
The Dark Report examines how AI is being used to predict the outcomes of FDA LDT lawsuits. Also, this issue is Part Two of a series about boosting pathology compensation in different settings, including hospitals. Two experienced pathology consultants identify the most effective approaches when negotiating Part A pathology agreements with hospitals and health systems, along with how to use data to bolster these negotiations.
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