TAG:
HHS
OIG Issues New Report on Medicare 2023 Lab Spend
CEO SUMMARY: When the Office of the Inspector General (OIG) at the Department of Health and Human Services (HHS) issued its latest report on Medicare spending in 2023 for clinical laboratory tests, it attracted relatively little attention from the lab industry. Maybe other issues—such a…
HHS Revises HIPAA Privacy, Security Rule
CEO SUMMARY: Officials at the Department of Health and Human Services (HHS) are proposing significant changes in what observers are calling a major revision to HIPAA’s requirements for protected health information (PHI) and cybersecurity. HHS issued a statement that the objective of the…
January 27, 2025, Intelligence: Late-Breaking Lab News
On Jan. 16, 2025, Paul Mango died at the age of 65. With his passing, the profession of laboratory medicine lost an ally and a friend. In the mid-1990s, while at the Institute for Transfusion Medicine in Pittsburgh, Mango convinced the CEOs of 40 hospitals to collaborate and create t…
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…
Lab Briefs: Dec. 16, 2024
55,000 Members of Class Action Case Involving Labcorp…
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 …
Change Healthcare Cyberattack Involved 100 Million Americans
AFTER EXPERIENCING WHAT MANY CYBERSECURITY EXPERTS consider to be one of the largest, most disruptive ransomware attacks ev…
September 3, 2024, Intelligence: Late-Breaking Lab News
To challenge the federal Food and Drug Administration (FDA) final rule on laboratory developed tests (LDTs,) the Association for Molecular Pathology (AMP) filed a lawsuit on August 20, 2024, in the United States District Court for the Southern District of Tex…
How Is COVID-19 Evolving? It’s Not Like Flu or Colds
CEO SUMMARY: It’s been 53 months since the SARS-CoV-2 virus triggered the worst global pandemic since 1918’s influenza pandemic. The coronavirus continues to surprise public health officials as new variants are detected, along with a multi-year pattern of summer surges in new cases. T…
CURRENT ISSUE
Volume XXXII, No. 4 – March 10, 2025
A bold new technology has entered the European lab marketplace, with the introduction of an autonomous robotic phlebotomy device, already in service at a Netherlands hospital. Also, The Dark Report announces its sale to LabX Media Group of Ontario Canada.
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