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Office of the Inspector General
Final Rule on AI Transparency Can Benefit Clinical Labs
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…
Feds Bar Elizabeth Holmes from Government Health Programs
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 …
Anatomic Pathology Referrals Topic of OIG Advisory Opinion 23-06
THANKS TO A RECENTLY-RELEASED ADVISORY OPINION issued this fall by the Office of the Inspector General (OIG) Department of Health and Human Services, there is a new compliance twist involving billing for the technical component (TC) for anatomic pathology procedures. A…
1999’s ‘To Err Is Human’ Still an Opportunity for Labs
NOT ONLY DID THE 1999 PUBLICATION OF ‘TO ERR IS HUMAN” trigger a wave of national news coverage about patient harm in hospitals, it also launched this nation’s healthcare system on a multi-decade journey to boost the quality of care, reduce medical errors, and increase the transparency of both pati…
January 10, 2022 Intelligence: Late-Breaking Lab News
Imagine a medical lab temporarily closing because of the demand for too many tests! That’s just what happened at one of Australia’s largest medical lab companies. Australian Clinical Labs had to temporarily discontinue offering COVID-19 testing because test volumes had gotten too large. Au…
CURRENT ISSUE
Volume XXXI, No. 5 – April 8, 2024
The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.
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