TAG:
lab risk & compliance
Federal Court Issues Ban on FTC’s Noncompete Rule
BY NOW, MOST CLINICAL LAB MANAGERS AND PATHOLOGY PRACTICE ADMINISTROATORS ARE AWARE of the Federal T…
HHS Issues Final Rule to Deal with Information Blocking
ANY HEALTHCARE PROVIDER DETERMINED TO HAVE COMMITTED “INFORMATION BLOCKING” can now be asse…
Language in Draft House Bill Directs FDA to Suspend LDT Rule
THERE IS AN INTERESTING NEW DEVELOPMENT associated with the regulation of laboratory deve…
Behind-the-Scenes Audits Often Hide Cause of Test Claim Denials
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Several Times, Feds Tried to ‘Redirect’ Lab Activities
CEO SUMMARY: Regulation of laboratory developed tests (LDTs) by the Food and Drug Administration (FDA) may turn out to be one of the most impactful federal laws or regulations ever promulgated, so far as it pertains to clinical laboratories.cThe Dark Report provides this historical look b…
New CISA Draft Rule Mandates Rapid Reporting of Cyberattacks
CEO SUMMARY: 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 ho…
Congressional Subcommittee Hears Testimony on FDA LDT Rule
DURING A MARCH 21 HEARING CONVENED by the U.S. House Energy and Commerce Subcommitt…
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…
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…
CMS Issues AI Guidance for Medicare Advantage
CEO SUMMARY: With its guidance on how Medicare Advantage plans should use artificial intelligence (AI) when making treatment decisions involving individual patients, the federal Centers for Medicare and Medicaid Services has opened one door in the coming debate on how the federal governme…
CURRENT ISSUE
Volume XXXI, No. 12 – September 3, 2024
This special intelligence briefing—presented in three parts—identifies the factors retarding a faster adoption of digital pathology. Also, how to protect your lab’s proprietary LDTs and assess the financial impact of compliance.
See the full table of contentsHow Much Laboratory Business Intelligence Have You Missed?
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