TAG:
lab risk & compliance
Hospital Lab Outreach: Still a Valuable Asset!
CEO SUMMARY: Hospital lab administrators everywhere are watching press releases announcing the latest agreement of a major health system selling its laboratory outreach business to one of the billion-dollar lab corporations. The pace of these sales is accelerating. These deals confirm the…
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…
CURRENT ISSUE
Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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