Lessons in Laboratory Compliance from a $30 Million Settlement
‘Lean lab’ setup appears to have caught the eyes of investigators
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Lab Compliance Advisor
Practical, “What-to-Do” and “How-to-Do-It” Help to Comply with the Latest State & Federal Laws, Rules & Regulations that Affect Your Diagnostic Lab or Pathology Practice
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Articles and Reports
FDA Watch: Zepto Life Technology Receives FDA Breakthrough Designation for Blood-Based Mold Test
Its FungiFlex assay can make determining the cause of fungal infections vastly more accurate
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How to Effectively Manage Indoor Air Quality in Clinical Labs
These core steps are fundamental for protecting laboratory workers from airborne contamination
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How Do You Solve a Problem Like AI Regulation?
How the current FDA AI/ML device regulations may be impeding innovation in the clinical lab
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How Shuren’s Departure from the FDA May Impact the LDTs Rule
FDA seems determined to push ahead with final rule, regardless of CDRH director’s departure, hiring of replacement.
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Fighting the FDA’s Final Rule on LDTs
CEO Laurie Menser discusses the Association for Molecular Pathology’s court case against the FDA’s rule on laboratory-developed tests.
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Special Analysis: HIPAA Compliance Risks of AI in the Lab: Trends and Tips
The most common AI compliance risk areas related to data security and patient privacy, and the current regulatory landscape
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LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
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Are Current Regulations Keeping Labs from Benefiting from AI?
Though needed to protect data and patient privacy, some in the industry say that more flexibility is needed
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Cybersecurity: What Your Lab Needs to Know
Recent government efforts to address increased cyberattacks in the healthcare space, and how your lab could benefit
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Using AI to Improve Reimbursement and Decrease Claim Denials
Though payers’ adoption of AI has made reimbursement more challenging for labs, providers can also use AI to address these issues
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Key Lessons for Clinical Labs from the CrowdStrike Outage
A few months on from the historic CrowdStrike outage, what lessons can clinical labs take away from the incident?
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In (Digital) Defense of HIPAA
How clinical laboratories and pathology groups can ensure that their digital pathology and AI workflows are HIPAA-compliant
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