FDA Watch: DOGE Changes at FDA Upend Approval Processes, Observers Say
Pre-submission and Q-Submission meetings apparently have been halted, for now
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Articles and Reports
Further Details to Note about Updated Clinical Lab Director Qualifications
Put into place late last year, the new rules place more emphasis on formal and continuing education requirements
Medical Laboratory Personnel Shortage Relief Act Aims to Dent the Staffing Crisis
How the 2024 proposal will fare on Capitol Hill in 2025 remains to be seen, though
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.
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
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
Cybersecurity: What Your Lab Needs to Know
Recent government efforts to address increased cyberattacks in the healthcare space, and how your lab could benefit
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
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?
In (Digital) Defense of HIPAA
How clinical laboratories and pathology groups can ensure that their digital pathology and AI workflows are HIPAA-compliant
FDA Watch: Could Guardant Health’s Colon Cancer Assay Be a Blockbuster?
The company is hiring at least 100 sales representatives this year to spread awareness and uptake of its recently FDA-approved Shield test
At-Home Genetic Testing: The Good, The Bad, and The Ugly
Direct-to-consumer (DTC) genetic testing has risen in popularity in recent years—but is it all it’s cracked up to be?
Private Payer Reimbursement for Genetic Testing Hinges on Clinical Utility
Two revenue cycle management experts offer tips for clinical labs to improve coverage decisions for genetic tests
