Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
Best practices and expert insight to help lab professionals comply with regulations and identify strategic trends in business and technology
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Lab Industry Advisor Subscriptions Include
Analysis and insight on key compliance, legal, and business developments affecting laboratories
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Latest Articles
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”
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
Smart Tools, Smarter Choices: Understanding AI and Automation in Clinical Lab RCM
Wednesday, Jan. 28, 2026, 1 p.m. ET
Attention Lab Directors: Four CLIA Updates from the Past Year to Examine
CMS tweaked its CE, documentation, and on-site visit requirements for directors
Lab Directors Should Follow cfDNA Testing Progress in Ongoing Study
AMP Annual Meeting attendees showed strong interest in the blood test
Diagnostics Pipeline: SimplyTest, Becton Dickinson Expand HPV Testing Capabilities
SimplyTest’s saliva-based HPV tests will be marketed to dentists and functional medicine practices
New Open-Source Tool Aims to Make Sepsis Prediction Models More Transparent for Clinicians
Platform enhances the interpretability of CBC-based machine-learning models
Quest Says It Will Release a More Powerful Alzheimer’s Test in 2026
The assay detects the presence of three different proteins and is slightly more accurate than a test Quest released earlier this year
New Tests Could Make Detecting Lyme Disease Speedier and More Accurate
Current assays often miss diagnoses in the early stages of the disease, delaying treatment
Prospective Changes to HIPAA Rules Would Affect Clinical Labs
With new modifications to HIPAA potentially on the horizon, we hear from experts on HHS' proposal
FDA Watch: CND Life Sciences Wins Breakthrough Device Designation for Skin-Based Neurodegenerative Test
The Syn-One assay can diagnose multiple conditions without needing a lumbar puncture
The Cost of Not Keeping Legacy Clinical Laboratory Technology Up to Date
By not modernizing legacy systems and software, labs risk incurring hidden costs
