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
National Lab Reporter
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Articles and Reports
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
Why Revenue Cycle Management Systems Fall Behind—and How to Modernize Them
Clinical lab billing teams face an overwhelming number of challenges if revenue cycle strategies fall short
Lawyers Give Their Tips to Spot Clinical Lab Fraud
Medical laboratories should monitor fraud cases across the country and also stay vigilant of suspicious patterns of behavior
Heed AKS and EKRA to Properly Market Clinical Lab Services
Read this overview of legislation and regulations governing laboratory marketing practices and learn tips to ensure these activities remain compliant
New CLIA e-Notifications: Here’s What Clinical Labs Need to Know
As of March 1, 2026, CMS will move CLIA away from paper-based transactions to improve efficiency and payments
HHS Suddenly Dismantles CLIAC After 33 Years
The board was eliminated as part of a sweeping reordering of the Department of Health and Human Services
Reporting Noncompliance in Clinical Labs Requires the Right Channels and Culture
A lawyer advises medical laboratories on how to improve their avenues for reporting unethical behavior
FDA Watch: CDRH Budget May Not See Steep Cuts in FY 2026
A leaked budget document for the next fiscal year suggested non-user fee funding may be up slightly compared to recent years.
No Signs of the DOJ Letting Off the Pedal with Medicare Fraud Investigations
However, a new memo instructs federal prosecutors to ‘avoid overreach’ when parties cooperate with authorities
Next Steps: With LDT Final Rule Now Null, Industry Groups Urge Lab Managers and Pathologists to Advocate for Change
CAP and AMP officials weigh in on plans to push for a legislative- or CLIA-based approach to future LDT oversight
LDT Appeal: Looking at the Legal Nuances Behind Potential FDA Actions Following Court Decision
Marginal LDT scenarios could be where the FDA focuses on next, a lawyer notes
