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
Diagnostics Pipeline: FDA Approves Visby Medical’s Over-The-Counter Women’s Sexual Health Test
It’s the first PCR-based sexually transmitted infection test platform for at-home use
Experts Discuss Opportunities and Challenges for NGS
Next-generation sequencing is reshaping how labs detect, understand, and manage disease
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.
Possible Job Description for a Diagnostic Health Consultant
The role at this point is theoretical, but our editors asked AI for help in drafting what the position might entail
Diagnostic Health Consultant: A New Role Proposed for the Clinical Laboratory
While still in the early stages, Clinical Lab 2.0’s pitch for this new position fits with the need to better use lab data
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
Audits, the False Claims Act and Clinical Lab Enforcement: 2025 Trends and Compliance Tips
June 11th, 1:00pm ET Significant cases decided in 2024 and 2025 are shaping the landscape of enforcement for clinical laboratories. Government regulators continue to focus on medical necessity and improper business relationships, but they have expanded their focus...
