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
- Updates on changes to regulations
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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
June 2024 Labs in Court
Examining DOJ and OIG investigations of labs and their owners: Recent cases show continued focus on the usual enforcement targets.
FDA Issues Four Warning Letters to Lab Companies in Less Than Two Months
Laboratory diagnostics manufacturers receive regulatory scrutiny for issues including marketing, quality, and unapproved changes to tests
Compliance Tool: Addressing EKRA When Selling Your Lab
Key steps to follow when selling your lab to ensure compliance with the Eliminating Kickbacks in Recovery Act of 2018 (EKRA)
Why You Need to Address EKRA When Selling Your Lab
When selling your laboratory, in order to remain compliant with federal code, EKRA is something you will want to consider
Marketing Your Clinical Lab
Outreach and advertising can be tricky prospects for the clinical lab—but the right questions and strategies can help guide your efforts
MCED: A New Screening Paradigm?
Multicancer early detection tests—and their promise of comprehensive, minimally invasive screening—are catching the eye of labs and lawmakers
3 Thoughts on the FDA’s Final LDTs Rule
Regulatory expert Julie Ballard shares her first thoughts on the final rule for lab-developed tests and immediate steps for labs
Special Report: The Lab Kickback Risks of “Freebies”
How to avoid six common compliance risks involving free supplies, equipment, software, and other non-monetary compensation
Tool: Third-Party Risk Management Guide for Medical Labs
Key cybersecurity points to address when working with a third party that has access to protected health information
FDA Watch: AI-Based Sepsis Prediction Test Receives FDA Authorization
Prenosis claims its test can detect the presence of the often deadly condition within 24 hours of a hospitalization
