Lab Compliance Advisor

Practical, “What-to-Do” and “How-to-Do-It” Help to Comply with the Latest State & Federal Laws, Rules & Regulations that Affect Your Diagnostic Lab or Pathology Practice

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Labs in Court: Two EKRA-Related Cases and Some Usual Suspects

By Danielle Sloane, Morgan Tandy | Oct 28, 2024 | 1 min read

Recent enforcement actions involved usual targets such as COVID-19, genetic, and urine drug testing, but EKRA also made an appearance

A judge’s gavel sits on a lab bench next to racks of test tubes and a pair of safety glasses, illustrating legal issues related to laboratories.

How Do You Solve a Problem Like AI Regulation?

By Oscelle Boye, MBiomed | Oct 28, 2024 | 1 min read

How the current FDA AI/ML device regulations may be impeding innovation in the clinical lab

Closeup of laboratory professional using a tablet, with several healthcare-related icons and charts coming out of it, illustrating a healthcare artificial intelligence concept.

How Shuren’s Departure from the FDA May Impact the LDTs Rule

By Tara Cepull, MA | Oct 28, 2024 | 1 min read

FDA seems determined to push ahead with final rule, regardless of CDRH director’s departure, hiring of replacement.

FDA sign at its headquarters in Washington DC. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.

Effective Compliance Program Could Have Thwarted Rogue Employees

By Glenn S. Demby | Feb 19, 2015 | 1 min read

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Legal Dispute Highlights Contract Terms that Also Raise Compliance Issues