ACLA Sues FDA Over Regulation of Laboratory-Developed Tests—in Texas
The choice of venue was likely inspired by the longstanding anti-regulatory stance of the state's federal judges.
Keep up to date on the latest legal, compliance, and business developments affecting the lab industry, while offering analysis and insight to ensure your lab’s success.
The choice of venue was likely inspired by the longstanding anti-regulatory stance of the state's federal judges.
How the Eliminating Kickbacks in Recovery Act of 2018 (EKRA) came to be, what laboratory leaders should know about it, and how to comply
Examining DOJ and OIG investigations of labs and their owners: Recent cases show continued focus on the usual enforcement targets.
Laboratory diagnostics manufacturers receive regulatory scrutiny for issues including marketing, quality, and unapproved changes to tests
Key steps to follow when selling your lab to ensure compliance with the Eliminating Kickbacks in Recovery Act of 2018 (EKRA)
When selling your laboratory, in order to remain compliant with federal code, EKRA is something you will want to consider
Outreach and advertising can be tricky prospects for the clinical lab—but the right questions and strategies can help guide your efforts
How to avoid six common compliance risks involving free supplies, equipment, software, and other non-monetary compensation
Key cybersecurity points to address when working with a third party that has access to protected health information
Prenosis claims its test can detect the presence of the often deadly condition within 24 hours of a hospitalization
Cybersecurity expert outlines steps labs and other healthcare providers should take to prepare for future cyberattacks