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.
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
The choice of venue was likely inspired by the longstanding anti-regulatory stance of the state's federal judges.
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
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
Cybersecurity expert outlines steps labs and other healthcare providers should take to prepare for future cyberattacks
Know where labs may fall foul of compliance requirements—and discover the actions your lab can take to mitigate the risk of noncompliance
Labs that invested heavily in POC molecular tests during COVID-19 are well positioned to leverage this equipment toward GAS diagnostics
Recent enforcement actions and court cases include kickback schemes a-plenty and a reminder to focus on HIPAA compliance
Factors laboratories should consider when evaluating their compliance challenges, needs, and goals to select compliance solutions