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.
Though UDT-related enforcement actions predominate, an uncommon vendor-related case was in the mix this month.
Recent cases involve COVID-19 fraud, UDTs, and the latest HIPAA Right of Access settlement.
While ChatGPT has its place, allowing lab staff to use it exposes you to liabilities—here are some ways to manage the risks involved.
As generative AI chatbot use increases, labs may want to implement a written acceptable use policy for staff.
A written policy helps establish your right to do excluded persons checks and take appropriate actions if they come back positive.
In recent key cases, the national drug retailer must stand trial for failing to protect customers from faulty Theranos products.
The new codes have garnered attention as a future mechanism for additional reimbursement and thus deserve further discussion.
Hiring, retaining, or simply doing business with the wrong people may expose your lab to significant financial penalties.
A recent False Claims Act settlement from Kentucky represents an unusual variation on a common theme.
The end of the COVID-19 public health emergency on May 11 also brings certain flexibilities for labs and other providers to an end.