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.
Healthcare attorneys explain three digital pathology models for laboratories to be aware of.
When structuring business arrangements, addressing six key risk areas can help laboratories avoid major compliance issues.
Ann Lambrix, vice president of RCM Solutions at Lighthouse Lab Services, discusses key developments in lab billing and coding.
Recent cases show labs should be wary of issues such as improper relationships, medical necessity, kickbacks, and potential telehealth fraud.
What clinical validation really means—and why every member of the laboratory should understand it.
Audits can be helpful not just for compliance purposes, but for maximizing reimbursement and maintaining a healthy business.
G2’s list of major FDA approvals includes cancer and liquid biopsy, COVID-19, STI, and neurologic tests.
Recent cases involve Medicare’s 14-Day Rule, improper PHI disclosure to a media outlet, kickbacks, and COVID-19 fraud.
Comments on the FDA’s proposed rule to regulate LDTs as in vitro diagnostic devices reveal mixed reactions.
Genialis CEO and co-founder Rafael Rosengarten, PhD, discusses key 2023 AI developments and what they could mean for laboratories.