COMPLIANCE GUIDANCE

HIPAA: New HIPAA Penalties System Rewards Labs that Try to Comply

New HHS rules significantly increase the amount of money your lab can save by making diligent and demonstrable efforts to prevent HIPAA violations even when those efforts don't succeed. We're … [Read more...]

EMERGING TESTS

HPV DNA from Oral Rinse Samples May Be Prognostic Marker for Head, Neck Cancer

Samples collected from a mouth rinse can detect human papillomavirus (HPV) DNA. These easily collected samples might provide important monitoring information for patients with certain head and neck … [Read more...]

ENFORCEMENT

Compliance Perspectives: Feds Using Medicare Laws to Prosecute Non-Medicare Arrangements

Myth: Risk of federal prosecution for health fraud and abuse applies only when you deal with Medicare, TRICARE or other federal health programs. Truth: While that used to be true, the times they are … [Read more...]

EMERGING TESTS

Improved Accuracy of Point-of-Care HbA1c Tests May Expand Access to Testing

The U.S. Food and Drug Administration-cleared POC Afinion HbA1c Dx test (Alere Technologies a subsidiary of Abbott Laboratories) is accurate and precise for diagnosing diabetes using both fingerstick … [Read more...]

FDA

Case of the Month: FDA Issues Warning Letter for Unapproved Changes to Approved Assay

As a rule of thumb, FDA approvals are a snapshot applicable only to the product as it exists at the time of review and approval. So, when the product undergoes significant changes, it often triggers … [Read more...]


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