Compliance Perspectives: Complying with HIPAA Isn’t Enough to Manage Data Breach Liability Risks

Memo to lab managers and compliance officers: It may be time to rethink your data breach response strategy. This directive is the result not of any substantive changes to the HIPAA rules but rather to … [Read more...]


Cybersecurity: The 10 Things HHS Says You Should Be Doing to Stop Phishing, Ransomware and Other Threats

HHS published guidance on cybersecurity for healthcare organizations. Even though it's voluntary, the new HHS Guidance is significant to the extent it lays out the agency's expectations of the … [Read more...]


Big Data Can Reshape Lab Reference Values in the Era of Personalized Medicine

As might be expected, there are substantial differences in "normal" laboratory values determined by healthy outpatients and critically ill patients in the intensive care unit (ICU). However, even … [Read more...]


One-Fourth of Myriad’s Variants of Unknown Significance Reclassified Over 10 Years

Variant reclassification following hereditary cancer genetic testing is common, according to a study published by Myriad Genetics (Salt Lake City) Sept. 25 in the Journal of the American Medical … [Read more...]


Case of the Month: Anthem Settles Massive HIPAA Breach Case for Record $16 Million

Pop Quiz: What's the highest amount a health care entity ever paid to the HHS Office for Civil Rights (OCR) to settle a HIPAA violation? The answer used to be $5.5 million paid by Advocate Health … [Read more...]


Cybersecurity: LabCorp Reports What Could Be a Major Data Breach

Cyberattacks and data breaches against health providers are a daily occurrence. But when the breach takes place at a firm as big and powerful as LabCorp and potentially affects the health records of … [Read more...]


Artificial Intelligence Merges Histology, Genomics to Predict Survival

A deep learning computational approach can predict survival with brain tumors directly from digital histological images and genomic biomarkers, according to a study published online March 12 in the … [Read more...]


Methods for Reanalysis of Exome Sequencing Emerging

Clinical whole-exome sequencing (WES) offers diagnosis for approximately 30 percent of patients, but it has exponentially increased the number of variants identified—many of which are of unknown … [Read more...]


Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry

ACLA Goes for Jugular in PAMA Challenge Case Case: Attorneys for the American Clinical Laboratory Association asked the federal court for summary judgment in its lawsuit challenging the legality of … [Read more...]


Case of Month: Using Window Envelope to Mail HIV Info Costs Aetna $17+ Million

You talk about a mailroom mess-up! A shockingly bad choice in envelopes has just cost one of the country's largest health insurers over $17 million. The Lawsuit On Jan. 16, Aetna agreed to pay … [Read more...]