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...]


Enforcement Trends: Whistleblowers Get in on the EHR “Meaningful Use” Action

Wrongful payment of electronic health records (EHR) "meaningful use" incentives has become a growth area in government health fraud enforcement. (See GCA, July 10, 2017). And now private … [Read more...]


EHR: Private Whistleblowers Getting in on “Meaningful Use” Crackdown

Wrongful payment of electronic health records (EHR) "meaningful use" incentives has become a growth area in federal health care fraud enforcement. And now private whistleblowers are getting … [Read more...]


New Bill Would Make Lab Employees Criminally Liable for Concealing Data Breaches

While massive data breaches have existed as long as massive data itself, legal accountability for organizations that commit them is a relatively recent phenomenon. Breach Liability of Labs Because … [Read more...]