Labs in Court: Two EKRA-Related Cases and Some Usual Suspects
Recent enforcement actions involved usual targets such as COVID-19, genetic, and urine drug testing, but EKRA also made an appearance
Lab Compliance Advisor
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How Do You Solve a Problem Like AI Regulation?
How the current FDA AI/ML device regulations may be impeding innovation in the clinical lab
How Shuren’s Departure from the FDA May Impact the LDTs Rule
FDA seems determined to push ahead with final rule, regardless of CDRH director’s departure, hiring of replacement.
Compliance Certification Keeps Staff Up-to-Date, Increases Compensation
From - G2 Compliance Advisor
Laboratories should encourage or even require their compliance professionals to obtain…
Why the New Massachusetts Law Matters, Regardless of Where Your Lab or Practice is Located
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Social Media and Hiring: Can You Use Facebook to Screen Job Applicants?
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Compliance Perspectives: PAMA—What We Know So Far, What You Need to Know to Comply
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Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
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News at a Glance – September 2016
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Drug Testing Case Settles for $7.4 Million
From - G2 Compliance Advisor
A Florida clinic has settled a False Claims Act case relating to drug testing for $7.4 million. Quantitative drug tests that…
Train Staff to Be Alert to Phishing Attacks
From - G2 Compliance Advisor
When asked why he robbed banks, the notorious outlaw Willie Sutton famously replied: "Because that's where they keep…
Industry Questions How Many Hospital Labs Will Be Reporting Under PAMA
From - G2 Compliance Advisor
When the Centers for Medicare & Medicaid Services (CMS) announced in mid-June the final rules governing the Protecting the…
Theranos Announces Appeal of CMS Sanctions
From - G2 Compliance Advisor
Theranos has announced that it is appealing the Centers for Medicare & Medicaid's threatened sanctions. The announcement also indicated that…