Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
Best practices and expert insight to help lab professionals comply with regulations and identify strategic trends in business and technology
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Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
- Healthcare-related laws
- FDA approvals
- Business deals in the diagnostics space, and more
Latest Articles
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
The End May Be Near for Theranos & Elizabeth Holmes
From - G2 Compliance Advisor
Four years ago, Theranos was a $10 billion company poised to turn a breakthrough blood testing technology into a diagnostics dynamo to the tune of…
Top of the News: ANDE Rapid DNA Platform First to Win FBI Approval
From - Laboratory Industry Report
"Great news! The FBI just called."
–Extremely rare phrase almost never uttered except sarcastically…
Report Finds Genetic Tests and Their Reimbursement Increasingly Complex
From - Diagnostic Testing & Emerging Technologies
The health care technology company Concert Genetics (formerly NextGxDx; Nashville, Tenn.) recently released its third edition of…
How PAMA’s Effect in 2018 Molecular Diagnostic Reimbursement Will Make Labs More Money
By Sean McSweeney bio
The year 2018 is slated to be much brighter for molecular diagnostic labs as PAMA fee schedules show a higher payment rate and amount for many cancer genomics and…
Enforcement Trends: OIG Report Suggests that Urine Drug Testing Is Making Labs a Juicy Target Once Again
From - National Intelligence Report
The Office of Inspector General just published its Semiannual Report to Congress (covering Oct. 1, 2017 through March 31, 2018). Here are the key things labs and lab managers need to…