Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
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Latest Articles
LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
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
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
LDTs, FDA-Approved Companion Diagnostics Perform Similarly; Off-Label Use of Companion Diagnostic Kits Common
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FDA Warns About Biotin Interference With Lab Tests
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PAMA-Geddon: Lab Industry Takes CMS to Court
From - G2 Compliance Advisor
The nearly three-year struggle between HHS and the lab industry over PAMA has entered a new phase. On December 11, the American Clinical Laboratory Association (ACLA) filed…
New Lawsuit Tests Limits of Medical Malpractice in Age of Precision Medicine
From - National Intelligence Report
One patient claims it is and wants $1.8 million in damages because she never got it…
FDA Continues Easing DTC, Home Use Test Regulations
From - Diagnostic Testing & Emerging Technologies
In a continued reversal of its 2013 crackdown on direct-to-consumer (DTC) genetic tests, the U.S. Food and Drug Administration (FDA) unveiled…
Diagnostic Deals: A Roundup of the Key Mergers, Acquisitions, Alliances, Licenses and Other Strategic Transactions From the Past Month
From - Laboratory Industry Report
Good news for any of you who slept through December 2017: You didn't miss much—at least as far as blockbuster strategic deals in the clinical laboratory space are…
OIG Work Plan Monthly Review: December 2017
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Novel Tests Emerging For Overlooked Conditions
From - Diagnostic Testing & Emerging Technologies
Undeniably, much of the emerging test focus is on cancer and infectious diseases. DTET wants to showcase other novel tests entering the marketplace. What follows is…
The Dx Pipeline: A Roundup of the Month’s Key New Product Launches
From - G2 Compliance Advisor
While massive data breaches have existed as long as massive data itself, legal accountability for organizations that commit them is…
New Bill Would Make Lab Employees Criminally Liable for Concealing Data Breaches
From - G2 Compliance Advisor
While massive data breaches have existed as long as massive data itself, legal accountability for organizations that commit them is…