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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Lab Industry Advisor Subscriptions Include
Analysis and insight on key compliance, legal, and business developments affecting laboratories
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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
Orgs Plan for Personalized Medicine Growth over Next Few Years
From - Diagnostic Testing & Emerging Technologies
Health care experts predict growth and maturation happening in the field of personalized medicine in the next two…
New OIG Advisory Opinion Addresses GPO That Includes Labs
From - National Intelligence Report
Group purchasing organizations (GPOs) are entities that act as a purchaser of supplies and equipment for a number of other entities—usually health care providers like…
Theranos Continues With Corporate Revamp
From - Laboratory Industry Report
Theranos continues to remake itself, shedding its longtime president and expanding its board of directors…
Tread Carefully When Disciplining Employees Who Have Blown the Whistle
From - G2 Compliance Advisor
The False Claims Act (FCA) has become the federal government's primary weapon in combating fraud and abuse. However, most FCA cases are initiated not by the government but…
House Appropriations Bill Seeks to Halt FDA Regulation of LDTs
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CMS Unveils Proposed Rule Implementing MACRA and Replacing Meaningful Use
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OIG Issues Advisory Opinion for Group Purchasing Organization That Includes Labs
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Drug Testing Enforcement Cases Lead to Costly Settlements and Convictions
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First Commercial Lab Gets FDA Emergency Clearance for Zika Test
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Focus Diagnostics Simplexa Test Kit Faces Recall
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