ADLM Calls on Feds to Regulate AI in the Clinical Lab Sector
But anti-regulatory stance taken by Trump administration could serve as a potential obstacle in the effort
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Articles and Reports
Dx Deals: Labcorp Buys Select Assets of Empire City Laboratories
The national lab giant swiftly merged Empire City’s operations into its own
Recent MD Labs Ruling Has Implications for Test Requisitions and Commissions
A federal appeals court upheld the idea that clinical laboratories can rely on physician orders to justify medical necessity
OIG Work Plan Monthly Review: December 2017
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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…
Enforcement Trends: 5 Takeaways from OIG’s New Semiannual Report
From - National Intelligence Report
Veteran OIG semiannual report aficionados will find little in the most recent edition to distinguish it markedly from its predecessors. But while a new…
Medicare Reimbursement: CMS Finalizes Controversial PAMA Fee Schedule
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FDA Watch: Agency to Allow DTC Marketing of Genetic Tests without Premarket Approval
From - National Intelligence Report
The FDA's longstanding policy of restricting direct-to-consumer (DTC) marketing of products without formal premarket approval is well known. But while it always applied to…
CMS Ignored Congressional Intent in Implementing New Clinical Lab Payment System Under PAMA, ACLA Charges in Suit
From - G2 Compliance Advisor
The government agency that runs the Medicare program failed to follow a congressional directive to implement a market-based laboratory payment system…
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
From - Laboratory Industry Report
Case: A California cardio clinic and its physician owners will pay $1.2 million to settle charges of falsely billing Medicare and Medicaid for…