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
- 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
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…
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…
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…