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
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…
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…