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Best practices and expert insight to help lab professionals comply with regulations and identify strategic trends in business and technology
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Keeps you up to date on the latest legal, compliance, and business developments affecting the lab industry, while offering analysis and insight to ensure your lab’s success.
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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
Brief Your CEO: New Penalties Double the Dollar Value of Protecting Your Lab from Liability
From - G2 Compliance Advisor
You may not realize this, but Congress has just doubled the dollar value of what you do as a compliance manager to keep your…
Case of the Month: $33.2 Million Alere Settlement Sends Warning Shot Across Bow of LDT & DX Device Makers
From - National Intelligence Report
One of the reasons Abbott Laboratories got cold feet about consummating the $5.3 billion Alere acquisition was concern over the legal proceedings against the…
FDA Watch: 23andMe Continues to Spearhead Direct-to-Consumer Marketing of LDT Genetic Tests
From - Laboratory Industry Report
On March 6, the FDA announced its first ever approval of a direct-to-consumer breast cancer gene test…
SIDs Results From Genetic Heart Disease Less Than Previously Thought
From - Diagnostic Testing & Emerging Technologies
The vast majority of sudden infant death syndrome (SIDS) cases are not the result of genetic heart diseases (GHDs) or a single genetic cause…
Researchers Develop First Multiplex Test for Tick-Borne Disease Detection
From - Diagnostic Testing & Emerging Technologies
Researchers have developed the first multiplex array for diagnosis of tickborne diseases, according to a study published online…
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
From - G2 Compliance Advisor
Case: A physician coding supervisor for a North Carolina health system that used billing software from Epic filed a qui tam lawsuit against the firm claiming that the…
By the Numbers: Spike in M.D. Practice Acquisitions Drives Up Costs of Hospital Care
From - Laboratory Industry Report
Hospitals are gobbling up M.D. practices at a record rate. In addition to endangering the independent physician practice, this trend is driving up the costs of…
Diagnostic danger in the lab: Time to reform how we process orders
Recent report examining 10,000 claims to understand the key drivers of medical malpractice suits found 52 percent involved lab-related errors.