Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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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
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”
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.