Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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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
Donor-Derived, Cell-Free DNA May Predict Lung Transplant Rejection
From - Diagnostic Testing & Emerging Technologies
Elevated donor-derived, cell-free DNA (ddcfDNA) in the 3 months post-lung transplant can identify clinically silent allograft injury and…
The Dx Pipeline: A Roundup of the Month’s Key New Product Launches
From - Laboratory Industry Report
After a slow January, new product development picked up steam in February. Here's a rundown of the key new launches…
DX Earnings Report: Lab Companies Finish 2018 Strong but Growth Slows for Established Firms
From - Laboratory Industry Report
The diagnostics industry capped a robust 2018 with most companies posting strong fourth quarter results. Of course…
Enforcement Trends: Record Breaking Year for HIPAA Fines
From - National Intelligence Report
The federal Office for Civil Rights (OCR) reports that 2018 was a record year for HIPAA enforcement, with 10 settlements and one judgment bringing in…
Enforcement Trends: New DOJ Policy Targeting Whistleblowers with Weak Cases May Make Life Easier for Labs
From - Lab Compliance Advisor
It's not just new laws, regulations or even court cases. Trends in health care fraud enforcement are sometimes driven by changes in prosecution policies, including…
Blood Markers Alone Okay For Surveillance With Some Pediatric Cancers
From - Diagnostic Testing & Emerging Technologies
Tumor markers alone may be adequate to monitor for relapse among children and teens with malignant germ cell tumors (MGCTs), according to a study published…