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
The Dx Pipeline: A Roundup of the Month’s Key New Product Launches
From - Laboratory Industry Report
How about an Alexa for verbally querying genetic data? The Amazon Alexa-compatible "digital genetic assistant" from OptraGuru was among…
CMS to OIG: Get Back the $66.3 Million You Improperly Paid to Labs for Urine Validity Tests
From - G2 Compliance Advisor
As if times were not already tense enough for labs that bill Medicare for urine drug tests, the OIG ratcheted up the pressure another notch on…
Diagnostic Deals: A Roundup of the Key Mergers, Acquisitions, Alliances, Licenses and Other Strategic Transactions From the Past Month
From - Laboratory Industry Report
Based on the early returns, the market analysts that predicted 2018 would see a slowdown in strategic Dx deal making appear to be right. But while…
Evidence for Liquid Biopsy Lacking, Expert Panel Finds
From - Diagnostic Testing & Emerging Technologies
There is not enough evidence, currently, to support the routine adoption of liquid biopsy tests for any of its promising clinical uses, according to a joint review published…
You Make the Call: Do Cost-Savings Payments to Referring Physician Violate Kickback Laws?
From - G2 Compliance Advisor
SITUATION
XYZ Consultants recommends that a hospital client cut costs by making 34 changes to its OR spinal fusion surgeries procedures…
FDA Watch: Agency Approves DTC Genetic Breast Cancer Test—But Attaches Strings
From - National Intelligence Report
On March 6, the FDA announced its first ever approval of a direct-to-consumer breast cancer gene test…