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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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”
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
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
Connecticut Hospital Settles Self-Disclosed Stark Violations for $423K
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The Dx Pipeline: A Roundup of the Month’s Key New Product Launches
From - Laboratory Industry Report
Here's a rundown of the key diagnostic product launches from mid-May through the third week of June…
Early Lactate Tests Impactful, But Often Not Performed With Sepsis
From - Diagnostic Testing & Emerging Technologies
Early lactate measurements appear to improve results for patients with sepsis, but initial and repeat serum lactate levels are frequently not drawn in the recommended…
CMS Mulls Stark Law Relief: This Time It May Be for Real
From - National Intelligence Report
After decades of complaining about the Stark Law, the lab industry may now have an actual opportunity to secure meaningful relief…
Case of the Month: Patients Can’t Sue Labs for Privacy Breaches, Federal Court Confirms
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Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
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Enforcement Trends: New Fraud Takedown Focuses on Opioid Drugs & Sophisticated Financial Schemes
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Criminal Charges May Spell the End for Theranos
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Cancer Center Hit with $4.3 Million HIPAA Fine for Failure to Encrypt
From - National Intelligence Report
Case: The University of Texas MD Anderson Cancer Center was on the wrong end of the fourth largest HIPAA fine ever dished out by the HHS Office for…
Diagnostic Deals: A Roundup of the Key Mergers, Acquisitions, Alliances, Licenses and Other Strategic Transactions From the Past Month
From - Laboratory Industry Report
Mid-May to mid-June was the busiest period of the year for diagnostic deal making in terms of both volume and magnitude. Here is…
