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
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…
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…
OIG Semiannual Report: Opioid Crackdown Is Making Labs a Prime Enforcement Target Once Again
From - G2 Compliance Advisor
Once the favorite whipping boy of federal enforcers, labs have been demanding less and less of the OIG's attention in recent years. But the newly published…
Lack of Utility Evidence Still Hampers Adoption of Pharmacogenomic Testing: Benefits Seen in the Field of Psychiatry
From - Diagnostic Testing & Emerging Technologies
For years it had been hoped that pharmacogenetic (PGx) testing would be a leading application for personalized medicine…
How to Adjust to the April 2018 Medicare Beneficiary Cards
By Sean McSweeney bio
In a press release on May 30, 2017, the Centers for Medicare & Medicaid Services (CMS) commented regarding their fraud prevention initiative program and their planned changes regarding…