Heed AKS and EKRA to Properly Market Clinical Lab Services
Read this overview of legislation and regulations governing laboratory marketing practices and learn tips to ensure these activities remain compliant
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Articles and Reports
LDT Appeal: Looking at the Legal Nuances Behind Potential FDA Actions Following Court Decision
Marginal LDT scenarios could be where the FDA focuses on next, a lawyer notes
LDT Oversight Remains Under CLIA, for Now
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
From - National Intelligence Report
Case: Next Health is in a legal fight for its life. Earlier this year, the feds indicted two officials of the Dallas lab company for accepting $190,000 in bribes in exchange for…
New Fraud Takedown Shows that Coordinated Enforcement Remains Alive & Well under Trump
From - National Intelligence Report
Last year at this time, the Justice Department announced the results of a nationwide takedown involving "the most defendants charged and largest alleged loss amount in…
Compliance Scorecard: Significant New HIPAA Fines
From - National Intelligence Report
Health data and information security figured prominently in May enforcement activity. In addition to the blockbuster eClinicalWorks EHR software settlement discussed on page 3, there was an unusually high volume of…
Notorious File: Feds Take Down Three More Doctors in BLS Lab Bribery Scheme
From - National Intelligence Report
The Biodiagnostic Laboratory Service (BLS) case continues to be the poster child for the evils of fraud and greed in the health care industry…
Electronic Health Records: The eClinicalWorks False Claims Settlement—Big Fines & Unprecedented CIA Obligations
From - National Intelligence Report
False Claims Act actions targeting health care vendors have become more common. eClinicalWorks (ECW), one country's biggest…
