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Articles and Reports
LDT Oversight Remains Under CLIA, for Now
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
FDA Watch: DOGE Changes at FDA Upend Approval Processes, Observers Say
Pre-submission and Q-Submission meetings apparently have been halted, for now
Compliance Perspectives: Complying with HIPAA Isn’t Enough to Manage Data Breach Liability Risks
From - Lab Compliance Advisor
Memo to lab managers and compliance officers: It may be time to rethink your data breach response strategy. This directive is…
Focus On: State AGs Break New Ground by Teaming Up to Enforce HIPAA
From - National Intelligence Report
Lab managers and compliance officers take note: For the first time ever, state attorneys general (AGs) have banded together to go after a health care provider for…
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OIG Monthly Work Plan Review: July 2019
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Developing Story: Doubt Grows as Obamacare Court War Enters Round 2
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Compliance Perspectives: Feds Using Medicare Laws to Prosecute Non-Medicare Arrangements
From - Lab Compliance Advisor
Myth: Risk of federal prosecution for health fraud and abuse applies only when you deal with…
State Law Round-up: New Privacy Breach Notification Laws Potentially Affecting Labs
From - Lab Compliance Advisor
As illustrated by the recent MIE settlement (click here for the story), security breaches involving patients' electronic protected health information…