Fighting the FDA’s Final Rule on LDTs
CEO Laurie Menser discusses the Association for Molecular Pathology’s court case against the FDA’s rule on laboratory-developed tests.
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Articles and Reports
Cybersecurity: What Your Lab Needs to Know
Recent government efforts to address increased cyberattacks in the healthcare space, and how your lab could benefit
In (Digital) Defense of HIPAA
How clinical laboratories and pathology groups can ensure that their digital pathology and AI workflows are HIPAA-compliant
AI in Healthcare: What Do Recent Developments Mean for Labs?
Genialis CEO and co-founder Rafael Rosengarten, PhD, discusses key 2023 AI developments and what they could mean for laboratories.
Eleven Things Labs Must Know to Comply with PAMA
An overview of PAMA and key aspects lab compliance officers should be aware of to help ensure compliance.
HHS Moves to Eliminate Controversial “SUNSET” Rule
On Oct. 28, the US Department of Health and Human Services served notice that it plans to repeal a controversial Trump rule.
EKRA: More than a Year Out, Major Questions Remain Unresolved
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From DAIA to the VALID ACT: The Latest Chapter in FDA Diagnostic Test Oversight Reform
From - Lab Compliance Advisor
While FDA oversight over new diagnostic tests is perfectly acceptable, what is objectionable is the…
Government Shutdown: The Impact on the Agencies that Regulate Labs
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New Broad All-Payor Kickback Law Impacting Laboratories, Commission-based Compensation and more
Case of the Month: Texas Court Strikes Down Obamacare—So, Now What?!
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Case of the Month: ACA Constitutionality Is Back in Play & This Time It May Get Taken Down
From - G2 Compliance Advisor
After a series of court setbacks, Republicans challenging the constitutionality of Obamacare, aka, the Affordable Care Act (ACA) are back at it…
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…
