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Charles Dunham IV
For AI Regulation, Look to Data Laws, FDA Action
CEO SUMMARY: AI is creating legal uncertainty for clinical labs, especially around data privacy and FDA oversight of AI tools in diagnostics. Few court cases exist yet that interpret AI use within clinical settings, but labs must watch how HIPAA and state laws wield influence. Vendor soft…
New OIG Advisory Opinion Dubious of ‘Fair Market’
CEO SUMMARY: There is a new advisory opinion from the Office of the Inspector General (OIG). It reviewed a proposal in which a clinical lab network would pay fair market value to hospitals for specimen collection based on volume of patients tested. The OIG said this arrangement woul…
Judge Vacates Provision in No Surprises Act
CEO SUMMARY: It …
CURRENT ISSUE
Volume XXXII, No. 15 – October 27, 2025
The Dark Report examines the momentous decision by the VA to switch accreditors from The Joint Commission to CAP. Also, we analyze retractions in pathology journals to gain insight into scientific fraud.
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