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Open access
Sep 2026
This manuscript defines AI-as-intervention as AI whose output is itself part of the assigned clinical intervention being evaluated for its effect on participant care or outcomes, and AI-for-trial-operations as AI used to support trial design, conduct, or analysis without itself constituting the treatment under study.
A. Armoundas, C. Tarabanis, J. Loscalzo
· EClinicalMedicine · 0 citations
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Open access
Sep 2026
How the new US AI framework may accelerate adoption while leaving clinically consequential tools outside traditional regulatory pathways is examined.
A. Armoundas
· Communications Medicine · 0 citations
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Review
Open access
Aug 2026
A pragmatic adoption approach is emphasized to prioritize high-volume, lower-risk clerical and communication workflows; maintain clinician verification and accountability; and apply governance and equity safeguards before scale-up before scale-up.
Michael Christof, Krish Patel, Jian-Dong Zhou et al.
· Communications Medicine · 0 citations
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