Texas APP Consulting Services (Nina Nwoko)
Themes it raises
The comment as filed
The discussion of generalist versus specialist clinicians should explicitly include registered nurses and nurse practitioners, who are often the first and most frequent users of AI outputs in hospitals, yet are rarely represented in validation studies.
Nurses act on AI-generated summaries, early-warning scores and documentation tools around the clock, frequently without a physician present. If a device is validated only with physician users, its real-world performance with the clinicians who actually use it most is unknown.
I recommend that premarket evaluation require: (1) testing with the intended user population as it exists in practice, including RNs and NPs where they will use the device; (2) reporting of human-AI team performance, not just autonomous model performance; and (3) specific assessment of automation bias under realistic workload, such as a nurse carrying a full assignment at 3 a.m., not a rested clinician in a controlled study.
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