Kennedy Brittany

CliniciansClinicianFiled October 16, 2026151 wordsFDA-2026-N-7874-0254

Themes it raises

2 of the 21 themes in the docket, each with the passage we counted, verbatim.

Whether human oversight is real oversightFDA Q3, Q4, Q14, Q20, Q21, Q26

“Will it be used blindly and just trusting that it makes no errors? Or will nurses be tasked with reviewing what AI determines and "error checking" its documentation in a field that is already overworked, understaffed, and underpaid.”

Privacy and protection of patient dataNot asked by the FDA

“Next, how are we going to protect patient PHI? When there are multiple leaks and data breeches happening more often than not, how are we protecting that private information?”

Machine-assisted draft, pending human review. The source text and highlighted passages appear below. Read the filing on regulations.gov ↗

The comment as filed

Comment submitted on regulations.gov. Passages we counted are highlighted.

How will AI be used and where is the line drawn? Will it be used blindly and just trusting that it makes no errors? Or will nurses be tasked with reviewing what AI determines and “error checking” its documentation in a field that is already overworked, understaffed, and underpaid. If it’s just in the nature that we (health care professionals) do our own assessments that we chart and AI is used to trigger say a “fall risk” plan of care for a patient who we documented scored high on the Morse fall risk scale, then that’s not so terrible. But it should only be based on factual documentation that has been verified in person by our own eyes and charted in person. Next, how are we going to protect patient PHI? When there are multiple leaks and data breeches happening more often than not, how are we protecting that private information?

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