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Brown Brandy

CliniciansClinicianFiled October 16, 2026285 wordsFDA-2026-N-7874-0281
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Themes it raises

2 of the 21 themes in the docket, each with the passage we counted, verbatim.
Who is accountable when something goes wrongFDA Q21
“Nurses need to be protected from an AI tool that does an incorrect assessment. Nurses should not have to sign off on a task they didn't perform.”
Whether human oversight is real oversightFDA Q3, Q4, Q14, Q20, Q21, Q26
“I am not comfortable with having AI write notes, and then a facility expecting me to sign off like I wrote it.”
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.

Please reconsider using AI Enabled Medical Devices in Nursing. I am not comfortable with having AI write notes, and then a facility expecting me to sign off like I wrote it. Regulations need put in place now. It raises some real ethical considerations as to what healthcare systems plan to use AI for. If you are using AI to double check work, for instance if a Radiologist reads a film, and AI double checks it, I think that can be useful, but I don’t think it should take the place of a doctor that went to school for 8 years, followed by a Residency. What if AI isn’t right when it reads it. Who is going to catch the error? If you move in this direction you start replacing people with computers but no one is monitoring the computers/AI to ensure quality. How is AI going to stand up in court with lawsuits against a healthcare system when something gets missed. Nurses need to be protected from an AI tool that does an incorrect assessment. Nurses should not have to sign off on a task they didn’t perform. Research should be done by NIH, CDC, and Health and Human Services for non-biased Research before any of these tools are put in place. Companies want to profit from offering these AI tools because it’s the next hot topic, but at what cost when AI is wrong. Please protect patients, staff working with patients, protect the people at the bedside instead of pushing untested, biased tools that could create real problems for the future of healthcare. Please, for once choose people over profits. Those of us working at the bedside actually care about the patients. Thank you.