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Rebecca Love

CliniciansClinicianFiled October 13, 2026219 wordsFDA-2026-N-7874-0194
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Themes it raises

1 of the 21 themes in the docket, each with the passage we counted, verbatim.
How this fits rules that already existFDA Q8, Q9, Q16, Q25
“many AI bots are doing triage which is outside the scope of practice without FDA clearance and oversight”

FDA questions it names

Questions this filing names by number.

Q2 · The spectrum of device activityQ3 · When an output becomes directiveQ6 · Care escalation functionsQ17 · Devices with many functions

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.

Re: FDA-2026-N-7874 — Considerations for the Regulation of Generative AI-Enabled Medical Devices: Discussion Paper and Request for Feedback

I am an RN, MSN with 21 years of experience working at the bedside on a medical-surgical unit. I am submitting this comment in response to the request for feedback above.

My comments come from direct experience with these AI tools: ambient AI scribes; early-warning alerts such as sepsis alerts; patient chatbots or AI-drafted portal replies; AI triage tools; AI-written patient education.

Regarding Question 2 (When does information become an instruction): In my work, I have seen education is the best for AI to better help patients inform their decisions.

Regarding Question 3 (Are AI tools that talk to patients riskier): I think this is helpful at times, but knowing when there is providing education - vs diagnosing is where things need to go to a human.

Regarding Question 6 (Missed escalations and false alarms): In my work, I have seen not seen it at the bedside but via ambulatory call centers - many AI bots are doing triage which is outside the scope of practice without FDA clearance and oversight.

Regarding Question 17 (AI that listens, sees, or records): In my work, I have seen AI scribes about 70% accurate - mostly because they fail on transcription accuracy.

Thank you for considering these comments.

Sincerely,
Rebecca Love, RN, MSN

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