kiley deborah
Themes it raises
1 of the 21 themes in the docket, each with the passage we counted, verbatim.
Who is accountable when something goes wrongFDA Q21
“As clinicians we are expected to be 100% accurate, and are held accountable for decisions and actions. Who is accountable for errors by a LLM?”
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.
The rush to increase applications for AI is concerning. Reports of hallucination by the LLM, as well as errors in transcribing medication names or health history indicate the technology is not ready for deployment in patient care. As clinicians we are expected to be 100% accurate, and are held accountable for decisions and actions. Who is accountable for errors by a LLM? Who is responsible for reviewing ’decisions’ made? It is time to slow down, and consider all the implications of this technology, and stop treating it like a shiny new toy. Human lives are at stake- both patients and clinicians. There are uses for the technology, but they must be meticulously evaluated before implementation