Judith Strunk
Themes it raises
1 of the 21 themes in the docket, each with the passage we counted, verbatim.
Devices that plan and take actionsFDA Q26
“These tools should only be informational, not able to take actions without humans. It is ridiculous this is even being considered.”
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.
These tools should only be informational, not able to take actions without humans. It is ridiculous this is even being considered. They should be tested extensively just like any medical device. I have been a nurse for 48 years. I do not want these tools used on me or my family. What are the safeguards? Who is responsible when AI messes up? What happens when AI does its own thing? This is very scary and I for one do. It want it.