Comment from Emmie O'Neil

AnonymousSupportAdvocacy
Summary: The Doctor Patient Forum is advocating for the FDA to regulate NarxCare as Software as a Medical Device (SaMD). They argue that the current lack of regulation allows for biased algorithms that negatively impact patient care, lead to wrongful law enforcement actions, and lack necessary transparency and accountability.
Please regulate NarxCare as Software as a Medical Device so it can be properly reviewed and regulated by the FDA- as it should be. These tools directly impact patient care and clinical decision-making; and must meet standards for safety, transparency, and accountability. The algorithms have been programmed with a strong bias that does not consider clinical findings. Law enforcement is relying on the metrics that are calculated and have turned practicing medicine into a potentially criminal activity. This is dangerous for both patients and their providers-especially when the algorithmic conclusion does not match reality. We are seeing AI wrongfully identify individuals via facial recognition, oftentimes giving the [law enforcement] user a 100% match-and individuals are being taken to jail on cases of mistaken identity. In all the years since these programs have been implemented, nobody has been willing to address the problems with them. It's beyond time. Please do the right thing and allow for individualized care that does not criminalize treatment. Additionally, patients should be able to see their reports (just like a credit score) and have a way to correct incorrect information. Thank you for your consideration.

View on Regulations.gov