Comment from Kara White
AnonymousSupportIndividual
Summary: An individual is requesting that the FDA regulate NarxCare as Software as a Medical Device (SaMD). The commenter argues that these tools significantly impact patient care and safety, citing personal experiences where data from such tools led to insurance denials and restricted access to medical treatment.
Please regulate NarxCare as Software as a Medical Device. It must be properly reviewed and regulated by the FDA. These tools directly impact patient care and must meet standards for safety, transparency, and accountability. I have experienced several ways in which improper data or opinions have negatively impacted my health and wellbeing. I have been denied life insurance due to these scores. I have been denied as a new patient by multiple doctors when my PCP retired. I have been denied access to appropriate pain relief for a genetic incurable disease. These are just a few instances that i aware of. The secret nature of these tools means that there may be other impacts that i do know of. These impacts are to important to leave to the hope that all parties will act with integrity. We must regulate these as Software as a medical device.