Citizen Petition from The Doctor Patient Forum

The commenter is requesting that the FDA classify NarxCare as Software as a Medical Device (SaMD) to ensure it is regulated and transparent. They argue that the current lack of oversight affects real medical care and that patients and doctors lack visibility into how the scores are generated.

A psychiatry resident argues that automated risk stratification tools for controlled substances currently lack sufficient oversight and evidence of efficacy. They support the petition's call for a formal FDA review process to ensure these tools meet safety and quality standards before continued clinical use.

An individual with a chronic spinal cord injury advocates for the FDA to regulate NarxCare as Software as a Medical Device. The commenter argues that these tools should be held to safety and accountability standards to ensure patients can access necessary medications like opioids to improve their quality of life.

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.

A patient representative argues that the current use of the Narxscore algorithm is unethical because it lacks transparency and oversight for patients. They support the action of monitoring Narxscore as a medical software device and demanding that patients have access to their scores and the ability to correct inaccuracies.

A private individual argues that the Narxcare scoring application by Bamboo Health is flawed, lacks transparency, and is being used to unfairly deny necessary medications. The commenter calls for the FDA to review these software tools to ensure public safety and accountability.