Comment from Chris Pratt

Formal Legal Objection and Petition for Immediate Reclassification of NarxCare (Bamboo Health) To: FDA Dockets Management Staff; HHS Office for Civil Rights (OCR) Subject: Formal Challenge to Unregulated "Risk Scoring" Algorithms as Misbranded Medical Devices under 2026 FDA Guidance and Section 1557 of the ACA. I. Violation of the January 6, 2026, FDA Clinical Decision Support (CDS) Final Guidance The FDA’s updated January 6, 2026, Guidance clarifies that software is a regulated medical device if it "interprets signals or images, issues time-critical directives, or obscures its logic." NarxCare fails the statutory exemption criteria under Section 520(o)(1)(E) of the FDCA for the following reasons: The "Black Box" Logic Deficit: Contrary to Criterion 4 of the 2026 Guidance, NarxCare’s proprietary "logistic regression" model is not transparent. Clinicians cannot "independently review the basis" for a 3-digit score, effectively forcing them to rely on an unvalidated, "black box" output rather than their own clinical judgment. Time-Critical Directives: While labeled "advisory," NarxCare functions as a de facto command in high-pressure pharmacy and clinical workflows. The 2026 Guidance reaffirms that software providing specific directives—particularly those that trigger immediate denial of care—remains subject to FDA oversight. II. Violation of ACA Section 1557 Algorithmic Nondiscrimination Rules (May 2025) As of May 1, 2025, Section 1557 of the ACA prohibits federally-funded health programs from using patient care decision support tools that discriminate based on disability. Disability Discrimination: NarxCare’s algorithm uses proxies (e.g., number of pharmacies or distance traveled) that disproportionately penalize patients with complex, incurable illnesses who must see multiple specialists. Failure of Due Diligence: Covered entities are now legally required to identify and mitigate bias in these tools. Because NarxCare remains a proprietary secret, it prevents clinicians from fulfilling their federal duty to ensure the algorithm is not harming a protected class. III. Violation of Constitutional Due Process and Judicial Precedent Ruan v. United States (2022): This unanimous 9-0 ruling protects a physician’s "good faith" medical judgment. By weaponizing an opaque "risk score" to trigger pharmacy blocks or investigations, NarxCare subjects clinicians to algorithmic coercion, criminalizing legitimate medical care through automation bias. CDC Admission of Harm (2022): The CDC formally admitted its 2016 metrics caused "serious harm." NarxCare continues to utilize these discredited metrics, essentially automating a standard of care that the federal government has disavowed. IV. Conclusion and Formal Demands We demand that the FDA and HHS OCR: Enforce SaMD Classification: Immediately classify NarxCare as Software as a Medical Device (SaMD), subject to premarket review and safety validation. Mandate Full Transparency: Require Bamboo Health to disclose the full weighting of all variables to patients and physicians to comply with HHS algorithm transparency rules. Issue a Recall/Stay: Order a stay on the use of "Overdose Risk Scores" (ORS) until they are independently audited for Section 1557 compliance.