ARKA· Compliance

CMS-0057-F compliance matrix

Requirement-by-requirement mapping of ARKA capabilities. Status reflects our posture as of July 24, 2026 — not a certification claim.

Implemented (sandbox)IG-conformant in ARKA sandbox — production activation is a pilot task.
In progressOn the roadmap or partially implemented — not certified.
N/A for our scopeOutside ARKA-INS initial release scope.

Generated on July 24, 2026. ARKA is Non-Device CDS for clinical scoring; ARKA-INS provides administrative-support functions under §520(o)(1)(A). This matrix requests diligence review — it is not FDA approval, SOC 2 attestation, or CMS certification.

This recommendation is intended to support, not replace, clinical judgment. It is generated by ARKA, software designed to meet the four criteria for Non-Device Clinical Decision Support under FD&C Act §520(o)(1)(E) and FDA's final guidance on Clinical Decision Support Software (January 2026). The clinician is responsible for the final decision.

Internal review pending — confirm each status row before distributing this PDF.