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ARKA Clinical Decision Support is designed to meet all four criteria for Non-Device CDS under FD&C Act §520(o)(1)(E) and FDA's January 2026 final guidance on Clinical Decision Support Software. Recommendations support, not replace, the clinician's judgment. Every recommendation is anchored in a published guideline or peer-reviewed source, with the basis available for independent review. CLIN emphasizes imaging appropriateness at order entry.
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.
AIIE Evidence
Do not order screening chest CT for patients outside USPSTF eligibility — harms outweigh benefits in low-risk groups.
Low-dose CT screening outside USPSTF eligibility (never/light smokers, age outside 50–80, quit >15 years) has an unfavorable benefit–harm balance: false positives, incidental findings, and radiation accrue without the mortality benefit demonstrated in trial populations.
The AIIE synthesis above is ARKA-authored; the sources below are the underlying external literature.
U.S. Preventive Services Task Force · 2021
New England Journal of Medicine · 2011doi:10.1056/NEJMoa1102873
