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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.
ARKA-CLIN — Standalone Clinical Decision Support (Web App View)
ARKA-CLIN provides real-time, point-of-order appropriateness scoring (under 800 ms) for imaging orders. Enter a clinical scenario or choose a demo case to receive an evidence-based appropriateness score (1–9), transparent factor breakdown (SHAP-style), alternatives, and links to peer-reviewed evidence.
Ordering physicians, radiologists, and healthcare organizations who want to align imaging orders with established appropriateness standards (RAND/UCLA method, peer-reviewed society guidance) and reduce unnecessary imaging while supporting appropriate studies.
ARKA-CLIN is the core CDS module in the ARKA suite. It feeds into ARKA-ED (imaging appropriateness training) and ARKA-INS (prior auth and payer alignment). Together they support ordering, workflow, and reimbursement with one evidence base.
ARKA-CLIN can be used two ways. (1) As the standalone web app you are using right now. (2) Embedded in the ordering workflow via CDS Hooks and SMART on FHIR — designed for Epic, Oracle Health (Cerner), and athenahealth after customer-specific validation, with no workflow change for the clinician. To see ARKA running in a simulated Epic-class chart, open the CDS Hooks Live Demo.
CDS Hooks Live DemoARKA (Imaging Intelligence Engine) helps healthcare providers decide when imaging is appropriate. You enter a clinical scenario; ARKA applies evidence-based rules and returns a score with a clear explanation. Below is the high-level flow and the FDA Non-Device CDS criteria ARKA satisfies.
Clinical scenario (complaint, duration, red flags, proposed imaging) is entered by the provider or pulled from the EHR.
AIIE applies weighted clinical factors from peer-reviewed literature to compute an appropriateness score (1-9) and explanation, and runs Duplicate & Redundant Advanced-Imaging Prevention over the episode bundle.
You see a score, category (Usually Appropriate / May Be Appropriate / Usually Not Appropriate), and factor-level explanation.
Clinical scenario and proposed imaging are the inputs; no hidden data drives the recommendation.
Recommendations are based on medical information (evidence, guidelines, clinical factors) you provide.
Output is intended to support, not replace, healthcare professional decision-making.
Users can independently verify the basis (literature, factor weights, explanation) for each recommendation.
AIIE uses a proprietary scoring methodology based on RAND/UCLA appropriateness methods and peer-reviewed literature. Every recommendation shows exactly WHY it was made.
Every evaluation starts at 5.0 (neutral). This represents "we don't know yet" — neither appropriate nor inappropriate until we assess the clinical factors.
Each clinical factor (red flags, duration, age, prior workup) has an evidence-based weight derived from peer-reviewed literature. Factors either increase (+) or decrease (-) the appropriateness score. Example: Cancer history → +3.0 points (Deyo & Diehl, JAMA 1988)
All factor contributions sum to produce a final score, capped between 1 and 9. 7-9: Usually Appropriate (green). 4-6: May Be Appropriate (yellow). 1-3: Usually Not Appropriate (red).
Unlike black-box systems, AIIE shows exactly which factors contributed to the score and by how much. This satisfies FDA Non-Device CDS Criterion 4 (independent review).
