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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.
For Health IT
Every new clinical tool lands on your build backlog and your security review — and CMS-0057-F adds four FHIR APIs due by January 1, 2027. You need the capability without another 6–12 month Epic project or a new PHI-risk surface.
Your scorecard
The KPIs your board and leadership team track — where imaging leakage shows up first.
The problem
Benchmark-backed pain points tied to the metrics you own.
6–12 mo typical
Net-new clinical tools usually mean a 6–12 month Epic project competing with your backlog.
PHI movement, BAAs, and access reviews gate every vendor before go-live.
4 APIs by 2027
CMS-0057-F requires four FHIR APIs — Patient Access, Provider Access, Payer-to-Payer, and Prior Authorization — by 2027.
The fix
Each lever maps to a pain above — same order, same grid, so the pairing is obvious.
CDS Hooks 2.0 is a native Epic-supported standard; ARKA is enabled by configuration in ~2–4 weeks, not a development project.
FHIR R4 throughout, an Epic App Orchard path, and a live discovery endpoint at /.well-known/cds-services.
HIPAA privacy and security program in force, SOC 2 Type I/II in progress, HITRUST e1 on the roadmap, encryption everywhere, immutable audit trails, and a 27-document compliance package available for hospital security review. Yes — ARKA processes structured FHIR in-context at order entry via CDS Hooks as your Business Associate. PHI is transient in the request path only; identifiers are hashed before persistence, and there is no bulk PHI export from the EHR. Federated analytics returns encrypted aggregate query results — never row-level patient records.
The numbers
Modeled or published figures — labeled with their basis.
2–4 wks
to integrate (vs 6–12 mo)
CDS Hooks configuration
0
row-level records in federated queries
federated analytics
<800ms
non-blocking response
engine SLA
Evidence
What we bring to the conversation — sourced from the ARKA buyer playbook.
Pushback
The concerns we hear most — and how we address them.
CDS Hooks requires no Epic build — it is configuration, not development, so it doesn't compete with your build queue.
HIPAA privacy and security program in force, SOC 2 Type I/II in progress, HITRUST e1 on the roadmap, encryption everywhere, immutable audit trails, and a 27-document compliance package available for hospital security review. Yes — ARKA processes structured FHIR in-context at order entry via CDS Hooks as your Business Associate. PHI is transient in the request path only; identifiers are hashed before persistence, and there is no bulk PHI export from the EHR. Federated analytics returns encrypted aggregate query results — never row-level patient records.
Live today — hit the public discovery endpoint at /.well-known/cds-services and run the sandbox.
Your agenda
Three questions to put on the table — we'll answer with your data, not generic slides.
Question 1: How long is your current Epic build backlog?
Question 2: What is your CMS-0057-F API plan and who owns it?
Question 3: What's your bar for SOC 2 / BAA before a sandbox?
Explore
Jump into the modules most relevant to your seat.
Technical session with a sandbox demo + an integration architecture one-pager.
Quick answers
No — it's CDS Hooks configuration; typical go-live is 2–4 weeks.
SOC 2 Type II + HIPAA BAA are available; see /security.
Technical session with a sandbox demo + an integration architecture one-pager.
