Compliance Native HIPAAFDA 21 CFR Part 11HITECHCMSHL7 FHIR R4GDPRSOC 2FDA MedWatch
Healthcare Execution Stack

Every prior auth delayed
is a patient waiting.

Prior AuthorizationClaimsClinical TrialsAE Reporting

Governed, auditable AI agents working directly inside Epic, Cerner, and payer portals — prior authorization same-day instead of 5 days, claims adjudicated with full ICD-10 validation, and adverse events filed within the 15-day FDA window. Physician review gates active at every clinical decision point.

65%PA processing time reduction
Same-dayPA vs 5-day average
100%HIPAA audit coverage
<90dContract to production
65%
PA cycle reduction
Same-day
PA vs 5-day average
100%
HIPAA audit coverage
Zero
PHI access without RBAC gate
<90d
Contract to production

The Shift

What changes when CAIBots
processes a prior authorization.

A specialty pharmacy PA request — before and after. Same payer criteria. Same clinical necessity standards. Different execution model. A patient waiting either way.

Before CAIBots
PA request — oncology patient, specialty biologics, payer criteria check required
Prior auth coordinator manually pulls patient record from Epic, verifies active coverage — 15 minutes
Retrieves payer-specific criteria, cross-references clinical necessity guidelines — 20 minutes
Identifies documentation gaps, contacts ordering physician's office for supporting records — 2–4 hours or next day
Submits PA to payer portal, waits for initial acknowledgment — 1–3 days processing
Payer returns decision; coordinator logs in Epic, notifies physician and patient — 1–2 days additional
⏱ Total: 3–5 business days — patient treatment delayed throughout
After CAIBots
Same PA. CAIBots executes the full review at the moment of submission.
Patient record retrieved from Epic via HL7 FHIR R4, active coverage verified against payer eligibility — automated
Payer-specific clinical criteria retrieved, necessity assessment scored against treatment protocol — automated
Documentation completeness checked, gaps identified and flagged with specific resolution guidance — automated
Standard cases auto-approved and submitted; complex cases routed to physician with complete brief — automated
Decision logged in Epic, patient notified via care portal, HIPAA audit record created — automated
✓ Total: Same-day for standard cases — physician reviews complex cases, not administrative steps
65%
PA cycle time reduction
Same-day
Decisions on clinically standard cases — vs 3–5 day average
100%
HIPAA-compliant PHI audit trail on every PA execution

Prior Authorization — Primary Execution Stack

Same-day decisions.
Physician gates never bypassed.

Prior authorization is where the largest clinical and financial impact exists for health systems and payers. CAIBots automates the full intake-to-decision cycle — coordinators handle complex cases requiring clinical judgment, not data gathering.

Prior Authorization AutomationHIPAA · CMS · HL7 FHIR

PA requests retrieved, eligibility verified against payer criteria, clinical necessity scored, and same-day decisions executed directly into Epic or Cerner and the payer portal. Mandatory physician review gate enforced on any case exceeding clinical complexity threshold.

Trigger
PA request submitted — oncology treatment requiring insurer approval
Cognition
Verify eligibility, score clinical necessity vs payer criteria, identify documentation gaps, classify auto-approve vs physician escalation
Execution
Epic EMR PA status updated · Payer Portal submission filed · Outlook physician briefed if escalation · Cerner care pathway updated
Output
65% faster PA cycleHIPAA nativePhysician gate active
Claims Processing & AdjudicationHIPAA · CMS · ICD-10

Claims received, ICD-10/CPT coding validated, payer adjudication rules applied, and payment routing executed — with automatic denial management and appeal brief generation including root cause analysis on any rejection.

Trigger
Claim submitted — inpatient procedure with complex coding
Cognition
Validate ICD-10/CPT codes, check payer contract rules, identify undercoding risk, assess clean claim probability
Execution
Claims System adjudication written · EHR billing record · Finance payment routed · Denial Mgmt appeal if rejected
Output
Cleaner claimsFaster adjudicationICD-10 compliant
Clinical Trial MatchingFDA 21 CFR · HL7 FHIR R4

New referrals matched against active trial criteria in real time — biomarker profiling, eligibility scoring, contraindication flagging, and pre-enrollment initiation executed into the EMR and trial management system. Physician sign-off gate enforced before any enrollment step.

Trigger
New oncology referral — specific biomarker profile requiring trial match
Cognition
Match biomarkers against active trial inventory, score eligibility, identify contraindications, rank candidate trials by fit score
Execution
Epic EMR match list added · Outlook oncologist briefed · Trial Mgmt pre-enrollment initiated · Cerner pathway updated
Output
Minutes to matchFDA 21 CFR compliantPhysician gate active
Adverse Event Detection & FilingFDA MedWatch · FAERS

Adverse event signals detected across EHR, lab, and medication records — classified for severity, assessed for FDA MedWatch reportability, and submitted with auto-generated case narratives within the 15-day regulatory window.

Trigger
Lab result flagged — unexpected safety signal in trial participant
Cognition
Classify event severity, assess MedWatch reportability, determine causality, generate case narrative with clinical context
Execution
FDA FAERS report filed · Safety DB case created · Outlook PI notified · Trial Mgmt safety record
Output
FDA MedWatch filed15-day deadline met100% audit trail

Live Demo Paths

Watch a PA approve same-day.
See a trial match in minutes.

Production-accurate scenarios. Live Epic and payer portal writes. Real HIPAA audit trails. Physician gates visible at every clinical decision step.

Demo 01
PriorAuthAI — Submission to Same-Day Decision
1
PA request received
Patient record retrieved from Epic via FHIR R4, active coverage verified
2
Payer criteria check
Clinical necessity scored against payer-specific coverage criteria
3
Documentation review
Completeness checked, gaps identified and flagged with resolution guidance
4
Decision execution
Standard cases auto-approved. Complex cases routed to physician with complete brief.
5
Epic and payer portal write
Decision logged, payer portal updated, patient notified. HIPAA audit record created.
Demo 02
Claims — Submission to Clean Adjudication
1
Claim received
ICD-10/CPT codes extracted, patient record cross-referenced
2
Code validation
Coding accuracy assessed, undercoding and bundling risks identified
3
Payer rule application
Contract-specific adjudication rules applied, clean claim probability scored
4
Adjudication executed
Payment routed to finance. Denial management triggered if rejected.
5
Audit record
HIPAA-compliant billing record created. Revenue cycle team notified.
Demo 03
ClinicalMatch — Referral to Trial Match in Minutes
1
Referral received
Patient demographics, diagnosis, and biomarker data extracted from Epic
2
Trial inventory scan
Active trials screened against patient profile, eligibility scored
3
Contraindication check
Exclusion criteria applied, conflicting medications flagged
4
Oncologist briefed
Ranked match list with eligibility rationale sent for physician review
5
Physician sign-off
Pre-enrollment initiated after MD approval. FDA 21 CFR Part 11 audit record created.

Start Here

30-day deployment
entry points.

Prior authorization first — where the largest clinical and financial impact exists. Claims coding and trial matching follow with clear expansion paths.

Entry Point 1 — Prior Auth
Prior Authorization Automation

Start with your highest-volume, highest-friction PA workflow — typically oncology, specialty pharmacy, or advanced imaging. Same-day approval rates replace 3–5 day manual average. Immediate reduction in coordinator administrative burden and provider escalations.

Live in 21–30 days
Entry Point 2 — Claims
Claims Coding Validation

Automate the ICD-10/CPT coding review queue before submission — identifying undercoding, unbundling risk, and documentation gaps. Measurable reduction in denial rate within the first billing cycle with zero disruption to existing clinical workflow.

Live in 14–21 days
Entry Point 3 — Intake
Patient Intake & Triage Routing

Automate intake data collection, eligibility verification, and clinical triage classification. Patients routed to the correct care setting automatically, with full HIPAA-compliant records created in Epic or Cerner before first clinical contact.

Live in 14–21 days

Agent Library

Pre-built healthcare
execution agents.

Every agent production-ready. Configures to Epic, Cerner, payer portals, and clinical trial systems in under 90 days. Physician review gates are mandatory at every clinical decision threshold — never configurable out.

Illustrative pricing shown. Ranges reflect typical deployments at mid-to-large health systems, payers, and life sciences organizations. Final pricing depends on PA volume, claims throughput, and integration complexity. Schedule a scoping call for a deployment-specific quote.
PriorAuthAI™
End-to-end prior authorization automation. Eligibility verification, clinical necessity scoring, payer criteria matching, and same-day decision execution for standard cases. Mandatory physician review gate on complex clinical presentations. Epic, Cerner, and all major payer portals.
$3,500 – $6,000 / month
Typical deployment for health systems and payers processing 500–5,000 monthly PA requests across oncology, specialty pharmacy, and procedure lines.
Enterprise pricing scales by PA volume, payer relationship complexity, and EMR integration scope.
📊
ClaimsCoder™
ICD-10/CPT coding validation and claims adjudication automation. Code accuracy review, undercoding detection, bundling analysis, payer rule application, and payment routing — with automatic denial management and appeal brief generation on any rejection.
$3,000 – $5,500 / month
Typical deployment for hospitals and health systems with 5,000–50,000 monthly claims across inpatient, outpatient, and physician billing.
Enterprise pricing scales by claim volume, payer mix complexity, and denial rate reduction targets.
🔬
ClinicalMatch™
Clinical trial matching via HL7 FHIR R4. Biomarker profiling, eligibility scoring, contraindication flagging, and enrollment pre-initiation. FDA 21 CFR Part 11 audit trail on every match decision. Physician sign-off gate enforced before enrollment initiation.
$4,000 – $7,000 / month
Typical deployment for academic medical centers and oncology networks with 2–20 active trials and 50–500 monthly referrals.
Enterprise pricing scales by active trial count, referral volume, and trial management system integration scope.
⚠️
AEReporting™
Adverse event detection and FDA MedWatch reporting automation. Signal detection in EHR, lab, and medication records — severity classification, reportability assessment, causality determination, case narrative generation, and FAERS submission within the 15-day window.
$3,500 – $6,000 / month
Typical deployment for life sciences organizations and hospital systems with 1–10 active trials and ongoing pharmacovigilance obligations.
Enterprise pricing scales by trial count, patient population, and FAERS integration requirements.
Pilot structure: Mid-market pilots start at $25K–$50K. Enterprise pilots at $50K–$150K. Includes workflow design, HIPAA integration, physician gate configuration, KPI baseline, and executive recommendation. 100% credited toward production deployment.
See Pilot Structure →

Compliance Architecture

HIPAA at the
architecture layer.

HIPAA is not a documentation exercise at CAIBots. PHI governance, physician review gates, and FDA regulatory compliance are enforced at the architecture layer — not configured after deployment and not overrideable by workflow settings.

HIPAA
Health Insurance Portability & Accountability Act

PHI access governed by RBAC at the Governance Layer — minimum necessary rule enforced at every data retrieval. Full BAA support. All PHI access logged with access purpose, actor identity, and timestamp on every interaction.

Enforced at: Governance Layer · RBAC · All layers
FDA 21 CFR Part 11
Electronic Records & Electronic Signatures

Audit trail requirements for electronic clinical records met at the Execution Layer — every write includes timestamp, actor, input context, and output state. Electronic signature workflows for clinical trial records comply with Part 11 authentication requirements.

Enforced at: Execution + Governance layers
HL7 FHIR R4
Fast Healthcare Interoperability Resources

Native FHIR R4 API integration for EHR data exchange — Epic, Cerner, and all major EMR systems accessed via standardized FHIR resources. Clinical data retrieved and written in FHIR-compliant format, no proprietary transformation layers.

Enforced at: Foundation + Execution layers
HITECH
Health Information Technology for Economic & Clinical Health

Breach notification workflows automated — any unauthorized PHI access triggers immediate notification protocols, incident documentation, and risk assessment. HITECH-compliant breach response executed and logged within the 60-day window automatically.

Enforced at: Governance + Execution layers
CMS
Centers for Medicare & Medicaid Services

Prior authorization, claims adjudication, and quality reporting executed against CMS coverage determination criteria and NCD/LCD policies. CMS interoperability rule compliance for payer data exchange automated via standardized API workflows.

Enforced at: Cognition + Execution layers
GDPR
General Data Protection Regulation — EU

European patient data residency enforced. Right-to-erasure workflow automated. Explicit consent verification at intake. EU patient data never leaves European infrastructure boundaries in on-premise deployments.

Enforced at: Governance Layer · Data residency

Governance Matrix

Physician gates —
enforced, never optional.

CAIBots never makes clinical decisions autonomously. Every workflow with clinical impact has a defined governance posture. Physician gates are mandatory — not configurable out — and generate an immutable sign-off record with FDA 21 CFR Part 11 compliance.

WorkflowTriggerGovernanceAuth RequiredReg Reference
PA — Standard ApprovalPA request · within coverage criteriaAuto-ApproveNoneCMS Interop Rule · HIPAA
PA — Clinical Edge CaseComplex presentation · documentation gapPhysician GateTreating Physician requiredHIPAA · FDA · CMS
Claims — Clean SubmissionValidated codes · payer criteria metAuto-ProcessNoneICD-10 · CMS NCD/LCD
Claims — Denial ManagementRejection · denial code detectedHITL GateRevenue Cycle ManagerCMS · Payer Contract
Trial Match — CandidateEligible biomarker match foundPhysician GateOncologist / MD sign-offFDA 21 CFR Part 11
Adverse Event — ExpeditedSerious unexpected safety signalAuto-Report + PIPI notification requiredFDA MedWatch · FAERS
Physician gates are never configurable out of clinical decision workflows. CAIBots provides matched options, eligibility scores, and clinical evidence briefs — physicians make and sign the clinical decision. Every sign-off generates a FDA 21 CFR Part 11-compliant authorization record. Review full governance architecture →

Built For

The teams managing
clinical and administrative AI.

VP Revenue Cycle / Director of Prior Auth
Health System · Integrated Delivery Network
"We process 8,000 PA requests per month. Each one averages 4.5 days. We have 22 coordinators spending 80% of their time on data gathering and status follow-up, not clinical review. My denial rate is 11% and climbing."
PA cycle from 4.5 days to same-day for clinically standard cases — coordinators handle clinical judgment, not administrative steps
ICD-10/CPT validation before submission reduces denial rate measurably within the first billing cycle
HIPAA-compliant execution — every PHI interaction role-gated and logged
ROI dashboards measure cost per PA, denial rate delta, and coordinator hours saved from day one
Launch PriorAuth demo →
Chief Medical Officer
Academic Medical Center · Health System
"My credentialing committee will not approve an AI system that makes autonomous clinical decisions. I need AI that augments clinical workflows without replacing physician judgment — and I need a governance model I can defend to the board."
Physician review gates are mandatory — not configurable out of any clinical decision workflow
AI provides matched options and evidence briefs — physicians make and sign every clinical decision
Every recommendation includes an explainability record with clinical evidence cited — reviewable by any credentialing body
FDA 21 CFR Part 11 compliant audit trail for all clinical record interactions
See the governance architecture →
Director of Clinical Trials / Principal Investigator
Academic Medical Center · CRO · Life Sciences
"We have 8 active oncology trials and 200+ monthly referrals. Manual matching takes 3 days per referral. We're missing eligible patients because the match process is too slow. Every missed match is a lost enrollment."
Referrals matched against all active trials simultaneously — results in minutes, not days
Biomarker profiling, eligibility scoring, and contraindication check automated at intake
Physician sign-off gate enforced before any enrollment step — FDA 21 CFR Part 11 compliant
Adverse event detection runs continuously — FDA MedWatch filings within the 15-day window automatically
Launch ClinicalMatch demo →
CTO / VP of Health IT
Health System · Payer · HealthTech
"Our environment is Epic, Cerner for the employed physician group, three payer portals, and a legacy claims system. Every AI project I've seen stalls at integration for 18 months. What does your actual integration model look like?"
Native HL7 FHIR R4 integration with Epic and Cerner — no custom middleware or screen-scraping
Claims system connectors via standard X12 EDI and proprietary API frameworks
On-premise deployment for health systems with data residency requirements
90-day path — discovery, configuration, controlled execution, autonomous production
Review the platform architecture →

Next Step

Watch a PA approve
the same day it's submitted.

30-minute session. We map your highest-volume PA or claims workflow, demonstrate a live HIPAA-compliant execution, and scope a 90-day path to production with full physician gate documentation.

Princeton, NJ · contact@caibots.com · +1 (609) 721-2815
ComplianceHIPAAFDA 21 CFRHITECHCMSHL7 FHIRGDPREU AI ActSOC 2