Compliance Native HIPAAFDA 21 CFR Part 11HITECH CMSHL7 FHIRGDPR SOC 2FDA MedWatch
Healthcare Execution Stack

Every prior auth delayed
is a patient waiting.

The CAIBots Healthcare execution stack executes directly inside Epic, Cerner, and payer systems — prior authorization, claims adjudication, clinical trial matching, and adverse event reporting with HIPAA-native governance and physician review gates at every clinically relevant decision point.

HIPAA-native execution — PHI governance at architecture layer
FDA 21 CFR Part 11, HL7 FHIR R4, CMS native
Physician review gates — always required for clinical decisions
<90 days contract to production
65%
PA processing time reduction
Same-day
PA decisions vs 5-day average
100%
HIPAA audit coverage
Zero
PHI access without RBAC gate
<90d
Contract to production

Active Execution Workflows

What executes in your
healthcare systems.

HIPAA-native execution workflows writing directly into Epic, Cerner, payer portals, and clinical systems — with physician review gates configured at every clinically relevant decision threshold.

Prior Authorization AutomationHIPAA · CMS

PA requests retrieved, eligibility verified against payer criteria, clinical necessity assessed against treatment protocols, and decisions executed directly into the EMR and payer portal — with automatic physician escalation for edge cases requiring clinical judgment.

Trigger
PA request submitted — oncology treatment requiring insurer approval
Cognition
Verify eligibility, assess clinical necessity vs payer criteria, identify documentation gaps, classify auto-approve vs escalation threshold
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 workflow triggered for any rejection, including root cause analysis and appeal brief generation.

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 updated · Finance payment routed · Denial Mgmt appeal initiated if rejected
Output
Cleaner claimsFaster adjudicationICD-10 compliant
Clinical Trial MatchingFDA 21 CFR · HL7 FHIR

New patient referrals matched against active trial criteria in real time — biomarker profiling, eligibility scoring, contraindication flagging, and enrollment pre-initiation executed directly into the EMR and trial management system.

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
Execution
Epic EMR match list added · Outlook oncologist briefed · Trial Mgmt pre-enrollment initiated · Cerner pathway updated
Output
Minutes to matchFDA 21 CFR compliantHL7 FHIR native
Adverse Event Detection & ReportingFDA MedWatch · FAERS

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

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

Start Here

30-day deployment
entry points.

Highest-value healthcare workflows to automate first — immediate clinical and financial impact with zero disruption to existing care workflows.

Entry Point 1
Prior Authorization Automation

Start with your highest-volume, highest-friction PA workflows — typically oncology, specialty pharmacy, or advanced imaging. Immediate reduction in administrative burden with same-day approval rates replacing 5-day manual average.

Live in 21–30 days
Entry Point 2
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 change to clinical workflow.

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

Automate intake data collection, eligibility verification, and clinical triage classification. Patients routed to the right 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 is production-ready. Configures to your Epic, Cerner, payer, and clinical trial systems in under 90 days. Physician review gates are mandatory — never configurable out of clinical decision workflows.

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, clinical trial size, and integration complexity. Enterprise and outcome-based structures available. 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 enforced on complex clinical presentations. Integrates with 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 (Epic vs Cerner vs multi-system).
📊
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 agreed at deployment scoping.
🔬
ClinicalMatch™
Clinical trial matching automation using HL7 FHIR R4. Biomarker profiling, eligibility scoring against active trial criteria, 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 requiring matching.
Enterprise pricing scales by active trial count, referral volume, biomarker complexity, 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 regulatory 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 size, reporting jurisdiction coverage, and FAERS integration requirements.
Model 1
Per-Agent Monthly
Fixed fee per deployed agent. Predictable cost structure ideal for health systems deploying 1–2 agents with defined scope. Preferred for initial deployment and clinical governance review phases.
$3,000 – $7,000 / agent / month
Model 2
Per-Transaction Volume
Pricing tied to PAs processed, claims adjudicated, or trial matches generated. Scales with patient volume. Particularly well-suited for growing health systems or organizations with seasonal volume patterns.
Custom rate per 1,000 transactions
Model 3
Outcome Sharing
Enterprise deployment with pricing tied to measurable outcomes — PA cycle time reduction, denial rate improvement, trial enrollment improvement, or adverse event reporting compliance rate. Aligns CAIBots economics to your clinical and financial targets.
Enterprise only · Scoped individually

Compliance Architecture

Healthcare compliance
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 configuration.

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 for Business Associate compliance. 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 and authorization 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, enabling seamless interoperability without 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 notification 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

For European patient data and life sciences research — 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 review 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 — Expedited ReportSerious 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 an FDA 21 CFR Part 11-compliant authorization record with timestamp, actor identity, and decision context. Review full governance architecture →

Built For

The teams managing
clinical and administrative AI.

Chief Medical Officer
Health System · Integrated Delivery Network
"I need AI that augments clinical workflows without replacing physician judgment. My credentialing committee will not approve a black box. How does governance work for clinical decision support?"
Physician review gates are mandatory — never configurable out of clinical decision workflows
AI provides matched options and evidence briefs — physicians make and sign the clinical decision
Every recommendation generates an explainability record with clinical evidence cited
FDA 21 CFR Part 11 compliant audit trail for all clinical record interactions
See the governance architecture →
VP of Revenue Cycle
Payer · Hospital System
"We deny 8% of claims on first submission. Each PA takes 5 days on average. My team is drowning in administrative work that produces zero clinical value. I need this automated without creating compliance risk."
PA cycle reduced from 5 days to same-day for clinically standard cases
ICD-10/CPT validation before submission reduces denial rate automatically
HIPAA-compliant execution — every PHI interaction role-gated and logged
ROI dashboards measure cost per PA, denial rate change, and hours saved from day one
See live execution demos →
Chief Technology Officer
Healthcare Technology · Life Sciences
"Our environment is Epic, Cerner, a proprietary claims system, and three payer portals. We've had AI projects stall at integration for 18 months. What does your integration model actually look like?"
Native HL7 FHIR R4 integration with Epic and Cerner — no custom middleware
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

See execution in your
healthcare systems.

30-minute session. We map your highest-value healthcare workflows, demonstrate a live PA or claims execution, and scope a 90-day path to production with full HIPAA compliance documentation.

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