Compliance Native HIPAA FDA 21 CFR Part 11 HITECH CMS GDPR HL7 FHIR SOC 2
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, 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 are 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 required · 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 are 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 care 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. Pharmacovigilance compliance executed, not documented.

Trigger
Lab result flagged — unexpected adverse signal in trial participant
Cognition
Classify event severity, assess MedWatch reportability, determine causality assessment, 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, measurable 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 automatically. Measurable reduction in denial rate within the first billing cycle.

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

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.

HIPAA
Health Insurance Portability & Accountability Act

PHI access governed by RBAC at the Governance Layer — no execution touches PHI without role-based authorization. Minimum necessary rule enforced at every data retrieval. Full BAA support for Business Associate compliance. All PHI access logged with access purpose and actor identity.

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
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

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 AI 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 implementation path — discovery, configuration, controlled execution, autonomous production
Review the platform architecture →

See It Work — No Sales Call Required

Prior auth completed in minutes.
Not days. Not phone calls.

Real healthcare execution scenarios with HIPAA governance, Epic/Cerner integration, and mandatory HITL gates for high-risk clinical decisions.

KYC / AML · Financial Services Demo — Healthcare Execution Same Architecture
CAIBots Execution — Healthcare Architecture

The CAIBots execution architecture — intent → cognition → orchestration → execution → governance → audit — is identical across all verticals. The KYC/AML demo shows the full pipeline in action: multi-agent execution, HITL authorization gates, real system writes, and immutable audit logs. Healthcare workflows (prior auth, claims, adverse events) use the same stack — different compliance frameworks, same deterministic execution model.

Epic EMR (Target) Cerner (Target) Payer APIs HL7 FHIR
Prior Authorization — Modeled Baseline
3–5 day manual prior auth cycle → same-day automated decision routing · HIPAA-native · CMS compliance enforced at architecture layer
Healthcare-specific demo available in pilot engagement · Contact for configuration walkthrough
Governance Matrix — Healthcare
Workflow Auto Execute HITL Gate Reg Reference
Prior Auth — StandardAuto-RoutesNoneHIPAA · CMS
Prior Auth — High Risk DxDrafts RequestPhysician ReviewHIPAA · CMS
Claims Adjudication — CleanAuto-AdjudicatesNoneICD-10 · CMS
Adverse Event DetectionFlags + DraftsClinical ReviewFDA MedWatch
Clinical Trial MatchingIdentifies MatchesPI AuthorizationFDA 21 CFR · FHIR
EMR Record UpdateWrites to EMRPost-Write ValidationHIPAA · HL7 FHIR
BAA available for all healthcare deployments. HIPAA compliance is enforced at the execution layer — not applied as a policy document afterward. Contact contact@caibots.com to request BAA documentation.

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 · [email protected] · +1 (609) 721-2815
Compliance HIPAAFDA 21 CFR HITECHCMS HL7 FHIRGDPR EU AI ActSOC 2