Clinical AI governance software built for hospitals and health systems
TRAIGA helps healthcare organizations inventory every clinical AI system, run patient-harm risk assessments, generate patient-facing disclosures required by TRAIGA, and produce board-ready AI governance reports — all in one HIPAA-compatible platform.
1,200+
Texas organizations subject to TRAIGA
Texas Health & Human Services estimates
~24,000
AI systems that will require registration
Projected under TRAIGA rollout
86%
of hospitals now use at least one clinical AI system
AHA Annual Survey 2024
$1M+
civil penalty exposure per TRAIGA violation
TRAIGA enforcement provisions
Which clinical AI systems require governance under TRAIGA?
TRAIGA covers any AI system used in a consequential decision affecting a patient or member. Here are the most common categories in healthcare — and why each carries regulatory risk.
Clinical decision support systems
AI systems that assist physicians with diagnosis, treatment selection, medication dosing, or discharge planning are high-risk under TRAIGA and FDA guidance. They require documented risk assessments, human oversight mechanisms, and patient-facing disclosures.
Prior authorization and utilization management
Insurers and health plans using AI to approve or deny care must document the AI system, assess bias risk across demographic groups, and provide member-facing disclosures. TRAIGA coverage extends to these systems.
Patient scheduling and triage algorithms
AI systems that prioritize which patients receive care — including ED triage support, appointment scheduling, and call-routing AI — affect patient access and require governance documentation under TRAIGA.
Revenue cycle and billing AI
AI-driven coding, billing optimization, and fraud detection tools carry regulatory risk when they influence financial outcomes for patients. TRAIGA requires inventory and risk documentation even for back-office AI.
Vendor-supplied AI embedded in EHR platforms
AI functionality embedded in Epic, Cerner, Oracle Health, and other EHR platforms is often invisible to compliance teams. TRAIGA holds the deploying organization — not the vendor — accountable for governance.
Predictive analytics and population health tools
Population health platforms that use AI to stratify patient risk, identify care gaps, or predict readmissions are AI systems under TRAIGA and require the same inventory, assessment, and oversight documentation.
Not sure if a specific AI system is covered? Read the TRAIGA compliance guide →
Everything a health system needs to govern clinical AI
Eight integrated capabilities purpose-built for the healthcare AI governance workflow — from initial inventory to ongoing board reporting.
Clinical AI System Inventory
Centralized registry for every AI system across your health system — from EHR-embedded tools to third-party clinical decision support. Capture the vendor, model, clinical context, patient population, and deployment setting regulators require.
Patient-Harm Risk Scoring
Healthcare-specific risk weighting that accounts for patient harm potential, clinical AI context, affected patient populations, and human-in-the-loop oversight mechanisms. Produces a calibrated risk tier that maps to TRAIGA and FDA guidance.
TRAIGA Disclosure Generator
One-click generation of patient-facing AI disclosures and public-facing notices required by the Texas Responsible AI Governance Act. Auto-populated from your AI system inventory — eliminating weeks of manual drafting.
Clinical Control Framework
Auto-generated control recommendations for each clinical AI system based on its risk tier. Covers human oversight checkpoints, explainability requirements, model monitoring, and bias testing — all trackable within the platform.
Board Governance Report Pack
Board-ready AI governance report packs generated in seconds. Includes executive summary, system inventory summary, risk heat map, control status, and open incident log — designed to satisfy the hospital governing board obligations emerging under AI regulation.
Clinical AI Incident Management
Structured workflow for logging, triaging, investigating, and resolving AI-related clinical incidents. Links incidents to AI system records, controls, and risk reviews for full traceability across the patient safety chain.
Multi-Framework Mapping
Map clinical AI controls to TRAIGA, FDA AI/ML action plan, EU AI Act, NIST AI RMF, and ISO 42001 simultaneously. Document your governance posture across every applicable framework without duplicating effort.
Continuous Monitoring
Schedule periodic risk re-assessments, track model performance drift, and maintain a living governance record as clinical AI systems are updated, replaced, or decommissioned. AI governance isn't a one-time exercise — TRAIGA treats it as ongoing.
The clinical AI governance workflow
TRAIGA guides your clinical informatics, compliance, and legal teams through a structured workflow that produces the exact artifacts TRAIGA and regulators expect.
Inventory every clinical AI system
Register all AI tools deployed across your health system — including EHR-embedded AI from Epic, Cerner, and Oracle Health. Capture clinical context, patient population, vendor details, and deployment setting. Most hospitals inventory their first 10 systems on day one.
Tip: TRAIGA provides a vendor questionnaire template to collect governance documentation from your AI suppliers.
Run patient-harm risk assessments
TRAIGA's healthcare-specific risk engine scores each clinical AI system on patient harm likelihood, clinical impact severity, affected population vulnerability (pediatric, elderly, underserved), reversibility, and human oversight adequacy.
Tip: TRAIGA automatically generates a risk tier — critical, high, moderate, or low — that maps directly to TRAIGA and FDA guidance.
Implement clinical controls and oversight
Receive auto-generated control recommendations for each system based on its risk tier. Assign owners (clinical informatics, legal, compliance), set due dates, track implementation, and maintain a complete audit trail. All controls link back to the AI system record.
Generate disclosures and board reports
One-click generation of TRAIGA-compliant patient disclosures, public-facing AI notices, and board AI governance report packs — all pre-populated from your verified inventory data. What used to take weeks takes minutes.
Tip: Board reports include the executive summary, risk heat map, and control status that hospital governing boards need to satisfy their oversight obligations.
Regulatory coverage for healthcare AI
Healthcare AI governance sits at the intersection of multiple regulatory frameworks. TRAIGA maps your controls to all of them simultaneously.
Texas Responsible AI Governance Act (TRAIGA)
Full CoverageScope
Texas-operating organizations deploying consequential AI
Key Requirements
- AI system inventory and registration
- Risk assessment for each AI system
- Patient-facing and public disclosures
- Human oversight documentation
- Incident reporting obligations
- Board-level attestation
FDA AI/ML-Based SaMD Action Plan
CoveredScope
AI/ML software that meets the definition of a medical device
Key Requirements
- Predetermined change control plan (PCCP)
- Real-world performance monitoring
- Transparency and labeling requirements
- Algorithm change protocols
EU AI Act
Full CoverageScope
High-risk AI in healthcare — diagnostic, treatment, monitoring
Key Requirements
- Conformity assessment
- Technical documentation
- Human oversight mechanisms
- Post-market surveillance
- EU database registration
NIST AI RMF
Full CoverageScope
Voluntary framework broadly adopted in healthcare
Key Requirements
- Govern, Map, Measure, Manage functions
- Trustworthy AI characteristics
- Organizational accountability
- AI risk measurement
Healthcare AI governance — frequently asked questions
Common questions from compliance officers, clinical informatics teams, and hospital legal counsel evaluating AI governance software.
- Does TRAIGA apply to hospitals and health systems?
- Yes. The Texas Responsible AI Governance Act applies to any organization operating in Texas that deploys AI systems in consequential decision-making contexts — including healthcare. Hospitals, health systems, insurers, and digital health companies using AI for clinical decision support, prior authorization, patient scheduling, or revenue cycle automation are all subject to TRAIGA's inventory, risk assessment, and disclosure requirements.
- Which clinical AI systems require documentation under TRAIGA?
- Any AI system that influences a consequential decision affecting a patient or member is covered. This includes clinical decision support tools, prior authorization AI, patient scheduling algorithms, triage support systems, predictive readmission models, and population health stratification tools. Critically, TRAIGA holds the deploying organization — not the AI vendor — accountable, so AI functionality embedded in EHR platforms like Epic or Cerner still requires your organization's governance documentation.
- What patient disclosures does TRAIGA require for healthcare AI?
- TRAIGA requires deploying organizations to provide notice when AI systems are used in decisions that materially affect a patient's access to services, health outcomes, or financial obligations. Disclosures must be in plain language, accessible to the affected individual, and available prior to the AI-influenced decision where practicable. TRAIGA's disclosure generator auto-produces these notices from your system inventory.
- How does TRAIGA handle vendor-supplied AI in EHR systems?
- TRAIGA's position is that deploying organizations bear governance accountability, regardless of whether the AI was developed in-house or procured from a vendor like Epic, Oracle Health, or a third-party clinical AI company. Your organization must inventory these systems, conduct or obtain risk assessments, implement oversight controls, and generate required disclosures. TRAIGA provides an AI procurement checklist to help you collect governance documentation from vendors.
- What does a hospital board AI governance report include?
- TRAIGA's board AI governance report pack includes an executive summary of your AI governance program, a complete inventory of clinical AI systems with risk tiers, a control implementation status summary, an open incident log, and a governance maturity score. It is designed to give hospital boards the evidence they need to satisfy their oversight obligations under AI regulation and Joint Commission guidance.
- How long does it take to complete a hospital's initial AI inventory?
- Most hospitals complete their initial AI system inventory within one to three weeks, depending on the number of systems and the responsiveness of internal stakeholders. TRAIGA provides a structured intake form, a vendor questionnaire template, and automated reminders to keep the process moving. Many organizations inventory their first ten systems on day one.
- Is TRAIGA HIPAA-compatible?
- Yes. TRAIGA is built with healthcare data handling requirements in mind. The platform does not require you to upload patient data — it documents governance metadata about your AI systems (vendors, use-cases, risk scores, controls) rather than actual patient records. TRAIGA's infrastructure is hosted on AWS with encryption at rest and in transit, role-based access controls, and audit logging consistent with HIPAA Security Rule requirements.
- Can TRAIGA handle multi-site health systems with dozens of AI systems?
- Yes. TRAIGA is a fully multi-tenant SaaS platform designed to scale from a single-hospital operator to a large integrated delivery network. Role-based access allows compliance officers, clinical informatics teams, legal counsel, and board members to have appropriately scoped access. You can organize AI systems by facility, service line, or business unit and generate consolidated governance reports across your entire system.
Start governing your clinical AI systems today
Hospitals and health systems using TRAIGA get their first AI system inventoried in under 10 minutes. Starting at $79/month — no implementation project, no waiting.
HIPAA-compatible — no patient data required
TRAIGA disclosures generated in one click
Board governance reports ready in minutes