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AI Assurance for Healthcare
The independent AI assurance platform for hospitals, payers, MedTech, digital health, and pharma. Clinical evaluation, runtime guardrails, monitoring, and regulatory automation — for every model that touches a patient.
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Clinical Coverage
5+
Jurisdictions
15+
Regulations
UK MHRA
HIPAA
EU MDR
FDA 510(k)
CMS
Section 1557
Patient safety at
the core
From academic medical centers to community hospitals, from health systems to digital health startups — Trusys provides clinical-grade AI assurance that puts patient safety first.
Framework
The challenge of clinical AI
Healthcare AI operates under the highest safety and regulatory standards
Patient Safety
Clinical AI errors have direct patient impact — diagnostic accuracy, treatment recommendations, triage decisions all carry clinical risk.
PHI Protection
HIPAA, GDPR, state privacy laws — every LLM interaction with patient data creates breach exposure.
Health Equity
FDA guidance, Section 1557, EU AI Act — fairness testing across race, gender, age, geography is not optional
Medical Device Regulation
FDA 510(k), EU MDR, UK MHRA — clinical decision support may be a medical device under regulatory scrutiny
Clinical Documentation
CMS, payers, state boards — every AI-generated clinical note, summary, or prior auth creates liability
Clinical Validation
Hospital committees expect prospective validation, ongoing monitoring, and physician oversight — not just technical testing
Industry Impact
Clinical-grade AI assurance
Evaluate, guard, monitor, and govern — for every clinical AI system
tru EVAL
Clinical evaluation
- Hallucination benchmarks on medical knowledge (UpToDate, clinical guidelines)
- Fairness testing across demographic subgroups (Section 1557, EU AI Act)
- Hallucination benchmarks on medical knowledge (UpToDate, clinical guidelines)
- Clinical accuracy validation on diagnosis, triage, treatment recommendations
- Third-party foundation model validation for hospital committees
tru GUARD
Runtime guardrails
- PHI redaction for MRN, SSN, insurance ID, clinical identifiers
- Clinical advice-boundary enforcement (diagnosis vs information)
- Hallucination benchmarks on medical knowledge (UpToDate, clinical guidelines)
- Crisis detection for suicide ideation, self-harm, abuse
- Crisis detection for suicide ideation, self-harm, abuse
tru PULSE
Continuous monitoring
- Clinical accuracy drift detection on live patient interactions
- Subgroup performance monitoring (race, gender, age, geography)
- Hallucination benchmarks on medical knowledge (UpToDate, clinical guidelines)
- Escalation pattern monitoring (when AI hands off to physicians)
- Real-time alerting on patient safety anomalies
tru Scout
Regulatory intelligence
- AI system inventory with clinical risk classification
- Regulatory mapping to HIPAA, FDA 510(k), EU MDR, Section 1557, CMS
- Hallucination benchmarks on medical knowledge (UpToDate, clinical guidelines)
- Clinical accuracy validation on diagnosis, triage, treatment recommendations
- Medical device lifecycle documentation (FDA, MHRA, TGA)
Multi-jurisdiction healthcare compliance
Native regulatory mapping across healthcare systems worldwide
Jurisdiction
United States
United States
United States
European Union
European Union
United Kingdom
Canada
Australia
Framework
HIPAA Privacy & Security Rules
FDA 510(k) for medical devices
CMS + Section 1557
EU AI Act (health as high-risk)
EU MDR (Medical Device Regulation)
UK MHRA + GDPR + NHS guidelines
Health Canada MDEL + PIPEDA
-
What Trusys covers
PHI containment, breach detection, BAA compliance, HHS OCR reporting
AI AI risk teams, security teams, compliance teams, product teams, enterprise AI ownersrisk teams, security teams, compliance teams, product teams, enterprise AI owners
Clinical documentation integrity, non-discrimination in health programs
High-risk classification, conformity assessment, post-market monitoring
Medical device lifecycle documentation, clinical evaluation, vigilance
Medical device regulation, data protection, NHS AI deployment guidance
Medical device licensing, personal health information protection
Therapeutic goods regulation, health privacy principles
Built for clinical workflows
Clinical decision support
Diagnostic assistance
Patient triage & routing
Clinical documentation (ambient)
Prior authorization automation
Patient communication chatbots
Medical coding & billing
Drug interaction checking
Radiology report generation
Treatment plan recommendations
Care coordination workflows
Population health analytics
Frequently Asked Questions
01.
Is Trusys a NeMo Guardrails alternative?
Yes. TruGuard provides PHI detection and redaction at the inference boundary, TruPulse monitors for PHI leakage patterns, and Argus maintains breach investigation workflows aligned to HHS OCR requirements. Trusys is BAA-compliant when deployed in customer VPC or on-premises.
02.
Can Trusys govern agentic AI?
Yes. TruGuard enforces agent tool-call policy at runtime, TruPulse monitors agent behavioural deviation, and Argus maintains the agent registry mapped to OWASP Top 10 for Agentic AI. Trusys is designed specifically for the governance of agentic systems, not only LLM applications.
03.
Can Trusys validate foundation models for clinical use?
Yes. TruEval provides independent third-party validation of clinical accuracy, hallucination rates, and fairness — the evidence hospital AI committees and medical staff expect before deployment.
04.
Is Trusys independent of model providers?
Yes. Trusys has no foundation model business, no EHR vendor affiliation, and no commercial conflict when clinical validation surfaces accuracy or safety issues on any provider's model.
Trusys Advantage
Clinical-grade AI assurance for healthcare
Patient safety first. PHI protection built in. Regulatory compliance automated. From HIPAA to FDA, EU MDR to CMS — Trusys is built for clinical AI.
Book a Demo
AI Assurance for Healthcare
The independent AI assurance platform for hospitals, payers, MedTech, digital health, and pharma. Clinical evaluation, runtime guardrails, monitoring, and regulatory automation — for every model that touches a patient.
Book Demo
Get Started
Clinical Coverage
5+
Jurisdictions
15+
Regulations
HIPAA
EU MDR
FDA 510(k)
UK MHRA
CMS
Section 1557
Patient safety at
the core
From academic medical centers to community hospitals, from health systems to digital health startups — Trusys provides clinical-grade AI assurance that puts patient safety first.
Framework
The challenge of clinical AI
Healthcare AI operates under the highest safety and regulatory standards
Patient Safety
Clinical AI errors have direct patient impact — diagnostic accuracy, treatment recommendations, triage decisions all carry clinical risk.
PHI Protection
HIPAA, GDPR, state privacy laws — every LLM interaction with patient data creates breach exposure.
Health Equity
FDA guidance, Section 1557, EU AI Act — fairness testing across race, gender, age, geography is not optional
Medical Device Regulation
FDA 510(k), EU MDR, UK MHRA — clinical decision support may be a medical device under regulatory scrutiny
Clinical Documentation
CMS, payers, state boards — every AI-generated clinical note, summary, or prior auth creates liability
Clinical Validation
Hospital committees expect prospective validation, ongoing monitoring, and physician oversight — not just technical testing
Industry Impact
Clinical-grade AI assurance
Evaluate, guard, monitor, and govern — for every clinical AI system
tru EVAL
Clinical evaluation
- Hallucination benchmarks on medical knowledge (UpToDate, clinical guidelines)
- Fairness testing across demographic subgroups (Section 1557, EU AI Act)
- Adversarial campaigns against prompt injection, patient data leakage
- Clinical accuracy validation on diagnosis, triage, treatment recommendations
- Third-party foundation model validation for hospital committees
tru GUARD
Runtime guardrails
- PHI redaction for MRN, SSN, insurance ID, clinical identifiers
- Clinical advice-boundary enforcement (diagnosis vs information)
- Consent verification for AI-mediated clinical interactions
- Crisis detection for suicide ideation, self-harm, abuse
- Crisis detection for suicide ideation, self-harm, abuse
tru PULSE
Continuous monitoring
- Clinical accuracy drift detection on live patient interactions
- Subgroup performance monitoring (race, gender, age, geography)
- Hallucination pattern detection in clinical summaries and notes
- Escalation pattern monitoring (when AI hands off to physicians)
- Real-time alerting on patient safety anomalies
tru Scout
Regulatory intelligence
- AI system inventory with clinical risk classification
- Regulatory mapping to HIPAA, FDA 510(k), EU MDR, Section 1557, CMS
- Clinical committee evidence packs (validation reports, ongoing monitoring)
- PHI breach investigation workflows (HHS OCR reporting)
- Medical device lifecycle documentation (FDA, MHRA, TGA)
Multi-jurisdiction healthcare compliance
Native regulatory mapping across healthcare systems worldwide
Jurisdiction
United States
United States
United States
European Union
European Union
United Kingdom
Canada
Australia
Framework
HIPAA Privacy & Security Rules
FDA 510(k) for medical devices
CMS + Section 1557
EU AI Act (health as high-risk)
EU MDR (Medical Device Regulation)
UK MHRA + GDPR + NHS guidelines
Health Canada MDEL + PIPEDA
TGA + Privacy Act
What Trusys covers
PHI containment, breach detection, BAA compliance, HHS OCR reporting
Clinical decision support validation, software as medical device documentation
Clinical documentation integrity, non-discrimination in health programs
High-risk classification, conformity assessment, post-market monitoring
Medical device lifecycle documentation, clinical evaluation, vigilance
Medical device regulation, data protection, NHS AI deployment guidance
Medical device licensing, personal health information protection
Therapeutic goods regulation, health privacy principles
Built for clinical workflows
Clinical decision support
Diagnostic assistance
Patient triage & routing
Clinical documentation (ambient)
Prior authorization automation
Patient communication chatbots
Medical coding & billing
Drug interaction checking
Radiology report generation
Treatment plan recommendations
Care coordination workflows
Population health analytics
Frequently Asked Questions
01.
Does Trusys cover HIPAA compliance for AI systems?
Yes. TruGuard provides PHI detection and redaction at the inference boundary, TruPulse monitors for PHI leakage patterns, and Argus maintains breach investigation workflows aligned to HHS OCR requirements. Trusys is BAA-compliant when deployed in customer VPC or on-premises.
02.
Can Trusys govern agentic AI?
Yes. TruGuard enforces agent tool-call policy at runtime, TruPulse monitors agent behavioural deviation, and Argus maintains the agent registry mapped to OWASP Top 10 for Agentic AI. Trusys is designed specifically for the governance of agentic systems, not only LLM applications.
03.
Can Trusys validate foundation models for clinical use?
Yes. TruEval provides independent third-party validation of clinical accuracy, hallucination rates, and fairness — the evidence hospital AI committees and medical staff expect before deployment.
04.
Is Trusys independent of model providers?
Yes. Trusys has no foundation model business, no EHR vendor affiliation, and no commercial conflict when clinical validation surfaces accuracy or safety issues on any provider's model.
Trusys Advantage
Clinical-grade AI assurance for healthcare
Patient safety first. PHI protection built in. Regulatory compliance automated. From HIPAA to FDA, EU MDR to CMS — Trusys is built for clinical AI.
Book a Demo