One Platform.
Every Jurisdiction.
Elyara maps your AI systems to six major regulatory frameworks simultaneously — so your compliance team never has to choose between markets or rebuild evidence from scratch.
Deep Coverage Across
Every Critical Regulation
EU AI Act
Regulation (EU) 2024/1689 · In force Aug 2026
The world's first comprehensive AI law classifies medical AI as High Risk, requiring conformity assessments, transparency obligations, and post-market surveillance before CE marking.
- High-risk AI conformity assessment
- Fundamental rights impact analysis
- Post-market surveillance architecture
- Technical documentation generation
- Human oversight controls mapping
CFM 2.454/2026
Conselho Federal de Medicina · Brasil · 2026
Brazil's medical AI resolution mandates physician oversight, algorithmic transparency, and audit trails for any AI tool used in diagnosis, treatment decisions, or patient monitoring.
- Physician oversight documentation
- Algorithmic transparency reports
- Clinical decision audit trails
- Informed consent AI disclosure
- Incident reporting workflow
UAE AI Regulation
AHCG / DHA / MOH · Dubai 2025–2026
The UAE's AI governance framework for healthcare (AHCG) emphasizes data sovereignty, ethical AI deployment, and mandatory registration of high-impact clinical AI systems with the DHA.
- AHCG compliance mapping
- Data sovereignty controls
- DHA registration evidence pack
- Ethical AI review documentation
- Dubai 2031 AI strategy alignment
FDA SaMD Guidance
Software as a Medical Device · 21 CFR 820
FDA's Software as a Medical Device framework requires predetermined change control plans, algorithm transparency, and real-world performance monitoring for AI/ML-based medical software.
- SaMD classification assessment
- Predetermined change control plan
- Algorithm transparency documentation
- Real-world performance monitoring
- Quality Management System alignment
LGPD + GDPR
Lei 13.709/2018 · GDPR 2016/679 · Cross-border
Health data is sensitive data under both LGPD and GDPR, requiring explicit consent, data minimization, and the right to explanation for any AI-driven processing affecting patient rights.
- Sensitive data processing controls
- Consent management framework
- Right to explanation (Art. 20 LGPD)
- Data Protection Impact Assessment
- Cross-border transfer safeguards
HIPAA
45 CFR Parts 160 & 164 · US Federal
HIPAA's Security and Privacy Rules apply to any AI system that creates, receives, maintains, or transmits PHI — including inference outputs derived from protected health information.
- PHI boundary detection in AI I/O
- Administrative safeguards mapping
- Technical safeguards validation
- Business Associate Agreement support
- Breach risk assessment for AI events
What Elyara Covers
Across Each Framework
Every Elyara feature is mapped to specific articles and requirements across all six frameworks — so your compliance team has instant cross-reference coverage.
| Capability | EU AI Act | CFM 2.454 | UAE/AHCG | FDA SaMD | LGPD/GDPR | HIPAA |
|---|---|---|---|---|---|---|
| SENTINEL Monitoring | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| RTaaS Red Teaming | ✓ | ✓ | ✓ | ✓ | Partial | ✓ |
| Shadow AI Detection | ✓ | ✓ | ✓ | Partial | ✓ | ✓ |
| Elyara Trust Score | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Audit Trail Generation | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| DPIA / Privacy Assessment | ✓ | Partial | ✓ | — | ✓ | ✓ |
| Incident Response | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| AI Simulation Sandbox | ✓ | ✓ | ✓ | ✓ | Partial | Partial |
| Evidence Pack Export | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
From Onboarding to
Full Compliance in 90 Days
Our structured compliance journey ensures continuous coverage — not a one-time audit.
AI Inventory & Discovery Done
Automated discovery of all AI systems in use — including Shadow AI — mapped to regulatory categories and risk tiers. Zero manual survey required.
Gap Analysis & Risk Scoring Done
Each system receives an Elyara Trust Score baseline and compliance gap report per framework. Executive-ready summary generated automatically.
Continuous Monitoring Live Active
SENTINEL connects to all monitored models via API. Real-time drift detection, anomaly alerts, and behavioral monitoring begin immediately.
RTaaS & Adversarial Testing Active
First full red teaming cycle across all high-risk models. Vulnerabilities documented, remediation guidance issued, re-test scheduled.
Evidence Pack & Audit Ready Milestone
Full regulatory evidence pack generated per framework. Compliance dashboard shows live status across all six regulations. Ready for external audit or regulator submission.
Know Your Compliance
Score in 15 Minutes
Run our free AI Compliance Checker and receive a preliminary gap analysis across all six frameworks — no registration required.