ENS — Categoría ALTA
Certified conformity with Spain's National Security Framework (RD 311/2022), High category.
Compliance
Compliance built into every layer of the platform.
GDPRBuilt against GDPRHIPAABuilt against HIPAAEHDSReadiness foundations
ISO/IEC 27001CertifiedCertified
ISO/IEC 27001CertifiedCertifiedStandards
Embedded compliance for global healthcare standards.
GDPR · Built against GDPR
Strict European data sovereignty with EU cloud or air-gapped hosting.
HIPAA · Built against HIPAA
Cryptographic access controls and message auditing for US PHI streams.
EHDS · Technical foundations for readiness
Fast-track semantic alignment for the European Health Data Space framework.
ISO/IEC 27001 · Certified
Enterprise-grade information security across all execution layers.
ENS · Certified · High category (RD 311/2022)
Spain’s National Security Framework compliance for public health systems.
Certifications
Independently audited, with the evidence on file.
Security and residency
Your data, inside your perimeter.
Residency
EU data residency, with sovereign, air-gapped and on-premise options.
Encryption and isolation
AES-256-GCM at rest, TLS in transit, per-organisation credentials and row-level tenant isolation on every table.
Immutable audit
Append-only, hash-chained log; updates and deletes are blocked at database level; six or more years of retention.
PHI protection
HIPAA Safe Harbor and Expert Determination de-identification, DICOM de-identification and a fail-closed egress guard on every model call.
AI and medical devices
Clear about what the platform is, and what it isn't.
Health Software Infrastructure, not a medical device
The platform has no medical purpose on its own. The intended purpose of each workflow or agent decides its regulatory route — and that decision stays with you.
EU AI Act
Tiet · Agentic registers each AI system with its risk tier, applies versioned policy packs, and keeps evaluation and release evidence attached. The ISO/IEC 42001 on AI Management System certification is in progress.
Build in-house under MDR Article 5(5)
Eligible health institutions can build and use their own in-house medical devices under Article 5(5) of the EU MDR where its conditions are met. Tietai supplies the evidence pack, the technical infrastructure and the backend to support that route.
