Xybern

AI that regulated healthcare
can actually trust.

Healthcare AI agents handle sensitive patient data and must comply with strict regulations including HIPAA, EU MDR, and GDPR. Xybern's authorisation layer intercepts every agent action before execution, giving compliance teams a full audit trail and an enforceable decision record. From clinical decision support to AI-assisted medical devices, every action is authorised before it runs.

How Xybern helps

Two products. One enforcement layer.

Product 01

Authorisation Layer

Authorisation at every clinical touchpoint.

  • Intercepts every AI action before it touches patient data or clinical records.
  • Applies HIPAA, EU MDR Article 22, and GDPR rules at the point of execution, not after.
  • Produces a timestamped, immutable audit trail ready for CQC and notified body review.
  • Prevents unauthorised access to patient records, clinical notes, and device data.
Learn about the Authorisation Layer

Product 02

Authorised Agents

Agents built for clinical compliance from day one.

  • Pre-built agents for clinical documentation, post-market surveillance, and MDR reporting.
  • Every agent action is cleared through the authorisation layer before it executes.
  • Designed to operate inside hospital networks and regulated cloud environments.
  • Skills for clinical evaluation reports, adverse event logging, and regulatory submissions.
Learn about Authorised Agents

Deployments

Real-world authorised AI.

MedStride

AI-powered medical device compliance.

MedStride deploys Xybern's authorisation layer to enforce MDR Article 22 requirements across AI-assisted clinical documentation workflows. Every agent action is intercepted, evaluated against regulatory rules, and logged to an immutable audit trail before execution.

Read case study →

Deploy in your organisation

Bring authorised AI
to Healthcare.

Talk to us about deploying Xybern in your healthcare environment. We work directly with your compliance and technical teams.

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