All use cases
Healthcare Digital Twins
A digital-twin provider modelling hospital outcomes uses AI to assess how treatments could improve, and must evidence every model-driven inference to stay compliant across the EU and UK.
The situation
A clinical digital-twin provider models hospital outcomes, using AI to assess how different treatments could improve patient results. Operating across the EU and UK, it must evidence every model-driven inference to satisfy medical-device and data-protection regimes in both. Aegis Trace seals each inference against the applicable framework, so the provider stays compliant on both sides of the Channel from a single trail.
The regulations
- EU MDR
- MHRA
- EU AI Act
- GDPR
- ISO 13485
The evidence
Each model-driven inference is sealed against the right framework.
POST /v1/decisions
{
"decision": "treatment_projection",
"regime": "EU_MDR",
"twin_id": "tw_3391",
"evidence": { "cohort": "anon", "metric": "los_reduction" }
}EU- and UK-aligned evidence from one trail.
{
"certificate_id": "crt_dt_6a24",
"status": "sealed",
"decision": "treatment_projection",
"regime": "EU_MDR",
"issued_at": "2026-03-14T09:21:07Z",
"inputs_hash": "sha256:3f8a…c1d2",
"model": { "name": "decision-engine", "version": "4.2.1" },
"signature": {
"alg": "ed25519",
"value": "MEUCIQD…Qz9w",
"anchored": "rfc3161"
}
}What the regulator receives
A sealed certificate for every model-driven inference, mapped to the applicable EU and UK frameworks, one trail that evidences compliance in both jurisdictions.