All use cases
Healthcare

A clinical decision-support system flags a drug interaction. The MHRA needs the audit trail, validated, redacted, sealed.

The situation

A clinical decision-support system flags a potential drug interaction. The MHRA requires the audit trail behind that alert, validated, with patient data appropriately redacted, and sealed so it cannot be altered. Aegis Trace captures each model-driven inference with its clinical inputs redacted at source, producing an evidence trail that is both compliant and confidential.

The regulations

  • MHRA
  • EU MDR
  • GDPR (special category)
  • NHS DSPT
  • FDA SaMD

The evidence

The clinical inference is recorded with PII redacted at source.

POST /v1/decisions
{
  "decision": "flag_interaction",
  "regime": "MHRA_SAMD",
  "redaction": "phi_tokenized",
  "evidence": { "rxnorm": "1049502", "severity": "major" }
}

A validated, redacted, sealed audit record.

{
  "certificate_id": "crt_hc_1f60",
  "status": "sealed",
  "decision": "flag_interaction",
  "regime": "MHRA_SAMD",
  "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 validated audit trail for the alert with patient data redacted at source and the record cryptographically sealed, evidence that is compliant and confidential at once.

Evidence the moment the decision is made.