The Act is not a threat to an audit-grade product. It is a tailwind. Every requirement it places on high-risk clinical AI, Axiisium already treats as the point of the product, not a compliance tax bolted on afterward.
Art. 12 & 19 · Record-keeping
Automatic, durable logs
High-risk systems must automatically log events and retain them for at least six months.
Axiisium binds every decision to a signed, tamper-evident record, anchored to an external append-only log. Not just retained: independently verifiable, by anyone, without trusting us.
Art. 13 · Transparency
Legible capabilities and limits
Operation must be transparent: intended purpose, accuracy level, and limitations disclosed to the deployer.
Each call shows which signal drove it, a calibrated confidence, the WHO 2022 / ICC 2022 rationale, and states plainly what is assumed and what is deferred.
Art. 14 · Human oversight
The clinician decides
Systems must let a competent human monitor operation, catch anomalies, and intervene.
A qualified clinician makes the diagnosis; a confirmatory assay gates any decision; the model ranks who to sequence but never makes the genetics call. Fail-safe by architecture, not by policy.
Art. 15 · Accuracy & robustness
Measured, not asserted
Appropriate accuracy, robustness, and cybersecurity, declared and evidenced.
Morphology assessed at a preliminary, patient-grouped, leakage-free 0.894 ±0.066 AUROC (small held-out N; external-cohort validation pending), calibrated confidence bands, and a configurable recall-floor that bounds the false-negative rate.
Art. 9 · Risk management
Safe by construction
A continuous risk-management process across the lifecycle.
The ranking cannot itself drive an unconfirmed clinical action: mandatory confirmatory gating and the recall-floor are properties of the pipeline, and it defers hard markers to the assay.
Art. 10 · Data governance
Provenance of the inputs
Training and evaluation data governed for quality and representativeness.
Validation is patient-grouped and leakage-free, and each signed record carries a digest of the exact inputs that produced the call.