Why Altio is not a high-risk AI system under the EU AI Act

Classified by function

Under the EU AI Act, systems get classified by what they actually do, not by what technology powers them. Altio functions as human-in-the-loop decision support: every regulated decision, a signal assessment, a submission response, is made by a qualified human expert. The system does not decide; it assembles the traceable evidence a decider needs.

Beyond what the classification requires

That functional role is the basis for our risk profile: minimal/limited risk, not classified as high-risk. We did not stop there: we meet the Act's transparency (Article 50) and AI literacy (Article 4) duties, marking AI-assisted content in a form software can detect, and we adopted Article 95 codes of conduct voluntarily, because a regulated life-sciences customer should not have to ask.

Evidence over claims

Compliance built on evidence, an actual risk-classification assessment, a documented rationale, holds up under scrutiny in a way that a marketing claim does not. That evidence is public in our Provider Evidence Package: 25 governance templates across 8 modules, mapped against ISO 42001, GxP, 21 CFR Part 11, GDPR, and CIOMS AI in Pharmacovigilance.