HAS 6th Cycle & EU AI Act Ready

The governance framework
your clinical AI needs

Custos gives healthcare institutions the evidence trail, compliance infrastructure, and oversight framework to deploy AI with confidence — and defend every decision.

Request a free AI maturity audit → How it works
100%Decision traceability
HAS6th cycle aligned
EU AI ActCompliance-ready
The problem

AI is entering your hospital.
Can you prove what happens next?

🔍

The discoverability trap

When a patient challenges an AI-assisted decision, can you demonstrate exactly who was alerted, what was flagged, and what action was taken? Today, that trail doesn't exist.

⚖️

The override paradox

Clinicians override AI recommendations daily — but no system documents why. Each undocumented override becomes a liability waiting to surface.

👻

Shadow AI

AI tools are already embedded in your clinical software. Most institutions have no visibility into which tools are running, how they're used, or what decisions they influence.

The solution

Clinical AI governance,
built for healthcare

Custos connects to your existing systems and provides the governance framework that unlocks safe, compliant AI adoption.

01

Legally defensible audit trails

Every AI alert, every clinical decision, every override — documented in an immutable, timestamped record that holds up under legal scrutiny.

02

Continuous compliance

Stay aligned with HAS 6th cycle criteria, the EU AI Act, and RGPD requirements — automatically, without diverting your teams to manual reporting.

03

Full AI visibility

Map every AI tool in your institution — embedded or standalone. Know what's running, who's using it, and how it impacts clinical decisions.

The regulatory window

Three deadlines are converging.
Preparation starts now.

Sept 2025
HAS 6th Cycle

AI governance is now a specific evaluation criterion in the certification framework.

Oct 2025
HAS A.V.E.C. Guide

First official governance framework for generative AI usage in healthcare institutions.

Aug 2027
EU AI Act

Full enforcement of high-risk AI system requirements — healthcare classified as high-risk.

A guardian for the age of clinical AI

Healthcare is embracing AI at unprecedented speed. But adoption without governance creates invisible risk — for patients, clinicians, and institutions alike.

We built Custos because we believe the institutions that govern AI well will be the ones that benefit from it most. Not by slowing innovation down, but by giving it the framework it needs to earn trust.

Custos is designed for the European healthcare landscape — built around HAS certification requirements, French bioethics principles, and the EU AI Act — because governance shouldn't be an afterthought imported from another system.

Custōs
Latin — noun, third declension
Guardian. Watchkeeper. Protector.

In Roman law, the custos was the appointed guardian of what mattered most — charged with vigilance, accountability, and the duty to act. In clinical AI governance, the role is the same: ensuring every decision is watched over, every action traceable, every responsibility clear.
Custos — Clinical AI Governance Platform Custos.CHU de Lyon — Pilote Dashboard Audit TrailOverride LogAI RegistryComplianceBreach DossierStakeholder Map GLAdmin Governance OverviewLast updated: March 5, 2026 — 14:32 CET Compliant REFLEXIVITY INDEX87% AI SYSTEMS TRACKED12+3 new OVERRIDE RATE4.2% AUDIT EVENTS2.4kThis month Decision Traceability TimelineAI alerts, overrides & clinical actions — 30 days ResolvedTotal eventsOverrides Recent Activity AI Alert #1847 — ResolvedDr. Martin — Cardiology — 2min ago Override #312 — DocumentedDr. Lefèvre — Oncology — 18min ago New AI system registeredPathologyAI v2.1 — DSI — 1h ago View all activity → Compliance Status ✓ HAS 6th Cycle18/18 criteria met ✓ EU AI ActHigh-risk ready ✓ RGPDConforme ⟳ HAS A.V.E.C.3/4 directives Falsifiability Idx0.92 — High validity

Start with clarity

A free, no-commitment AI maturity audit on your institution. In two weeks, get a concrete map of your AI landscape, risk exposure, and compliance gaps.

Request your audit

We'll reach out within 24 hours to schedule.

Free for healthcare institutions. No engagement required.