Healthcare under the EU AI Act: Your Compliance Guide

Clinical decision-support systems that help diagnose or treat patients are treated as high-risk under the EU AI Act. Companies must keep technical documentation, ensure human oversight, and log every assisted decision. Even wellness chatbots that only give general health tips usually stay outside the high-risk rules.

Do you come under the EU AI Act?

The EU AI Act reaches any company whose AI output is used in the European Union — regardless of where the company is based. If your product has EU users or clients, the rules apply to you. The first question is always the same: which risk tier does your system fall into, and what duties come with that tier?

Which risk tier applies to you?

The Act sorts AI into four tiers: prohibited (banned outright), high-risk (heavy duties), limited-risk (transparency only), and minimal-risk (no mandatory duties). Most software starts in limited or minimal risk. The expensive surprises live in high-risk and prohibited — which is exactly why scanning early matters.