Clinical AI usually qualifies as a medical device under EU rules and is therefore high-risk under the AI Act, while administrative AI usually is not. The product's stated intended purpose decides which category applies. Classifying Clinical AI under the EU AI Act The EU AI Act's "high-risk list" names only a few healthcare uses, but that list is not the main route for clinical AI. AI that diagnoses, guides treatment, or monitors a patient's condition is usually a medical device under EU rules...

Validaitor is going to be exhibiting at Infosecurity Europe 2026, 2-4 June.

AI governance and EU AI Act readiness insights from ENBW