EU AI Act for Healthcare

A sector track that gives clinical and operational staff the Article 4 literacy they need to place clinical AI on the right side of the EU AI Act — in the context of the medical-device and data-protection law they already work under, from risk classification and deployer duties through oversight, data, incidents, patient transparency and procurement.

What you’ll cover

1. 1
   How the EU AI Act reaches clinical AI

   Map clinical AI onto the Act's risk tiers: the MDR/IVDR overlap that makes most clinical software high-risk via Art. 6(1), the Annex III edges that still matter, provider versus deployer roles, the prohibited practices, and when each duty starts to bite.

   35 min · 3-question quiz
2. 2
   Patient safety, human oversight & automation bias

   Understand what the Act means by effective human oversight of clinical AI (Art. 14 on providers, Art. 26(2) on you), recognise automation bias and de-skilling, keep use inside the instructions for use, and make oversight work under real ward conditions.

   35 min · 3-question quiz
3. 3
   Clinical data governance & bias

   Understand why representative clinical data is a legal requirement (Art. 10 on providers, Art. 26(4) on you), recognise where clinical bias comes from, manage the GDPR overlap for health data, and run practical input-data checks before and after go-live.

   30 min · 3-question quiz
4. 4
   Incidents, monitoring & the paper trail

   Know what counts as a serious incident and the Art. 73 reporting deadlines, understand how the Act's reporting dovetails with MDR vigilance, keep the monitoring and log evidence Art. 26 demands, and build a feedback loop that catches drift and near-misses.

   30 min · 3-question quiz
5. 5
   Patient transparency, rights & governing your AI estate

   Know what patients must be told and when, the explanation right that attaches to Annex III decisions, what to demand at procurement of CE-marked AI, and the inventory and literacy cadence that keep the whole programme audit-ready.

   35 min · 3-question quiz