Is this a medical device? Is it high-risk?
Someone needs to know which rules apply before this can proceed.
Regulatory content in this module is stated as of 28 August 2026 and reflects the AI Act timeline as amended by the 2026 digital omnibus package. Timetables, national implementation and guidance change; verify the current position against the primary sources in the references before any real decision. Nothing here is legal advice.
Start here
Regulatory & governance passport
Twelve fields that record what a system is, which rules apply, and who signed what.
Understand first
Three short lesson steps that make the answers mean something. Each opens directly at the right place in the course.
Practise
Also useful
Visual Guide 07 — AI Governance in Healthcare
Keep the terminology map next to you while you continue the technical track.
Go deeper
This pathway is the short route. The full module carries the cases, exercises and evidence behind it.
Module 9 — Regulation & Governance