Direct answer
We use AI in healthcare. Which AI Act rules apply there?
You describe: AI in a healthcare context, from triage and administrative support to AI in or around medical devices. Likely role: deployer (healthcare organisation).
This applies now
- Article 4: AI literacyApplicable
- Article 50: transparencyApplicable
Coming up
- Annex III: high-risk AIfrom 2 December 2027
Healthcare has two routes: AI under the medical device rules follows Annex I (from 2 August 2028), other use cases such as emergency call triage fall under Annex III (from 2 December 2027). AI literacy for healthcare staff applies now.
Your first actions
- Classify the use case and document the outcome. Assess Article 5, Article 6 and Annex III in that order and document purpose, context and any Article 6(3) exception.
- Take role- and context-specific AI literacy measures. Determine for each role, system and context which combination of instruction, guidance, practice or training is appropriate.
- Implement the applicable disclosure, marking or label. First determine which paragraph of Article 50 applies, then implement the specific transparency measure.
Record this
- Article 6 and Annex III classification record
- AI literacy measures record
- Transparency implementation record
General interpretation, not legal advice. The official source remains authoritative.
Full map for your situationExecution
Record the classification in an AI register
A classification without a register and ownership is not demonstrable. Embed AI guides classification, register and reassessment in a fixed approach.
See the Embed AI approach