We use AI in healthcare. Which AI Act rules apply there?

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

1. 1Justify the Article 6(3) exception against each individual condition. Name which of the four Article 6(3) conditions you invoke, with facts, and separately justify why the system poses no significant risk of harm to health, safety or fundamental rights and does not materially influence the outcome of decision making.
2. 2Take role- and context-specific AI literacy measures. Determine for each role, system and context which combination of instruction, guidance, practice or training is appropriate.
3. 3Implement the applicable disclosure, marking or label. First determine which paragraph of Article 50 applies, then implement the specific transparency measure.