AI Act in healthcare: qualify your systems and organise compliance
We start from the systems actually used or supplied to identify roles, obligations, risks and actions, then connect them with GDPR and health-data governance.
Who it is for
Providers and deployers of AI systems in healthcare, facilities, vendors and management teams governing professional AI use.
Situations that trigger the need
The best time to structure the issue is before an urgent request, procurement process or inspection dictates the timetable.
You do not yet have a reliable inventory of AI systems in use.
You need to determine your role and the obligations attached to one or more systems.
Teams use AI tools without a consistent approval and governance process.
A customer, partner or management team asks for a documented AI Act roadmap.
What we put in place
A clear scope, identified deliverables and a handover that can be used by the teams responsible for decisions, operations and assurance.
- Qualification of your systems under the AI Act.
- Mapping of obligations according to your roles.
- AI literacy programme for the teams concerned.
- Articulation of AI Act, GDPR and health data.
- Roadmap aligned with the regulatory timeline.
- Organisation of governance decisions and evidence.
Before we start
Should we start with an AI policy?
A policy alone does not show which systems are actually in use. We start with scope, use cases and roles, then build documentation around that reality.
Do you cover shadow AI?
Yes. Unapproved uses must be brought into governance so the organisation can distinguish what is allowed, conditional or prohibited and document the controls it chooses.
Does the work also cover GDPR?
Yes where personal data is processed. The objective is to avoid separate AI and privacy workstreams that produce inconsistent rules or evidence.
Discuss your need: AI Act healthcare
A first conversation to confirm scope, priorities and the most appropriate form of support.