AI Governance for a University Hospital
AI Governance Lead
A university hospital sought to deploy AI applications in diagnostics, documentation and patient services — from triage assistance to text classification and decision support. A governance framework integrating GDPR, medical device law and the EU AI Act was absent.
Approach
Development of an institution-wide AI governance framework with risk classification, validation processes and defined roles — compliant with the EU AI Act and MDR, and operable in a clinical context.
Outcomes
- Institution-wide AI governance framework with defined roles and processes
- Risk classification of all planned AI applications under the EU AI Act
- Validation and review processes established for new AI deployments
- Improved auditability vis-à-vis regulatory authorities