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AI Governance

Sigma Health

Fictional company. Used as a recurring case-study across the 12-stage journey — any resemblance to a real organisation is unintended.

Jurisdiction
European Union
Industry
Clinical decision support software
Protagonist
Dr Lukas Mertens — Head of AI Governance
Use-cases
  • Clinical note summarisation
  • Triage-acuity scoring
  • Discharge-letter drafting

Sigma Health operates under EU AI Act, MDR (Medical Device Regulation), and German federal health-data law. Their flagship product — a clinical-note summariser — is classified as a high-risk AI system under EU AI Act Annex III §5(a) (intended use in health emergency triage).

Sigma is the recurring EU-jurisdiction case study, with emphasis on conformity assessment, notified-body engagement, and the data-governance overhead of operating on patient records. Dr Mertens leads a five-person AI governance function that sits in the Quality + Regulatory department, not in Engineering.

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