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PlaceholderWave 2Owner: TBDReviewers: unassignedLast review: not yet reviewed
Who should read this:Policy makersLegal expertsSecurity advisorsData protection officers
Governance requirements to implement here:DG II.4DG V.1.1

2.1 Legal and regulatory constraints

In short
  • To be written: three plain-language bullets that answer the questions below.

What this page must answer​

  • Which legal acts apply (GDPR, EHDS Regulation 2025/327, the HealthData@EU implementing act (draft), NIS2, the EDIC implementing decision, national law)?
  • What does each act require from the architecture, in one line each?
  • Where does Genome EDIC sit in the EHDS (authorised participant under Art. 75(4) EHDS) and what does that imply for connection, compliance checks and incident notification?

Sources to start from​

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