Ringholm-Logo Ringholm Ringholm page header
Training    |   Whitepapers    Blog    Events    About us    Partners    Clients    Contact
Home > Current column | Ringholm bv | rene.spronk@ringholm.com

EHDS Governance Models

Publication date: May 06, 2026

What's the EHDS governance model as documented in the regulation? Understanding that model will help to understand the EHDS itself.

Whilst developing the content for our new EHDS-on-FHIR training course (aimed at EHDS implementers) I found a need to include some slides on the EHDS governance model. Although not implementation-oriented the governance model provides context for content of the EHDS regulation.

EHDS Governance

The EHDS regulation documents the various governance roles. Initially I tried to create one single governance model for the entire scope of the EHDS, but that turned out to be impractical - the governance model for primary differs significantly from that of secondary use. Let's start by looking at the governance mode for primary use.


EHDS Governance - Primary Use

Key roles include:

  • Member States (EU/EEA members, shown in green), the European Comission (shown in blue) and the EHDS Board (shown in grey, controlled jointly by the EC and the member states).
  • The left hand side of the diagram depicts the comitology process whereby the comission and the meber states create implementing acts. Implementing acts are used to specify implementation details of the regulation. Implentaing acts will be defined up to the initial EHDS deadline of March 2029, as well as after that date.
  • The Digital Health Authority (DHA) has the responsibility to establish the MyHealth@EU infrastructure and the National Contact Point (NCP).
All governance roles shown in green are to be set up by member states - are you aware which (new) organisations will be playing these roles ? Most member states are still in the process of defining which organisations will be involved.

The governance model for secondary use looks quite different.


EHDS Governance - Secondary Use

Key roles include:

  • Member States (EU/EEA members, shown in green), the European Comission (shown in blue) and the EHDS Board (shown in grey, controlled jointly by the EC and the member states).
  • The left hand side of the diagram depicts the comitology process whereby the comission and the meber states create implementing acts. Implementing acts are used to specify implementation details of the regulation. Implentaing acts will be defined up to the initial EHDS deadline of March 2029, as well as after that date.
  • The Health Data Access Body (HDAB), one or more per member state, has the responsibility to establish the HealthData@EU infrastructure and the National Contact Point (NCP). The Union HDAB and the 'Authorised Participants' are efectively a special category of HDAB.
  • The roles shown in black identify the data users and data holders.

'All models are wrong, but some are useful" (attributed to George Box) - I'm sure these models are incomplete in places, but they'll serve us well as part of the EHDS training course.

-Rene

PermaLink to this page: https://www.ringholm.com/column/ehds-governance-model-primary-secondary-use.htm

Index of columns:

About Ringholm bv

Ringholm bv is a group of European experts in the field of messaging standards and systems integration in healthcare IT. We provide the industry's most advanced training courses and consulting on healthcare information exchange standards.
See https://www.ringholm.com for additional information.
Rene's Column (English) Rene is the Tutor-in-chief of Ringholm.
[e-mail]