Getting Ready for Research Using the European Health Data Space

Author(s)

Petra Wilson, -, Health Connect Partners, FTI Consulting, Brussels, Belgium and Adam Day, -, FTI Consulting, Brussels, Belgium

Presentation Documents

Opening and introduction to the European Health Data Space Regulation, setting out its key building blocks of FAIR data; interoperability standards; governance; and infrastructure.

We will then zoom in on secondary use, setting out the EHDS model for Health Data Access Bodies, Secure Processing Environments, the role of single data holders, the rights to citizens and the duties of data holders and researchers. In this we will outline what is already set in the Regulation, and the gaps which are still to be addressed in secondary legislation.

Following this 15-minute introduction we will open a polling asking people to rate which aspects of the new EHDS they believe are most worrying, and where they would like to push their country and the EU to take particular action. Based on the voting we will share background information on what we see emerging in Brussels and beyond to address the problem issues voted most problematic (a number of candidate issues will be shown on a slide). In order to avoid a negative focus, we will then asks for votes on the most positive aspects, and again provide Brussels commentary on those issues.

We will close the session with a final vote in which we ask participants to rate their current access to data for secondary research from 1-10 and then to predict how the EHDS may impact this number.

Conference/Value in Health Info

2024-11, ISPOR Europe 2024, Barcelona, Spain

Code

112

Topic

Organizational Practices

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