EHDS Jurist

EHDS everywhere or just a layer on top?

EHDS everywhere or just a layer on top?

Building the EHDS as a new layer

Oskar Thunman wrote an insightful piece on how different countries prepare for the EHDS. More specifically, he describes how they build EHDS access services on top of their current national systems. As a legal expert in the field of  health data, I am astounded by the lack of discussion regarding to what extent the EHDS Regulation actually allows this.

Maximum harmonisation

There is an ongoing discussion on the correct interpretation of Article 1(8): can secondary data users individually choose whether to apply for an EHDS permit? That seems contrary to the concept of a permit, and the workings of EU law. However, a similarly open-to-interpretation article seems to be lacking in respect to the chapters on the primary use of health data and ICT. EU Regulations are usually based on maximum harmonisation. They prescribe the exact rules that will always apply in every Member State, unless the regulation explicitly states that Member States may deviate. This is currently the case with the GDPR: it applies directly and everywhere in the EU, not solely when data crosses member state borders. Article 9(4) of the GDPR allows for certain national deviations, but the EHDS states that Member States may no longer maintain these.

What would the EU court say?

So, I wonder how it is possible that everybody presumes that continuing ‘business as usual’ within national borders is legally allowed? It is not allowed under the GDPR either. Why the different reading? And thus, to answer Oskar Thunman’s question “now what,” I’d say: let’s go to the EU Court and force Member States to actually build one “European Data Space,” as the Regulation appears to prescribe?

ethische toets EHDS datavergunning

The EHDS prescribes a comprehensive and uniform assessment by the HDAB. A separate ethical assessment adds nothing and hinders science.

juridisch onderzoek gezondheidsgegevens

How does the EU define 'scientific research' in the Digital Omnibus? There has been criticism of this, but it is unjustified.

Many people are afraid that their jobs are at risk due to AI. I decided to turn the question around and asked Gemini: which jobs are you going to take over, in a way that make us happy? Here is her own optimistic answer.