The EHDS prescribes a comprehensive and uniform assessment by the HDAB. A separate ethical assessment adds nothing and hinders science.
Who can be member of the board?
The EHDS Board: a new job in Brussels
The European Health Data Space (EHDS) has been in force for a year. Currently, the European Commission is working hard on the practical elaborations. As a result, the first implementing regulation is now a fact. This regulation focuses on establishing the EHDS Board. But who is actually allowed to sit on this board on behalf of a Member State?
That question is less clear than it seems. Specifically, the EHDS stipulates that the board consists of two representatives per Member State. One member is appointed for primary data use, and the other for secondary use. This sounds quite broad. Consequently, you might think a country like the Netherlands can send anyone with relevant expertise. For example, this could be someone from the Health Data Access Body (HDAB) or a university professor. It could even be an expert from a national public health organization.
Affiliated with an authority?
However, the new implementing regulation tightens the reins. Member States must submit the names of their representatives. In addition, they must explicitly state to which “Member State authorities” these individuals are affiliated. What exactly is meant by this requirement? This can be interpreted in two different ways.
- The broad interpretation: This could mean any public authority of a Member State. This aligns perfectly with the broad European definition of ‘authority’, as seen in the Farrell judgment. Therefore, organizations like the RIVM or ZonMw could simply join as full members instead of advisory experts.
- The narrow interpretation: In this view, the word ‘authority’ refers exclusively to the Digital Health Authority (ADG) and the HDAB. This is analogous to how the GDPR handles the concept. In that case, we must establish these bodies quickly to participate in the EHDS Council.
Subgroups in the EHDS Board
Article 92(6) of the EHDS does not make the situation any clearer. It states that the Council may be divided into subgroups. Furthermore, it stipulates that the ADGs and HDABs must be represented in these specific subgroups.
Does this mean (a contrario) that the Board itself does not have to consist exclusively of such representatives? Or is this precisely proof that all Council members must come from those two specific authorities?
Preferably someone who sees the benefits
Ultimately, the answer to this question is crucial for structuring public data governance. If the narrow interpretation is correct, an organization like the RIVM cannot hold the seat for secondary use. However, excluding public health organizations would be a missed opportunity. Sending a representative who experiences the practical benefits of the EHDS seems like an excellent idea. Conversely, a regulator might act mainly from the perspective of enforcement and risk.
Therefore, I hope for the broad interpretation, but I fear the stringent one. If the narrow interpretation is indeed correct, quick action is essential. Member States must establish the ADG and the HDAB as soon as possible. Otherwise, they risk missing the first crucial meetings of the Board.
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