Published on 22.09.2023 22.09.2023

TEHDAS requires clarity for cross-border provisions in EHDS

For the secondary use of health data to function seamlessly across the EU, legislation and guidelines need to be clear. The European health data space (EHDS) is currently not sufficiently accurate to ensure the consistent realisation of the regulation across member states.

A recent report by the joint action Towards the European Health Data Space (TEHDAS) calls for clarification of the provisions in the EHDS concerning the secondary use of health data across the EU borders. The report argues that in its current form the EHDS is not precise enough to enable harmonised implementation across the member states.

The report contains several recommendations to address ambiguous points in the EHDS proposal given by the European Commission in May 2022 before the regulation is agreed upon in the legislative procedure. These include:

• Providing guidelines to member states for establishing the health data access bodies (HDAB) and dedicating significant human, technical and financial resources, given the multitude of tasks assigned to the bodies. Each member state will create one or more health data access bodies to enable access to health data for secondary purposes.
  
  
• Clarifying the role and responsibilities of the national coordinator of the health data access bodies in member states in cases where there are several bodies involved.
  
  
• Refining the concept of mutual recognition. The EHDS proposal includes the intention that the health data access bodies will collaborate but doesn’t specify how. Mutual recognition means that a data permit issued by one health data access body in one country would be recognised by a health data access body in another country.
  
  
• Providing a clear answer to whether pooling data from multiple countries to one secure processing environment, meaning transferring data cross-borders, is possible. The use of secure processing environment takes place after a data permit has been granted.
  
  
• Addressing the language regime. For instance, metadata catalogues (information about data) are often only available in the local language.
  
  
• Designing fee policy to consider the different phases of using data, such as preparing data and making it available for research.
  
  
• The European Commission could provide a model for data use agreements between HDABs and data users, such as researchers, that would include conditions of use. This would avoid the need for each member state to develop its agreements.

Currently, researchers who need data from several European countries for their research are faced with diverging national authorisation processes, which are often untransparent and lengthy. Furthermore, their work is complicated by the fact that the procedures often cannot be conducted in English and that the data available may not be interoperable.

This concludes the work of TEHDAS on data governance.

The project steering group has approved the report. The European Commission gives final approval to all joint action’s deliverables.