The European Health Data Space (EHDS)

What is the European Health Data Space?

The European Health Data Space (EHDS) is an initiative to facilitate the exchange of electronic health records (EHRs) between healthcare providers in the European Union. The aim is to create a common set of standards and interoperability frameworks for EHRs, which will allow for the exchange of patient data between different healthcare systems across Europe, as well as to improve the use of health data for research, innovation, and policy-making. 

What are the main pillars of EHDS? 

European Health Data Space focuses on 2 main pillars, which concentrate on the primary use of data and the secondary use of data. 

The primary use of data aims at giving individuals digital access and control of their electronic health data – both at national and EU-wide levels. It should also enable Healthcare Professionals to have access to relevant health data of their patients, across borders, supporting the free movement of people and their health information. 

The secondary use of data focuses on providing a consistent and trustworthy setup for the further use of anonymized health data, for research and innovation. It should also help policy-makers make better decisions based on relevant non-identifiable health data.

What are the problems EHDS is trying to solve?

European Health Data Space is, above all, trying to solve the problem of different legislative frameworks in different member states with regard to health data.  

Regarding the primary use of data, it’s addressing the problems of the limited control of patients over their health data, as well as the limited interoperability between healthcare providers.  

On the secondary use of data, it focuses on the low reuse of health data and hard access to both national and international datasets for the researchers and MedTech companies.  

What are the challenges of EHDS?

There are a number of challenges that need to be addressed before the European Health Data Space can be fully implemented, including:  

  • Ensuring that member states have adequate infrastructure in place to support the exchange of electronic health records; 
  • Ensuring that healthcare providers have the necessary skills and training to use the common infrastructure and frameworks;  
  • Ensuring that patient data is protected; and  
  • Ensuring that privacy is respected. 

What are the implications of EHDS for hospitals?

According to the current proposal, all healthcare providers (including i.e. hospitals) will be obliged to integrate with the cross-border digital infrastructure for the primary use of data (MyHealth@EU) to ensure the secure sharing of patient data between the borders.  

In addition, all data holders, such as hospitals and health institutions, will be required to catalogue all the data they hold and make it available to data users (such as researchers and businesses), who can apply to the national health data access authorities to access data held by data holders. Data holders will be required to make data available to data users on the basis of an authorized request.

Meanwhile, all data made available for secondary use will have to be anonymized or pseudonymized, but the regulation does not specify any details of a common mechanism for this at the moment. Therefore, we can currently assume that the process of anonymization and data sharing will be part of the data holder’s obligation.

Why is EHDS important?

The European Health Data Space is the first European Data Space, created based on the European Strategy for data. The strategy aims at creating a single market and common standards for data, which should ensure Europe’s global competitiveness and data sovereignty.  

The COVID-19 pandemic has shown the great need for the digitalization of healthcare services. EHDS should allow for better coordination of care, and help to improve the quality of care for patients. It should also help to ensure that patient data is protected and that privacy is respected.

What are the next steps of EHDS?

The Proposal for a Regulation on the European Health Data Space has been put forward by the European Commission and should be further discussed by the Council and the European Parliament. The goal is to implement the frameworks in all member states by the end of 2025.

If you are interested in more details about the EHDS, here are a few useful links:

Medical data anonymization and sharing

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