BBMRI.at focuses on upcoming European Health Data Space (EHDS) Regulation

EHDS - a topic relevant for the Austrian Biobanking Community

All over the EU, doctors, nurses, pharmacists, researchers and health regulators generate and use large numbers of essential healthcare data.

The European Health Data Space (EHDS) is an ambitious project which aims to generate an EU-wide common health data governance framework allowing the seamless exchange across EU countries. The EHDS establishes rules, common standards and practices, infrastructures and a governance framework for both the primary and secondary use of electronic health data across the European Union (EU). The EHDS Regulation was approved by the European Parliament in April, 2024 and will be published (and, consequently, will enter into force) this autumn. As part of the European strategy for data, the EHDS Regulation introduces new actors and procedures to allow the secondary use of electronic health data.

The decision to organize a webinar and workshop on this legal topic was made considering the needs and interest expressed by the BBMRI.at Biobank partners and medical universities. The aim was to bring attention to the upcoming EHDS Regulation and its implications for biobanks and research using biobank samples.

As potential ‘health data holders’ within the meaning of the Regulation, also biobanks are affected, as they will be required to make the electronic health data they store available to a wide range of users within the European Union. This will enhance their role as interfaces between researchers and data.

BBMRI.at webinar & workshop - “Use of data in the EHDS and biobanks: Changes, opportunities and possible implementations“

From all BBMRI.at consortium members, biobankers, researchers, clinicians, managers, and representatives from legal departments participated in the webinar which was followed by a workshop.

The BBMRI.at experts from BBMRI.at WP2 “Legal and Regulatory Challenges and Opportunities” provided a brief introduction and overview of the EHDS and its provisions regarding secondary use of health data. Emphasis was placed on the progression from the General Data Protection Regulation (GDPR) to the EHDS Regulation and the new concepts and actors introduced by the Regulation.

The main section of the webinar was dedicated to the general implications of the EHDS Regulation for biobanks, which extends from the potential qualification of biobanks as data holders to ethical issues that biobanks may face when coordinating the legal permissibility of secondary data processing and protecting the rights of sample donors as data subjects.

The potential implementation of the EHDS in Austria was covered in the final section of the webinar. The legal experts introduced the Regulation’s opening  clauses, which describe those situations in which Austria has further discretion to implement the Regulation in line with the existing national framework. For example, Austria has discretion with respect to   the configuration and number of the Health Data Access Bodies (HDABs), which every EU member state has to set up.” The legal experts explained: “Under the EHDS, every member state has to make their electronic health data available to such public health data access bodies (HDABs). These will then make the data available in a secure environment to health data users (researchers) who obtained a permit.”.

The webinar was recorded and is now available to the wider public below and in the Legal Knowledge Base on the BBMRI.at website (coming soon)

The webinar was followed by a workshop which included a discussion based on a case study scenario developed by WP2. The discussion centered on the implementation of the EHDS Regulation and on the secondary use of health data.

Results and upcoming activities 

As one of the outcomes from the workshop, BBMRI.at WP2 received a request to further discuss the topic of the ethical and legal issues pertaining to consent, as they emerge within the Austrian legal landscape and the upcoming EHDS Regulation. This is going to be addressed in an upcoming workshop (planned for autumn/winter 2024) and the conclusions from the meeting’s discussion consolidated into a resource for the legal Knowledge Base.