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Short abstract:

The European Health Data Space proposes a secondary use framework and establishing Health Data Access Bodies in each Member State. These bodies oversee processes and make decisions on data access applications. The study investigates whether HDABs can revolutionize healthcare data accessibility.

Long abstract:

The potential of AI to improve healthcare is widely recognized. It is a known fact that to develop AI technologies, data is a fundamental element. However, accessing high-quality health data is challenging due to special protection under the General Data Protection Regulation. The European Health Data Space (EHDS) aims to be the first domain-specific European data space under the European Strategy for Data policy, overcoming this hurdle stated as one of its goals. EHDS proposes to address this issue with its secondary use framework provisions. According to Articles 33-58, each Member State will establish a supervisory authority named Health Data Access Bodies (HDAB). HDABs will oversee the process and act as the decision-making body on several issues in the operation of secondary use. Many tasks are envisioned for HDABs, but the most pertinent ones could be summarized as follows: data holders shall provide the elements of their datasets (Art. 55/2), and they will make the data categories available to HDABs (Art. 33/1). Data access applications will be decided by HDABs (Art. 37/1), and while evaluating these applications, they will assess the application regarding the purposes for data use (Art. 34 and 35). This study will explore if this framework would make sense in actualizing the proposed system. As an initial finding, it is not clear how the system would prevent forum shopping. Thus, the question of whether HDABs can revolutionize healthcare data accessibility will be investigated.