Interoperability and governance in the European Health Data Space regulation

Abstract

The proposal for a regulation on the European Health Data Space (EHDS) is a much-awaited project. It aspires to create a harmonised framework – a common European data space – for the administration of health data (primary use) across Member States and the promotion of healthcare research and innovation (by establishing rules for the secondary use of health data). As such, although the EHDS proposal is a legal document, in its essence, it includes provisions that introduce not only legal, but also institutional, and technical-infrastructural changes. Overall, together with the Regulation 2017/745 on medical devices, the Data Governance Act (DGA), the Data Act, the AI Act, and the General Data Protection Regulation (GDPR), the EHDS proposal will complete the regulatory canvas for the use of health data in the European Union. Although we are supportive of the EHDS initiative, there are aspects of the proposal that require further debate, reconsideration, and amendments. Following previous work on potential power asymmetries encapsulated in the Proposal, in this commentary, we focus on the provisions of/for interoperability of the Electronic Health Record (EHR) systems (Ar. 14–32) as well as the provisions on the structure of Health Data Access bodies and their cross-border organisation (section 3). We recommend a series of amendments to orientate the EHDS project better to its constitutive goals: the promotion of public health research and respect for the rights of the individuals.