Health Data that Follows the Patient: The European Health Data Space and its Perspectives for Clinical Practice, Clinical Studies, and AI

Health data are generated across Europe in great volume, yet remain distributed across institutions, registries, and national systems that do not communicate. For clinicians, relevant information is hard to assemble, and eligible patients remain invisible to research. The European Health Data Space (EHDS) Regulation is the EU’s response. Its primary use is setting common interoperability requirements and individual rights, so that records can be exchanged and accessed by citizens and HCPs across systems and borders. Its secondary use is to establish a governance framework in which national Health Data Access Bodies (HDAB) grant controlled access for research, innovation, and policy-making. Most obligations will apply in stages from 2029. This article considers the implications for clinical practice, clinical studies, and AI, with examples from two European projects. REpresentative Clinical Research – ADvancing Inclusivity in Europe (READI) addresses the representativeness of clinical studies, in part by helping study sites and patients find each other. The Supporting Health Data Access Bodies to establish AI pathways enabling Deployment of AI as medical device tools (SHAIPED) project examines HDAB pathways for AI-based medical devices, including the transportability of a chronic kidney disease risk model to other European countries. The EHDS offers a foundation, not a guarantee: legacy systems, uneven digital maturity, partly paper-based documentation, governance, and patient trust will shape whether better access translates into more equitable care and research. Whether implementation narrows or widens existing gaps between member states remains open.