{"entity":{"id":"european-health-data-space","kind":"term","name":"European Health Data Space Regulation (EU) 2025/327","aka":["European Health Data Space","EHDS","Regulation 2025/327","health data access body","health data access bodies","secondary use of health data","MyHealth@EU","HealthData@EU"],"tldr":"A 2025 EU regulation that gives patients electronic access to their health records across the Union and creates national bodies that can grant researchers, regulators and companies permission to use anonymised or pseudonymised health data, phased in over the rest of the decade.","summary":"European Union, regulation. Regulation (EU) 2025/327 on the European Health Data Space was published in the Official Journal on 5 March 2025 and entered into force on 26 March 2025, with its provisions applying in stages over the following years. Primary text: EUR-Lex.\n\nWhat it does: for primary use, patients gain a right to access and share their electronic health data in a common format across member states through the MyHealth@EU infrastructure, and electronic health record systems must meet interoperability rules. For secondary use, each member state sets up a health data access body that can issue data permits for research, innovation, policy and regulatory purposes over defined categories of data, including registries, genomic data and claims, delivered in secure processing environments, with a Union-level HealthData@EU network. Patients may opt out of secondary use. Uses such as marketing, insurance underwriting and decisions harmful to individuals are prohibited.\n\nWhy it matters for oncology and the arguments: cancer registries, molecular tumour boards and real-world evidence studies are among the prime intended beneficiaries, and the European Commission's Cancer Mission and the Beating Cancer Plan both counted on it. Industry welcomed a route through the GDPR's national maze; privacy groups and some medical associations fought for the opt-out and worry about re-identification of genomic data; hospitals worry about cost. The secondary-use provisions apply from 2029 for most data categories, so the system's real test lies ahead.","asOf":"2026-09-17","wikipedia":"https://en.wikipedia.org/wiki/European_Health_Data_Space","links":[{"label":"Wikipedia","url":"https://en.wikipedia.org/wiki/European_Health_Data_Space"},{"label":"EUR-Lex: Regulation (EU) 2025/327","url":"https://eur-lex.europa.eu/eli/reg/2025/327/oj"}],"tags":["law","eu"],"related":["gdpr","oncology-real-world-data","real-world-evidence","hipaa","uk-data-protection-act","eu-clinical-trials-regulation","eu-hta-regulation"],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":["b-data-silos","b-real-world-evidence"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"category":"Regulation & policy"},"route":"/terms/european-health-data-space/","neighbours":{"term":[{"id":"eu-clinical-trials-regulation","kind":"term","name":"Clinical Trials Regulation (EU) No 536/2014 and CTIS","route":"/terms/eu-clinical-trials-regulation/"},{"id":"eu-hta-regulation","kind":"term","name":"EU HTA Regulation (EU) 2021/2282: joint clinical assessments","route":"/terms/eu-hta-regulation/"},{"id":"gdpr","kind":"term","name":"GDPR and health data (Regulation (EU) 2016/679)","route":"/terms/gdpr/"},{"id":"hipaa","kind":"term","name":"HIPAA (Health Insurance Portability and Accountability Act)","route":"/terms/hipaa/"},{"id":"real-world-evidence","kind":"term","name":"Real-world evidence","route":"/terms/real-world-evidence/"},{"id":"uk-data-protection-act","kind":"term","name":"UK Data Protection Act 2018 and health data law","route":"/terms/uk-data-protection-act/"}],"technology":[{"id":"oncology-real-world-data","kind":"technology","name":"Oncology EHR and real-world data platforms","route":"/technologies/oncology-real-world-data/"}],"bottleneck":[{"id":"b-data-silos","kind":"bottleneck","name":"Data silos","route":"/bottlenecks/b-data-silos/"},{"id":"b-real-world-evidence","kind":"bottleneck","name":"Weak real-world evidence and registries","route":"/bottlenecks/b-real-world-evidence/"}]}}