{"title":"Opting Out of Scientific Research with Health Data: The Limits of the EHDS and the GDPR.","authors":"Maret Kruus","doi":"10.1163/15718093-bja10141","DOIUrl":null,"url":null,"abstract":"<p><p>In the future, the European Health Data Space (EHDS) Regulation will enhance the secondary use of electronic health data in the EU, including for scientific research purposes. From the data subjects' perspective, the EHDS introduces a significant change, a new opt-out mechanism for the secondary use of data, in which data subjects shall have the right to opt out at any time without stating reasons. However, not all scientific research with health data will be covered by the opt-out rules of the EHDS. This article aims to clarify the effects of the EHDS' opt-out mechanism and its scope of application. It also suggests a balanced approach for Member States to implement the EHDS opt-out mechanism and reassess the implementation of the GDPR's right to object that remains relevant in the future in addition to the opt-out introduced by the EHDS.</p>","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":" ","pages":"1-25"},"PeriodicalIF":0.6000,"publicationDate":"2025-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"EUROPEAN JOURNAL OF HEALTH LAW","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1163/15718093-bja10141","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"LAW","Score":null,"Total":0}
引用次数: 0
Abstract
In the future, the European Health Data Space (EHDS) Regulation will enhance the secondary use of electronic health data in the EU, including for scientific research purposes. From the data subjects' perspective, the EHDS introduces a significant change, a new opt-out mechanism for the secondary use of data, in which data subjects shall have the right to opt out at any time without stating reasons. However, not all scientific research with health data will be covered by the opt-out rules of the EHDS. This article aims to clarify the effects of the EHDS' opt-out mechanism and its scope of application. It also suggests a balanced approach for Member States to implement the EHDS opt-out mechanism and reassess the implementation of the GDPR's right to object that remains relevant in the future in addition to the opt-out introduced by the EHDS.
期刊介绍：
The European Journal of Jewish Studies (EJJS) is the Journal of the European Association for Jewish Studies (EAJS). Its main purpose is to publish high-quality research articles, essays and shorter contributions on all aspects of Jewish Studies. Submissions are all double blind peer-reviewed. Additionally, EJJS seeks to inform its readers on current developments in Jewish Studies: it carries comprehensive review-essays on specific topics, trends and debated questions, as well as regular book-reviews. A further section carries reports on conferences, symposia, and descriptions of research projects in every area of Jewish Studies.
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