{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T03:03:24Z","timestamp":1790046204559,"version":"4.0.1"},"reference-count":144,"publisher":"Cambridge University Press (CUP)","license":[{"start":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T00:00:00Z","timestamp":1790035200000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J. Law. Med. Ethics"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Digitalization and data-driven research are widely recognized as key drivers of innovation in healthcare, with the potential to improve clinical outcomes, accelerate research, and support evidence-based policymaking. Nevertheless, across jurisdictions, obstacles such as fragmented data governance, limited interoperability, and tensions between data protection and data reuse continue to hinder the effective use of health data. The Regulation on the European Health Data Space (Regulation (EU) 2025\/327) represents a significant shift in EU health data governance. It seeks to create a single European market for health data by introducing harmonized rules, shared technical standards, and new institutional structures, while simultaneously reinforcing patients\u2019 rights, access to their data, and control over its use. This paper aims to provide a clear and systematic account of the Regulation for a broad international and interdisciplinary audience. It situates the legal piece within its broader political and legal context, highlighting the factors that shaped its design and providing a comprehensive analysis of its core concepts. Using the patient opt-out regime as a case study, the paper critically examines the enduring tensions between safeguarding fundamental rights, ensuring patient autonomy, and fostering innovation and economic objectives, all while accommodating national preferences.<\/jats:p>","DOI":"10.1017\/jme.2026.10284","type":"journal-article","created":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T02:39:46Z","timestamp":1790044786000},"page":"1-12","source":"Crossref","is-referenced-by-count":0,"title":["The EHDS Regulation: Health Data at the Crossroads of Patient Autonomy, Data Protection, and Innovation"],"prefix":"10.1017","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3405-0359","authenticated-orcid":false,"given":"Elisabeth","family":"Steindl","sequence":"first","affiliation":[{"id":[{"id":"https:\/\/ror.org\/01v1jam04","id-type":"ROR","asserted-by":"publisher"}],"name":"Ludwig Boltzmann Institute for Digital Health and Patient Safety"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"56","published-online":{"date-parts":[[2026,9,22]]},"reference":[{"key":"S1073110526102848_r25","first-page":"498","article-title":"Disruptive and Avoidable: GDPR Challenges to Secondary Research Uses of Data\u201d; Ciara Staunton et al., \u201cEthical and Social Reflections on the Proposed European Health Data Space","volume":"32","author":"Peloquin","year":"2024","journal-title":"European Journal of Human Genetics"},{"key":"S1073110526102848_r45","unstructured":"45. Slight delays for technical reasons are tolerated. Additionally, it is possible to delay access for a limited amount of time for the protection of patients. EHDS recital 10 exemplifies that it may be unethical to inform patients through an electronic channel about a diagnosis of an incurable disease likely to be terminal before consulting with the patient."},{"key":"S1073110526102848_r118","unstructured":"118. Draghi, Mario , The Future of European Competitiveness: Part A: A Competitiveness Strategy for Europe Report (Publications Office of the European Union, 2024). https:\/\/commission.europa.eu\/topics\/competitiveness\/draghi-report_en (last visited December 27, 2025)."},{"key":"S1073110526102848_r76","unstructured":"76. EHDS art. 55."},{"key":"S1073110526102848_r137","unstructured":"137. Svingel et al., \u201cShaping the Future EHDS: Recommendations for Implementation of Health Data Access Bodies in the HealthData@EU Infrastructure for Secondary Use of Electronic Health Data.\u201d"},{"key":"S1073110526102848_r58","unstructured":"58. EHDS art. 75."},{"key":"S1073110526102848_r99","unstructured":"99. Petro\u010dnik, Tja\u0161a , \u201cSecondary Use of Health Data in the EHDS: Public Interest and the Role of HDABs.\u201d"},{"key":"S1073110526102848_r22","unstructured":"22. See also GDPR recital 52."},{"key":"S1073110526102848_r19","unstructured":"19. GDPR art. 9(1)."},{"key":"S1073110526102848_r93","unstructured":"93. Staunton, Ciara et al., \u201cEthical and Social Reflections on the Proposed European Health Data Space.\u201d"},{"key":"S1073110526102848_r60","doi-asserted-by":"publisher","DOI":"10.1093\/eurpub\/ckaf033"},{"key":"S1073110526102848_r37","unstructured":"37. Health data holders are legally defined in EHDS art. 2(2)(t)."},{"key":"S1073110526102848_r52","unstructured":"52. EHDS art. 23."},{"key":"S1073110526102848_r65","unstructured":"65. Donia and Marelli, \u201cAnticipating Ethical and Social Dimensions of the European Health Data Space: A Rapid Systematic Review.\u201d"},{"key":"S1073110526102848_r86","doi-asserted-by":"publisher","DOI":"10.71265\/z7r0t122"},{"key":"S1073110526102848_r127","unstructured":"127. Cervera de la Cruz and Shabani, \u201cFair Enough? Exploring the Role of Fairness in Secondary Uses of Health Data in the European Health Data Space.\u201d"},{"key":"S1073110526102848_r134","unstructured":"134. Misek et al., \u201cGuideline for Health Data Access Bodies on Implementing Opt-Out from the Secondary Use of Health Data.\u201d"},{"key":"S1073110526102848_r103","unstructured":"103. Consumer Attitudes to Health Data Sharing: Survey Results from Eight EU Countries (BEUC, 2023), https:\/\/www.beuc.eu\/reports\/consumer-attitudes-health-data-sharing."},{"key":"S1073110526102848_r135","unstructured":"135. Misek et al., \u201cGuideline for Health Data Access Bodies on Implementing Opt-Out from the Secondary Use of Health Data.\u201d"},{"key":"S1073110526102848_r84","doi-asserted-by":"publisher","DOI":"10.5281\/zenodo.20266473"},{"key":"S1073110526102848_r1","unstructured":"1. Regulation (EU) 2025\/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011\/24\/EU and Regulation (EU) 2024\/2847, OJ (L 2025\/327)."},{"key":"S1073110526102848_r8","unstructured":"8. Consolidated versions of the Treaty on European Union and the Treaty on the Functioning of the European Union, October 16, 2012, 2012 OJ (C 326) [hereinafter TFEU]."},{"key":"S1073110526102848_r32","unstructured":"32. EHDS art. 105."},{"key":"S1073110526102848_r11","unstructured":"11. Donia and Marelli, \u201cAnticipating Ethical and Social Dimensions of the European Health Data Space: A Rapid Systematic Review.\u201d"},{"key":"S1073110526102848_r42","unstructured":"42. GDPR art. 15."},{"key":"S1073110526102848_r80","unstructured":"80. EHDS art. 69."},{"key":"S1073110526102848_r77","unstructured":"77. EHDS art. 57\u201359. For first draft guidelines for HDABs see TEHDAS2, Public consultations https:\/\/tehdas.eu\/public-consultations\/ (last visited December 22, 2025)."},{"key":"S1073110526102848_r5","volume-title":"Assessment of the EU Member States\u2019 Rules on Health Data in the Light of GDPR","year":"2021"},{"key":"S1073110526102848_r121","unstructured":"121. Petro\u010dnik, Tja\u0161a , \u201cSecondary Use of Health Data in the EHDS: Public Interest and the Role of HDABs.\u201d"},{"key":"S1073110526102848_r53","unstructured":"53. EHDS art. 24."},{"key":"S1073110526102848_r139","unstructured":"139. Misek et al., \u201cGuideline for Health Data Access Bodies on Implementing Opt-Out from the Secondary Use of Health Data.\u201d"},{"key":"S1073110526102848_r101","unstructured":"101. Donia and Marelli, \u201cAnticipating Ethical and Social Dimensions of the European Health Data Space: A Rapid Systematic Review.\u201d"},{"key":"S1073110526102848_r70","unstructured":"70. EHDS art. 48."},{"key":"S1073110526102848_r24","unstructured":"24. Donnelly and McDonagh, \u201cHealth Research, Consent and the GDPR Exemption\u201d; Becker et al., \u201cCOVID-19 Research: Navigating the European General Data Protection Regulation.\u201d"},{"key":"S1073110526102848_r74","unstructured":"74. First guidance on the implementation of EHDS art. 54 EHDS can be found in Andacheh, et al., \u201cGuideline for Health Data Access Bodies on Minimum Categories and Limitations on the Reuse of Health Data,.\u201d"},{"key":"S1073110526102848_r71","unstructured":"71. EHDS art. 48."},{"key":"S1073110526102848_r87","unstructured":"87. GDPR recital 26. See also \u201cGuidelines 01\/2025 on Pseudonymisation,\u201d European Data Protection Board, January 16, 2025, https:\/\/www.edpb.europa.eu\/public-consultations\/guidelines-012025-on-pseudonymisation_en."},{"key":"S1073110526102848_r95","unstructured":"95. EHDS recital 61. See also Directorate-General for Health and Food Safety, \u201cFrequently Asked Questions on the European Health Data Space,\u201d section 39; Andacheh, et al., \u201cGuideline for Health Data Access Bodies on Minimum Categories and Limitations on the Reuse of Health Data.\u201d"},{"key":"S1073110526102848_r122","unstructured":"122. EHDS art. 10."},{"key":"S1073110526102848_r30","unstructured":"30. \u201cEnsuring the Full Potential of EHDS: Stakeholders\u2019 Recommendations on How to Make the Digital Transformation a Success Across Europe,\u201d press release, EFPIA, October 20, 2022, https:\/\/www.efpia.eu\/news-events\/the-efpia-view\/statements-press-releases\/ensuring-the-full-potential-of-ehds-stakeholders-recommendations-on-how-to-make-the-digital-transformation-a-success-across-europe\/ (last visited December 21, 2025)."},{"key":"S1073110526102848_r78","unstructured":"78. EHDS art. 67."},{"key":"S1073110526102848_r35","unstructured":"35. EHDS c. III."},{"key":"S1073110526102848_r69","unstructured":"69. EHDS art. 47."},{"key":"S1073110526102848_r126","unstructured":"126. Cervera de la Cruz and Shabani, \u201cFair Enough? Exploring the Role of Fairness in Secondary Uses of Health Data in the European Health Data Space.\u201d"},{"key":"S1073110526102848_r33","unstructured":"33. EHDS art. 105."},{"key":"S1073110526102848_r123","volume-title":"Corresponding to the exemption from the prohibition of processing special category data pursuant to Article 9(2)(c)"},{"key":"S1073110526102848_r83","unstructured":"83. EHDS article 73."},{"key":"S1073110526102848_r26","unstructured":"26. Mi\u0161\u0107eni\u0107 and Hoffmann, \u201cThe Role of Opening Clauses in Harmonization of EU Law: Example of the EU\u2019s General Data Protection Regulation (GDPR).\u201d"},{"key":"S1073110526102848_r55","unstructured":"55. Pi\u0161torov\u00e1, Barbora and Plev\u00e1k, Ond\u0159ej , \u201cStakeholders Doubtful EU Health Data Space Will Launch on Schedule,\u201d Euractiv, November 22, 2022, https:\/\/www.euractiv.com\/news\/stakeholders-doubtful-eu-health-data-space-will-launch-on-schedule\/ (last visited July 16, 2026)."},{"key":"S1073110526102848_r2","unstructured":"2. \u201cA European Strategy for Data,\u201d European Commission, https:\/\/digital-strategy.ec.europa.eu\/en\/policies\/strategy-data (last visited December 23, 2025)."},{"key":"S1073110526102848_r82","unstructured":"82. EHDS recital 70."},{"key":"S1073110526102848_r66","unstructured":"66. Consumers Need Strong Safeguards to Protect Their Health Data: BEUC Position Paper on the Proposed European Health Data Space (BEUC, 2022) https:\/\/www.beuc.eu\/position-papers\/consumers-need-strong-safeguards-protect-their-health-data (last visited December 28, 2025)."},{"key":"S1073110526102848_r128","unstructured":"128. EHDS recital 54."},{"key":"S1073110526102848_r44","unstructured":"44. GDPR art. 15(3)."},{"key":"S1073110526102848_r39","unstructured":"39. Pursuant to EHDS art. 2(2)(d), primary use is legally defined as \u201cthe processing of electronic health data for the provision of health care, in order to assess, maintain or restore the state of health of the natural person to whom those data relate, including the prescription, dispensation and provision of medicinal products and medical devices, as well as for relevant social, administrative or reimbursement services.\u201d"},{"key":"S1073110526102848_r91","unstructured":"91. EHDS art. 40."},{"key":"S1073110526102848_r129","unstructured":"129. EHDS art. 71."},{"key":"S1073110526102848_r7","doi-asserted-by":"publisher","DOI":"10.1038\/s41591-024-03246-6"},{"key":"S1073110526102848_r88","unstructured":"88. If adopted, the recently proposed Digital Omnibus Regulation (Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2016\/679, (EU) 2018\/1724, (EU) 2018\/1725, (EU) 2023\/2854 and Directives 2002\/58\/EC, (EU) 2022\/2555 and (EU) 2022\/2557 as regards the simplification of the digital legislative framework, and repealing Regulations (EU) 2018\/1807, (EU) 2019\/1150, (EU) 2022\/868, and Directive (EU) 2019\/1024 (Digital Omnibus), COM(2025) 837 final (Nov. 11, 2025)) may introduce further developments in this area. In particular, it could affect the regulatory treatment of pseudonymized data within the data protection framework. See also \u201cGuidelines 02\/2026 on Anonymisation,\u201d European Data Protection Board, https:\/\/www.edpb.europa.eu\/public-consultations\/guidelines-022026-on-anonymisation_en#no-back (last visited July 16, 2026)."},{"key":"S1073110526102848_r112","unstructured":"112. EHDS recital 52."},{"key":"S1073110526102848_r62","unstructured":"62. Pursuant to EHDS art. 50(1), independent researchers and microenterprises are excluded from the obligation to make their data available."},{"key":"S1073110526102848_r29","doi-asserted-by":"publisher","DOI":"10.1016\/S2589-7500(23)00156-5"},{"key":"S1073110526102848_r113","doi-asserted-by":"crossref","first-page":"223","DOI":"10.1093\/idpl\/ipae014","article-title":"Legal Bases for Effective Secondary Use of Health and Genetic Data in the EU: Time for New Legislative Solutions to Better Harmonize Data for Cross-Border Sharing?","volume":"14","author":"also","year":"2024","journal-title":"International Data Privacy Law"},{"key":"S1073110526102848_r28","unstructured":"28. \u201cEuropean Health Data Space Regulation: What is the Timeline for the Implementation of the EHDS Regulation?,\u201d European Commission, https:\/\/health.ec.europa.eu\/ehealth-digital-health-and-care\/european-health-data-space-regulation-ehds_en#what-is-the-timeline-for-the-implementation-of-the-ehds-regulation (last visited December 21, 2025)."},{"key":"S1073110526102848_r34","unstructured":"34. EHDS c. II."},{"key":"S1073110526102848_r56","doi-asserted-by":"publisher","DOI":"10.4324\/9781003544111-13"},{"key":"S1073110526102848_r61","unstructured":"61. EHDS art. 51."},{"key":"S1073110526102848_r38","unstructured":"38. Pursuant to EHDS art. 2(2)(u), health data user means \u201ca natural or legal person, including Union institutions, bodies, offices or agencies, which has been granted lawful access to electronic health data for secondary use pursuant to a data permit, a health data request approval or an access approval by an authorised participant in HealthData@EU.\u201d"},{"key":"S1073110526102848_r85","unstructured":"85. EHDS art. 66."},{"key":"S1073110526102848_r110","unstructured":"110. Spajic, Daniela , \u201cTransforming the Secondary Use of Patient Data in the European Health Data Space: A Challenge for the Patient\u2019s Right to Medical Confidentiality?\u201d"},{"key":"S1073110526102848_r23","doi-asserted-by":"publisher","DOI":"10.1163\/15718093-12262427"},{"key":"S1073110526102848_r68","doi-asserted-by":"publisher","DOI":"10.4324\/9781003544111-5"},{"key":"S1073110526102848_r116","unstructured":"116. EHDS recital 1."},{"key":"S1073110526102848_r51","unstructured":"51. EHDS art. 21."},{"key":"S1073110526102848_r6","doi-asserted-by":"publisher","DOI":"10.2196\/19799"},{"key":"S1073110526102848_r4","unstructured":"4. Panel for the Future of Science and Technology Scientific Foresight Unit (STOA), EU Health Data Centre and a Common Data Strategy for Public Health (European Parliamentary Research Service, 2021), https:\/\/www.europarl.europa.eu\/RegData\/etudes\/STUD\/2021\/690009\/EPRS_STU(2021)690009_EN.pdf."},{"key":"S1073110526102848_r72","unstructured":"72. First guidance on the implementation of EHDS art. 53 can be found in Nima Andacheh, et al., \u201cGuideline for Health Data Access Bodies on Minimum Categories and Limitations on the Reuse of Health Data,\u201d Zenodo, March 24, 2026, https:\/\/doi.org\/10.5281\/zenodo.20269996, (last visited August 10, 2026)."},{"key":"S1073110526102848_r12","doi-asserted-by":"publisher","DOI":"10.1016\/j.lanepe.2024.100906"},{"key":"S1073110526102848_r94","unstructured":"94. EHDS art. 53."},{"key":"S1073110526102848_r43","unstructured":"43. GDPR recital 59."},{"key":"S1073110526102848_r50","unstructured":"50. With regard to the different sensitivities in the Member States on the degree of patients\u2019 control over their health data, EHDS recital 18 stipulates that Member States should be able to provide for an absolute right to opt out from access, without any possibility to override that opt out in emergency situations."},{"key":"S1073110526102848_r100","unstructured":"100. F\u00e5hraeus, David et al., \u201cThe European Health Data Space: Challenges and Opportunities European Policy Analysis,\u201d Sieps, February 2024, https:\/\/sieps.se\/en\/publications\/2024\/the-european-health-data-space-challenges-and-opportunities\/ (last visited December 24, 2025)."},{"key":"S1073110526102848_r109","unstructured":"109. \u201cGuidance Note: Legal Bases for Processing Personal Data,\u201d Data Protection Commission (Ireland), https:\/\/www.dataprotection.ie\/en\/dpc-guidance\/guidance-legal-bases-processing-personal-data (last visited December 26, 2025)."},{"key":"S1073110526102848_r130","unstructured":"130. EHDS recital 54."},{"key":"S1073110526102848_r105","doi-asserted-by":"publisher","DOI":"10.1007\/s11553-025-01200-z"},{"key":"S1073110526102848_r111","unstructured":"111. GDPR art. 9(4)."},{"key":"S1073110526102848_r97","unstructured":"97. Andacheh, et al., \u201cGuideline for Health Data Access Bodies on Minimum Categories and Limitations on the Reuse of Health Data.\u201d"},{"key":"S1073110526102848_r96","unstructured":"96. Andacheh, et al., \u201cGuideline for Health Data Access Bodies on Minimum Categories and Limitations on the Reuse of Health Data.\u201d"},{"key":"S1073110526102848_r119","doi-asserted-by":"publisher","DOI":"10.1136\/medethics-2017-104550"},{"key":"S1073110526102848_r107","unstructured":"107. As noted above, anonymized data is not considered personal data within the EU data protection framework. As a result, the following considerations regarding the protection of personal data under the GDPR do not apply to data that has been anonymized."},{"key":"S1073110526102848_r120","unstructured":"120. In this context, for the sake of completeness, it should be noted that the EU has adopted the Data Governance Act (Regulation (EU) 2022\/868, hereinafter referred to as DGA) in pursuit of the concept of data altruism, conceived as a willingness to share data for the betterment of society and the common good without compensation. However, the DGA understands data altruism as a purely voluntary and consensual activity, rooted in the willingness of individuals and organizations to contribute to the common good without expecting personal gain, motivated by both consent and a sense of collective responsibility. In contrast, secondary use under the EHDS is grounded in a legal obligation imposed on health data holders, rather than individual consent. For further discussion see, inter alia, Ruth Horn and Angeliki Kerasidou, \u201cSharing Whilst Caring: Solidarity and Public Trust in a Data-Driven Healthcare System,\u201d BMC Medical Ethics 21 (2020): 110, https:\/\/doi.org\/10.1186\/s12910-020-00553-8 (last visited December 27, 2025); Eila El Asry et al., \u201cStriking the Balance: Genomic Data, Consent and Altruism in the European Health Data Space,\u201d in European Health Data Space: Examining A New Era in Data Protection, ed. Santa Slokenberga et al. (Routledge, 2025)."},{"key":"S1073110526102848_r131","unstructured":"131. EHDS art. 71(4)."},{"key":"S1073110526102848_r31","unstructured":"31. EHDS art. 105."},{"key":"#cr-split#-S1073110526102848_r20.1","unstructured":"20. Article 29 Data Protection Working Party, Annex - Health Data in Apps and Devices (2015), https:\/\/ec.europa.eu\/justice\/article-29\/documentation\/other-document\/files\/2015\/20150205_letter_art29wp_ec_health_data_after_plenary_annex_en.pdf (last visited December 14, 2025)"},{"key":"#cr-split#-S1073110526102848_r20.2","doi-asserted-by":"crossref","unstructured":"Werner Sch\u00e4fke-Zell, \"Revisiting the Definition of Health Data in the Age of Digitalized Health Care,\" International Data Privacy Law 12, no. 1 (2022): 33-43, https:\/\/doi.org\/10.1093\/idpl\/ipab025 (last visited 14 December 2025)","DOI":"10.1093\/idpl\/ipab025"},{"key":"#cr-split#-S1073110526102848_r20.3","doi-asserted-by":"crossref","unstructured":"Anni-Maria Taka, \"A Deep Dive into Dynamic Data Flows, Wearable Devices, and the Concept of Health Data,\" International Data Privacy Law 13, no. 2 (2023): 124-140, https:\/\/doi.org\/10.1093\/idpl\/ipad007. For a body of relevant case law see Lee A. Bygrave and Luca Tosoni, \"Article 4(15). Data concerning health,\" in EU General Data Protection Regulation (GDPR): A Commentary, ed. Christopher Kuner et al. (Oxford University Press, 2020).","DOI":"10.1093\/idpl\/ipad007"},{"key":"S1073110526102848_r102","doi-asserted-by":"publisher","DOI":"10.2196\/47066"},{"key":"S1073110526102848_r54","unstructured":"54. Secondary use is legally defined in EHDS art. 2(2)(e) as \u201cthe processing of electronic health data for the purposes set out in Chapter IV of this Regulation, other than the initial purposes for which they were collected or produced.\u201d"},{"key":"S1073110526102848_r106","volume-title":"European Health Data Space: Examining A New Era in Data Protection","author":"de la Cruz","year":"2025"},{"key":"S1073110526102848_r40","unstructured":"40. EHDS art. 1(2)(a)."},{"key":"S1073110526102848_r16","unstructured":"16. Mi\u0161\u0107eni\u0107 and Hoffmann, \u201cThe Role of Opening Clauses in Harmonization of EU Law: Example of the EU\u2019s General Data Protection Regulation (GDPR).\u201d"},{"key":"S1073110526102848_r125","unstructured":"125. Donia and Marelli, \u201cAnticipating Ethical and Social Dimensions of the European Health Data Space: A Rapid Systematic Review.\u201d"},{"key":"S1073110526102848_r48","doi-asserted-by":"publisher","DOI":"10.1016\/j.clsr.2023.105913"},{"key":"S1073110526102848_r21","doi-asserted-by":"publisher","DOI":"10.1080\/13600834.2017.1335468"},{"key":"S1073110526102848_r124","doi-asserted-by":"publisher","DOI":"10.21428\/9885764c.83333982"},{"key":"S1073110526102848_r3","unstructured":"3. \u201cCommon European Data Spaces,\u201d European Commission, https:\/\/digital-strategy.ec.europa.eu\/en\/policies\/data-spaces (last visited December 23, 2025)."},{"key":"S1073110526102848_r79","unstructured":"79. EHDS art. 68."},{"key":"S1073110526102848_r49","unstructured":"49. EHDS art. 8."},{"key":"S1073110526102848_r59","doi-asserted-by":"crossref","first-page":"iii3","DOI":"10.1093\/eurpub\/ckaf073","article-title":"Piloting an Infrastructure for the Secondary Use of Health Data: Learnings from the HealthData@EU Pilot","volume":"35","author":"Christiansen","year":"2025","journal-title":"European Journal of Public Health"},{"key":"S1073110526102848_r27","unstructured":"27. Health and Food Safety Directorate-General, Assessment of the EU Member States\u2019 Rules on Health Data in the Light of GDPR."},{"key":"S1073110526102848_r18","unstructured":"18. GDPR art. 4(15) defines data concerning health as \u201cpersonal data related to the physical or mental health of a natural person, including the provision of health care services, which reveal information about his or her health status.\u201d"},{"key":"S1073110526102848_r81","doi-asserted-by":"publisher","DOI":"10.5281\/zenodo.20267597"},{"key":"S1073110526102848_r15","doi-asserted-by":"crossref","unstructured":"15. Mi\u0161\u0107eni\u0107, Emilia and Hoffmann, Anna-Lena , \u201cThe Role of Opening Clauses in Harmonization of EU Law: Example of the EU\u2019s General Data Protection Regulation (GDPR),\u201d in EU 2020 \u2014 Lessons from the Past and Solutions For the Future, Dunja Dui\u0107, and Tunjica Petra\u0161evi\u0107, eds., EU and Comparitive Law Issues and Challenges Series (ECLIC), vol. 4 (Faculty of Law, Josip Juraj Strossmayer University of Osijek, 2020).","DOI":"10.25234\/eclic\/11895"},{"key":"#cr-split#-S1073110526102848_r10.1","unstructured":"10. Abboud, Linda et al., Deliverable 5.1: Report on Secondary Use of Health Data Through European Case Studies (Toward European Health Data Space, 2022), https:\/\/tehdas.eu\/app\/uploads\/2022\/08\/tehdas-report-on-secondary-use-of-health-data-through-european-case-studies-.pdf"},{"key":"#cr-split#-S1073110526102848_r10.2","doi-asserted-by":"crossref","unstructured":"Joseph Donia and Luca Marelli, \"Anticipating Ethical and Social Dimensions of the European Health Data Space: A Rapid Systematic Review,\" Health Policy 162 (2025): 105443, https:\/\/doi.org\/10.1016\/j.healthpol.2025.105443.","DOI":"10.1016\/j.healthpol.2025.105443"},{"key":"S1073110526102848_r98","unstructured":"98. GDPR recital 159; \u201cGuidelines 03\/2020 on the Processing of Data Concerning Health for the Purpose of Scientific Research in the Context of the COVID-19 Outbreak,\u201d European Data Protection Board, April 21, 2020, https:\/\/www.edpb.europa.eu\/documents\/guideline\/guidelines-032020-on-the-processing-of-data-concerning-health-for-the-purpose_en; Article 29 Working Party, \u201cGuidelines on Consent under Regulation 2016\/679,\u201d European Commission, July 6, 2018, https:\/\/ec.europa.eu\/newsroom\/article29\/item-detail.cfm?item_id=623051 (last visited December 24, 2025); \u201cGuidelines 1\/2026 on Processing of Personal Data for Scientific Research Purposes,\u201d European Data Protection Board, https:\/\/www.edpb.europa.eu\/public-consultations\/guidelines-12026-on-processing-of-personal-data-for-scientific-research_en (last visited July 16, 2026)."},{"key":"S1073110526102848_r117","unstructured":"117. EHDS recital 61."},{"key":"S1073110526102848_r133","unstructured":"133. Misek et al., \u201cGuideline for Health Data Access Bodies on Implementing Opt-Out from the Secondary Use of Health Data.\u201d"},{"key":"S1073110526102848_r138","unstructured":"138. Inter alia, the GDPR, the Clinical Trials Regulation (European Parliament and Council Regulation 536\/2014, 2014 OJ (L158)), the NIS2 Directive (European Parliament and Council Directive 2022\/2555, 2022 OJ (L333)), the Data Governance Act (European Parliament and Council Regulation 2022\/868, 2022 OJ (L152)), the Data Act (European Parliament and Council Regulation 2023\/2854, 2023 OJ (L2023\/2854)), and the Artificial Intelligence Act (European Parliament and Council Regulation 2024\/1689, 2024 OJ (L2024\/1689))."},{"key":"S1073110526102848_r41","unstructured":"41. EHDS art. 3."},{"key":"S1073110526102848_r89","unstructured":"89. EHDS art. 2(2)(k)."},{"key":"S1073110526102848_r13","doi-asserted-by":"publisher","DOI":"10.1177\/20539517231224258"},{"key":"S1073110526102848_r46","unstructured":"46. Pursuant to EHDS art. 14, the priority categories include patient summaries; electronic prescriptions; electronic dispensations; medical imaging studies and related imaging reports; medical test results, including laboratory and other diagnostic results and related reports; and discharge reports."},{"key":"S1073110526102848_r108","unstructured":"108. \u201cGuidelines 1\/2024 on Processing of Personal Data Based on Article 6(1)(f) GDPR,\u201d European Data Protection Board, https:\/\/www.edpb.europa.eu\/public-consultations\/guidelines-12024-on-processing-of-personal-data-based-on-article-61f-gdpr_en."},{"key":"S1073110526102848_r132","unstructured":"132. GDPR art. 21 GDPR."},{"key":"S1073110526102848_r73","unstructured":"73. EHDS art. 53(2)."},{"key":"S1073110526102848_r104","volume-title":"European Health Data Space: Examining A New Era in Data Protection","author":"Spajic","year":"2025"},{"key":"S1073110526102848_r17","unstructured":"17. Regulation (EU) 2016\/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95\/46\/EC (General Data Protection Regulation), 2016 OJ (L119) [hereinafter GDPR]."},{"key":"S1073110526102848_r136","unstructured":"136. Misek et al., \u201cGuideline for Health Data Access Bodies on Implementing Opt-Out from the Secondary Use of Health Data.\u201d"},{"key":"S1073110526102848_r141","unstructured":"141. Petro\u010dnik, Tja\u0161a , \u201cSecondary Use of Health Data in the EHDS: Public Interest and the Role of HDABs.\u201d"},{"key":"S1073110526102848_r57","unstructured":"57. EHDS art. 81."},{"key":"S1073110526102848_r67","unstructured":"67. EHDS art. 51(4)."},{"key":"S1073110526102848_r115","unstructured":"115. Misek, J\u00e1nos P\u00e9ter et al., \u201cGuideline for Health Data Access Bodies on Implementing Opt-Out from the Secondary Use of Health Data,\u201d Zenodo, March 24, 2026, https:\/\/doi.org\/10.5281\/zenodo.20280387; Space: A New Paradigm for Secondary Uses of Health Data for Scientific Research?,\u201d in European Health Data Space: Examining A New Era in Data Protection, ed. Santa Slokenberga et al. (Routledge 2025)."},{"key":"S1073110526102848_r63","unstructured":"63. For examples illustrating what is within\/beyond the scope: Directorate-General for Health and Food Safety, \u201cFrequently Asked Questions on the European Health Data Space,\u201d Section 33."},{"key":"S1073110526102848_r92","unstructured":"92. Ganna, Andrea et al., \u201cThe European Health Data Space Can Be a Boost for Research Beyond Borders.\u201d"},{"key":"S1073110526102848_r14","unstructured":"14. Health and Food Safety Directorate-General, Assessment of the EU Member States\u2019 Rules on Health Data in the Light of GDPR."},{"key":"S1073110526102848_r36","unstructured":"36. EHDS c. IV."},{"key":"S1073110526102848_r140","unstructured":"140. Donia and Marelli, \u201cAnticipating Ethical and Social Dimensions of the European Health Data Space: A Rapid Systematic Review.\u201d"},{"key":"S1073110526102848_r75","doi-asserted-by":"publisher","DOI":"10.1016\/j.clsr.2024.105993"},{"key":"S1073110526102848_r114","unstructured":"114. Pursuant to 52 EHDS, the legal basis for the purpose of the initial processing, for example the delivery of health care, remains unaffected."},{"key":"S1073110526102848_r9","unstructured":"9. TFEU art. 4."},{"key":"S1073110526102848_r47","unstructured":"47. For the differences between the right to portability under the GDPR and the EHDS see Directorate-General for Health and Food Safety, \u201cFrequently Asked Questions on the European Health Data Space,\u201d sec. 11, European Commission, March 26, 2026, https:\/\/health.ec.europa.eu\/latest-updates\/frequently-asked-questions-european-health-data-space-2025-03-05_en (last visited August 10, 2026)."},{"key":"S1073110526102848_r90","unstructured":"90. EHDS art. 39."},{"key":"S1073110526102848_r64","volume-title":"Joint Opinion 03\/2022 on the Proposal for a Regulation on the European Health Data Space","year":"2022"}],"container-title":["Journal of Law, Medicine &amp; Ethics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.cambridge.org\/core\/services\/aop-cambridge-core\/content\/view\/S1073110526102848","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T02:40:12Z","timestamp":1790044812000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.cambridge.org\/core\/product\/identifier\/S1073110526102848\/type\/journal_article"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,9,22]]},"references-count":144,"alternative-id":["S1073110526102848"],"URL":"https:\/\/doi.org\/10.1017\/jme.2026.10284","relation":{},"ISSN":["1073-1105","1748-720X"],"issn-type":[{"value":"1073-1105","type":"print"},{"value":"1748-720X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,9,22]]}}}