Skip to main content
SpringerLink
Log in

An Overview of the Secondary Use of Health Data Within the European Union: EU-Driven Possibilities and Civil Society Initiatives

  • Conference paper
  • First Online:
Privacy Symposium 2022 (DPLICIT 2022)

Abstract

In recent years, the European Union has been heavily impacted by the increasing costs of the healthcare systems: data-driven health research could play a major role in such a framework. This chapter aims at presenting the legal framework and the initiatives currently implemented for the secondary use of health data. The European Commission has defined a strategy that aims at supporting the exploitation of data while ensuring the fundamental rights of citizens, and it is working on the definition of a legislative framework allowing the secondary use of data. The reference point related to the processing of personal data is the General Data Protection Regulation (GDPR) that defines the main fundamental principles to be complied with and the Data Governance Act proposal, which aims at enabling the safe reuse of certain categories of public-sector data subject to the rights of others, such as data concerning health. However, the proposal compliance with the GDPR has been questioned by the European Data Protection Board and Secretariat. Within the healthcare sector, initiatives were developed to boost the secondary use of data. Some of these are led by the policymakers, such as the European Health Data Space, while others have emerged from the civil society and leverage on the concepts of data donation and data altruism. Still, the application of both these concepts raises legal uncertainty: therefore, it is crucial to guarantee a legislative framework that supports the positive exploitation of data.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Log in via an institution
Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 169.00
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 219.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD 219.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

Similar content being viewed by others

Notes

  1. 1.

    The document defines 13 Recommendations that will shape the mission. The ones mentioned above are Rec. 2 – Develop an EU-wide research programme to identify (poly-) genic risk scores; Rec. 4 – Optimise existing screening programmes and develop novel approaches for screening and early detection; Rec. 5 – Advance and implement personalised medicine approaches for all cancer patients in Europe; and Rec. 8 – Create a European Cancer Patient Digital Centre where cancer patients and survivors can deposit and share their data for personalised care.

  2. 2.

    Even though the document refers to the Data Protection Directive 95/46/EC, the reasoning and the motivation of the Working Party might be considered applicable to the GDPR as well.

  3. 3.

    To be noted that, in the Explanatory Memorandum of the DGA, the EC states that ‘the measures in the DGA are designed in a way that fully complies with the data protection legislation, and actually increases in practice the control that natural persons have over the data they generate’.

  4. 4.

    It has to be noted that the two types of donations present, of course, remarkable differences as well, such as the lack of physical intrusion and lack of urgency for PMDD, and the fact that a living person can withdraw the consent to donation any time. In addition, data processing might result in the discovery of information related to the deceased person’s relatives that might have harmful consequences, such as the discrimination for insurance coverage based on a hereditary disease.

  5. 5.

    On the Salus Coop website, two documents are available for download: a pdf with the Terms of Use defining the five necessary conditions of the projects and a text (Word) document which is a template for the consent (information sheet) that should be signed by the data subjects and filled in with the project details. The documents have been used as reference for the definition of its ambiguities with GDPR.

  6. 6.

    Given the context, it seems unlikely that Salus Coop is the entity determining the purposes of the processing.

  7. 7.

    Of course, GDPR prescribes that by means of the informed consent citizens are aware of the necessary information related to the purposes of the research and how data will be treated is included; this statement was just meant to better frame the concept of donation and its implications.

  8. 8.

    To be established within the Data Governance Act.

  9. 9.

    “Where data that was originally sensitive personal data is being uploaded for open dissemination through Zenodo, the uploader shall ensure that such data is either anonymised to an appropriate degree or fully consent cleared.” Zenodo policies available at https://help.zenodo.org/#policies – last visit 16 November 2021.

References

  1. Eurostat, Healthcare expenditure statistics – https://ec.europa.eu/eurostat/statistics-explained/index.php?title=Healthcare_expenditure_statistics#Healthcare_expenditure

  2. European Semester Thematic Factsheet on Health Systems https://ec.europa.eu/info/sites/info/files/file_import/european-semester_thematic-factsheet_health-systems_en_0.pdf – last visit 27 April 2021.

  3. Communication from The Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, “A European strategy for data”, Brussels, 19.2.2020, COM (2020) 66 final - https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:52020DC0066&from=EN – last visit 27 April 2021.

  4. Abedjan Z. et al, (2019). Data science in healthcare: Benefits, challenges and opportunities. In Data Science for Healthcare. Springer: Cham, pp. 3–38

    Chapter  Google Scholar 

  5. Kariotis, T., Ball, M., et al. (2020). Emerging health data platforms: From individual control to collective data governance. Data & Policy, 2, E13. doi:https://doi.org/10.1017/dap.2020.14

    Article  Google Scholar 

  6. Directorate-General for Research and Innovation, Conquering Cancer: mission possible, September 2020 https://op.europa.eu/en/publication-detail/-/publication/b389aad3-fd56-11ea-b44f-01aa75ed71a1/ – last visit 27 April 2021.

  7. https://digital-strategy.ec.europa.eu/en/news/member-states-meet-european-commission-discuss-protection-personal-data-health-sector – last visit 13 May 2021

  8. Ducato R., Data Protection, Scientific Research, and the Role of Information (January 10, 2020). Computer Law and Security Review, doi:https://doi.org/10.1016/j.clsr.2020.105412.

  9. Consolidated version of the Treaty on the Functioning of the European Union (TFEU), art. 179 (1) available at https://eur-lex.europa.eu/legal-content/HU/TXT/?uri=OJ:C:2016:202:TOC

  10. Article 29 Working Party, Guidelines on consent under Regulation 2016/679. Adopted on 28 November 2017, as last Revised and Adopted on 10 April 2018.

    Google Scholar 

  11. Article 29 Working Party, ANNEX - health data in apps and devices available at https://ec.europa.eu/justice/article-29/documentation/other-document/files/2015/20150205_letter_art29wp_ec_health_data_after_plenary_annex_en.pdf

  12. Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on European data governance (Data Governance Act) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52020PC0767

  13. EDPB - EDPS, Joint Opinion 03/2021 on the Proposal for a regulation of the European Parliament and of the Council on European data governance (Data Governance Act), published 11 March 2021, available at https://edpb.europa.eu/our-work-tools/our-documents/edpbedps-joint-opinion/edpb-edps-joint-opinion-032021-proposal_en

  14. Digital health data and services – the European health data space https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12663-A-European-Health-Data-Space- - last visit 30 April 2021.

  15. Communication from The Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions (Annexes to the) Commission Work Programme 2021 19.10.2020 https://eur-lex.europa.eu/resource.html?uri=cellar%3A91ce5c0f-12b6-11eb-9a54-01aa75ed71a1.0001.02/DOC_2&format=PDF

  16. Piai S., Allocato A., Besana G., Story 6 – The Secondary Use of Health Data and Data-driven Innovation in the European Healthcare Industry, IDC, 2020. This report is part of the Call for tenders of the European Commission DG Connect: Update of the European data market study — SMART 2016/0063.

    Google Scholar 

  17. Gesetz zum Schutz elektronischer Patientendaten in der Telematikinfrastruktur available at https://www.bundesgesundheitsministerium.de/fileadmin/Dateien/3_Downloads/Gesetze_und_Verordnungen/GuV/P/PDSG_bgbl.pdf; Koyuncu A., Mei V., Germany Prepares New Law for Patient Data Protection and Increased Digitalisation in Healthcare and for “Data Donations” for Research Purposes. Available at https://www.covingtondigitalhealth.com/2020/08/germany-prepares-new-law-for-patient-data-protection-and-increased-digitalisation-in-healthcare-and-for-data-donations-for-research-purposes/ - last visit 7 May 2021.

  18. Prainsack B., Data Donation: How to Resist the iLeviathan, in J. Krutzinna, L. Floridi (eds.), The Ethics of Medical Data Donation (2019), Philosophical Studies Series 137, doi:https://doi.org/10.1007/978-3-030-04363-6_6

    Chapter  Google Scholar 

  19. Piéchaud Boura M., Personal Data Donation: a Legal Oxymoron Beneficial to Science? Available at https://www.timelex.eu/en/blog/personal-data-donation-legal-oxymoron-beneficial-science - last visit 12 May 2021.

  20. Malgieri, G. (2018). R.I.P.: Rest in Privacy or Rest in (Quasi-)Property? Personal Data Protection of Deceased Data Subjects between Theoretical Scenarios and National Solutions in R. Leenes, R. Van Brakel, S. Gutwirth & P. De Hert (Eds.). Data Protection and Privacy: The Internet of Bodies. (pp. 300 – 320) Hart Publishing.

    Google Scholar 

  21. Harbinja E. Posthumous Medical Data Donation: The Case for a Legal Framework in J. Krutzinna, L. Floridi (eds.), The Ethics of Medical Data Donation (2019), Philosophical Studies Series 137, doi:https://doi.org/10.1007/978-3-030-04363-6_6

    Chapter  Google Scholar 

  22. Convention for the protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, Oviedo, ETS No.164.

    Google Scholar 

  23. J. Krutzinna, L. Floridi (eds.), The Ethics of Medical Data Donation (2019), Philosophical Studies Series 137, doi:https://doi.org/10.1007/978-3-030-04363-6

    Book  Google Scholar 

  24. Harbinja E., Pearce H., Your data will never die, but you will: A comparative analysis of US and UK post-mortem data donation frameworks, Elsevier 2020, doi:https://doi.org/10.1016/j.clsr.2020.105403

    Book  Google Scholar 

  25. Shaw D.M., Gross J.V., Erren T.C., Data donation after death, The Lancet, Volume 386, Issue 9991, P 340, July 25, 2015, doi:https://doi.org/10.1016/S0140-6736(15)61410-6

  26. Bietz, M., Patrick, K., & Bloss, C. (2019). Data Donation as a Model for Citizen Science Health Research. Citizen Science: Theory and Practice, 4(1), 6. DOI: https://doi.org/10.5334/cstp.178 cited in Piai S., Allocato A., Besana G. (2020)

  27. Data for Good Foundation Homepage https://dataforgoodfoundation.com/en - last visit 8 May 2021.

  28. Salus Coop Homepage https://www.saluscoop.org/ - last visit 8 May 2021.

  29. Salus Coop licence page https://www.saluscoop.org/licencia - last visit 8 May 2021.

  30. Van Quathem K., The GDPR and Clinical Trials – Are study sites controllers or processors?, Pharm. Ind. 81, Nr. 6, 809–813 Editio Cantor Verlag, Aulendorf, 2019.

    Google Scholar 

  31. Stocks Allen F., Crawford G.E., Clinical trials under the GDPR: What should sponsors consider?, Privacy laws & business United Kingdom Report, January 2019.

    Google Scholar 

  32. REGULATION (EU) No 536/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, Available at https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/reg_2014_536/reg_2014_536_en.pdf

  33. Hummel P., Braun M., Dabrock P., Data Donations as Exercises of sovereignty in J. Krutzinna, L. Floridi (eds.), The Ethics of Medical Data Donation (2019), Philosophical Studies Series 137, https://doi.org/10.1007/978-3-030-04363-6_6

    Chapter  Google Scholar 

  34. Raj M., De Vries R., Nong P., Kardia S. L. R., Platt J. E. Do people have an ethical obligation to share their health information? Comparing narratives of altruism and health information sharing in a nationally representative sample (2020) PLoS One. 2020; 15(12): e0244767. Published online 2020 Dec 31. https://doi.org/10.1371/journal.pone.0244767

  35. Garante della Privacy, Parere alla Provincia autonoma di Trento sul disegno di legge provinciale concernente “Ulteriori misure di sostegno per le famiglie, i lavoratori e i settori economici connesse all’emergenza epidemiologica da COVID-19 e conseguente variazione al bilancio di previsione della Provincia autonoma di Trento per gli esercizi finanziari 2020-2022” - 8 maggio 2020 available at https://www.garanteprivacy.it/web/guest/home/docweb/-/docweb-display/docweb/9344635 - last visit 29 April 2021.

  36. Article 29 Data Protection Working Party, Opinion 05/2014 on Anonymisation Techniques, available at https://ec.europa.eu/justice/article-29/documentation/opinion-recommendation/files/2014/wp216_en.pdf

  37. AEPD-EDPS, Joint paper on 10 misunderstandings related to anonymisation, published on 27 April 2021, available at https://edps.europa.eu/data-protection/our-work/publications/papers/aepd-edps-joint-paper-10-misunderstandings-related_enReferences

  38. Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL LAYING DOWN HARMONISED RULES ON ARTIFICIAL INTELLIGENCE (ARTIFICIAL INTELLIGENCE ACT) AND AMENDING CERTAIN UNION LEGISLATIVE ACTS, Available at https://eur-lex.europa.eu/resource.html?uri=cellar:e0649735-a372-11eb-9585-01aa75ed71a1.0001.02/DOC_1&format=PDF

  39. ETHICS GUIDELINES FOR TRUSTWORTHY AI, Independent high-level expert group on artificial intelligence set up by the European Commission, Available at https://www.aepd.es/sites/default/files/2019-12/ai-ethics-guidelines.pdf

  40. WHITE PAPER on Artificial Intelligence - A European approach to excellence and trust, Available at https://ec.europa.eu/info/sites/default/files/commission-white-paper-artificial-intelligence-feb2020_en.pdf

  41. A PROPOSAL FOR (AI ) CHANGE? A succinct overview of the Proposal for Regulation laying down harmonised rules on Artificial Intelligence, Rubén Cano, Available at https://lawreview.luiss.it/files/2016/09/A-proposal-for-AI-Change-A-succint-overview-of-the-Proposal-for-Regulation-laying-down-harmonised-rules-on-Artificial-Intelligence.pdf - last visit 10 February 2022.

  42. EDPB - EDPS, Joint Opinion 05/2021 on the proposal for a Regulation of the European Parliament and of the Council laying down harmonised rules on artificial intelligence (Artificial Intelligence Act), published 18 June 2021 https://edps.europa.eu/system/files/2021-06/2021-06-18-edpb-edps_joint_opinion_ai_regulation_en.pdf

  43. Mayora Ibarra O., Forti S., Conforti D., Tessari P., Testa S., Trentino salute 4.0 - the creation of a competence center on digital health integrating policy, healthcare trust and research in trentino territory. International Journal of Integrated Care. 2019;19(4):56. DOI: https://doi.org/10.5334/ijic.s3056

    Article  Google Scholar 

  44. Zuo Z., Watson M., Budgen D., Hall R, Kennelly C., Al Moubayed N., Data Anonymization for Pervasive Health Care: Systematic Literature Mapping Study JMIR Med Inform 2021;9(10):e29871 doi: https://doi.org/10.2196/29871

    Article  Google Scholar 

  45. EDPS web page on Synthetic Data, available at https://edps.europa.eu/press-publications/publications/techsonar/synthetic-data_en - last visit 10 February 2022.

Download references

Acknowledgements

This work was partially funded by the Competence Center of Digital Health of the Autonomous Province of Trento ‘TrentinoSalute4.0’. The author thanks the anonymous reviewers for their constructive comments. A special thanks goes to O. Mayora for his valuable feedback on the definition and revision of this chapter.

Author information

Authors and Affiliations

  1. Fondazione Bruno Kessler, Via Santa Croce, Trento, Italy

    Sara Testa

Authors
  1. Sara Testa
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Sara Testa .

Editor information

Editors and Affiliations

  1. University of Münster, Münster, Germany

    Stefan Schiffner

  2. Mandat International, Geneva, Switzerland

    Sebastien Ziegler

  3. Mandat International, Geneva, Switzerland

    Adrian Quesada Rodriguez

Rights and permissions

Reprints and permissions

Copyright information

© 2022 The Author(s), under exclusive license to Springer Nature Switzerland AG

About this paper

Check for updates. Verify currency and authenticity via CrossMark

Cite this paper

Testa, S. (2022). An Overview of the Secondary Use of Health Data Within the European Union: EU-Driven Possibilities and Civil Society Initiatives. In: Schiffner, S., Ziegler, S., Quesada Rodriguez, A. (eds) Privacy Symposium 2022. DPLICIT 2022. Springer, Cham. https://doi.org/10.1007/978-3-031-09901-4_1

Download citation

  • DOI: https://doi.org/10.1007/978-3-031-09901-4_1

  • Published:

  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-031-09900-7

  • Online ISBN: 978-3-031-09901-4

  • eBook Packages: Computer ScienceComputer Science (R0)

Publish with us

Policies and ethics

Search

Navigation