Unlocking the Power of Health Data by Ensuring the Public can Trust the EHDS
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Keywords
health data, electronic health records, big data, information governance , transparency
Abstract
It is vitally important to assure public trust during the European scaling up of health data reuse for research, public health and health systems strategy. The European Health Data Space (EHDS) proposals are catalysing the multi-stakeholder debate on this, and include some provisions that are aimed at giving that assurance, such as strict purposes for which data may be reused, and which may not be used. However, the public needs a way of trusting that the organisations that reuse their data are bound to by ethical and transparency principles. Furthermore, these organisations are to be held accountable for how they use data. This paper summarises the Big Data rationale for needing a European scale for the secondary use of health data, and the provisions in the proposal for a Regulation for the EHDS to enable and safeguard this secondary use. It proposes a complementary measure, a Societal Compact, that could strengthen public trust in the EHDS.
References
2. The European Commission. Joint Report on Health Care and Long-Term Care Systems & Fiscal Sustainability. The European Commission Institutional Paper 37, October 2016. https://economy-finance.ec.europa.eu/publications/joint-report-health-care-and-long-term-care-systems-fiscal-sustainability_en. Accessed June 12, 2024.
3. European Alliance for Value in Health. Health systems after COVID-19 – Building resilience through a value-based approach. August 2021. https://www.europeanallianceforvalueinhealth.eu/library/health-systems-after-covid-19-building-resilience-through-a-value-based-approach. Accessed June 12, 2024.
4. Kalra D. Scaling up the big health data ecosystem: engaging all stakeholders. International Journal of Telemedicine and Applications, eHealth 2020;8:e16. https://doi.org/10.29086/JISfTeH.8.e16. Accessed June 12, 2024.
5. Hughes N, Kalra D. Data Standards and Platform Interoperability. In: He, W., Fang, Y., Wang, H. (eds) Real-World Evidence in Medical Product Development. Springer, Cham, Switzerland. 2023. https://doi.org/10.1007/978-3-031-26328-6_6. Accessed June 12, 2024.
6. Medical Informatics Initiative Germany. Strengthening research and advancing healthcare. https://www.medizininformatik-initiative.de/en/start. Accessed June 12, 2024.
7. French Health Data Hub. https://www.health-data-hub.fr (in French). English FAQ at https://www.health-data-hub.fr/page/faq-english. Accessed June 12, 2024.
8. European Medicines Agency. Data Analysis and Real World Interrogation Network (DARWIN EU®). https://www.ema.europa.eu/en/about-us/how-we-work/big-data/data-analysis-and-real-world-interrogation-network-darwin-eu. Accessed June 12, 2024.
9. ELIXIR. https://elixir-europe.org. Accessed June 12, 2024.
10. European Reference Networks. https://health.ec.europa.eu/european-reference-networks_en. Accessed June 12, 2024.
11. The European General Data Protection Regulation. What is GDPR, the EU’s new data protection law?, May 2018. https://gdpr.eu/what-is-gdpr. Accessed June 12, 2024.
12. European Health Data Space. https://health.ec.europa.eu/ehealth-digital-health-and-care/european-health-data-space_en. Accessed June 12, 2024.
13. European Parliament News. Announcement of the provisional political agreement on a European Health Data Space (EHDS). 15th March 2024. https://www.europarl.europa.eu/news/en/press-room/20240304IPR18765/eu-health-data-space-to-support-patients-and-research. Accessed June 12, 2024.
14. Wilkinson M, Dumontier M, Aalbersberg I, et al. The FAIR Guiding Principles for scientific data management and stewardship. Nature Scientific Data 3, 160018 (2016). https://doi.org/10.1038/sdata.2016.18. Accessed June 12, 2024.
15. The Digital Health Society and the European Institute for Innovation through Health Data. Proposal for a societal compact for the secondary use of health data. https://echalliance.com/news/round-table-6-proposal-for-a-societal-compact-for-the-secondary-use-of-health-data. Accessed June 12, 2024.
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