.png)
4 hours ago
1
Contemporary healthcare is undergoing a transition, shifting from a population-based approach to personalized medicine on an individual level1. In October 2023, the European Partnership for Personalized Medicine was officially launched2 to communicate the benefits of this approach to citizens and healthcare systems in member countries. The main debate revolves around the inconsistency in regulatory changes within personal data access and its potential commercialization. Moreover, the lack of unified consensus within European Union (EU) countries is leading to problems with data sharing to progress personalized medicine. Here we discuss the integration of biological data with personal information on a European scale for the advancement of personalized medicine, raising legal considerations of data protection under the EU General Data Protection Regulation (GDPR)3.
Personalized medicine is a data-driven approach, for which ‘big data’ and its accessibility are of key importance. Big data can be based on epidemiological information and increasingly on ‘-omics’ data4, particularly genomics, transcriptomics, proteomics and metabolomics. Integrating ‘-omics’ profiles with clinical data makes it possible to study an individual’s molecular makeup. However, compliance with the GDPR, along with varying country-specific interpretations, presents obstacles to the deposition of health-related ‘-omics’ data. Additionally, most such data repositories operate beyond EU borders, in the USA, the UK and Japan. There is a pressing need for a GDPR-approved data repository within EU borders to streamline ‘-omics’-driven personalized medicine.
This is a preview of subscription content, access via your institution
Access options
Access Nature and 54 other Nature Portfolio journals
Get Nature+, our best-value online-access subscription
$32.99 / 30 days
cancel any time
Subscribe to this journal
Receive 12 print issues and online access
$209.00 per year
only $17.42 per issue
Buy this article
- Purchase on SpringerLink
- Instant access to full article PDF
Prices may be subject to local taxes which are calculated during checkout
Additional access options:
References
Tobias, D. K. et al. Nat. Med. 29, 2438–2457 (2023).
European Union. EUR-Lex https://go.nature.com/49HibD7 (2015).
Directorate-General for Research and Innovation. European Commission https://go.nature.com/49ScPFi (25 October 2023).
Karczewski, K. J. & Snyder, M. P. Nat. Rev. Genet. 19, 299–310 (2018).
Jensen, A. B. et al. Nat. Commun. 5, 4022 (2014).
Zerdick, T. EDPS https://go.nature.com/4gnfTeL (2021).
Panagopoulos, A., Minssen, T., Sideri, K., Yu, H. & Compagnucci, M. C. Comput. Law Secur. Rev. 45, 105670 (2022).
Charles, W. M. et al. JMIR Res. Protoc. 13, e50339 (2024).
Statistics Denmark. https://go.nature.com/41FREUC (accessed 22 December 2024).
Acknowledgements
C.L.Q. was funded by Lundbeck Fonden. T.M. and M.C.C. were funded by a Novo Nordisk Foundation grant for a scientifically independent Inter-CeBIL program (grant NNF23SA0087056). T.M. also received support from the Horizon Europe project CLASSICA (grant 101057321). While based at Steno Diabetes Center Copenhagen, K.S. was funded by a Novo Nordisk Foundation grant (NNF0074491). N.J.W.A. is supported by a European Foundation for the Study of Diabetes Future Leader Award (NNF21SA0072746), Independent Research Fund Denmark (1052-00003B; 10.46540/4308-00056B; 10.46540/4285-00131B), and Novo Nordic Foundation (NNF23OC0084970, NNF19OC0055001 and NNF24OC0088402).
Ethics declarations
Competing interests
C.L.Q. received consultancy fees from Pfizer; honoraria, travel or speakers’ fees from Biogen; and research funds from Pfizer and Novo Nordisk and is the director of the company BrainLogia. N.J.W.A. has received research support, personal support and speaker fees from EvoSep, Mercodia, Novo Nordisk, Merck, MSD and Boehringer Ingelheim. F.P. received advisory, speaking and lecture fees from Sanofi Aventis. P.R. received consultancy and/or speaking fees (to his institution) from Abbott, AstraZeneca, Bayer, Boehringer Ingelheim, Daichii Sankyo, Eli Lilly, Gilead, Novo Nordisk and Sanofi, as well as research grants from AstraZeneca Bayer and Novo Nordisk. T.M. served as a consultant to Corti, Microsoft, The European Union and the World Health Organization. The current paper was initiated and written when K.S. was employed at Steno Diabetes Center Copenhagen. During the review process and the final submission, K.S. changed affiliation to Novo Nordisk. The other authors declare no competing interests.
About this article
Cite this article
Legido-Quigley, C., Wewer Albrechtsen, N.J., Bæk Blond, M. et al. Data sharing restrictions are hampering precision health in the European Union. Nat Med 31, 360–361 (2025). https://doi.org/10.1038/s41591-024-03437-1
Published: 17 January 2025
Issue Date: February 2025
DOI: https://doi.org/10.1038/s41591-024-03437-1
