Will The European Health Data Space Help Advance Research into Women’s Health? The Case of Femtech
- Autor(en)
- Klaudia Kwiatkowska
- Abstrakt
The European Health Data Space (EHDS) regulation aims to empower individuals by giving them access to and control over their electronic health data and to foster research and innovation by providing rules for the secondary use of this data. These aims both form an important promise considering that clinical research has historically overlooked and under-represented marginalised groups, including people of colour and women. This article explores what the impact of the EHDS regulation could be on bridging the gender data gap by harnessing data collected through menstruation apps and other femtech devices and to what extent menstruation apps could fall within the scope of the EHDS under the label of ‘wellness applications’. To this extent, this contribution considers what types of user-generated data collected by femtech apps could be considered health data within the meaning of the General Data Protection Regulation (GDPR) and the EHDS as well as why it is difficult to simply qualify data from menstruation apps as health data from a feminist perspective. The article further discusses legal and practical obstacles to the integration of menstruation apps in the EHDS by focusing on three factors: data quality, data protection and privacy, and data accessibility. The contribution demonstrates that the EHDS might not be able to address the existing concerns around data protection and consent on menstruation apps as well as concerns surrounding data quality, and that some of the definitions and concepts around wellness apps under the EHDS need to be further clarified.
- Organisation(en)
- Institut für Innovation und Digitalisierung im Recht
- Journal
- European Health & Pharmaceutical Law Review
- Seiten
- 114-126
- DOI
- https://doi.org/10.21552/ehpl/2025/3/4
- Publikationsdatum
- 10-2025
- Peer-reviewed
- Ja
- ÖFOS 2012
- 505002 Datenschutz, 505003 Europarecht
- Link zum Portal
- https://ucrisportal.univie.ac.at/de/publications/88b45df6-7a3b-4b2c-95b1-b11ea6e4aa9a