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Quantifying effects of the European Health Data Space on the app ecosystem and data access
Stefanie Brückner1, Ronja Riedel2, Sven Hetmank2
1Else Kröner Fresenius Center for Digital Health, Technische Universität Dresden, Dresden, Germany. stefanie.brueckner@ukdd.de.
Many health apps may soon be part of the European Health Data Space (EHDS), enabling patient data sharing for care and research. Over 60,000 app providers could qualify under EHDS regulations, impacting connected care.
Area of Science:
- Digital Health
- Health Informatics
- European Health Policy
Background:
- Patient-generated health data from mobile apps and wearables are crucial for connected care.
- The European Health Data Space (EHDS) framework designates app providers as health data holders with data-sharing responsibilities.
- Understanding app provider eligibility within the EHDS is vital for data integration.
Purpose of the Study:
- To assess the potential integration of consumer health apps into the European Health Data Space (EHDS).
- To determine the proportion of health app providers that meet EHDS health data holder criteria.
- To estimate the number of app providers eligible for the EHDS secondary-use ecosystem.
Main Methods:
- Systematic review of 100 health apps, analyzing privacy policies and public data.
- Mapping of EHDS health data holder criteria against app data disclosures.
- Extrapolation of findings to the global population of health apps.
Main Results:
- 18% of reviewed apps met criteria for the Personal Health Data Pathway.
- 21% of reviewed apps met criteria for the Anonymous Health Data Pathway.
- Over 60,700 and 70,800 app providers globally could potentially qualify for EHDS pathways.
Conclusions:
- A significant number of consumer health apps may become part of the regulated EHDS secondary-use ecosystem.
- The integration of health apps into EHDS depends on regulatory enforcement and provider adaptation.
- This integration has substantial implications for connected care and health data research.
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