Quantifying effects of the European Health Data Space on the app ecosystem and data access

Access to patient-generated health data from mobile apps and wearables is increasingly central to connected care. The European Health Data Space (EHDS) introduces app providers as health data holders with obligations to share data for patient care and secondary use. We mapped EHDS health data holder criteria and applied them to a systematic review of 100 health apps, using privacy policies and related public sources to identify disclosed health data types and processing purposes. Overall, 18% of apps could qualify under the Personal Health Data Pathway and 21% under the Anonymous Health Data Pathway. Extrapolated to the currently globally available 337,000 health apps in app stores, more than 60,700 and 70,800 app providers could qualify. This suggests that a substantial share of consumer health apps may become integrated into the regulated EHDS secondary-use ecosystem. The scale of data availability will depend on enforcement and how providers adapt their data practices.