Sharing wearable data for the greater good, like healthcare, a debatable issue?
In the rapidly evolving landscape of digital health, two significant EU initiatives are set to reshape the way wearable health data is used: the Data Act and the European Health Data Space (EHDS). Launched in 2025, these initiatives aim to facilitate the secondary use of wearable data, particularly in health and wellness contexts, while ensuring stringent data protection and privacy standards.
The Data Act, scheduled to become applicable from September 2025, plays a crucial role in facilitating the reuse of data, including wearable data. It provides a legal framework for data sharing, enabling individuals to share their health data securely and privacy-compliantly. The EHDS, on the other hand, became applicable in March 2025, establishing a common framework for using and exchanging electronic health data across the EU.
To explore data sharing in the EHDS, the JRC and the Data Spaces Support Centre organized a role-playing exercise in 2025. Participants, who assumed roles such as manufacturers, intermediaries, and health ministries, aimed to identify ways to make wearable data available in the EHDS for secondary use while respecting privacy and considering the interest of all participating parties.
The simulation exercise highlighted a complex interplay and a clear divide between public and private interests. It revealed manufacturers as central data holders, and their cooperation is essential for effective data sharing. Some participants formed strategic alliances during the exercise, illustrating the complexity of policy implementation.
The role-playing exercise also brought forward the issue of financial incentives and facilitating the flow of data exchange that would satisfy both private and public stakeholders. The discussion emphasised the importance of data intermediaries as trusted actors in charge of handling consent on behalf of consumers.
The EHDS and the Data Act are part of a broader EU effort to create a European data economy. They aim to build a centralized health data platform (HealthData@EU) that aggregates diverse datasets, including from wearables, to accelerate AI-driven medical research and diagnostics.
The secondary use of wearable data in the EHDS will facilitate research, innovation, and healthcare improvements across EU Member States. Given the sensitive nature of health data, the EHDS imposes strict data protection requirements aligned with GDPR and other related frameworks. From March 2027, wellness apps and devices that interact with EHR systems, including wearables, will be subject to CE-marking requirements without Notified Body involvement.
The evolving regulatory landscape also introduces clearer liability rules for digital health products leveraging wearable data. Manufacturers and providers may face increased exposure via EU-wide representative actions (class actions) if devices or applications lead to harm, underscoring the importance of compliance when handling secondary wearable data.
In summary, the Data Act and EHDS create a harmonized regulatory environment in the EU that promotes the secondary use of wearable health data for research and innovation while ensuring high data protection and safety standards. However, transitional challenges such as ensuring consistent enforcement across member states and clarifying clinical strategy discussions remain under discussion.
- The Data Act, due to become applicable in September 2025, aims to establish a legal framework for secure and privacy-compliant sharing of health data, including wearable data, in the landscape of digital health.
- The European Health Data Space (EHDS), which became applicable in March 2025, establishes a common framework for using and exchanging electronic health data across the EU, including data from wearable devices.
- As part of the broader EU effort to create a European data economy, the EHDS and the Data Act aim to build a centralized health data platform (HealthData@EU) that aggregates various datasets for AI-driven medical research and diagnostics.
- Following the role-playing exercise organized by the JRC and the Data Spaces Support Centre in 2025, it was revealed that manufacturers are central data holders for wearable data and their cooperation is essential for effective data sharing in the EHDS.
