European Health Data Space: A Game-Changer for Digital Device Assessment
By Amanda Maxwell
19 Mar 2025
The European Health Data Space (EHDS) is poised to dramatically reshape how digital health devices are evaluated, according to recent reports. A key factor in this transformation is the EHDS’s ability to generate real-world evidence and gather patient-reported outcomes (PROs), which could substantially benefit health technology assessment (HTA), particularly within the realm of digital health.
The initiative is anticipated to create an environment where the safety and efficacy of digital health devices undergo more rigorous scrutiny. The increased availability of comprehensive real-world data will allow for in-depth analysis of how these devices perform in practical settings, providing insights that are often unavailable through traditional clinical trials. This will enable a better understanding of potential risks and benefits, ultimately making it possible to approve of, and give access to, better digital health technologies.
Explosion of available digital health data to improve digital device safety.
