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    Home ยป European Health Data Space: A Game-Changer for Digital Device Assessment
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    European Health Data Space: A Game-Changer for Digital Device Assessment

    techgeekwireBy techgeekwireMarch 19, 2025No Comments1 Min Read
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    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.

    Digital health data explosion
    Digital health data explosion

    Explosion of available digital health data to improve digital device safety.

    digital health EHDS health technology assessment patient-reported outcomes real-world evidence
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