What question did this study set out to answer?

The aim is to explore regulatory and evaluative challenges of digital therapeutics in isolated areas and suggest improvements.

February 27, 2026Open Access

ROSIA Positioning paper

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Key Points

The aim is to explore regulatory and evaluative challenges of digital therapeutics in isolated areas and suggest improvements.
Analysis of the current state of digital therapeutics in Europe
Evaluation of existing regulatory frameworks
Development of policy recommendations for better integration into healthcare systems
Identification of key barriers to the adoption of digital therapeutics
Proposed recommendations for policy changes to enhance acceptance
Insights into the regulatory landscape for digital therapeutics in Europe

Abstract

This positioning paper is a deliverable of the project ROSIA (Remote Rehabilitation Service for Isolated Areas, GA number 101017606) that addreesess the challenges related to the regulation, evaluation and prescription of Digital Therapeutics (DTx), analyzing the state of the art in Europe and proposing a series of policy recommendations to improve the adoption of DTx by healthcare systems

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Authors

Sofía Moreno-Pérez

Innova (Hungary)

Iris Menéndez Fernández

Instituto Aragonés de Ciencias de la Salud

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Instituto Aragonés de Ciencias de la Salud

Innova (Hungary)

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ROSIA Positioning paper

Key Points

Abstract

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