The Italian landscape of digital therapeutics in a European context - Takeaways - MDSpire

The Italian landscape of digital therapeutics in a European context

  • By

  • Giulia Ivagnes

  • Michela Di Pietro

  • Valentina Lacalamita

  • Davide De Pascale

  • Andrea Oliva

  • June 11, 2026

  • 0 min

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  • 1

    Digital Therapeutics (DTx) are evidence-based interventions requiring clinical validation to manage diseases like diabetes and depression.

  • 2

    In Italy, 13 DTx-related clinical trials were identified, including 11 interventional studies and 2 observational studies.

  • 3

    The European Medical Device Regulation now recognizes stand-alone software as a medical device, impacting DTx regulation.

  • 4

    Regulatory frameworks for DTx in Italy are less defined than in other EU countries, affecting market entry for stakeholders.

  • 5

    Clinical trials for DTx share features with drug trials but face unique challenges due to their digital and interactive nature.

Original Source(s)

The Italian landscape of digital therapeutics in a European context

  • by Giulia Ivagnes, Michela Di Pietro, Valentina Lacalamita, Davide De Pascale, Andrea Oliva

  • June 11, 2026

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