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
Clinical Scorecard: The Role of Digital Therapeutics in Italy Within the European Healthcare Framework
At a Glance
Category Detail
Condition Digital Therapeutics (DTx) Key Mechanisms Evidence-based therapeutic interventions powered by software. Target Population Patients with chronic conditions such as diabetes, anxiety, depression, and hypertension. Care Setting Healthcare systems in Italy and the broader European context.
Key Highlights
DTx require robust clinical validation to demonstrate efficacy. Clinical trials for DTx follow rigorous methodologies similar to traditional drug trials. Regulatory frameworks for DTx are evolving, with recognition of software as a medical device. Heterogeneity in study design regarding control arm strategies was observed. Post-market surveillance responsibilities are crucial for ensuring patient safety. Guideline-Based Recommendations
Diagnosis
Clinical trials must demonstrate safety and efficacy for DTx registration. Management
Manufacturers should adhere to ISO 14155 and MDCG 2020-1 guidelines for clinical evaluation. Monitoring & Follow-up
Continuous monitoring is essential for ensuring therapeutic effectiveness. Risks
Regulatory compliance and risk classification are critical for market entry. Patient & Prescribing Data
Patients with chronic physical and behavioral conditions.
DTx can optimize treatment adherence and effectiveness through iterative design improvements.
Clinical Best Practices
Conduct pilot studies to assess technical performance and usability. Implement pivotal studies to gather comprehensive safety and effectiveness data. Ensure strict inclusion and exclusion criteria in clinical trials. Related Resources & Content
