Implementation Challenges and Policy Strategies for Digital Therapeutics in European Healthcare Systems (Preprint)

BACKGROUND Digital therapeutics (DTx) have emerged as new solutions for delivering therapies. These medical software solutions are clinically proven and can prevent, manage, or treat various medical disorders. Despite numerous applications already approved under the European Medical Device Regulations, their widespread adoption remains limited. OBJECTIVE The objectives of the study are to investigate the barriers to DTx implementation from healthcare providers’ perspectives in European healthcare institutions and to support these institutions by optimally allocating resources in order to effectively implement DTx. METHODS This study identifies 10 key barriers to DTx implementation in European healthcare institutions from the perspective of healthcare providers, through literature reviews and interviews with experts in the field. Questionnaires were then distributed to physicians, nurses, and other medical staff personnel to examine the interrelationships between barriers using Interpretive Structural Modeling, and to categorize them through Importance–Resistance Analysis. RESULTS The study proposes a validated implementation roadmap to address each barrier in a determined and recommended sequence: (1) Trust and Data Security, (2) Unharmonized Regulation, (3) Physician Expertise, (4) Clinical Validation, (5) User Capability, (6) Access and Support, (7) Human Interaction, (8) User Acceptability, and (9) Engagement and Personalization. The last barrier, Reimbursement Complexity, should be addressed in parallel across all stages due to its autonomous nature and high impact. CONCLUSIONS This scientifically grounded framework offers strategic guidance to overcome key barriers, enabling greater integration of DTx into European healthcare systems.