Rewiring care delivery through Digital Therapeutics (DTx): a machine learning-enhanced assessment and development (M-LEAD) framework.

Background: Digital transformation has sparked profound change in the healthcare sector through the development of innovative digital technologies. Digital Therapeutics offer an innovative approach to disease management and treatment. Care delivery is increasingly patient-centered, data-driven, and based on real-time information. These technological innovations can lead to better patient outcomes and support for healthcare professionals, also considering resource scarcity. As these digital technologies continue to evolve, the healthcare field must be ready to integrate them into processes to take advantage of their benefits. This study aims to develop a framework for the development and assessment of Digital Therapeutics.

Methods: The study was conducted relying on a mixed methodology. 338 studies about Digital Therapeutics resulting from a systematic literature review were analyzed using descriptive statistics through RStudio. Machine learning algorithms were applied to analyze variables and find patterns in the data. The results of these analytical analyses were summarized in a framework qualitatively tested and validated through expert opinion elicitation.

Results: The research provides M-LEAD, a Machine Learning-Enhanced Assessment and Development framework that recommends best practices for developing and assessing Digital Therapeutics. The framework takes as input Digital Therapeutics characteristics, regulatory aspects, study purpose, and assessment domains. The framework produces as outputs recommendations to design the Digital Therapeutics study characteristics.

Conclusions: The framework constitutes the first step toward standardized guidelines for the development and assessment of Digital Therapeutics. The results may support manufacturers and inform decision-makers of the relevant results of the Digital Therapeutics assessment.