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

"Declarations Ethics approval and consent to participateThis study has been entirely performed following guidelines and regulations. The study did not require approval from an ethics committee because this study did not change in any way patients’ therapy plans, as stated by the Decree of the Minister of Health dated February 1, 2022, and by the Regulations of the “National Ethics Committee for trials of public research institutions (EPRs) and other public institutions of national character,” at the Istituto Superiore di Sanità (ISS). This study included interviews with stakeholders other than patients; no personal data or health-related information was collected. Such laws state that ethics committee approval is required in the following circumstances: evaluation of clinical trials under EU Regulation 536/2014 carried out by ISS, EPRs, and other public bodies of national character; evaluation of protocols of other studies (including clinical, observational, diagnostic, public health, with medical devices, with the use of human biological material, with environmental ethics implications) carried out by ISS and, possibly, by other EPRs and public bodies of national character; Advice and expression of opinions on ethical aspects of activities and interventions of ISS, concerning its functions and duties as defined by the Statute of ISS, the Rules of Organization and Operation of ISS, and in compliance with applicable regulations. In the current paper, experts about Digital Therapeutics were involved in this study just to express their anonymous opinions about these technologies. Participants were informed of the purpose of this study and the policy for data collection, processing, and communication (aggregated and anonymously) coherently to the GDPR indications. Participants expressed their acceptance through an informed consent form. Participants were informed about the treatment of the data according to the European General Data Protection Regulation. Participants were also explicitly asked to accept the conditions regarding the data used for this study. The semi-structured interviews and focus groups used in this study were developed for this research and have never been published elsewhere. Consent for publicationNot applicable. Competing interestsThe authors declare that they have no competing interests. Competing interests The authors declare that they have no competing interests."

"Funding Not applicable."