Digital Therapeutics in Perspective: From Regulatory Challenges to Post-Marketing Surveillance

Digital therapeutics (DTx) are innovative therapeutic interventions, in which the activity is carried out by algorithms and software. They represent a new opportunity especially for treatment of chronic pathologies associated with dysfunctional lifestyles behaviors, where conventional drug therapy not fully effective. DTx highly customizable tools, allowing better involvement patient management disease. To date, clinical use Europe still generally limited. One main issues related to general lack education healthcare professionals this sector that leads knowledge gap between data scientists, physicians, who should identify all those needs could be addressed through DTx. From regulatory perspective, classified as Medical Devices. However, their research development process similar drugs, since they tested trials approval refers specific indications. For reason, precise criteria marketing approval, health technology assessment reimbursement these therapies need defined. Moreover, it also fundamental conduct post-marketing studies on DTx, aiming at re-evaluating benefit-risk profile collecting information large-scale real world setting. The aim review describe challenges development, regulation widespread use.