Access and reimbursement pathways for digital health solutions and IVD devices

Digital therapeutics (DTx) are innovative solutions that use meaningful data to provide evidence-based decisions for the prevention, treatment, and management of diseases. Particular attention is paid to software-based in vitro diagnostics (IVDs). With this point of view, a strong connection between DTx and IVDs is observed.

The recent paper “Access and reimbursement pathways for digital health solutions and in vitro diagnostic devices: Current scenario and challenges” investigates the current regulatory scenarios and reimbursement approaches adopted for DTx and IVDs.

The initial assumption was that countries apply different regulations for the access to the market and adopt different reimbursement systems for both DTx and IVDs. The final aim was to provide a general comparative overview and identify those aspects that should be better addressed to support the adoption and commercialization of DTx and IVDs.

The paper “Access and reimbursement pathways for digital health solutions and in vitro diagnostic devices: Current scenario and challenges” is co-authored by Andrea Mantovani, Claudia Leopaldi, and Cassandra Maria Nighswander from Alira Health and Rossella Di Bidino, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Graduate School of Health Economics and Management (ALTEMS).