Success Factors for Scaling Up the Adoption of Digital Therapeutics Towards the Realization of P5 Medicine

Abstract

DTx strategies should be considered as an integral part of digital health strategies and legislation, and specific DTx pathways with clear and transparent assessment and guidelines that balance regulation and innovation should be defined. To help manufacturers, countries should recommend and list methods that are widely accepted and ensure scientific robustness, aligned to the MDR requirements to support transfer of relevant and comparable data across countries. To facilitate rapid uptake of innovation, countries should add flexibility to the framework by allowing temporary market authorization to enable data collection that can support the clinical and socio-economic evaluation and data gathering phase. Certification should trigger rapid price setting and reimbursement mechanisms, and dynamic ways to adjust price and reimbursement levels in time should be established. Relevant stakeholders should be approached on the potential impacts of DTx through transparent communication and change management strategies should be considered. These findings should be validated with a wider range of stakeholders.