There is a broad number of DTx solutions, but in order to thrive and be successfully adopted, prescribed and reimbursed, is essential to prove their efficacy and safety. How can we measure properly DTx efficacy and safety so that they are validated with the same rigor as a drug? Considering the challenges DTx companies are facing when it comes to performing RCTs (cost, time and constantly evolving softwares/devices), is RWE the best choice or is it a variation of gold standard RCTs? Do all DTx products need third-party validation of the efficacy and safety claims by regulatory national bodies? What are the payers requirements for efficacy and safety before they decide to reimburse DTx solutions?