There is a broad variety of digital health (DH) solutions, but in order to thrive and be successfully adopted, prescribed and reimbursed, is essential to clinically prove their efficacy and safety. How to design trials for DH tools so that they are validated and regulated with the same rigor as a drug? Considering the challenges DH companies are facing when it comes to performing RCTs (mainly cost, time and constantly evolving softwares/devices), what is the alternative? Is Real World Evidence the best choice for the validation of DH tools or is it a variation of RCTs? Some frameworks have attempted to standardize the trial design and method of evidence generation but is a universal standard practice feasible? What guidance should product developers or pharma partners be using to design the most appropriate trials for their digital health solutions?