The trialist's perspective: what do you need to prove for remote monitoring devices to be approved?

Due to contrasting results from clinical trials, remote monitoring devices have so far rarely been approved for heart failure (HF) management in European countries. Implementation of telemedicine into clinical practice of heart failure outpatient care is still limited. As part of an expert meeting on physiological monitoring in the complex mutimorbid HF patient, the needs to establish evidence supporting the use of devices in heart failure outpatient care was discussed according to a trialist's perspective. This document reflects the key points debated by a multidisciplinary panel of leading international experts on this topic.