Last month the German government added Endo-App, a digital therapeutic for endometriosis sufferers, to its DiGA directory after the app successfully completed the Federal Institute for Drugs and Medical Devices’ (in German: Bundesinstitut für Arzneimittel und Medizinprodukte aka BfArM) assessment procedure. The DiGa database is essentially a collection of regulated digital health products reimbursed via the government’s fast-track program.
Per definition DiGAs are CE-marked medical devices of risk class I or IIa, whose main function is based on digital functionalities and whose medical purpose is achieved by way of this digital function. So essentially digital therapeutics as we like to call them around here.
Endo-App was designed to help endometriosis sufferers self-manage the condition in addition to “care-as-usual”. The goal is to improve patients’ quality of life through symptom tracking, evidence-based behavioral intervention, and education. Recommended treatment duration is 90 days; treatment cost is €598,95.