Background
Digital health solutions (DiGA) provide Germany’s new, structured way for patients to get access to digital therapeutics as one element of regulated care. Everything happens through the German statutory healthcare system – a system that covers around 75 million citizens.
DiGA are seen as “digital helpers” or “digital assistants” in the hands of patients. They provide therapies and interventions for chronic conditions to help patients shift towards healthy lifestyles. They need to count as medical devices (class I or IIa) to be considered as a DiGA.
DiGA must successfully pass an approvals process, and must be included in an official directory. They can be sold or given to patients.
The online application form for DiGA has been live since May 2020 at BfArM (Federal Institute for Drugs and Medical Devices – the German equivalent to the American Food and Drug Administration (FDA).
How to find out more
Image from cover sheet to report published by BfArM
Current types of apps described in the report focus on conditions like diabetes type 2, mental illnesses, pain, sleep disorders, and strokes. Important characteristics of the apps relate to data protection, quality of data, interoperability, security, and suitability.
A focus on the fast track
DiGA is focusing on a Fast Track process. Fast-tracking is intended to get things moving inside a three-month time-period. It offers quick approval and integration of solutions. Its speed can really help in the fight against COVID-19.
The German health innovation hub (hih), the think tank financed by the Federal Ministry of Health, was “a sparring partner” for the ministry as well as BfArM during the development and implementation of the DiGA Fast Track. It now communicates on the new regulation to a wide range of stakeholders. Example stakeholders include digital health companies, policy makers, and payers.
The German hih is holding an in-depth introductory event to DiGA and the application process on 16 September 2020, 16:00-19:00 CET. Held in English, it could provide your first introduction to understanding this major new digital health opportunity in Germany. This introduction offers a first step understanding ahead of reading more detailed documents.
German hih documents published in English include a view of the DiGA Fast Track and its relationship with COVID-19.
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