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Germany’s Digital Healthcare Act (DVG) defined a new way of integrating digital healthcare solutions into the country’s statutory healthcare system, when it came into effect in December 2019. It provides patients with a way to get access to healthcare through digital health solutions.


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).

DiGA that successfully pass the application process can be prescribed by any German physician or psychotherapist.

How to find out more

Do you have questions like: What exactly is a DiGA, what evidence is there of the positive healthcare effects of using a DiGA, and how to get your DiGA listed in Germany’s DiGA directory? These are all issues covered in a detailed report out in August 2020. Published in both English and German, it is a mine of useful information for manufacturers, service providers, and users.
DigaImage 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 DiGA directory will go live in early September 2020. The directory will be a user-friendly, searchable, web portal. It will offer different views for doctors/psychotherapists and for patients. From a patient perspective, it is intended to help guide persons who are insured under the German health insurance system to find suitable digital health solutions.

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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