What is a DiGA

Digital health apps (known by the German initials “DiGA”) open up a range of possibilities to support patients in the recognition and treatment of diseases and to put them on a pathway to an autonomous, health-promoting lifestyle.

DiGA are significantly different from conventional health apps, as only approved DiGAs can be prescribed by doctors and psychotherapists with a health insurance prescription as a prescription app.

The statutory basis for these apps is the Digital Healthcare Act (DVG) that came into force in December 2019.

Grafische Darstellung einer Beratung zwischen einer Ärztin und einem Patienten

DiGA at a glance

  • DiGA are class I or IIa medical devices and are tested by the German Federal Institute for Drugs and Medical Devices (BfArM).
  • DiGA receive a permanent approval only if they can demonstrate a positive treatment effect (e.g. in a controlled clinical study).
  • The patient safety, the quality of the medical content,
    accessibility and consumer protection of a DiGA must meet the BfArM’s requirements.
  • Data security and data protection must meet the requirements of the BfArM that go beyond the General Data Protection Regulation (GDPR).

The costs of a DiGA are covered by all statutory and most private health insurers.

Smartphone mit Darstellung von somnio
Grafische Darstellung von somnio und einem Wissenschaftler

Efficacy as criterion

A central feature of all DiGA and thus also of somnio is medical benefit. This also fundamentally distinguishes DiGA from all non-certified health apps.

The medical benefit of somnio has been proven in an RCT conducted by the University of Zurich.

Improving health

The evidence provided by the positive treatment effect (improved state of health) and the assessment decision of the BfArM for permanent approval as a digital health app is also based on the findings of this randomised controlled trial. The BfArM’s opinion: “The results of the statistical analysis demonstrate that the use of the DiGA somnio can successfully reduce the symptoms of insomnia in the long term.” Accordingly, the BfArM considers the requirements set out in 139e SGB V (German Social Code V) and in
the Digital Health Applications Ordinance (DiGAV) for inclusion in the list according to 139e para. 1 SGB V as fulfilled.

Detailed information on BfArM and the DiGA process are available here.

Junge Frau nutzt Smartphone auf ihrer Couch