Germany approves new digital mental health app for prescription


Germany is the first country in the world to prescribe digital apps – DiGAs, as the Germans call them, and reimburse them through the statutory health system. To drive innovation and speed up the regulatory process around those digital health applications, Germany has introduced a ‘Fast Track’ for approval, testing, piloting and evaluation of these apps – which is open to all companies in the European Union.

As of today, 11 out of 56 applications have been successfully approved, with another 21 undergoing the approval process.

The DiGA directory includes digital health applications that can currently be prescribed and reimbursed. It not only provides information on the approval, but also on the proof of benefit and the diagnoses for which the corresponding DiGA can be prescribed – all essential information for DiGA users, doctors and psychotherapists.

The 11 approved digital health applications are:

  • deprexis from GAIA AG treats depression.
  • Selfapy targets depression.
  • elevida is aimed at multiple sclerosis patients who suffer from chronic fatigue.
  • Invirto and velibra are two DiGAs designed for patients with panic disorders, social phobias and anxiety disorders.
  • Kalmeda from mynoise GmbH is the first approved app for behavioural tinnitus therapy.
  • With M-Sense is an established headache and migraine app, which provides patients with a chronic pain diary with analysis tools and preventive recommendations.
  • Rehappy is a tool developed for the aftercare of stroke patients.
  • somnio is the DiGA which can be used for non-organically triggered sleep disorders and helps to optimise sleep rhythms and obstacles.
  • The movement therapy app Vivira from Vivira Health Lab treats back, knee and hip pain caused, for example, by arthrosis, but also non-specific pain around the spine, hips, knees and back.
  • The application zanado from aidhere GmbH is used for problems associated with being overweight.

Observing these first approvals, MobiHealthNews asked Julia Hagen, Director Regulatory & Politics at the Health Innovation Hub (hih), the German Federal Ministry of Health (BMG)’s in-house think-tank on digitalisation – which specialises in the DiGA directory – about her thoughts on the promising progress in digitsation in Germany.

Hagen commented: “We currently see a focus on applications in the field of mental illness. This is because the mental health area is already very well developed with numerous applications, companies, studies and scientific findings.”

Furthermore she stressed that the entire DiGA spectrum would be relatively broad: “There are also applications from completely different areas. Looking at the ongoing discussion and applications that are in the pipeline, we will soon see many other DiGA for various indications.”

In order to speed up the approval process for digital health applications, the so-called ‘Fast Track’ process has been set up in Germany. “The core idea of the Fast Track is that there is a structured, rapid path to reimbursement”, Hagen said.

At this point, there have been various ways for digital products to enter the care system in Germany. However, many of these pathways were not well suited to them, as they were designed, among other things, for classic medical aids.

“The Fast Track is thus the record of a specific pathway for digital health applications into standard care. It allows manufacturers more clarity about the requirements and the process,” remarked Hagen.

“We (Health Innovation Hub) supported our colleagues from the BMG and BfArM in the conception and development of the procedure and the DiGA directory.

“We also help various stakeholders to educate their members, e.g. the medical societies. They now increasingly want to know which digital health applications exist in their field, which studies already exist and how the prescription works,” Hagen continued.

The regulatory work around the DiGA approval will most likely benefit further digitalisation in the care sector. Digital care applications, known as DiPA are already in discussion in Germany.

Those “siblings for the DiGA” are “still at the stage of a draft law”, states the hih and await a legal basis to become part of standard care as the Digital Care and Nursing Modernisation Act (DVPMG) is still on its way to the parliamentary procedure.

“The DiGAs will serve as orientation while the BfArM will also be responsible”, explained Hagen in more detail. Looking ahead she concluded: “Equally intensively discussed at present is the consideration from the Ministry of Labour and Social Affairs to integrate DiGAs more strongly in rehabilitation.”