Researchers at FAU Erlangen-Nürnberg criticise, in a publication, the methodology used in approval studies for DiGA. They are meeting opposition from several quarters, however.
According to the analysis, approval studies for DiGA sometimes show considerable methodological shortcomings, such as a lack of blinding, inadequate control groups and high dropout rates. It also criticises the fact that many DiGA are offered at high prices despite unclear evidence.
Industry representatives and manufacturers firmly reject the criticism of the approval studies for digital health applications (DiGA) and point to the BfArM’s fast-track procedure, which they say contains clear statutory requirements for scientific quality and transparency.
The call for more strongly blinded studies in particular meets with objections: Dominik Böhler of the Deggendorf Institute of Technology considers blinding to be barely feasible for DiGA, since they are not a “digital pill”. In his view, a so-called placebo app makes little sense. The psychologist Mathias Harrer also supports this assessment and stresses that in psychotherapy research it is extremely difficult to develop an app that pretends to provide therapy without users seeing through it.
Read the full Handelsblatt article here: Apps auf Rezept: Das steckt hinter der neuen DiGA-Kritik