Ministry of health provides draft of decree for DiGAV (digital healthcare apps)

Manufacturers of digital healthcare apps (DiGAs, German abbreviation for "digitale Gesundheitsanwendungen") have to fulfil minimun standards  regarding patient safety, data security and functional capability to prove that they are allowed to be reimbursed by statutory health insurances.

The federal ministry of health provided the draft of the decree for the DiGAV ("Digitale Gesundheitsanwendungen-Verordnung"). It contains a questionnaire of 120 questions to be answered by the manufacturers prior to the app's admission by BfArM (federal institution for pharmaceuticals and medical devices) as a DiGA. In general, the DiGAs must be certified as medical devices before BfArM's admission. Therefore, the different responsibilities of the involved institutions may become a bottleneck for the admission of the apps.

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