Eleven months after the approval of the Digital Versorgung Gesetz (DVG), the Digital Health Care Act (DVG), two apps are now prescribed by German doctors.
The DVG stipulates that digital therapies must be approved by the Federal Institute for Pharmaceuticals and Medical Devices (BfArM) for safety, functionality, quality, security and data protection.
Once approved, the apps are provisionally reimbursed by public health insurance for one year. During this period, manufacturers must demonstrate to the Federal Institute that their application improves patient health. The manufacturers then negotiate the amount they will receive for the app with the central federal mutual insurance association.
The first two apps that have been approved are Kalmeda, a digital therapy for the treatment of tinnitus and Velibra, an app to treat anxiety disorders.
Kalmeda treats tinnitus through cognitive-behavioural therapy. The patient has to formulate his own disorders in order to obtain an individual therapy plan. The app guides the patient step by step through the exercise program which consists of seven parts. After completing the exercise program, the app continues to support the patient and helps him/her achieve the goals set.
In order to obtain the app, the patient must have a three-month therapy with Kalmeda prescribed by his doctor. He must then send the prescription to his health insurance company to receive a 16-digit activation code that he/she will insert in the app downloaded from Apple or Google stores. Entering the code will unlock the app that can then be used.
Velibra does offer exercises and suggestions based on cognitive behavioral therapy for the treatment of anxiety. Velibra is indicated for patients aged 18 years or older with symptoms of generalized anxiety disorder, panic disorder with or without agoraphobia or social anxiety disorder. It should not be used in case of psychotic illnesses (e.g. Schizophrenia), bipolar disorders or if there are thoughts of suicide.
The therapy takes place through a dialogue. Velibra asks the user short questions and the user selects the answers from a predetermined number of options the one that most interests him/her and/or that best suits the individual situation. The app responds empathically to the answers and then asks other questions to which the user can react, thus generating a flow of interactions.
Even in this case the activation of the app is obtained through a code provided by your health insurance following a doctor’s prescription.