[Digital health applications from a regulatory perspective-Experiences and current developments]

Since 2020 digital health applications, or DiGA for short, can be prescribed and reimbursed by health insurance companies, making them one of the pioneers in the integration of digital therapeutics in patient care. The prerequisite for these "apps on prescription" is a listing in the DiGA directory after successfully passing an evaluation process at the Federal Institute for Drugs and Medical Devices (BfArM). The DiGA directory of the BfArM contains information on the individual DiGAs and their properties that are transparent and tailored to the target group. In addition to a positive effect on care a DiGA must meet extensive quality, data protection and security parameters. Of the 59 DiGAs currently available on prescription 28 deal with psychiatric indications. The proof of positive effects on care were overwhelmingly demonstrated in randomized controlled trials. A DiGA should be used after proper diagnostics, determination of indications and education, both as a preparation for therapy and as a supplement to therapy. They can be prescribed by medical or psychotherapeutic practices but also by inpatient treatment providers as part of discharge management. Patients who use DiGAs appreciate their availability in their individual everyday lives, the opportunities for information and exchange within the therapy setting and the increased sense of self-management.