[Digital health applications: statutory introduction of patient-centred digital innovations into healthcare]

The Digital Healthcare Act (DVG) and the Digital Health Applications Ordinance (DiGAV) defined digital health applications (DiGA) and included these as an entitlement of statutory health insurance (GKV). Further development of this new area of healthcare occurred within the Digital Healthcare and Care Modernization Act (DVPMG). Every doctor and psychotherapist can prescribe digital applications at the expense of statutory health insurance funding, provided the applications have successfully undergone a three-month test procedure at the Federal Institute for Drugs and Medical Devices (BfArM) and are listed in their DiGA directory. Provisional admissions of DiGA accompanied by scientific studies and evaluations are also possible.The legislator has thus actively incorporated the highly dynamic technological and social development of digital innovations into healthcare by introducing mobile applications for therapeutic purposes. The legal framework is designed in such a way that DiGA can not only potentially support aspects of patient-centred care, such as strengthening of self-management, health literacy and adherence but also optimize treatment procedures and interaction between patients and service providers in many ways.Extensive specifications for technical interoperability between DiGA and other types of medical devices and implants, as well as the electronic patient record (ePA), will accelerate the integration of DiGA into day-to-day care. Overall, it is of utmost importance to incorporate DiGA into existing care as enriching, user-friendly and digitally supported processes. Hence, the initial regulatory framework will continuously be adapted and developed in the years to come - shaped by the experiences gained with innovative products and the administrative procedures used to admit them.