Case Study
Pre-Clinical Study for a Digital Health Application
Starting Point Following the introduction of the DVG (Digitale-Versorgung-Gesetz / digital healthcare act) in Germany in December 2019, patients insured by the public health system can claim the prescription of digital health applications (Digitale Gesundheitsanwendungen or DiGAs). As an ‘App on prescription’, these applications can support the identification and treatment of conditions and help patients to lead a self-determined, healthier life. As medical devices of risk classes I or IIa, DiGAs must undergo a testing procedure at the German Federal Institute for Drugs and Medical Devices (BfArM). After successful testing, they are listed in the DiGA directory and can be prescribed by physicians and psychotherapists, and reimb