Compliance Requirements for Digital Health Products

Digital health products, known as Digital Therapeutics and especially in German “Digitale Gesundheitsanwendungen (DiGA)” (digital health applications), have become an integral component of modern healthcare delivery models. They combine clinically validated interventions with mobile applications, while requiring strict regulatory and technical compliance. This chapter provides a practice-oriented overview of the regulatory framework ranging from the Medical Device Regulation (MDR), the General Data Protection Regulation (GDPR), and the Digital Health Applications Regulation (DIGAV) to Social Code Book Five (Statutory Health Insurance Act), covering the requirements established by the Federal Institute for Drugs and Medical Devices (BfArM) and the Federal Office for Information Security (BSI) regarding safety, data protection, interoperability, and evidence-based evaluation. By meeting these requirements, manufacturers can not only comply with high standards but also secure reimbursement eligibility within Germany’s statutory health insurance system. Once a digital application is listed in the BfArM directory, it can be prescribed by physicians in the same manner as pharmaceuticals, with manufacturers receiving corresponding remuneration.