What is a DiGA?

DiGA stands for Digitale Gesundheitsanwendungen, or digital health applications. It is a German reimbursement category created by the Digital Healthcare Act (Digitale-Versorgung-Gesetz) that allows certain software-based medical devices to be prescribed by doctors and reimbursed by statutory health insurance. To qualify, an application must be a low risk medical device under the MDR, meet requirements on data protection, security, and interoperability, and demonstrate a positive healthcare effect. BfArM operates a fast-track assessment and maintains the official DiGA directory of listed applications, which may be listed permanently or provisionally while evidence is gathered. The DiGA pathway has been closely watched internationally as one of the first national models for systematically reimbursing digital therapeutics, and several other countries have designed comparable schemes.