Table 1.

Classification of Positive Care Effects of DiGA the Proof of Which Is a Prerequisite for the Reimbursement of Costs by the Statutory Heath Insurers in Germany.

Positive care effects
Medical benefits	Patient-relevant structure and procedure improvements
Improving health status	More effective coordination of treatment procedures
Shortening the duration of the disease	Closer alignment of treatments with guidelines and recognized standards
Prolongation of survival	Improved treatment adherence
Improved quality of life	Easier access to care
	Improved patient safety
	Better health literacy
	Patient sovereignty
	Better coping with illness-related everyday problems
	Reduction of therapy-related efforts and burdens for patients and their relatives

A special focus is on the patient-centering of the positive effects that must be demonstrated to the Federal Institute for Drugs and Medical Devices (BfArM) by the manufacturer. The workload of medical professionals or health or health economic indicators are not classified as patient-relevant endpoints in this context. ⁶

Abbreviation: DiGA, Digital Health Applications.