From July 1, 2027, Section 374a SGB V will require certain manufacturers of medical aids and implants to provide interoperable interfaces so that health data from their products can be transferred in standardised form to a DiGA listed in the DiGA directory. This affects manufacturers whose products are billed through statutory health insurance and whose devices transmit patient data electronically to manufacturer backends.
In practice, this typically concerns connected medical devices such as continuous glucose monitoring systems, insulin pumps or smart orthoses. In future, these will have to offer a standardised interface so that health data can be transferred automatically to a DiGA where required and processed further there. The technical specifications are provided by the Federal Institute for Drugs and Medical Devices via the HIIS server, among others.