What are the requirements for 'Authentisierung von GKV-Versicherten' for DiGAs in Germany from January 1st?

According to recent updates from Gematik, the authentication process for GKV-insured users currently involves using either the alternative insurance identity (al.vi) or the electronic health card (eGK) with a corresponding 6-digit PIN. Moving forward, a federated identity provider will be introduced by the insurers to provide users with an electronic identity (eID).

For DiGAs to integrate with the ePA (electronic patient record), you will need to be connected to the Telematikinfrastruktur (TI). This involves obtaining a connector and a card reader, as well as an SMC-B card from Gematik. If your servers are on-premise, you operate the hardware locally. If your servers are cloud-based, you can use a data center connector via a service provider. The SMC-B card contains the telematics ID used to authenticate your DiGA with the TI and the ePA system.

Once a user authorizes your DiGA for write access to their ePA, you can transmit data either in the structured DiGA MIO format or unstructured as a PDF, as regulated by the DiGA ordinance. Currently, DiGA manufacturers are not authorized to read data from the ePA.

The technical documentation and further details can be found via Gematik and the official DiGA-Verordnung. More specific integration documentation is usually provided directly by Gematik or your integration partner.