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This guide will be iteratively developed. If relevant aspects and/or questions are missing, please provide us feedback via the following e-mail address: diga@gematik.de Update on 06.09.2023: Information was added on testoptions, which are now available for integrating the Health ID resp. the IDP-Federation. Update on 22.11.2023: Information on the next steps after the successful testing of the Health ID has been added. Update on 21.02.2024: Information on the confirmation process of the gematik, the 'ePA for all', and data submission to the BfArM has been added. |
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Following a comprehensive review of all the Telematics Infrastructure ( TI ) use cases in the context of Digital Health Applications ( DiGA), this document will particularly emphasize two mandatory use cases. The first one is the uploading of DiGA data into the Electronic Patient Record (ePA) by the DiGA manufacturer. The second focuses on the integration of digital identities (HealthID) provided by the health insurance companies for the insured individuals.
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Under the Digital Health Applications Regulation (DiGAV), DiGA manufacturers are mandated to transfer data from the DiGA into the Electronic Patient Record (ePA) at the user's behest. If the user gives authorization, treating healthcare providers can view the relevant DiGA data from their familiar primary system without needing to operate an additional, DiGA-specific interface. The data should ideally be entered into the ePA in the form of a DiGA-MIO, as specified by mio42 GmbH, although it can technically also be stored as a PDF. Given that the current protocol only allows data entry into the ePA from the DiGA backend via access to the closed network of the Telematics Infrastructure ( TI ) – essentially, via a connector used in conjunction with a unique SMC-B DiGA smart card (smart card that uniquely identifies a participant of the TI) – DiGA manufacturers must equip themselves with the necessary components to implement this use case.
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The user can only authorize the DiGA when the gematik, as the issuer of the SMC-B DiGA (see chapter Implementation options for TI access), has entered the DiGA manufacturer in the gematik directory. This happens immediately after the SMC-B DiGA has been delivered to the DiGA manufacturer. Only then can the user find the corresponding DiGA in his ePA-Frontend and grant the corresponding authorization. When the user grants authorization, a DiGA-specific folder is created in the user's ePA record system, into which the supply-relevant DiGA data can subsequently be stored.
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Applying for the SMC-B DiGA is only possible after the DiGA has been successfully listed in the DiGA directory. According to § 351 Abs. 3 SGB V, the gematik is the card issuer for SMC-B DiGA. DiGA manufacturers can apply for SMC-Bs via the application portal of d-trust, the card provider of gematik (link). The BfArM will confirm to the gematik that the applicant is authorized to receive an SMC-B.
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Important: As part of the SMC-B order, it is necessary for the DiGA manufacturer to undergo an identity verification process. It is mandatory imperative that the person listed as the contact person in the BfArM application portal undergoes goes through the corresponding appropriate identity verification process. Please ensure this before proceeding with the identity verification process applying for the SMC-B according to the following document: |
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Once DiGA manufacturers have successfully tested the HealthID and retrieved an ID token, they must be confirmed by the gematik as a DiGA in the TI Federation. According to § 327 SGB V, confirmation by the gematik is required when components or products of the telematics infrastructure are used by further applications. The aim is to ensure in this way that the manufacturers meet the requirements specified by the gematik and maintain them during the confirmation period. The entire confirmation process from application to issuance of the confirmation notice can be found in detail at the following following link, under "Digitale Gesundheitsanwendungen (DiGA) → Verfahrensbeschreibung Bestätigung Digitale Gesundheitsanwendungen".
The requirements that a DiGA manufacturer must meet are summarized in an application profile (Anwendungssteckbrief). This can be found at the following link,. DiGA manufacturers must provide evidence of meeting these requirements through self-declarations as part of the confirmation process. The gematik itself will not test the implementations of DiGA manufacturers. Applications for confirmation can now be made via the digital application portal of the gematik. A fee of €500 per DiGA for the confirmation process has been set (see "Gebührenübersicht → Bestätigungsverfahren DiGA").
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