Gematik product expertise
Are you looking for a trustworthy partner for the preparation of Gematik product reports?
SRC GmbH is a leading independent company in the field of IT security and consulting services. Our team of highly qualified experts supports you in securing your IT systems and complying with legal and regulatory requirements. We specialize in the assessment and certification of products and services in the healthcare sector, particularly in the area of telematics infrastructure. On this page you can find out more about our comprehensive services, including product assessments, security assessments and consulting services for regulated and non-regulated areas of healthcare. Let our experts support you in the development and certification of your digital healthcare solutions and benefit from our many years of experience.
Telematics infrastructure product report
Products that are to become part of the telematics infrastructure in the healthcare sector must meet various requirements in terms of functionality, interoperability and security in order to be approved by gematik GmbH.
As proof of the safety-related suitability of a product, gematik requires a so-called product certificate for numerous approvals.
As part of the preparation of a product report in accordance with the gematik security suitability testing guideline (gemRL_PruefSichEig_DS), we check and evaluate the implementation of the requirements relevant to the approval object as independent experts. SRC has access to a wide range of specialist expertise. We are therefore able to offer product testing from a single source.
Many of the services and products approved by gematik today, including popular services such as the electronic patient file, the e‑prescription, the central IDP service, basic and KTR consumer or the high-speed connector as well as the associated applications or apps for insured persons, have been and are being assessed by our highly qualified experts.
Benefit from our many years of experience, which goes back to the beginnings of the telematics infrastructure.
In addition to product reports, we are also happy to prepare all other reports required for approval by gematik, such as security reports for your products or operating environments or, as a BSI-approved test laboratory, Common Criteria (CC) evaluations and Accelerated Security Certifications (BSZ), and we will guide you through the approval process with our experience.
Product assessments in the (as yet) unregulated healthcare sector
The obvious gaps in the digitalization of the healthcare system that have come to light during the coronavirus pandemic have made it clear that there is a particular need for action in the digitalization of processes, and not just in Germany. This trend is also reflected in the digital strategy for healthcare and nursing published by the Federal Ministry of Health in March 2023. In the coming years, it is to be expected that new products and services will continue to enter the market and that the regulatory requirements in the previously unregulated market will gradually increase, and not only in the context of the telematics infrastructure, although some new products will certainly interact with it.
Especially in this gray area of (as yet) unregulated products and services, security and data protection issues should not be taken lightly, as the legislator already provides for severe penalties here.
With our many years of experience in testing processes and products in the digitalized healthcare sector, from apps, server applications and hardware to processes at manufacturers and operators of such solutions, we can also support you in the non-regulated area. We also offer modular consulting services tailored to your specific needs in order to make you fit for upcoming certifications at an early stage. Questions about secure software architecture and the documentation required for approvals or the requirements for various approval and testing procedures can be clarified as early as the planning phase, saving you from costly surprises later on.
Contact: Dr. Jens Putzka, eHealth Product Expertise +49 (228) 2806 — 162 jens.putzka@src-gmbh.de, gutachten_ti@src-gmbh.de