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 in 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 learn more about our comprehensive services, including product appraisals, safety appraisals, and consulting services for regulated and non-regulated healthcare settings.
Let our experts help you develop and certify your digital healthcare solutions and benefit from our many years of experience.
Product expertise telematics infrastructure
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 expertise for numerous approvals.
As part of the preparation of a product expert opinion in accordance with the gematik security suitability testing guideline (gemRL_PruefSichEig_DS), we test and evaluate the implementation of the requirements relevant to the approval object as independent experts. Here SRC can draw on a broad expertise of specialists. We are thus in a position 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 record, 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 continue to be reviewed by our highly qualified experts.
Benefit from our many years of experience, dating back to the beginnings of the telematics infrastructure.
In addition to product assessments, we are also happy to prepare all other assessments required for gematik approval, such as security assessments for your products or operating environments or, as a BSI-approved testing laboratory, Common Criteria (CC) evaluations and Accelerated Security Certifications (BSZ), and we will accompany you through the approval process with our experience.
Product evaluations in the (as yet) unregulated health care sector
At the latest with the obvious gaps in the digitization of the healthcare system, as they came to light during the Corona pandemic, it is clear that there is a particular need for action in the digitization of processes, and not only in Germany. This trend is also reflected in the Digital Strategy for Healthcare and Nursing published by the German Federal Ministry of Health in March 2023. In the coming years, it can be expected that more and more new products and services will enter the market and that, as a result, 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, questions of security and data protection should not be taken lightly, as the legislature already provides for severe penalties here.
With our many years of experience in testing processes and products in digitalized healthcare, 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. Furthermore, we offer modular consulting services tailored to your needs to make you fit for upcoming certifications at an early stage. In particular, questions regarding secure software architecture and the necessary documentation for approvals or the requirements for various approval and testing procedures can be clarified in the planning phase and save you from costly surprises later on.