Siemens application lifecycle management solution supports gematik in the development of telematics infrastructure

Product: Siemens, Polarion ,ALM
Industry: Medical devices and pharmaceuticals

Polarion ALM enables end-to-end requirements and test management for hardware and software for Germany’s digital healthcare networkEvery change to a specification has an effect on tests and approvals and can be viewed immediately and tracked in an audit-proof manner. This automatically leads to an improvement in communication and interdisciplinary cooperation.Polarion ALM enables end-to-end requirements and test management for hardware and software for Germany’s digital healthcare network

René Weidner, Project Manager gematic

Polarion ALM enables end-to-end requirements and test management for hardware and software for Germany’s digital healthcare network

Digitalizing the healthcare sector

gematik GmbH in Berlin was founded in January 2005 as a service company by the leading organizations of the German health care system. Since May 2019, the Federal Ministry of Health has held 51 percent of the shares. Originally, the statutory mandate provided for the introduction, maintenance and further development of an electronic health card (eGK) in the field of statutory health insurance in Germany. The project included defining the infrastructure required for telecommunications and information technology, ensuring its security and the interoperability of the components involved.

With the E-Health Act of 2015, these tasks were expanded to include the introduction of an electronic patient file and an electronic patient compartment (ePF). These should enable insured persons to access their treatment data at any time and make it available electronically to their infrastructurerespective service providers. gematik does not develop its own hardware and software, but every manufacturer and service provider requires approval from gematik for the use of the telematics infrastructure (TI). Based on specifications, tests and approvals by gematik, companies developing hardware and sofware for use in the healthcare infrasructure can assure that their products are secure and interoperable, and can reliably exchange data in the healthcare system.

New, integrated software environment required

gematik’s main tasks include requirements management for the preparation of specifications and test execution and management for testing hardware and software products submitted for approval. In addition to word processing and spreadsheets, for both tasks gematic has used four different industry-standard software products with separate data storage.

In order to close process gaps, improve the flow of information between requirements and test management, and to remain fit for the future, in 2015 gematik launched a joint selection project for a new solution to support the core processes. “We wanted to replace the exchange of documents with a system-supported requirements management system that provides both divisions with all information in a common database,” says René Weidner, who as project manager has specialist responsibility for the overall system.

As early as the end of 2015, a Europe-wide tendering process was launched; in February 2016, the catalog of system requirements was completed, based on three rounds of tenders. “Polarion ALM from Siemens best meets the requirements of both groups,“ says Weidner. “The strengths of the system are balanced almost equally between requirements and test management. The web-based solution also convinces with a modern user interface, high flexibility for extensions and continuous versioning based on Subversion. As a standard solution, Polarion provides so many functions that we were able to meet our difficult requirements with little customizing and expect correspondingly low maintenance costs.”

Automated processes

In requirements management, specifications are written for connectors and other TI components as well as for the structure and security of insured master data, the electronic patient file, the electronic emergency data record or medication plan and e-prescription. Polarion can be used to automatically create the profiles that form the basis for approval by gematik. “The software enables a smooth process from document management to final publication on the internet,” says Gunnar Schopf, who, as deputy project manager, is responsible for gematik’s document management system, among other tasks.