As a partner of industry, gematik is responsible for the technical conception, implementation as well as construction and operation of the digital infrastructure in 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.
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.”
The implementation project began in summer 2016 with a rough concept, migration planning and implementation design. In summer 2017, the rollout – based on the waterfall principle – could begin with milestones: Polarion was also used to track the specifications and document the current status. “This enabled us to handle the entire implementation project more easily,” reports Martin Losch of Siemens Digital Industries Software. In addition to the implementation for 150 of gematik’s 270 workstations, the project also included the migration of 17,650 requirements, 17,100 test cases, 37,700 links between the two and 190 text documents.
Mapping the complex business processes presented the team with repeated challenges: “There were many detailed discussions in the area of test execution/test management,“ says Katharina Lange, who as a project member consolidates the requirements of test management at gematik. “With a team of almost 60 employees and the complexity of the test processes, it’s no wonder.” For other open requirements, Siemens also prioritized developments that were subsequently incorporated into the standard product. After an extended pilot phase, the project was successfully completed in May 2018.
Polarion replaced four legacy systems, together with their support and maintenance costs. For the employees, the regular data transfer between the different systems using manual typed tables has become obsolete. Today, the departments not only work from a common database, but version management is also automated. “Every change to a specification has an effect on tests and approvals and can be viewed immediately and tracked in an audit-proof manner,” says Weidner. “This automatically leads to an improvement in communication and interdisciplinary cooperation.”
Without restrictions, all users in all areas can view the associated information and documents. This transparency leads to faster processes and higher quality. The efficiency of the core processes in requirements and test execution/test management has been increased. “With the parallel introduction, we were able to significantly increase the frequency of release publications,” Weidner says.
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.
The users in gematik’s test management group create the necessary test cases based on the requirements in Polarion. These are transferred via an interface to the test automation, which works in its own separate domain. The result data also automatically returns to Polarion. “With Polarion, test reports are now created automatically which we previously had to create manually,” explains Lange. “In addition to the actual tester report, the individual manufacturers now receive error tickets from us, which are also generated automatically.”
Just how much Polarion supports the core processes of the entire gematik today is illustrated by a few figures: Of the now more than 350 employees, 185 have write access; every second employee works actively with Polarion. Another 85 employees have access to the system with read rights, so that a total of almost 80 percent of the employees benefit from Polarion.
The functional enhancements of Polarion will support gematik staff in realizing their task – in other words, in launching the next service levels of the digitalization of the healthcare system. “In the future, we want to connect more staff to the core processes and map more business processes with Polarion,” reports Weidner. “In this process, we benefit from the good configurability of the system. We can use it to design our processes ourselves.” For example, the change management of the specification was only recently transferred to Polarion. This continues the successful cooperation with Siemens.