Certification of the Diagnostic Report Module, part of the Genetic Information Management Suite developed by bio.logis, as an “Internet medicine quality product” and a "Medical Device Class I" according to European standards
bio.logis Genetic Information Management GmbH has achieved the next decisive level for establishing its Genetic Information Management Suite (GIMS) as a quality product for genetic diagnostics: The software suite’s currently most important component—the Diagnostic Report Module (DRM)—has been certified by the Federal Association for Internet Medicine (BiM) as an “Internet medicine quality product” and has also received the CE mark as a Medical Device Class I (according to EEC 93/42, EC 2007/47).
GIMS, a dedicated software suite, supports laboratories with several modules in interpreting genetic data and providing clinically relevant information for physicians and patients. The Diagnostic Report Module (DRM) is used to efficiently generate diagnostic reports—a process which is still highly manual, complex, fragmented, and therefore very time-consuming. The DRM integrates with the laboratory’s IT infrastructure via standard interfaces to receive anonymized findings that are relevant for the diagnosis. The module contains a fully functional CMS (Content Management System) for the management of content and centralized generation of diagnostic reports. Based on the imported data, a Report Engine then compiles the right content into a diagnostic report. The main advantage for laboratories is the fact that they will be able to handle complex clinical data structures and save significant time and costs by automating previously manual process steps. With all the necessary content being created and managed in a centralized instance, DRM also helps laboratories to design consistent high-quality diagnostic reports. Currently, DRM is being implemented in seven selected university hospitals in seven European countries as part of the Horizon 2020 Initiative’s Ubiquitous Pharmacogenomics EU project.
With the CE mark for its DRM, bio.logis emphasizes standardized medical quality. The seal not only certifies the product’s quality according to valid European guidelines but also confirms its fitness to be used for the intended medical purpose. With this tool, bio.logis offers all users of the Genetic Information Management Suite more efficient processes as well as legal certainty in the application of this high-quality product for genetic diagnostics.
About bio.logis Genetic Information Management GmbH
bio.logis Genetic Information Management GmbH supports laboratories in translating genetic data into medically leverageable information and making it available to physicians and patients. To that end, it has developed a special "Genetic Information Management Suite (GIMS)" which, in the process chain required for genetic diagnostics, focuses on the "last mile" from physician to patient by merging raw genetic data with clinically leverageable knowledge for prompt application. GIMS supports physicians both in laboratories for automatically generating such expert content, and in hospitals or surgeries with specific clinical treatment proposals. The physician reports and recommended action generated by GIMS is delivered straight to the point of care via laboratory and physician information systems as well as electronic health records.
Dr. Maike Post
bio.logis Genetic Information Management GmbH
60438 Frankfurt am Main
Telefon:+49 (0) 69-530 8437-33
Fax: +49 (0) 69-530 8437-11
c/o Torstrasse 140
Telefon: +49 (0) 30-400 54 752