Since December 2024, we have been a recognized assessor for BSI TR-03161.
We have officially received the certificate as an accredited testing body for the BSI Technical Guideline TR-03161. This underscores our expertise in the field of digital health and care applications (DiGA/DiPA) and enables us to offer manufacturers and providers comprehensive support in the technical evaluation of their applications.
TR-03161 is a key requirement for providers who wish to officially register their digital health and care applications with health insurance companies or the Federal Institute for Drugs and Medical Devices (BfArM). At the end of the development phase, a technical assessment is required to ensure the security and compliance of the application. We carry out this assessment and submit the results to the Federal Office for Information Security (BSI), which ultimately grants approval.
As experts in IT security for the healthcare sector, we offer a wide range of services to secure digital health and care applications. These include the implementation of an Information Security Management System (ISMS), protection needs analyses, secure software development, data protection management, as well as comprehensive penetration tests and audits in accordance with BSI requirements. Through close collaboration with relevant authorities such as BSI and BfArM, we ensure that manufacturers are optimally prepared for the assessment and approval of their applications.
With this certification, we strengthen our position as a trusted partner for the security and quality of digital health applications and contribute to the sustainable protection of sensitive patient data.
Dr. Jürgen Kohr, Managing Director of TÜV TRUST IT GmbH, TÜV AUSTRIA Group, emphasizes:
“We are very pleased with the certification, as it further reinforces our expertise in IT security. The certification enables us to support manufacturers of digital health applications even more effectively in implementing secure and compliant solutions. In doing so, we make an important contribution to strengthening trust in digital health applications.”
v. l. n. r. Holger Hinzmann (TTIT), Sandro Amendola (BSI), Hendrik Dettmer (TTIT)