Since December 2024, we have been a certified auditor for BSI TR 03161.
Cologne, February 2025. We have been officially certified as auditor for the BSI Technical Guideline TR 03161. This underlines 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 auditing of their applications.
TR-03161 is a key requirement for providers who intend to register their digital health and care applications officially by health insurance companies or the German Federal Institute for Drugs and Medical Devices (BfArM). At the end of the development process, a technical audit is required to ensure the safety and conformity of the application. We carry out this audit and submit the results to the German Federal Office for Information Security (BSI), which ultimately issues the authorisation.
As experts in IT security for the healthcare sector, we offer a wide range of services to secure digital health and care applications. This includes the development of an information security management system (ISMS), protection needs analyses, secure software development, data protection management and comprehensive penetration tests and audits in accordance with the requirements of the BSI. By working closely with relevant authorities such as the BSI and the BfArM, we ensure that manufacturers are well-prepared for the audit and authorisation of their applications.
With this certificate, we strengthen our position as a trusted partner for the security and quality of digital healthcare applications and help to ensure the long-term protection of sensitive patient data.
Dr Jürgen Kohr, Managing Director of TÜV TRUST IT, emphasises: ‘We are delighted with the certificate, as it further underlines our expertise in the field of IT security. The certification enables us to support manufacturers of digital health applications even more specifically in the implementation of secure and compliant solutions. We are thus making an important contribution to strengthening trust in digital health applications.’
Holger Hinzmann (TTIT), Sandro Amendola (BSI), Hendrik Dettmer (TTIT)