{"id":5828,"date":"2025-06-11T16:47:23","date_gmt":"2025-06-11T14:47:23","guid":{"rendered":"https:\/\/www.bayoomed.com\/news\/close-the-gap-everything-about-bsi-tr-03161\/"},"modified":"2025-06-11T16:47:23","modified_gmt":"2025-06-11T14:47:23","slug":"close-the-gap-everything-about-bsi-tr-03161","status":"publish","type":"news","link":"https:\/\/www.bayoomed.com\/en\/news\/close-the-gap-everything-about-bsi-tr-03161\/","title":{"rendered":"\u201cClose the Gap\u201d – Everything about BSI TR-03161"},"content":{"rendered":"

DiGA test for technical guideline 03161<\/h2><\/h2><\/div>

Author: Lukas Schmidt <\/strong>Software Engineer at BAYOOMED\nCo-author: Alexandra Heuel <\/strong>Project Manager at BAYOOMED<\/p>\n<\/div>

With TR-03161, the Federal Office for Information Security (BSI<\/a> ) is implementing a comprehensive guideline for increasing the security standards and data integrity of Digital Health Applications (DiGA)<\/a> and Digital Care Applications (DiPA).<\/p>\n

This is intended to increase user confidence in digital health applications in the long term. Since January 1, 2025, certification in accordance with TR-03161 has been mandatory for all DiGAs and DiPAs in accordance with Section 139e SGB V. Certificates are currently required from all DiGAs seeking new inclusion in the register. A valid BSI certificate must also be submitted for formal completeness. <\/p>\n

DiGAs already in the register do not have a fixed transition period, but should complete the procedure as quickly as possible and report to the BfArM <\/a>.<\/p>\n<\/div><\/div><\/div><\/div><\/div>

Time-critical implementation<\/h2><\/h2><\/div>

The average certification process takes 8-12 weeks, whereby the preparation time depends heavily on the initial situation. In addition, there is a backlog at the accredited test centers<\/a> (currently T\u00dcV IT, Secuvera and PWC) due to the large number of DiGAs in the BfArM portal and in the application process. <\/p>\n

The testing body discusses the conformity of the product with TR 03161 in accordance with the guidelines and delivers a test report to the BSI. The BSI in turn allows itself an average of 3 weeks for testing – a test should be planned accordingly and budgeted with sufficient time. <\/p>\n<\/div>

\"BAYOOMED<\/span><\/div>

The three-part structure of the directive<\/h2><\/h2><\/div>

The directive is divided into three documents:<\/p>\n<\/div>