For a digital health application (DiGA) developed by the company, QuickBird Medical has received the data security certificate under BSI TR-03161 for the first time, a significant step for the DiGA market.
The TR-03161 guideline has been a mandatory security requirement for DiGA manufacturers since the beginning of the year and is regarded across the industry as one of the biggest regulatory hurdles. In recent months, many DiGA providers expressed doubts about whether the extensive requirements could be met in practice. After intensive preparation and close collaboration with the test body, the QuickBird team successfully completed the certification.
The successful certification is not only an important individual case, but also a signal to the entire industry: TR-03161 certification is in fact achievable, which until then was not a given. The extremely high requirements and the months-long assessment process pose major challenges for DiGA manufacturers. The usability of DiGA in particular suffers under the requirements of BSI TR-03161, which makes the adoption of digital therapies in practice more difficult. Users of DiGA often have to go through a considerably more cumbersome login and registration process before they gain access to a health application. In recent months, these hurdles have triggered an important political debate whose relevance is not diminished by this success.
Announcement of the certification by QuickBird Medical: Click here
The first BSI TR-03161 certification is an important milestone for QuickBird Medical.