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Technical Guideline TR-03161: Requirements for Healthcare Applications - Part 1: Mobile Applications, Version 3.0

date 09.10.2024

CoverTechnical Guideline BSI TR-03161

Health applications (e-health) follow the overall goal of supporting the treatment and care of patients and utilizing the opportunities offered by modern information and communication technologies (IKT) (see [BMG-EH]). In the context of this Technical Guideline (TR), digital health applications and digital care applications should be highlighted in particular:
According to Section § 33a of the German Social Code Book V (SGB V), those with German statutory health insurance have, under certain conditions, the right to the supply of so-called digital health applications.
According to Section § 40a of the German Social Code Book XI (SGB XI), patients in social care insurance have, under certain conditions, the right to the supply of so-called digital care applications.

The TR is aimed at developers of healthcare applications for mobile devices. In addition, it can be considered as a directive for mobile applications that process or store sensitive data.