On June 23, 2022, the German Federal Office for Information Security (“Office”) published technical guidelines on security requirements for healthcare apps, including mobile apps, web apps, and background systems. Although the technical guidelines are aimed at healthcare app developers, they contain useful guidance for developers of any app that processes or stores sensitive data.
The guidelines set out a number of security levels and a security risk assessment. The risk assessment takes into account the following aspects: (1) the apps’ purpose; (2) its architecture; (3) the source code; (4) third party software integrations; (5) cryptographic implementation; (6) authentication mechanisms; (7) data storage and protection; (8) auditing of paid resources; (9) network communication; (10) platform-specific interactions; and (11) resilience. The guidelines also include specific security requirements for digital healthcare apps with biometric authentication mechanisms.
The guidelines are based on state-of-the-art security techniques used in the healthcare sector and the Office’s findings in several of its projects. They also take into account feedback received from industry stakeholders, the German Federal Institute for Drugs and Medical Devices, and the German Federal Commissioner for Data Protection and Freedom of Information.
The Office offers a certification to healthcare apps that comply with the guidelines.