Subject of the Technical Guideline

According to § 33a of the German Social Security Code, Volume Five (SGB V, Sozialgesetzbuch (SGB) Fünftes Buch (V)), persons with statutory health insurance are under certain conditions entitled to be provided with so-called eHealth applications. These applications are designed to support the “detection, monitoring, treatment or alleviation of diseases or the detection, treatment, alleviation or compensation of injuries or disabilities” [SGB V section 33a]. This Technical Guideline is addressed to manufacturers of eHealth applications for mobile devices. Furthermore, it can be used as a guideline for mobile applications that process and store sensitive data.

Objective of the Technical Guideline

Digitalisation of all areas of life, whether at work, in home environments, in individual or public transport, is progressing steadily. In 2018, the number of Internet users already exceeded the four billion mark. Two thirds of the world’s current population of 7.6 billion use a smartphone. More than three billion people use social networks, and nine tenths of them do so on their smartphone (see [GDR18]). This development in the health care sector is continuing with the trend towards ‘self-tracking’, but also with the increasing demand for efficient use of medical data once it has been collected. Especially in the health care sector, it is convenient to be able to access own medical records independent of time and place. In this case, mobile applications store sensitive and personal data, from heart rate and rhythm of sleep records to medication plans as well as medical prescriptions and certificates. They connect the user to the corresponding services and act as communication hubs. A compromised smartphone can hence unintentionally expose the user’s entire digital life. Compliance with adequate security standards, especially in mobile applications, can make this considerably more difficult and possibly even prevent it. Already during the development phase, manufacturers should meticulously plan how a mobile application will process, store and protect personal and other sensitive data.
IT security essentially pursues three protection goals: Confidentiality, integrity and availability.

Compliance with these requirements is particularly important for mobile health applications. In contrast to the financial sector, where fraudulently transferred money can be refunded to customers by the banks, the confidentiality of health data that is unwillingly disclosed will be lost once and for all. Although the patient could receive compensation for this, the disclosure cannot be undone. Furthermore, unintentional disclosure of health data, both in the social and professional environment, can lead to undesirable consequences with significant impacts.

Should an attacker be able to manipulate the health data of a third party and thereby violate its integrity, this could have a significant impact on treatment decisions and ultimately the individual’s health.

This Technical Guideline is designed to assist developers of eHealth applications in developing secure mobile applications.

Technical Guideline BSI TR-03161 Security requirements for eHealth applications