Background

The use of smartphones and digital applications has increased significantly over the last decade. Digital media is used to search for general health information or to collect personal health data, e.g. blood pressure or blood sugar. Nowadays thousands of mobile health apps and so called wearables are available which can help to increase physical fitness or to create personalized diet plans. But at the same time these digital applications collect a wide range of additional data, e.g. location or contact data.

The user of such apps often do not have any insights into the data's collection, processing and sharing. More than half of the available apps do not contain any information about data protection regulations. Existing disclosure of such regulations and terms of conditions is often difficult to understand, lengthy, and therefore rarely read by users.

Nevertheless an informed consent is essential for using digital media and it is of high relevance from a juridical and ethical point of view. For this reason the specific design of the consent form, which helps to fully inform the users of digital media, is of great importance.

Objectives

The main goal of the present study is to develop new consent forms regarding health-related apps. As a first step, existing forms of consent are outlined. Furthermore, a set of ethical and legal criteria is evolved which should be fulfilled by consent forms. In the next step, qualitative interviews are used to get insight into the users’ and experts’ preferences and potential problems regarding consent forms. Additionally, a representative survey is carried out in the general population. Based on the theoretical and empirical results new consent forms are developed and empirically evaluated to ensure an informed consent regarding the use of digital media.