| Abstract [eng] |
Our bodies produce a constant data stream that can be recorded, evaluated, registered, and analyzed in order to track changes in our health. This data ranges from calorie consumption, daily exercise, sleep and body position to sexual activity, fertility, menstrual cycles and breathing patterns. Since the end of the last decade, when the first app stores were launched, the number of mobile applications has grown tremendously. There are currently more than 250,000 health applications (for example, the Flo app that can track and predict your menstrual cycle) and related wearable devices (such as: smart jewelry and implants; fitness tracking devices such as the Fitbit wireless meter, smart watches; as well as smart baby diapers or socks that measures the baby's heart rate, temperature, oxygen saturation and movement) on the market. Thus, body tracking through technology has become part of our daily lives. It is for this reason that a comprehensive analysis of the concept and regulation of smart health apps and devices, which is the subject of this paper, is particularly relevant and necessary in order to raise public awareness on the processing of personal data by health technologies and the compliance of emerging products with the existing regulation. The first part of the thesis explores the concept, benefits, challenges of smart health applications as well as the meaning and importance of the distinction between smart health applications and medical devices. The second part discusses the specificities and challenges of the regulation of this health technology in the context of the GDPR, highlighting the essence of the special categories of data (health data), the requirement of explicit consent of the data subject, the concept of the DPIA process and the problem of inadequate implementation of the GDPR to protect health data. The third part focuses on alternative ways of regulating smart health applications and devices in the context of data protection. Finally, the fourth part examines the key legal innovations contained in the EHDSR proposal in terms of the relevance for smart health applications and devices. |
