Wireless glucometers, digital pills or fitness trackers are just some examples of mobile health products (mHealth). mHealth refers to the use of smart or wireless devices for supporting patient care. The pandemic has shown the importance of mHealth as a solution for remote monitoring, and also recent studies prove how contact tracing apps contribute to prevent infections. The Commission holds that mHealth contributes to patient’s empowerment and provides healthcare in a cost-effective way. Data collected by mHealth has the potential to improve research and innovation in areas such personalized medicine and drug discovery. Yet, the Commission also acknowledges that overarching issues in mHealth are access to health data, privacy, lack of standards and interoperability. To tap the full potential of these technologies and especially data collected by them, these issues need to be resolved.
As several technologies, stakeholders and interests’ interplay in the mHealth ecosystem, this research aims to provide a holistic data governance model. By analysing several legal areas like data protection, device regulation and competition law, we will explore the strengths and pitfalls of the current European legal framework to deal with mHealth. To this end, our research project is divided into five parts: first, regarding the technology itself, a taxonomy of the mHealth solutions is provided. This part also includes a description of its various stakeholders and different interests in health data. Secondly, this research will delve into the regulatory framework for mobile medical devices, and the new special rules for apps which qualify as software as a medical device included in the Medical Device Regulation. In the third part, we will analyse health data in the context of Data Protection. Our project will provide a comprehensive study of relevant dispositions of the GDPR: purpose limitation, consent, portability and the research exception. In the fourth chapter, the role of competition law in the data economy will be analysed. As just few actors may have access to mHealth data, and a strong interoperability problem exists, it is pivotal to see how competition law could contribute to solve these data access issues. Yet, the competition tools seem outdated for the particularities of mHealth (Sanofi/Google merger). Hence, these project aims to explore in which areas of competition law any form of data access exists, and how this can be applicable to the mHealth data. Finally, a more comprehensive health data governance model will be proposed. The aim is to design a health data ecosystem where several actors can benefit from the data while respecting data protection. On the hand, to provide data subjects with more control over the use of their data, we will explore different mechanisms such as data trusts. And, on the other hand, to allow public institutions and private firms to use these anonymised data and innovate, a data access regime will be devised.