mHealth refers to the use of smart or wireless devices to support patient care. Glucose monitoring sensors, digital pills or fitness trackers are some examples of mHealth products. The pandemic has shown the importance of mHealth as a solution for remote monitoring. In addition, the Commission believes that mHealth contributes to patient empowerment and provides healthcare in a cost-effective way. Data collected by mHealth might improve research and innovation in personalised 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. These issues need to be addressed and resolved to tap the full potential of these technologies and the data they pervasively collect.
Against this background, this research aims to provide a holistic data governance model that promotes fair access and sharing of mHealth data. To achieve this, this researcher explores to what extent data protection and competition law offer data access and sharing mechanisms. This research project is divided into five parts: first, a taxonomy of the mHealth solutions is provided. This part also includes a description of its various stakeholders, business models, and different interests in health data. Secondly, this research briefly delves into the regulatory framework for mobile medical devices. It queries whether the Medical Device Regulation includes any framework for the data collected by apps and software as a medical device. In the third part, we will analyse health data in the context of Data Protection. This project will comprehensively study relevant provisions of GDPR related to primary and secondary uses of health data. The fourth chapter will analyse the role of competition law in the data economy. The hypothesis of this project is that device manufacturers might be the only de facto data holders who might pose technical limitations to entrench their privileged access to the data. Hence, it is pivotal to see how competition law could contribute to solving these data access issues and the risk of abuse of dominance. Yet, the preliminary analysis shows that competition tools seem outdated for the particularities of mHealth data-driven markets. Sanofi/Google and other cases in the platform economy have shown that. Given the limitations of the above-mentioned legal regimes, in the last part of this research, we will recommend a more comprehensive health data governance model. The aim is to propose tools such as data trusts, that promote a health data ecosystem where several actors can benefit from fair access to data while respecting data protection.
