Promoting Access and Sharing of Health Data from IoT (mHealth) Devices: A Holistic Approach to Balancing Data Protection, Competition, and Innovation

Mobile health, or mHealth, refers to the use of smart wireless devices in healthcare provision. It includes technologies such as glucose-monitoring sensors, digital pills and heart-monitoring wearables. The European Commission recognizes mHealth as a tool for empowering patients and delivering healthcare cost-effectively. The significance of mHealth, particularly for remote monitoring and disease management, was underscored during the pandemic, but its potential extends beyond this. Specifically, data from mHealth applications offer significant opportunities to enhance personalized medicine, drug discovery and research. However, access and sharing of mHealth data face critical challenges such as limited access to health data for patients and researchers, complex and misaligned legal rules on data in the EU, privacy issues, reduced interoperability and private parties’ de facto role as data controllers. Overcoming these obstacles of legal, economic and technical nature is crucial to unlock the full potential of mHealth for research and innovation.