Data Sharing in the Internet of Medical Things: Between the Data Act and the EHDS

Summary Healthcare systems are increasingly exploiting the advantages of Internet of Things technologies: cloud-connected devices with perceptive sensors can gather very accurate health data from people even if they do not get to the hospital or private clinics. For potential innovators of new medical IoT devices, the legal framework applicable was until now limited to the application of the General Data Protection Regulation and the Medical Devices Regulation. This paper will investigate what will happen when medical IoT-generated data are shared to create new products or services according to the framework now depicted by the Data Act and the European Health Data Space. Given that the EHDS and the Data Act are both aimed at facilitating the secondary use of (health) data, the contribution will compare the two processes set up to establish a roadmap to solve health-data sharing theoretical and practical queries.