Health and Health-Related Connected Objects: Regulatory Intersections, Grey Zones and Blind Spots

Abstract

The present paper explores legal issues concerning connected objects used for health or health-related purposes and their corresponding usage of health and health-related data. It focuses on a patient/healthcare-user-centred perspective and researches the EU legal framework for health data and health-related data. Arguing that the legal framework, as recently complemented with the European Health Data Space (EHDS) Act, is plagued by complex intersections, between this recently enacted legislation and various other legal instruments, e.g. Medical Device Regulation (MDR), General Data Protection Regulation (GDPR), Data Act, Data Governance Act, Artificial Intelligence Act, etc. Furthermore, the legal framework applicable to health and health-related connected objects also contains several grey zones (i.e. areas of legal uncertainty concerning interpretation and applicability of existing norms), and unintended blind spots (i.e. areas potentially left untouched by the existing frameworks). The paper focuses on data quality, acceptability of connected objects, availability and accessibility of data, as well as the overarching topic of privacy and data protection. Concluding that, examined in conjunction, existing regulatory safeguards and certification mechanisms do not offer sufficient protection and simultaneously result in an excessively complex, cumbersome and opaque regulatory framework that has underestimated the specific needs of users in the health and health-related sectors.