El Reglamento de Inteligencia Artificial: un análisis desde el punto de vista sanitario

The new Artificial Intelligence Act will modify
the regulation of medical devices in the European
Union. This study examines the introduced changes
and their interaction with other sources of law, including
those concerning medical devices as well as
those referring to artificial intelligence and use of
health data, with the aim of analyzing whether the
proposal will simplify the situation or, to the contrary,
will deepen the fragmentation that, despite the
implementation of its own Regulation, has been suffered
by the regulation of medical devices. The conclusions
warn about possible imbalances against
patients’ and health professionals’ rights, possibly
consequence of the generic character of the norm.