‘Software as Medical Device’ Regulation: What the US Can Teach to the EU for a Fairer Balance Towards Its Digital Sovereignty?

Abstract The AI presence in healthcare (e.g., telemedicine platforms and Software as Medical Devices) is uncontroversial by now. Beyond the Big Tech already for some time large investors this field, States, repeatedly accused to be unable keeping pace with exponential technological development, are growingly called upon deal it. Taking distance from those who perceive US a regulatory model oppose order assert EU digital sovereignty, present analysis will prove that glimpse across Atlantic could only help legislator. With specific focus on SaMD regulation, it shown how choices made appear grounded fair balance between patient economic operators’ rights. Building it, new balancing formula needs put forward guide intensive legislative activity world.