'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 in this field, the States, repeatedly accused to be unable keeping pace with the exponential technological development, are growingly called upon to deal with it. Taking the distance from those who perceive the US as a regulatory model to oppose in order to assert the EU digital sovereignty, the present analysis will prove that a glimpse across the Atlantic could only help the EU legislator. With a specific focus on the SaMD regulation, it will be shown how the choices made in the US appear to be grounded on a fair balance between patient and economic operators' rights. Building on it, a new balancing formula needs to be put forward to guide the EU intensive legislative activity for the digital world.