The Digital Omnibus: Europe’s chance to lead, not just legislate
Last autumn, I sat across from a mid-sized European medtech manufacturer who told me something that has stayed with me. They had developed an AI-assisted mammography screening tool with strong clinical evidence behind it, one that could detect early signs of breast cancer more accurately and at a greater scale than current screening programmes allow. They were not waiting for the science to catch up. They were waiting for someone to tell them which rulebook applied.
The EU is moving fast on the Digital Omnibus on AI proposal, an initiative intended to streamline and future-proof Europe’s digital rulebook, with key discussions in the European Parliament expected in the coming weeks and a political compromise to follow in the months ahead. It is a welcome step. But the question is whether it goes far enough. In healthcare, a framework that falls short on ambition is not simplification. It is a setback. And the current trajectory, if left uncorrected, points in that direction.
