Politico February 28, 2025
WORLD VIEW
Across the pond in Europe, those in the health care industry are wondering what the European Union’s new Artificial Intelligence Act means for them.
The AI Act, provisions of which started going into effect in August 2024 and will be fully applicable in August 2026, sets new rules for AI products, including health-related AI technology.
But there’s still some confusion over how the rules will impact the field, where it coexists with rules such as the EU’s Medical Devices Regulation, our POLITICO colleagues in Europe report.
How does it work? The AI Act uses a risk-based approach, categorizing products and regulating them based on the risk level: unacceptable, high, limited and minimal.
In health care, high-risk devices might...
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