The AI Regulation and the AI Act: Why the Digital Omnibus Helps the Large Medical AI Providers, Not the Small Ones
The Digital Omnibus has once again postponed the substantive requirements of the AI Regulation—known in English as the AI Act, or Regulation (EU) 2024/1689 on Artificial Intelligence—for high-risk AI in the healthcare sector, now to no later than August 2, 2028. At first glance, this sounds like a relief. However, a new economic study by Wiens and Dieler shows that for small medical AI companies, the exact opposite is true.

