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GovernanceAugust 20, 2026Source: HealthSeed VC

The AI Act deadline moved a year. Three obligations did not

A new EU Digital Omnibus on AI has delayed key high-risk compliance deadlines for AI embedded in regulated products, including medical devices, shifting some obligations to 2027–2028. However, core requirements around transparency, general-purpose AI duties, and prohibited practices still apply, directly affecting how clinical AI and AI-enabled medical devices manage patient safety, bias, and data governance now.

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