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Global edition · EN

Health AI goes clinical.

What the market offers patients and clinicians, what the evidence shows and the rules in each jurisdiction.

v1.2 · 34 pages · 25 Oct 2026 · Edition

Archived edition, preserved unchanged. Contributor and contact credits in this predecessor are superseded; use the current edition and media kit for current authorship and contact. Global edition. Source populations and dates remain attached to each finding. For medical AI, Article 6(1) high-risk classification depends on the system being a regulated product or safety component that requires third-party conformity assessment. The relevant duties apply from 2 Aug 2028.

Health AI goes clinical. · EN · v1.2
Global edition · EN · v1.2

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Health AI goes clinical. · Health AI at a glance · EN
Health AI at a glance · Page 3/34
Health AI goes clinical. · AI has become part of clinical work · EN
AI has become part of clinical work · Page 6/34
Health AI goes clinical. · Rules and dates · EN
Rules and dates · Page 14/34
Edition, source scope and file

health-global-en-v1.2.pdf · Edition 1.2

Archived edition, preserved unchanged. Contributor and contact credits in this predecessor are superseded; use the current edition and media kit for current authorship and contact. Global edition. Source populations and dates remain attached to each finding. For medical AI, Article 6(1) high-risk classification depends on the system being a regulated product or safety component that requires third-party conformity assessment. The relevant duties apply from 2 Aug 2028.

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