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Wire · regulatory

EU Sets Ground Rules for AI Use in Health Technology Assessments

10 September 2026 · By · Wire by Fusion42

Published

10 September 2026

Topic

regulatory

◆ Sectors

Healthtech Infrastructure

◆ Geography

Europe

◆ Source

Read at lexology.com →

◆ Verified

Fusion42 · 10 September 2026 · Fusion42 review

The European Union has established clear principles for the use of AI in health technology assessments, emphasizing human oversight, transparency, and accountability while allowing AI to assist in evidence preparation for regulatory and reimbursement decisions.

This Wire brief sits within Fusion42's coverage of Healthtech Infrastructure.

◆ ◆ The Wire takeaway

You must now document and justify AI use in EU health assessments clearly to maintain dossier approval. Transparency about AI tools is not optional, making compliance a key hurdle this year.

◆ Coverage

1 source · 10 Sep 2026

◆ Related on Wire

◆ Topics

Healthtech Infrastructureeuaihealthtechregulationtransparency