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EC consults on high-risk AI systems in life sciences and healthcare

A surgical robot at work at Glasgow Royal Infirmary.
Photo: Jane Barlow-Pool/Getty Images

Amélie Chollet | CMS, Dr. Roland Wiring

3 min read
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Many life sciences and healthcare companies develop or deploy AI-based medical devices and digital health solutions that may fall within the high-risk category.

On June 6, 2025, the European Commission launched a targeted stakeholder consultation on high-risk artificial intelligence systems under the EU Artificial Intelligence Act (AI Act). The aim is to help the EU Commission develop guidelines for classifying and regulating high-risk AI systems in the future.

This consultation is of particular interest for

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