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ARTICLE · 06 MARCH 2026

EU Digital Omnibus: What The Proposed Reforms Mean For Pharma And MedTech

Arnold & Porter
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On November 19, 2025, the European Commission introduced two proposals aimed at simplifying and streamlining various digital and data laws across the European Union (EU).

United StatesPrivacy
Alexander Roussanov
Alexander Roussanov
Fabien Roy
Fabien Roy
Camille Vermosen
Camille Vermosen
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On November 19, 2025, the European Commission introduced two proposals aimed at simplifying and streamlining various digital and data laws across the European Union (EU). The Digital Omnibus on AI Regulation Proposal sets out amendments to the EU AI Act (Regulation (EU) 2024/1689), while the more comprehensive Digital Omnibus Regulation Proposal includes changes to several EU regulations, including but not limited to the GDPR (Regulation (EU) 2016/679), ePrivacy Directive (2002/58/EC), EU Data Act (Regulation (EU) 2023/2854), and NIS2 Directive ((EU) 2022/2555) (together Proposals).

Following the publication of the Proposals, Arnold & Porter shared an initia lblog post highlighting key considerations for Life Sciences companies. In this more in-depth contribution, we take a comprehensive look at the proposed amendments across the EU AI, digital and data regulatory framework. This advisory analyses the practical implications for pharmaceutical and MedTech

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