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On Tuesday, 28 to Wednesday, 29 April, AmCham EU travelled to the European Parliament in Strasbourg, France for a series of meetings with policymakers to discuss ongoing EU healthcare policy initiatives. The delegation met with Members of the European Parliament, Accredited Parliamentary Assistants and Group Policy Advisers, to discuss priorities for the EU’s health agenda. This included exchanges on how to strengthen Europe’s life sciences competitiveness and support resilient supply chains. Members also stressed the need for urgent action to simplify overlapping rules and reduce complexity. They underlined that proportionate, risk-based regulation is essential to support innovation. This approach can also help ensure timely patient access to medicines, medical technologies and diagnostics.

Together with 14 other associations, AmCham EU has signed a joint statement on the European Commission’s Digital Omnibus on AI, calling for a clear, simple and innovation-friendly implementation of the AI Act. Co-legislators should swiftly reach an agreement on an ambitious final text that keeps simplification at its core. Measures to streamline overlaps with existing EU legislation and improve legal certainty are essential, alongside targeted adjustments to ensure the framework remains practical. This includes extending grace periods for generative AI labelling requirements, ensuring greater legal clarity for AI systems entering the EU market, preserving the risk-based approach of the AI Act by exempting non high-risk systems from registration, and supporting fixed compliance deadlines for high-risk systems.

Learn how the EU can support a clear and innovation friendly framework in the joint statement.

The EU’s digital regulatory landscape has expanded significantly in recent years. While the creation of these rules pursues important objectives, their interaction has not always been fully aligned, creating legal uncertainty and increased compliance burdens for businesses.  

The European Commission’s proposals for a Digital Omnibus and the Digital Omnibus on AI Regulation Proposal (AI Omnibus) both offer opportunities to improve coherence across the EU’s digital rulebook while supporting Europe’s competitiveness in the digital economy. Both initiatives represent a positive step forward, but further refinements will be needed to ensure they fully deliver on their objectives while maintaining high standards for safety and fundamental rights. 

The AI Omnibus focuses on the AI Act, while the Digital Omnibus addresses broader elements of the digital acquis, including data and cybersecurity legislation. Together, they aim to reduce fragmentation and streamline obligations across multiple frameworks. Explore below how these proposals can better support innovation and competitiveness in Europe.