The European Commission has unveiled a sweeping package of AI proposals aimed at improving public health outcomes and strengthening the resilience and competitiveness of the EU’s healthcare sector.

The measures focus on three priority areas: boosting Europe’s health biotechnology industry, tackling cardiovascular disease, and simplifying regulatory rules for medical devices. Together, the initiatives are designed to modernize healthcare systems while ensuring patient safety and faster access to innovation.

At the center of the package is a proposed Biotech Act intended to position Europe as a global leader in health biotechnology. The Commission plans to introduce a new EU-level investment facility to improve access to funding for biotech firms, alongside targeted support for high-impact projects to expand bio-manufacturing capacity. Additional measures would accelerate the approval of clinical trials across member states, fast-track the development of advanced therapies, and simplify EU regulations to reduce costs and administrative burdens for companies.

The Commission is also addressing cardiovascular disease, the leading cause of death in Europe, through a new “Safe Hearts” plan. EU-funded actions under the initiative would strengthen prevention, early detection, and treatment. The plan emphasizes the use of personalized prediction tools and therapies, greater application of artificial intelligence and digital health technologies, and efforts to close research gaps. Reducing health inequalities and improving access to care across regions are also key objectives.

A third pillar of the proposal targets long-standing concerns around medical device regulation. The Commission aims to simplify EU rules to cut unnecessary costs, reduce uncertainty for manufacturers, and shorten delays for patients. Planned reforms include expanded digital procedures, clearer timelines for conformity assessments, and a stronger role for the European Medicines Agency in monitoring shortages and identifying critical medical devices.

According to the Commission, the combined measures seek to balance innovation with safety, ensuring patients benefit more quickly from new technologies while reinforcing Europe’s healthcare systems against future challenges.

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