On 1 September 2026, the EU Council published a new 'Apply AI Strategy' aimed at integrating artificial intelligence into the healthcare sector, including pharmaceuticals and medical devices. The strategy seeks to drive adoption of trustworthy AI to improve healthcare outcomes, boost competitiveness, and enhance EU technological sovereignty. Key legislative frameworks enabling this strategy include the AI Act, the Medical Devices Regulation (MDR), the In Vitro Diagnostic Medical Devices Regulation (IVDR), and the European Health Data Space (EHDS).
Four flagship initiatives
The strategy proposes four flagship initiatives: establishing AI-powered advanced screening centres; creating a European Network of Expertise on AI deployment; launching an AI drug discovery challenge; and streamlining market entry for AI-based medical devices. These initiatives aim to accelerate AI adoption across the healthcare value chain, from diagnosis to drug development.
Building data infrastructure and skills
The Council also calls for building specialised health data infrastructures to support AI applications, alongside investing in AI skills training for healthcare workers. This dual focus on data and skills is intended to ensure that the EU can leverage its health data assets while preparing the workforce for AI-enabled workflows.
Trade-offs and stakeholder impacts
The strategy presents several trade-offs. For EU healthcare providers and patients, AI promises faster diagnosis and personalised treatments, potentially improving outcomes and reducing costs. However, integration of AI systems may require significant upfront investment in infrastructure and training, which could strain public health budgets. For EU pharmaceutical and medical device companies, streamlined market entry for AI-based devices could reduce time-to-market and foster innovation, but compliance with the AI Act and medical device regulations may impose additional administrative burdens. EU regulatory bodies will face the challenge of ensuring AI systems are safe and effective without stifling innovation. Civil society groups may welcome the focus on trustworthy AI but could raise concerns about data privacy and algorithmic bias, particularly in sensitive health applications.
Institutional follow-up
The strategy is a Council document outlining policy orientations. It will now be transmitted to the European Parliament and the European Commission for further discussion and potential legislative proposals. The Commission is expected to propose implementing measures in the coming months, including possible revisions to existing regulations to facilitate AI adoption in healthcare.