AI in European Healthcare: Urgent Call for Proactive Governance to Address Risks and Boost Benefits

September 30, 2026
AI in European Healthcare: Urgent Call for Proactive Governance to Address Risks and Boost Benefits
  • The report aligns with ongoing EU efforts, including the AI Act and the European Health Data Space, and offers ten policy recommendations to policymakers aimed at ensuring patient-centered, effective, safe, fair, and transparent AI in healthcare.

  • Annexed policy actions cover robust evaluation of AI’s added value, responsible deployment guidelines, expanded ethical frameworks, implementation challenges, AI as a learning health system, interoperability and data sharing, training and education, stakeholder engagement and public trust, defining strategic research priorities, and strengthened governance and oversight.

  • EASAC and FEAM publish a call for responsible AI use in European healthcare, arguing for treating AI as a healthcare measure with proven benefits, understood risks, and ongoing performance monitoring.

  • Prominent figures cited include Eva Fialová of the Czech Academy of Sciences and Andr é Knottnerus, EASAC Co-Chair, highlighting leadership and expert input on regulatory frameworks.

  • Two-thirds of Czech hospitals are currently using AI tools, chiefly for diagnostics and imaging evaluation, with rapid uptake across healthcare applications.

  • Emphasis on transparency, representative data, and avoidance of biased training to safeguard patients and maintain trust in AI-enabled care.

  • The report notes AI in healthcare is outpacing regulatory oversight, raising risks such as data breaches, algorithmic bias, and potential loss of human control, and calls for proactive governance.

  • Warning that development outpaces regulation, highlighting risks of data breaches, bias, and loss of human oversight in sensitive healthcare settings.

  • Recommendations stress integrating AI provisions with existing regulations (Medical Devices Regulation, GDPR, European Health Data Space), ensuring real clinical benefit, high-quality representative data, meaningful patient explanations, and clear liability to avoid dependence on any single provider.

  • A push for proactive, harmonised EU-wide regulation to prevent fragmented standards and enable safe, scalable AI across member states.

  • The report is intended to inform the EU AI Act, European Health Data Space, and other forthcoming legislative initiatives, authored by a 22-member European scientific working group.

  • Policy recommendations include testing AI in regulatory sandboxes, investing in research with carefully selected datasets, and pairing deployment with transparent evaluation and governance.

Summary based on 2 sources


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