Between January 2024 and May 2025, PwC EU Services and Open Evidence conducted a comprehensive study for DG SANTE on the state of artificial intelligence (AI) in healthcare across the European Union.
📊 The report identifies key needs where AI could help address challenges related to:
• Growing demand for healthcare
• Administrative burden
• Delays in diagnosis and treatment
• Disparities in healthcare access
Despite notable progress in AI-driven healthcare innovations, adoption remains slow. The study outlines several barriers that still need to be addressed:
🔧 Technological & Data Challenges
— Lack of interoperability, outdated IT infrastructure, and limited transparency in AI models
📜 Regulatory Complexity
— Navigating overlapping regulations and ensuring compliance
💰 Organisational & Financial Barriers
— Absence of clear financing and reimbursement frameworks, and difficulty in assessing local added value
🧠 Social & Cultural Concerns
— Ethical implications and trust in AI reliability
🌐 Countries that have successfully deployed AI in healthcare offer valuable lessons and good practices that can support overcoming these challenges.
👉 At Instituto Pedro Nunes (IPN), we help innovators in digital health and medtech navigate the EU regulatory landscape — including MDR, IVDR, and the new AI Act.
🔗 Read the full report (PDF)