Ethical AI in healthcare: insights from European policy discourses

The rapid integration of Artificial Intelligence (AI) into healthcare presents unprecedented opportunities for innovation in diagnostics, treatment and patient care. However, this paradigm shift is accompanied by a concomitant series of critical regulatory and ethical challenges. Relying on the pillars of the New Institutional Theory, this study undertakes a comprehensive examination of how ethical AI in healthcare is discursively constructed in European Commission’s (EC) policy communications and how institutional narratives shape emerging governance frameworks. A multi-method approach was employed, integrating both deductive qualitative content analysis and computational topic modelling using Latent Dirichlet Allocation (LDA) applied to 95 official European Commission documents published between 2018 and 2025. The sequential combination of qualitative and computational methods enable both theory-informed interpretation and systematic identification of latent thematic patterns. Our findings reveal four dominant themes: (1) healthcare AI applications and data governance, including privacy and interoperability issues; (2) regulatory risk frameworks, emphasizing liability and high-risk classification; (3) Europe’s stance as a leader in trustworthy and ethical AI; and (4) the socioeconomic ramifications of AI adoption, including risks of bias, exclusion, and unequal access. While the Commission frequently emphasizes “trustworthy AI” as a guiding principle, ethical challenges such as algorithmic bias and opacity are primarily framed at a high level of abstraction, with limited specification of operational implementation mechanisms. This study adds to the ongoing discussions on ethical AI by demonstrating how institutional communication functions as a form of institutional work that constructs legitimacy, normative alignment, and ethical responsibility in healthcare AI governance. Rather than evaluating policy adequacy, the analysis highlights how ethical considerations are discursively positioned within broader regulatory narratives.