A design framework for operationalizing trustworthy artificial intelligence in healthcare: Requirements, tradeoffs and challenges for its clinical adoption

Abstract

Artificial Intelligence (AI) holds great promise for transforming healthcare, particularly in disease diagnosis, prognosis, and patient care. The increasing availability of digital medical data, such as images, omics data, biosignals, and electronic health records, combined with advances in computing, has enabled AI models to approach expert-level performance. However, widespread clinical adoption remains limited, primarily due to challenges beyond technical performance, including ethical concerns, regulatory barriers, and lack of trust. To address these issues, medical AI systems must align with the principles of Trustworthy AI (TAI), which emphasize human agency and oversight, algorithmic robustness, privacy and data governance, transparency, bias and discrimination avoidance, and accountability. Yet, the complexity of healthcare processes (e.g., screening, diagnosis, prognosis, and treatment) and the diversity of stakeholders (clinicians, patients, providers, regulators) complicate the integration of TAI principles. To bridge the gap between TAI theory and practical implementation, this paper proposes a design framework to support developers in embedding TAI principles into medical AI systems. Thus, for each stakeholder identified across various healthcare processes, we propose a disease-agnostic collection of requirements that medical AI systems should incorporate to adhere to the principles of TAI. Additionally, we examine the challenges and tradeoffs that may arise when applying these principles in practice. To illustrate the discussion, we focus on cardiovascular diseases, which is a field marked by both high prevalence and active AI innovation, and demonstrate how TAI principles have been applied and where key obstacles persist.