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Background/Objectives: Artificial intelligence (AI) is increasingly integrated into everyday life, including the complex and highly regulated healthcare sector. Given healthcare’s essential role in safeguarding human life and well-being, AI deployment requires careful oversight to ensure safety, effectiveness, and ethical compliance. This paper aims to examine the current regulatory landscapes governing AI in healthcare, particularly in the European Union (EU) and the United States (USA), and to propose practical tools to support the responsible development and implementation of AI systems. Methods: The study reviews key regulatory frameworks, ethical guidelines, and expert recommendations from international bodies, professional associations, and governmental institutions in the EU and USA. Based on this analysis, the paper develops structured questionnaires tailored for AI developers and implementers to help operationalize regulatory and ethical expectations. Results: The proposed questionnaires address critical gaps in existing frameworks by providing actionable, lifecycle-oriented tools that span AI development, deployment, and clinical use. These instruments support compliance and ethical integrity while promoting transparency and accountability. Conclusions: The structured questionnaires can serve as practical tools for health technology assessments, public procurement, accreditation processes, and training initiatives. By aligning AI system design with regulatory and ethical standards, they contribute to building trustworthy, safe, and innovative AI applications in healthcare.
Jenko et al. (Fri,) studied this question.