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Ethical, Liability, and Regulatory Governance in AI-Embedded Healthcare Systems
The integration of artificial intelligence (AI) into healthcare systems and analytics has revolutionized clinical workflows, enabling predictive analytics, diagnostic support, and personalized interventions. However, this embedding raises profound ethical, liability, and regulatory challenges that must be addressed to ensure safe, equitable, and effective deployment. This narrative review synthesizes literature governance frameworks for AI-embedded healthcare, focusing on systems-level infrastructure and clinical analytics.Ethically, AI systems introduce risks of bias amplification, where algorithms trained on non-representative datasets perpetuate disparities in health outcomes, as seen in racial biases in risk prediction tools. Privacy concerns escalate as data mining from digital phenotyping proliferates, necessitating robust consent mechanisms and transparency in algorithmic decision-making. Liability allocation remains ambiguous, particularly for physicians using AI tools, where harms from opaque “black-box” models complicate accountability among developers, clinicians, and institutions. Regulatory governance demands a shift from product-centric to system-view approaches, incorporating human-AI interactions, ongoing monitoring, and adaptive oversight, as proposed for AI/ML-based software as medical devices (SaMD).In healthcare systems, AI analytics facilitate end-to-end loops from data ingestion to intervention feedback, but require governance to mitigate distributional shifts and automation complacency. Clinical decision support systems (CDSS) exemplify this, where AI augments human judgment but risks reinforcing outdated practices without ethical recalibration. Radiology is a key domain, and AI in imaging analytics underscores the need for multisociety ethical statements and regulatory vetting.This review provides an original synthesis that structures AI governance across data ecosystems, model transparency, deployment integrity, and feedback mechanisms. It underscores the imperative for interdisciplinary frameworks that prioritize patient well-being, fairness, and accountability, while avoiding over-speculation. By integrating cross-study insights, we position governance as integral to AI’s infrastructural role in healthcare, advocating for actionable ethics to bridge regulatory gaps and enhance the reliability of clinical analytics. Ultimately, effective governance will enable AI to converge with human expertise, fostering high-performance medicine without compromising equity or safety.
Journal of Artificial Intelligence for Healthcare Systems
Review | Open access | 20 July 2023 | Article: 17
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AI-driven Diagnostics Artificial Intelligence in Health Informatics Artificial Intelligence in Healthcare Big Data in Healthcare Clinical Data Mining Clinical Decision Support Systems Clinical Informatics Computer Vision Connected Health Systems Deep Learning Digital Health Digital Healthcare Innovation Digital Transformation in Healthcare Electronic Health Records Ethical AI in Healthcare Explainable AI Health Data Analytics Health Data Privacy Health Informatics Health Information Management Health Information Systems Health System Optimization Health Technology Assessment Healthcare Data Science Healthcare Informatics Healthcare Information Security Healthcare Management Healthcare Management Information Systems Intelligent Medical Systems Internet of Medical Things (IoMT) Interoperability in Healthcare Systems Machine Learning Medical Data Analytics Medical Data Management Medical Imaging Mobile Health (mHealth) Natural Language Processing Precision Medicine Predictive Analytics Remote Patient Monitoring Smart Healthcare Systems Telemedicine Wearable Health Technologies e-Health




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