Sep 2026· AI and Ethics· Vol 6· 0 citations· 29 references
TL;DR
The proposed Lifecycle-Integrated Healthcare AI Governance Framework (LIHAG), a four-layer deployment-oriented governance model integrating technical robustness, ethical safeguards, regulatory compliance, regulatory compliance, and human oversight as interdependent dimensions of responsible AI deployment is proposed.
Abstract
Artificial intelligence (AI) is increasingly being integrated into healthcare for diagnosis, decision support, and operational optimization, yet real-world deployment remains inconsistent and institutionally challenging. This study presents a critical and integrative review of the ethical, regulatory, technical, and socio-technical issues shaping responsible healthcare AI implementation. Rather than proposing a new algorithm method, the study develops a governance-oriented conceptual synthesis that reframes deployment as a lifecycle integration challenge. Drawing on interdisciplinary literature and global regulatory frameworks, the review identifies recurring barriers, including dataset shift, performance drift, algorithmic bias, accountability gaps, and institutional misalignment. While these challenges are widely recognized, they are often treated as isolated concerns. The central contribution of this study is the proposed Lifecycle-Integrated Healthcare AI Governance Framework (LIHAG), a four-layer deployment-oriented governance model integrating technical robustness, ethical safeguards, regulatory compliance, and human oversight as interdependent dimensions of responsible AI deployment. Through illustrative healthcare use cases, the analysis demonstrates how lifecycle-integrated governance can support ethically aligned, regulation-ready, and institutionally sustainable AI implementation. By shifting evaluative emphasis from predictive accuracy alone to coordinated governance design, this study contributes a structured framework for responsible and sustainable healthcare AI deployment.
A multi-layered governance model is proposed in which the four accountability layers operate through continuous feedback loops, enabling a lifecycle-oriented approach to the responsible development and deployment of AI in the UK healthcare system.
M. Unver, I. Ogu· The Paris Journal on AI &...· 0 citations
This work proposes nine operational measures - covering transparency-oriented risk and change control, traceability, subgroup and independent validation, usability-based explainability, calibrated clinical evaluation, structured labeling, version-controlled updates, and regulated end-of-life data handling - to support...
E. Bianchini, L. Billeci, Noemi Conditi et al.· Expert Review of Medical Dev...· 0 citations
A compliance-by-design framework is proposed that translates overlapping legal requirements into a set of auditable governance artefacts covering system classification, regulatory mapping, data governance, validation, human oversight, conformity assessment, post-market monitoring, and change control.
Qaiser Khan, Abdul Raffay Saeed· Frontiers in Digital Health· 0 citations
This scoping review examined the ethical and regulatory issues surrounding AI-enabled SaMD across jurisdictions and across the product lifecycle, drawing together peer-reviewed literature, standards, and official guidance.
Shaharyar Ahsan, Vivian Annastasia Chinyem Obi, Danish Noor et al.· Clinical Therapeutics· 0 citations
This review addresses the primary ethical principles relevant to AI in medicine - including respect for patient autonomy, beneficence, non-maleficence, and justice - alongside key legal frameworks with respect to liability, data protection, regulatory compliance, and algorithmic transparency.
Sebastian Schleidgen, O. Friedrich· European journal of internal...· 0 citations
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