Background: Artificial Intelligence as a Medical Device (AIaMD) introduces regulatory, methodological, ethical, and clinical challenges that are not fully addressed by traditional device trial frameworks. Given rapidly evolving and jurisdiction-specific guidance, a consolidated mapping of trial design expectations and regulatory requirements is needed. Objective: To map regulatory requirements and clinical trial design approaches for AIaMD across major jurisdictions and to identify key methodological and implementation gaps relevant to adaptive/continuously learning systems. Methods: A scoping review was conducted in accordance with the PRISMA-ScR reporting guideline. Peer-reviewed literature (2017–2025) was searched in PubMed, Embase, Web of Science, and the Cochrane Library. Gray literature was identified from major regulators and policy bodies (FDA, EMA, MHRA, PMDA, WHO, CDSCO). Eligible records addressed AIaMD clinical evaluation, trial design, regulatory pathways, post-market surveillance, or reporting standards. Data were charted using a predefined extraction framework and synthesized descriptively with thematic analysis across regulatory, methodological, ethical, and clinical implementation domains. Results: Included sources demonstrate substantial heterogeneity in evidence expectations and AI-specific pathways across jurisdictions. Recurrent themes include the need for predefined change management, performance monitoring and drift controls, dataset representativeness and bias evaluation, transparency and versioning, cybersecurity, and real-world evidence integration. Reporting frameworks (SPIRIT-AI, CONSORT-AI, MI-CLAIM) are frequently cited as mechanisms to improve reproducibility and regulatory readiness. Conclusions: Evidence and regulatory expectations for AIaMD remain fragmented. Harmonization of terminology, trial design principles, and post-market governance—supported by standardized reporting—would improve clinical validity, safety assurance, and scalability across regions. This review has several limitations. As a scoping synthesis, it prioritizes breadth of coverage rather than quantitative meta-analysis. Included sources vary in methodological rigor and reporting detail, and evolving regulatory guidance may change rapidly over time. Nevertheless, integrating peer-reviewed and regulatory evidence provides a comprehensive overview of current expectations and emerging gaps. In conclusion, effective evaluation of AIaMD requires a shift from static, one-time validation toward continuous lifecycle oversight that integrates adaptive trial designs, transparent reporting standards, bias surveillance, and structured post-market monitoring. Regulatory heterogeneity currently poses significant barriers to multinational development; however, coordinated adoption of standardized evidence frameworks and collaborative governance mechanisms may reduce duplication while preserving patient safety. By translating methodological principles into operational guidance, this review aims to support regulators, sponsors, and clinical investigators in designing trials that are both scientifically rigorous and practically implementable for continuously learning systems.

Objective: This paper develops a conceptual theory-building framework for understanding and managing AI-enabled workplace conflict. It reframes AI-mediated conflict as a socio-technical justice problem and proposes the Hybrid Conflict Governance Model (HCGM), which links HR policy design, ethical governance mechanisms, and workforce capability development to conflict outcomes through procedural justice, trust, contestability, and human oversight pathways. Methods: This study adopts a conceptual theory-building design based on interdisciplinary literature synthesis. Literature from human resource management, artificial intelligence governance, organizational justice, socio-technical systems theory, digital work, and workplace conflict was synthesized using a problem-driven conceptual approach. The study integrates these literature streams to develop a theoretical framework explaining how AI-enabled workplace conflict emerges and how governance mechanisms may influence conflict outcomes. Conceptual Findings: The analysis identifies four major AI-enabled conflict dynamics: algorithmic bias, algorithmic surveillance, human–AI decision misalignment, and opacity in AI-supported decision making. The proposed HCGM explains how AI system characteristics influence employee justice perceptions, trust, and conflict escalation or reduction. The model identifies four interdependent governance layers: foundational rights, structural governance, operational integration, and capability development. These layers interact dynamically and are shaped by boundary conditions including organizational culture, AI autonomy, workforce digital literacy, and regulatory context. Conclusion: AI-enabled workplace conflict cannot be managed through technical controls alone. Effective governance requires integrated HR policies, ethical oversight, transparent decision processes, human review mechanisms, and workforce capability development. The HCGM contributes to AI governance, HRM, and workplace conflict literature by explaining how socio-technical governance mechanisms shape fairness perceptions, trust, and conflict outcomes in AI-mediated workplaces.

Artificial Intelligence (AI) is increasingly embedded within supply chain and information systems, where decision-making depends on the quality, integrity and reliability of operational data. While previous studies have examined data poisoning, data drift and data integrity independently, limited research has integrated these governance risks within a single AI governance perspective. This review addresses that gap by synthesising current literature and developing a case-informed governance framework for managing interconnected AI risks in operational environments. The study adopts a structured narrative review supported by published literature and an illustrative supply chain case scenario to examine how data poisoning, data drift and data integrity failures affect AI performance, organisational resilience and governance. Rather than reporting experimental findings, the paper synthesises existing evidence and demonstrates how these risks interact throughout the AI lifecycle. The review demonstrates that effective AI governance extends beyond technical safeguards alone. Maintaining reliable and resilient AI systems requires continuous lifecycle assurance, robust data governance, organisational accountability, and appropriate regulatory oversight. Drawing on these findings, the study proposes an Integrated AI Governance Framework that brings together technical assurance, organisational governance, and internationally recognised governance principles within a unified lifecycle model. This study contributes to AI governance literature by providing an integrated governance perspective that connects technical AI risks with organisational governance and practical implementation considerations. The framework offers guidance for organisations deploying AI within complex data-driven environments.