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General Background: Healthcare infrastructure development involves complex legal, financial, and institutional requirements that demand systematic project management. Specific Background: Hospital expansion projects face changing regulations, contractual obligations, and compliance requirements that may generate disputes, delays, and cost overruns. Knowledge Gap: Previous research frequently separates legal considerations from project management, leaving integrated approaches to regulatory uncertainty insufficiently developed. Aims: This study identifies major legal risk categories and develops an integrated conceptual framework using a systematic literature review guided by PRISMA. Seventeen relevant studies were examined through thematic analysis and narrative synthesis. Results: Four interconnected dimensions emerged: contractual and public private partnership risks, governance and compliance risks, project governance risks, and legal risks associated with healthcare digital transformation. Regulatory uncertainty was identified as a concern for financing stability, institutional coordination, project performance, and dispute prevention. Novelty: The study proposes an interdisciplinary framework integrating regulatory uncertainty, legal risk, project governance, and project performance into a unified analytical structure specifically addressing hospital infrastructure development. Implications: The proposed framework provides a conceptual foundation for hospital administrators, investors, legal practitioners, and policymakers to formulate adaptive compliance strategies, strengthen contractual arrangements, and manage regulatory challenges. Highlights: Seventeen studies identified contractual, compliance, managerial, and digital exposures. Policy instability threatens financing stability and increases the potential for disputes. Fragmented disciplinary approaches demonstrate the need for an integrated conceptual framework.
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Asya et al. (2026) studied this question.
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