As healthcare institutions undergo rapid digitalization, compliance and data governance are no longer secondary safeguards—they have become foundational pillars of institutional strategy, accountability, and trust. This chapter offers a grounded framework for embedding these functions into the operational core of public hospitals, particularly within the context of Swiss legal and regulatory complexity. It examines the convergence of legal obligations, ethical mandates, and institutional practice, demonstrating how compliance has evolved from reactive oversight into a proactive and value-generating institutional discipline. Drawing from both Swiss federal and cantonal frameworks, and engaging with broader European regulatory developments, the analysis highlights how instruments like ISO 37301 and ISO/IEC 27701 can support institutional maturity. Emphasis is placed on governance-by-design, interdisciplinary collaboration, and the role of data stewardship in navigating technological change without compromising fundamental rights. Rather than presenting compliance as a constraint, the chapter positions it as a driver of ethical innovation and public legitimacy in digitally transforming healthcare systems.

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Healthcare Compliance and Data Governance

  • Andrea Saporito,
  • Baroum Mrad Georgis

摘要

As healthcare institutions undergo rapid digitalization, compliance and data governance are no longer secondary safeguards—they have become foundational pillars of institutional strategy, accountability, and trust. This chapter offers a grounded framework for embedding these functions into the operational core of public hospitals, particularly within the context of Swiss legal and regulatory complexity. It examines the convergence of legal obligations, ethical mandates, and institutional practice, demonstrating how compliance has evolved from reactive oversight into a proactive and value-generating institutional discipline. Drawing from both Swiss federal and cantonal frameworks, and engaging with broader European regulatory developments, the analysis highlights how instruments like ISO 37301 and ISO/IEC 27701 can support institutional maturity. Emphasis is placed on governance-by-design, interdisciplinary collaboration, and the role of data stewardship in navigating technological change without compromising fundamental rights. Rather than presenting compliance as a constraint, the chapter positions it as a driver of ethical innovation and public legitimacy in digitally transforming healthcare systems.