Objective
The growing use of artificial intelligence (AI) in healthcare demands robust regulatory frameworks to ensure safety, ethics, and legal compliance, particularly regarding algorithmic transparency, data privacy, and bias. This systematic review analyzes AI regulations and grey literature (2019–2024) from the Food and Drug Administration (FDA), the World Health Organization (WHO), the Organization for Economic Co-operation and Development (OECD), and the International Organization for Standardization/International Electrotechnical Commission (ISO/IEC).
Methods
This systematic review, following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, analysed 26 studies (Peer-reviewed studies: n = 17 & Grey literature: n = 9) on AI regulatory frameworks in healthcare between 2019 and 2024. A systematic literature search and rigorous inclusion criteria ensured relevance, with data consolidated into safety, effectiveness, and ethical themes. The analysis integrates a low-middle income countries (LMIC) perspective via WHO policy and a handful of studies, but the main academic body is drawn primarily from high-income contexts.
Bias risk was assessed systematically.
Results
The reviewed studies highlight the critical need for AI regulatory frameworks in healthcare, focusing on patient safety, ethics, and trust. Key findings stress the necessity for transparent, equitable integration and clear guidelines addressing bias, legal issues, and validation. Grey literature consistently emphasizes risk-based safety models and principles like transparency and human oversight. However, a significant gap remains in translating equity commitments into enforceable standards for bias mitigation, underscoring a critical need for future regulatory action.
Conclusion
This review identifies critical gaps in AI regulatory frameworks, particularly in equity, real-world validation, and liability, and proposes actionable, interdisciplinary strategies to ensure AI's safe, ethical, and equitable integration into healthcare.
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