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<p>Artificial intelligence offers transformative potential for global health, yet regulatory disparities threaten equitable adoption. This brief examines whether the World Health Organization’s Prequalification (PQ) framework should extend to AI. We highlight limitations of applying static product paradigms to dynamic systems, outline targeted reforms, and propose a reimagined PQ4AI that balances global technical assurance with local regulatory accountability to foster safe, effective, and equitable deployments.</p>

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Do we need prequalification of AI as a medical device to drive equitable adoption

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年12月17日

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  • Bilal A. Mateen,
  • Bernard Aryeetey,
  • Delese Mimi Darko

摘要

Artificial intelligence offers transformative potential for global health, yet regulatory disparities threaten equitable adoption. This brief examines whether the World Health Organization’s Prequalification (PQ) framework should extend to AI. We highlight limitations of applying static product paradigms to dynamic systems, outline targeted reforms, and propose a reimagined PQ4AI that balances global technical assurance with local regulatory accountability to foster safe, effective, and equitable deployments.