PDF(Pubmed)
Abstract：
Artificial intelligence (AI)-enabled technologies in the MedTech sector hold the promise to transform healthcare delivery by improving access, quality, and outcomes. As the regulatory contours of these technologies are being defined, there is a notable lack of literature on the key stakeholders such as the organizations and interest groups that have a significant input in shaping the regulatory framework. This article explores the perspectives and contributions of these stakeholders in shaping the regulatory paradigm of AI-enabled medical technologies. The formation of an AI regulatory framework requires the convergence of ethical, regulatory, technical, societal, and practical considerations. These multiple perspectives contribute to the various dimensions of an evolving regulatory paradigm. From the global governance guidelines set by the World Health Organization (WHO) to national regulations, the article sheds light not just on these multiple perspectives but also on their interconnectedness in shaping the regulatory landscape of AI.
摘要：
医疗技术领域的人工智能（AI）技术有望通过改善获取途径来改变医疗保健服务。质量,和结果。随着这些技术的监管轮廓正在被定义，关于关键利益相关者的文献明显缺乏，例如在塑造监管框架方面有重要投入的组织和利益集团。本文探讨了这些利益相关者在塑造人工智能医疗技术监管范式方面的观点和贡献。人工智能监管框架的形成需要伦理的趋同，监管,技术,社会,和实际考虑。这些多种观点有助于不断发展的监管范式的各个维度。从世界卫生组织（WHO）制定的全球治理准则到国家法规，这篇文章不仅揭示了这些多重观点，还揭示了它们在塑造人工智能监管格局方面的相互联系。
