Scholarlink

<p>Effective regulatory oversight is a key step in ensuring that artificial intelligence as a medical device (AIaMD) is safe in real-world clinical settings. In this Perspective, we provide insights from our experience working with international regulatory databases, informed by our recent research and the expertise of the multidisciplinary authorship team. We highlight four key challenges, discuss attempts to circumvent these limitations, and highlight emerging initiatives. Nevertheless, the underlying issue of the quality and availability of input data from regulatory databases remains. We discuss considerations for improving accessibility and transparency, outline key aspects for a next-generation regulatory data ecosystem for AIaMDs, and call on global stakeholders to come together and align efforts to develop a clear roadmap to accelerate safe innovation and improve outcomes for patients worldwide.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Current challenges and the way forwards for regulatory databases of artificial intelligence as a medical device

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年2月11日

查看全文
  • Ariel Yuhan Ong,
  • Aditya U. Kale,
  • Joe Antoun,
  • Henry David Jeffry Hogg,
  • Ben Hammond,
  • Pearse A. Keane,
  • Russell Pearson,
  • Hugh Harvey,
  • Alastair K. Denniston

摘要

Effective regulatory oversight is a key step in ensuring that artificial intelligence as a medical device (AIaMD) is safe in real-world clinical settings. In this Perspective, we provide insights from our experience working with international regulatory databases, informed by our recent research and the expertise of the multidisciplinary authorship team. We highlight four key challenges, discuss attempts to circumvent these limitations, and highlight emerging initiatives. Nevertheless, the underlying issue of the quality and availability of input data from regulatory databases remains. We discuss considerations for improving accessibility and transparency, outline key aspects for a next-generation regulatory data ecosystem for AIaMDs, and call on global stakeholders to come together and align efforts to develop a clear roadmap to accelerate safe innovation and improve outcomes for patients worldwide.