Center for Advanced Endoscopy, Division of Gastroenterology, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts, USA.
Former GI Deputy Division Director, U.S. Food and Drug Administration.
Gastrointest Endosc. 2020 Oct;92(4):801-806. doi: 10.1016/j.gie.2020.05.040. Epub 2020 Jun 3.
Artificial intelligence (AI) technologies in clinical medicine have become the subject of intensive investigative efforts and popular attention. In domains ranging from pathology to radiology, AI has demonstrated the potential to improve clinical performance and efficiency. In gastroenterology, AI has been applied on multiple fronts, with particular progress seen in the areas of computer-aided polyp detection (CADe) and computer-aided polyp diagnosis (CADx), to assist gastroenterologists during colonoscopy. As clinical evidence accrues for CADe and CADx, our attention must also turn toward the unique challenges that this new wave of technologies represent for the U.S. Food and Drug Administration and other regulatory agencies, who are tasked with protecting public health by ensuring the safety of medical devices. In this review, we describe the current regulatory pathways for AI tools in gastroenterology and the expected evolution of these pathways.
人工智能（AI）技术在临床医学领域已成为密集研究和广泛关注的焦点。在病理学到放射学等领域，AI 已显示出提高临床性能和效率的潜力。在胃肠病学领域，AI 已在多个方面得到应用，在计算机辅助息肉检测（CADe）和计算机辅助息肉诊断（CADx）方面取得了特别进展，以协助结肠镜检查期间的胃肠病学家。随着 CADe 和 CADx 的临床证据不断增加，我们还必须关注这一波新技术为美国食品和药物管理局（FDA）和其他监管机构带来的独特挑战，这些机构的任务是通过确保医疗器械的安全性来保护公众健康。在这篇综述中，我们描述了当前用于胃肠病学的 AI 工具的监管途径以及这些途径的预期发展。
