书面答复 · 2023-05-08 · 第 14 届国会
AI诊断方案的可信度与监管
Credibility and Adoption of AI-based Diagnostic Solutions
质询聚焦于AI诊断方案的可信度及其广泛应用的监管考量。政府回应指出新加坡已在医疗领域广泛应用AI，强调安全、临床有效性和成本效益为采用前提，介绍了现有的监管框架和未来发布的治理指南，同时关注伦理问题。核心争议在于如何平衡技术创新与安全监管。
关键要点
- • AI广泛应用医疗
- • 安全有效为前提
- • 完善监管与伦理
支持安全有效的AI医疗应用
关注AI诊断可信度与监管
加强AI医疗监管框架
"The Ministry of Health (MOH) is open to the use of AI technologies in healthcare where they are proven to be safe, clinically efficacious and cost-effective."
参与人员（2）
完整译文（中文）
Hansard 英文原文译文 · 翻译日期：2026-05-02
39 赖志明副教授向卫生部长提问：(a) 卫生部是否探讨过基于人工智能的诊断解决方案的可信度；(b) 如果有，若此类技术被更广泛采用，最重要的监管考量是什么？
王乙康先生：人工智能（AI）无处不在，并已在新加坡医疗保健中得到应用。例如，它被用于新加坡卫生集团和国大合办的JARVISDHL项目，以预防糖尿病、高血压、高脂血症。它是SELENA+（新加坡眼病分析仪加）的核心，用于诊断糖尿病视网膜病变。它还用于心血管和慢性病的诊断与管理。它被部署在预防保健的健康应用中，也用于药物研究。
卫生部（MOH）欢迎在医疗保健中使用经证明安全、临床有效且具成本效益的人工智能技术。随着AI技术的快速发展，我们相信将出现许多基于AI的治疗方法。挑战在于如何拥抱并鼓励这些技术，同时确保AI在医疗中的安全采用和部署。为此，我们在过去几年逐步建立了保障措施。
卫生部的《医疗保健中的人工智能指南》指导AI医疗设备（AI-MD）开发者和实施者在向患者推出此类临床服务时应采用的良好实践。
卫生科学局作为医疗设备注册流程的一部分，监管AI医疗设备开发的多个方面，以确保AI医疗设备的质量、安全性和有效性，并要求持续的上市后监测，以确保其持续的实际效果。
卫生部将发布医疗保健领域的人工智能治理框架，推荐详细的发展和实施层面的良好实践，例如风险提示以帮助识别风险，以及风险缓解的控制措施。
生物伦理咨询委员会也于2023年5月2日发布了关于大数据和人工智能在人类生物医学研究中伦理使用的草案咨询报告和建议，供公众咨询。
卫生部将继续研究国际最佳实践，整合并发展我们的人工智能治理框架。
英文原文
SPRS Hansard 原始记录 · 抓取日期：2026-05-02
39 Assoc Prof Jamus Jerome Lim asked the Minister for Health (a) whether the Ministry has explored the credibility of AI-based diagnostic solutions; and (b) if so, what are the regulatory considerations that will be most important if there are more widespread adoption of such technologies.
Mr Ong Ye Kung : Artificial intelligence (AI) is ubiquitous and being used in healthcare in Singapore. For example, it is used in JARVISDHL, a programme by SingHealth and NUS to prevent diabetes, hypertension, hyperlipidemia. It is the engine for SELENA+ (Singapore Eye LEsioN Analyzer plus) to diagnose diabetic retinopathy. It is also used for diagnosis and management of cardiovascular and chronic diseases. It is deployed in health apps for preventive care, as well as in pharmaceutical research.
The Ministry of Health (MOH) is open to the use of AI technologies in healthcare where they are proven to be safe, clinically efficacious and cost-effective. With the rapid advancement of AI technology, we believe many treatments using AI will emerge. The challenge is to embrace and encourage them, while ensuring the safe adoption and deployment of AI in healthcare. To do so, we have progressively put in place safeguards over the past few years.
The MOH’s AI in Healthcare Guidelines guide AI Medical Device (AI-MD) developers and implementers on the good practices they should adopt in rolling out such clinical services to patients.
The Health Sciences Authority regulates multiple aspects of AI-MD development as part of its medical device registration process to ensure the quality, safety and efficacy of AI-MDs and requires continued post-market surveillance to ensure continued real-world effectiveness.
MOH will be issuing an AI Governance Framework for healthcare that recommends detailed development and implementation-level good practices, such as risk prompts to help identify risks, and controls for risk mitigation.
The Bioethics Advisory Committee has also issued a draft advisory report and recommendations on the ethical use of big data and AI in human biomedical research on 2 May 2023 for public consultation.
MOH will continue to study international best practices, consolidate and develop our AI governance framework.