書面答覆 · 2023-05-08 · 屆國會 14
AI診斷方案的可信度與監管
質詢聚焦於AI診斷方案的可信度及其廣泛應用的監管考量。政府回應指出新加坡已在醫療領域廣泛應用AI，強調安全、臨床有效性和成本效益為採用前提，介紹了現有的監管框架和未來發布的治理指南，同時關注倫理問題。核心爭議在於如何平衡技術創新與安全監管。
關鍵要點
- • AI廣泛應用醫療
- • 安全有效為前提
- • 完善監管與倫理
支援安全有效的AI醫療應用
關注AI診斷可信度與監管
加強AI醫療監管框架
“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.”
參與人員 (2)
完整譯文（中文）
Hansard 原始記錄 · 2026-05-02
39 賴志明副教授向衛生部長提問：(a) 衛生部是否探討過基於人工智慧的診斷解決方案的可信度；(b) 如果有，若此類技術被更廣泛採用，最重要的監管考量是什麼？
王乙康先生：人工智慧（AI）無處不在，並已在新加坡醫療保健中得到應用。例如，它被用於新加坡衛生集團和國大合辦的JARVISDHL專案，以預防糖尿病、高血壓、高脂血症。它是SELENA+（新加坡眼病分析儀加）的核心，用於診斷糖尿病視網膜病變。它還用於心血管和慢性病的診斷與管理。它被部署在預防保健的健康應用中，也用於藥物研究。
衛生部（MOH）歡迎在醫療保健中使用經證明安全、臨床有效且具成本效益的人工智慧技術。隨著AI技術的快速發展，我們相信將出現許多基於AI的治療方法。挑戰在於如何擁抱並鼓勵這些技術，同時確保AI在醫療中的安全採用和部署。為此，我們在過去幾年逐步建立了保障措施。
衛生部的《醫療保健中的人工智慧指南》指導AI醫療裝置（AI-MD）開發者和實施者在向患者推出此類臨床服務時應採用的良好實踐。
衛生科學局作為醫療設備註冊流程的一部分，監管AI醫療裝置開發的多個方面，以確保AI醫療裝置的質量、安全性和有效性，並要求持續的上市後監測，以確保其持續的實際效果。
衛生部將釋出醫療保健領域的人工智慧治理框架，推薦詳細的發展和實施層面的良好實踐，例如風險提示以幫助識別風險，以及風險緩解的控制措施。
生物倫理諮詢委員會也於2023年5月2日釋出了關於大數據和人工智慧在人類生物醫學研究中倫理使用的草案諮詢報告和建議，供公眾諮詢。
衛生部將繼續研究國際最佳實踐，整合並發展我們的人工智慧治理框架。
英文原文
SPRS Hansard · Fetched: 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.