서면 답변 · 2023-05-08 · 국회 14
AI 진단 솔루션의 신뢰도와 규제
질의는 AI 진단 솔루션의 신뢰도와 그 광범위한 적용에 대한 규제 고려사항에 초점을 맞추었습니다. 정부 응답은 싱가포르가 이미 의료 분야에서 광범위하게 AI를 적용하고 있으며, 안전, 임상 유효성, 비용 효율성이 채택의 전제 조건임을 강조했습니다. 정부는 기존의 규제 프레임워크와 향후 발표할 거버넌스 지침을 소개했으며, 동시에 윤리 문제에 주목했습니다. 핵심 분쟁은 기술 혁신과 안전 규제 사이의 균형을 어떻게 맞힐 것인가입니다.
핵심 요점
- • AI widely used in healthcare
- • Safety and efficacy as preconditions
- • Strengthen regulation and ethics
안전하고 효과적인 AI 의료 응용 지원
AI 진단의 신뢰도와 규제에 관심
AI 의료 규제 프레임워크 강화
“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.”
참여자 (2)
영어 원문
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.