8. Emerging regulatory policy issues

The Ministry of Health (MOH) proactively scans the environment through various channels, like horizon scanning and stakeholder engagements, to identify emerging regulatory issues to enable forward planning and timely regulatory response to such issues. Two such emerging developments are the use of artificial intelligence (AI) and the applications of precision medicine in healthcare.

Artificial Intelligence

The application of Artificial Intelligence (AI) spans multiple areas, including administration, clinical decision support and research such as drug development. AI has tremendous potential to improve patient care and outcomes. However, the widespread use of AI also includes inherent risks, underscoring the importance of safe and responsible design and use of AI in healthcare.

AI in Healthcare Guidelines

Singapore is committed to adopt AI thoughtfully, prioritising patient safety and clinical effectiveness. MOH continues to develop guidelines to support the safe and responsible use of AI in the healthcare sector. Updated jointly by MOH and the Health Sciences Authority (HSA), the Artificial Intelligence in Healthcare Guidelines(AIHGle 2.0) ↗ (opens in new tab)(read as ‘agile’) clarifies that AI should augment and empower our healthcare professionals in enhancing healthcare delivery, with patients at the heart of it.

Building on the 2021 framework, AIHGle 2.0 provides practical guidance to support the safe development, deployment, and use of AI in healthcare, benefitting patients and improving trust. It also complements HSA’s Regulatory Guidelines for Software as Medical Devices ↗ (opens in new tab). Key updates include:

• Strengthening accountability through clarity of responsibilities for each stakeholder group – developers (e.g. manufacturers), deployers (i.e. healthcare organisations), and users (i.e. healthcare professionals);

• Improving trust via guidance on transparency to facilitate informed decision-making; and

• Updated guidance on AI deployment, such as assessing and mitigating risks.

AIHGle is a living document that will be periodically updated to provide appropriate guidance in light of developments and new technologies. Let us work together to enable safe and trusted AI across the healthcare ecosystem.

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If you have feedback, please share it with us here: https://go.gov.sg/aihgle-feedback ↗ (opens in new tab).

Precision Medicine

Precision Medicine is a new and evolving field that has the potential to transform healthcare through early detection, targeted prevention and personalised care and management of genetic diseases which may reduce diagnostic testing and treatment costs. Interventions and emerging technologies in Precision Medicine include clinical and non-clinical genetic testing, ‘omics’-based biomarkers, pharmacogenomics tests, complex AI-based algorithms, and digital health applications. As technologies become more prevalent in clinical practice and healthcare use, there are also increasing challenges and issues such as:

• Concerns about complexity in interpreting test results;

• Lack of strong scientific evidence in demonstrating safety and efficacy;

• Lack of consumer awareness on novel precision medicine technologies;

• Concerns on data privacy and security; and

• Genetic discrimination in insurability and employment.

MOH is responding to these challenges in a variety of ways, from regulating the provision of clinical genetic and genomic testing, providing guidance on the use of direct-to-consumer genetic test kits, and putting in place a Moratorium on the use of genetic testing results in insurance underwriting.

Regulation of Genetic Testing

MOH issued a Code of Practice (COP) on the Provision of Clinical Genetic Testing in 2018 which sets out the minimum standards and requirements for the provision of clinical and laboratory genetic/genomic testing by healthcare institutions, licensees, and medical practitioners. The COP is currently under review and will be translated to regulations to be implemented under the Healthcare Services Act (HCSA) subsequently.

Read more on the COP standards [PDF, 940 KB] ↗ (opens in new tab).

Non-clinical Genetic Testing

Non-clinical or direct-to-consumer (DTC) genetic test kits are increasingly widespread. They do not address medical conditions and are typically used for general wellness and recreational purposes, such as testing for innate behaviour or talents, fitness, and nutrigenomics. There are several risks of DTC genetic testing, such as unreliability of test results and unauthorised commercialisation of genetic data gleaned from tests.

MOH has developed guidance on the provision of non-clinical or DTC genetic testing ↗ (opens in new tab), which provides information to providers of non-clinical genetic testing who are operating or wish to operate in Singapore to ensure safety, welfare, and privacy of the consumers. The guide also informs and guides the expectations of potential consumers of non-clinical genetic testing.

Find out more about non-clinical or DTC genetic testing ↗ (opens in new tab).

Moratorium on the Use of Genetic Test Results in Insurance Underwriting

MOH and the Life Insurance Association (LIA) developed the ‘Moratorium on Genetic Testing and Insurance’ to support Precision Medicine (PM) in Singapore. The Moratorium aims to give individuals the assurance to undergo clinical genetic testing for medical care and to participate in PM research, by protecting genetic test results from use by insurers in underwriting. It applies to all LIA members that includes life insurers and reinsurers that are licensed to operate in Singapore.

The Moratorium prohibits the use of genetic test results in insurance underwriting. The Moratorium was first introduced in 2021 (“2021 Moratorium”) and was later amended and re-signed in 2025 (“2025 Moratorium”) to enhance protections for individuals undergoing genetic testing for FH under the National Familial Hypercholesterolaemia (FH) Genetic Testing Programme. This aims to support early identification and interventions for individuals with FH and forms part of MOH’s broader preventive care efforts.

For more information please click here for the Moratorium and the Consumer Guide ↗ (opens in new tab)

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