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 can increase system efficiency and has the potential to improve patient outcomes. However, the widespread use of AI also includes inherent risks and ethical concerns, underscoring the importance of safe and responsible design and use.

Aligned with Singapore’s national strategy to build a trusted and responsible AI ecosystem, MOH, the Health Sciences Authority (HSA), and Synapxe co-developed the MOH Artificial Intelligence in Healthcare Guidelines (AIHGle) (read as ‘agile’).

AIHGle seeks to support patient safety and improve trust in the use of AI in healthcare by:

• Sharing good practices with AI developers (e.g. manufacturers or companies) and AI implementers (e.g. healthcare institutions – hospitals, clinics, laboratories); and

• Complementing HSA’s Regulatory Guidelines for Software as Medical Devices.

AIHGle is a living document that will be periodically updated to provide appropriate guidance on new technologies and ethical concepts.

Visit Synapxe's Health AI to find out more about how Synapxe harnesses AI to better predict adverse health events, provide innovative solutions for patient care and improve healthcare outcomes.

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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].

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, 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..

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’ in 2021, to prevent the discriminatory use of genetic information in insurance underwriting and to mitigate concerns about insurability when genetic tests have been taken. The Moratorium bans the use of genetic test results from biomedical research and non-clinical or DTC genetic test results in insurance underwriting. It also controls the use of predictive genetic test results in insurance underwriting.

Find out more on Moratorium [PDF, 207KB].

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