Singapore Ministry of Health addresses AI-developed drugs and patient data safeguards

Singapore’s Ministry of Health has said that drugs developed with the use of AI will be subject to the same regulatory expectations as conventionally developed medicines, including requirements on quality, safety and efficacy. The ministry made the statement in response to a parliamentary question on the regulation of AI-developed drugs, clinical trials and safeguards for patient data used in AI-related healthcare innovation. It said the Health Sciences Authority’s approach is aligned with international regulatory principles on the responsible use of AI in drug development, including those outlined by the US Food and Drug Administration and the European Medicines Agency. The ministry also said that patient data used for AI development is covered by existing data protection and cybersecurity safeguards, including obligations under Singapore’s Personal Data Protection Act to maintain patient confidentiality and prevent data leakage. Authorities will continue to monitor developments in AI-related healthcare innovation and strengthen safeguards where necessary.