Regulating Artificial Intelligence and New Technologies for Precision Medicines
Ministry of HealthSpeakers
Summary
This question concerns how the Government regulates artificial intelligence (AI) and precision medicine to protect patient safety and data privacy while addressing potential increases in healthcare costs. Mr Yip Hon Weng inquired about the regulatory measures for these technologies and their financial impact compared to generic alternatives. Minister for Health Ong Ye Kung replied that the Health Sciences Authority regulates AI-driven medical devices, with clinical genetic and genomic services slated for regulation under the Healthcare Services Act in late 2023. He emphasized that patient data is protected by existing laws and that the Ministry of Health is developing frameworks to ensure ethical, clinical, and cost-effective deployment. The Government continues to evaluate these nascent technologies to balance their transformative potential with rigorous governance and affordability.
Transcript
31 Mr Yip Hon Weng asked the Minister for Health (a) how does the Government regulate AI and new technologies used for precision medicine in order to protect data privacy and patient confidentiality as well as ensure patient safety; and (b) how does the Government address concerns that customised treatments and precision medicines may increase healthcare costs for patients, compared to cheaper generic drugs.
Mr Ong Ye Kung: Artificial intelligence (AI) and precision medicine are all major technological breakthroughs that can potentially transform healthcare. Some of the use cases promise to deliver greater cost efficiency and clinical effectiveness. Other potential uses are less straightforward. There may be a promising new precision medicine which may work only on certain individuals and cost significantly more.
Having said that, the healthcare sector is characterised by very tight regulation. In Singapore, any new technologies, including the use of AI, are regulated by the Health Sciences Authority (HSA) as medical devices if they diagnose, manage or treat medical conditions. For example, clinical genetic and genomic services will be regulated as part of the Healthcare Services Act in end 2023. Patient data, including genomic data, are already subject to laws and regulation that safeguard patients’ privacy.
Many precision medicine technologies are still nascent, with many applications that are experimental in nature. The Ministry of Health (MOH) will continue to develop our governance framework and policies to ensure that we can deploy these technologies in healthcare in ethical and clinically and cost-effective ways.