A Trustworthy Regulatory Environment for AI-enabled Assisted Reproduction in Hong Kong

Digital technology is widely used in healthcare, and assisted reproduction (AR) is no exception. Notably, artificial intelligence (AI) is now used in embryo selection to increase the success of in vitro fertilization (IVF). However, there is (at least at the time of writing) limited evidence to show that such use of AI greatly advances clinical outcome. A recent study (to be discussed below) appears to point to the contrary, even if there may be savings in labour cost. In the context of IVF, I highlight the need to establish a regulatory environment that facilitates evidence generation for AI-based medical interventions in Hong Kong. Currently, it can be argued that the regulatory regime in Hong Kong does not adequately support the evaluation of innovation in AI-enabled AR. In Part II of this summary, I broadly consider the regulatory regime for AR in Hong Kong and its focus on sufficiency of information for the purposes of informed consent. I then consider in Part III, why a focus on informed consent has not been adequate in relation to novel reproductive technologies like non-invasive prenatal testing (NIPT). Recent findings from a clinical trial of an AI-enabled IVF treatment are broadly discussed in Part IV, and its regulatory implications are then considered in Part V. A copy of the full report is available here: https://cmel.hku.hk/research-health/report-governance-of-medical-ai-in-hong-kong-and-other-jurisdictions/