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

<p dir="ltr">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 <i>in vitro fertilization</i> (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.</p><p dir="ltr">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.</p><p dir="ltr">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/ </p>