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The main aim of the proposed study is to examine how a participatory and collaborative approach to the regulatory governance of medical devices based on artificial intelligence (AI) or machine learning (ML) should be developed and implemented in Hong Kong SAR, as part of the Guangdong-Hong Kong-Macau Greater Bay Area (GBA). In this connection, it also seeks to explicate what it means to be “participatory” and “collaborative”; these being regulatory principles that have been put forward by the International Medical Device Regulators Forum (IMDRF), and implicit in the “Guangdong-Hong Kong- Macau Greater Bay Area Pharmaceutical and Medical Device Regulatory Innovation and Development Work Plan” (GBA Medical Device Work Plan).

AI/ML-based medical devices are increasingly being incorporated into medical workflows and clinical care pathways. Expected benefits include earlier and more cost-effective interventions, greater diagnostic and prognostic accuracy, better access to care, and more effective cost control. However, ethical and legal challenges that need to be addressed include means to ensure the safety and effectiveness of these devices, improper data appropriation and use, decisional opacity, bias and liability. The three constituent jurisdictions in the GBA currently have different regulatory approaches to govern medical devices, and there is no specific ethical or regulatory guidance on AI/ML-based medical devises. Findings in this study are expected to: (1) Identify obstacles to the uptake of AI/ML-based medical devices in the GBA from the perspectives of the healthcare institutions, healthcare providers and device developers/manufacturers (“key stakeholders”); (2) Indicate the extent that these obstacles are attributable to different ethical, professional, institutional and/or regulatory differences; and (3) Set out possible solutions or responses to these obstacles that are proposed by the key stakeholders.