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  • Grant
  • 2022

Regulatory governance of AI in medicine in the Greater Bay Area

Principal Investigator: Gilberto K. K. Leung; Co-Investigator: Dr Li Du, Dr Calvin W. L. Ho, Prof Eric C. Ip, Dr Ping Ji and Dr Haihong Zhang
Grant from the RGC General Research Fund

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.

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  • Journal Article
  • 2023

Generative AI and the foregrounding of epistemic injustice in bioethics

by Calvin W. L. Ho
in American Journal of Bioethics

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  • Journal Article
  • 2023

Implementing the human right to science in the regulatory governance of artificial intelligence in healthcare

by Calvin W. L. Ho
in Journal of Law and the Biosciences

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  • Journal Article
  • 2022

Scaling up the research ethics framework for healthcare machine learning as global health ethics and governance

co-authored by Calvin W. L. Ho
in The American Journal of Bioethics

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  • Grant
  • 2021

Comparative analysis of the digitalization of public health interventions in India and China

Principal Investigator: Calvin W. L. Ho
Grant from the World Health Organization

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  • Book Chapter
  • 2021

When learning is continuous: Bridging the research – therapy divide in the regulatory governance of Artificial Intelligence as medical devices

by Calvin W. L. Ho
in The Cambridge Handbook of Health Research Regulation (Cambridge University Press)

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  • Book Chapter
  • 2021

Human biomedical research in the age of ‘Big Data’ analytics and artificial intelligence

by Calvin W. L. Ho
in The Future of Bioethics in Singapore

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  • Grant
  • 2021

“Machine M.D.: How should we regulate AI in health care”, Grant from the Canadian Institutes of Health Research

Co-Investigator: Calvin W. L. Ho
Grant from the Canadian Institutes of Health Research

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  • Journal Article
  • 2020

Heralding the digitalization of life in post-pandemic East Asian societies

co-authored by Calvin W. L. Ho
in Journal of Bioethical Inquiry

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  • Journal Article
  • 2020

Ensuring trustworthy use of Artificial Intelligence and big data analytics in health insurance

co-authored by Calvin W. L. Ho
in Bulletin of the World Health Organization

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  • Journal Article
  • 2019

Governance of automated image analysis and artificial intelligence analytics in healthcare

lead author: Calvin W.L. Ho
in Clinical Radiology

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