Rights-Based Approach to Counter Exacerbating Health Inequities in the Regulatory Governance of Artificial Intelligence in Healthcare
Wai Loon Calvin Ho1, University Of Hong Kong 1University Of Hong Kong
Abstract
Artificial intelligence (AI) enables a medical device to optimize its performance through machine learning (ML), including the ability to learn from past experiences. In healthcare, ML is currently applied within controlled settings in devices that are able to diagnose conditions like diabetic retinopathy without clinician input. This is due in part to essentially risk-based regulatory approaches that have been adopted in major jurisdictions that are involved in the development and manufacture of AI-based medical devices (AIMDs). In order to allow AIMDs to adapt actively to its data environment through ML, risk-based regulatory approaches are inadequate in facilitating technological progression and are likely to exacerbate health inequities. Innovative regulatory changes recently introduced to regulate AIMDs as a software, or ‘software as a medical device’ (SaMD), and the adoption of a total device/product-specific lifecycle approach (rather than one that is point-in-time), reflect a shift away from the strictly risk-based approach to one that is more collaborative and participatory in nature, and anticipatory in character. The proposition I advance in this paper is that a rights-based approach to the regulatory governance of AIMDs better account for these changes and could help to reduce health inequities. I first explain the ways in which the regulatory governance of AIMDs is risk-based and how this approach has contributed to health inequities. I then show why recent regulatory changes introduced through the establishment of SaMDs as a regulated entity will not be effective in sustaining a fundamentally risk-based approach, and that rights-based approaches (and/or elements thereof) will need to be adopted. The paper concludes with an outline of what such a rights-based approach could look like.
Biography
Calvin Wai-Loon Ho is Associate Professor with the Faculty of Law and Co-Director of the Centre for Medical Ethics and Law, University of Hong Kong.