Malaysian Medical Device Regulation for Artificial Intelligence in Healthcare: Have all the pieces fallen into position?

Abstract

Artificial Intelligence (AI) ability of self-learning and adaptation has challenged the medical device regulation in overseeing the safety and effectiveness of medical devices. Thus, this research aims to evaluate the adequacy of the pre-market requirements under the Medical Device Act 2012 in governing AI modification. Employing the doctrinal research methodology, systematic means of legal reasoning pertinent to AI for healthcare applications are produced. An effective medical device regulation is pivotal to foster trustworthiness in the governance and adoption of AI. However, the research findings indicate the deficiency of the current conformity assessment for medical devices in addressing AI modifications. Keywords: Artificial Intelligence and Law, Artificial Intelligence and Medical Device Regulation, Malaysian Medical Device Regulation eISSN: 2398-4287© 2021. The Authors. Published for AMER ABRA cE-Bs by e-International Publishing House, Ltd., UK. This is an open access article under the CC BYNC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). Peer–review under responsibility of AMER (Association of Malaysian Environment-Behaviour Researchers), ABRA (Association of Behavioural Researchers on Asians/Africans/Arabians) and cE-Bs (Centre for Environment-Behaviour Studies), Faculty of Architecture, Planning & Surveying, Universiti Teknologi MARA, Malaysia. DOI: https://doi.org/10.21834/ebpj.v6i16.2635

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