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

Authors

  • Nurus Sakinatul Fikriah Mohd Shith Putera Faculty of Law, Universiti Teknologi MARA, Shah Alam, Malaysia
  • Sarah Munirah Abdullah Faculty of Law, Universiti Teknologi MARA, Shah Alam, Malaysia
  • Noraiza Abdul Rahman Faculty of Law, Universiti Teknologi MARA, Shah Alam, Malaysia
  • Rafizah Abu Hassan Faculty of Law, Universiti Teknologi MARA, Shah Alam, Malaysia
  • Hartini Saripan Faculty of Law, Universiti Teknologi MARA, Shah Alam, Malaysia
  • Imam Haryanto Faculty of Law, Universitas Pembangunan Nasional ‘Veteran’, Jakarta, Indonesia

DOI:

https://doi.org/10.21834/ebpj.v6i16.2635

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

Published

2021-03-28

How to Cite

Mohd Shith Putera , N. S. F. ., Abdullah, S. M., Abdul Rahman, N. . ., Abu Hassan, R. . ., Saripan, H. ., & Haryanto, I. . (2021). Malaysian Medical Device Regulation for Artificial Intelligence in Healthcare: Have all the pieces fallen into position?. Environment-Behaviour Proceedings Journal, 6(16), 137-144. https://doi.org/10.21834/ebpj.v6i16.2635

Most read articles by the same author(s)