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

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

A dialogue on cognitive semiotics: minds, and machines

Technologies of Intelligence and Digital Design, abbreviated tidd, the interdisciplinary postgraduate program of the Catholic University of São Paulo, founded by Lucia Santaella, was inaugurated in 2006. In its 15th year of existence, it is offering a number of series under the name “tidd digital”, each dealing with topics from the program’s various study fields. We have had series on artificial intelligence and art, artificial intelligence and law, artificial intelligence and ethics, and on intelligent business technologies. Today, I am pleased to introduce a new series on cognitive semiotics. It is divided into two episodes.Today, in English, the question is “Cognitive semiotics: What is it?” The interdisciplinary ma and PhD program tidd deals with the contemporary challenges posed by the digital technologies. It counts on the cooperation of the following interdisciplines: computation, information technologies, social network, cognition and education, design and esthetic technologies, and artificial intelligence. Today’s focus is on cognition, a research field of an interdiscipline of its own, called cognitive science. Collaborators of this research field are scholars from the disciplines of cognitive psychology and philosophy, linguistics and anthropology, computer science, and artificial intelligence.

ARTIFICIAL INTELLIGENCE AND LAW: PROBLEMS AND PROSPECTS

In the modern scientific space, artificial intelligence researches are becoming popular and, as theresult, disputes about the prospects and risks of its wider use are growing. The rapid development ofdigital technologies causes the urgent need of expansion the boundaries in the sphere of legal regulationand emergence new segments in it. Today, the development of digital technologies demonstrates the longterm tendency to reduce the protective abilities of existing legal institutions, which aggravates the conflictbetween the advantages of modern technologies and current legislation. In this regard, it seems relevant to study the concept of artificial intelligence, its appearance as an independent scientific field, as well as thelegal risks of using artificial intelligence and ways to overcome them.The social and practical significance of the study lies in the search for optimal legal regulation, which,in turn, will facilitate the unhindered introduction of the latest technologies, which are the catalyst foreconomic growth and contribute to the development of the digital economy.Keywords: digital technologies, digital law, artificial intelligence, legal risks, digital economy