A study of the legislative framework governing rehabilitation and assistive robots in Malaysian healthcare institutions: a comparison with the United States / Nurus Sakinatul Fikriah Mohd Shith Putera

Rehabilitation and assistive robots used in rehabilitation therapy programmes and for
personal care, is a newly emerging collaborative effort between medical and robotic
studies. This robotic evolution is being keenly felt in Malaysia, precisely in
responding to community with neurodevelopmental disorders such as Autism
Spectrum Disorders (ASD) and Cerebral Palsy. Nevertheless, the closer proximity of
humans and robots demonstrates the risk of exposing human subjects to the
unpredictable robotic behaviour and thus, the issue of safety becomes central.
Consequently, the interaction motivates this research to revisit the adequacy of the
current legislative framework in governing rehabilitation and assistive robots in
comparison with the United States. The novel challenges related to rehabilitation and
assistive robots result with the inadequacy of the current legislative framework to
govern the risk arising from such technology. This problem revolves around two
concerns namely the incompatibility of the traditional theories of liability, and the
vagueness of the scope of the Medical Device Act 2012 to govern rehabilitation and
assistive robots. The objectives of this research are achieved by adopting the doctrinal
methodology of data collection and data analysis focusing on the comparative,
interpretational, analogy, historical and jurisprudential approaches. The findings of the
research concluded that the law lags behind technology, the fault-based theory of
liability is unworkable for autonomous robots, the difficulty in establishing the
element of causation in a strict liability claim, the generalisation of the medical device
regulatory framework, the disorganized standards associated with rehabilitation and
assistive robots and that the legal personhood model is insignificant to the Malaysian
robot regulation. This research contributes in setting forward suggestions and
recommendations to improve the current legislative framework, assists in the
formulation of national policy and specific law on robots, subsequently benefiting the
industrial player, healthcare institutions as well as the community with disabilities.
Ultimately, this research contributes to a body of literature on the law of robots.