Year: 2015
Type: article
Abstract: Many emerging technologies are associated with 'risk'. While the concept of risk is protean, it is usually conceived of as the potential of something damaging or harmful happening. Thus, risks are a primary target of many regulatory regimes. In this article, after articulating an understanding of risk, we assess the European medical devices regulatory regime from a risk perspective, focusing on its handling of 'smart' implantable medical devices. In doing so, we discuss the empirical evidence obtained from expert participants in the Implantable Smart Technologies Project, which evidence is framed around three risk typologies: materiality, geography and modality. We conclude that none of these risks are sufficiently addressed within the existing regime, which falls down not just from a standards perspective, but also from the perspective of transparency and balance.
Source: Law Innovation and Technology
Authors: Shawn H.E. Harmon, Gill Haddow, Leah Gilman
Institution: University of Edinburgh
Language: English
Subfield: Law
Field: Social Sciences
Domain: Social Sciences
Open Access status: hybrid
Estimated APC paid: $663
OpenAlex ID: W2256497276