Living in a material world? Regulatory challenges of software as a medical device

Abstract

Abstract Software as a medical device (SaMD) offer significant promise for care and have become near ubiquitous within healthcare and medicine. Yet, the regulation of SaMD in the UK and Europe has not kept up with the technological state-of-the-art. In this paper we argue that there is a conceptual mismatch between regulatory frameworks designed for physical devices and the intangible nature of software. To demonstrate this, we identify three key gaps in the application of medical devices regulations to SaMD: (1) how the ‘intended use’ of digital devices impacts on whether they are captured by the relevant Regulations; (2) the problems created by the boundaryless nature of software for determining the device ‘manufacturer’; and (3) the challenges of managing changes to SaMD, especially where these are updated rapidly and frequently. Whilst recognising that recently published guidance and planned proposals to update medical devices regulation in the UK and EU attempt to address these challenges, we argue that they do not go far enough. Namely, they fail to properly attend to the foundational mismatch at the heart of regulating SaMD. In response, we propose three potential solutions to ensure that any forthcoming regulatory changes appropriately capture the nuances and risks specific to software.