Software as a Medical Device: Living in a Material World?

Muireann Quigley is Professor of Law, Medicine, and Technology at the University of Birmingham Law School. She has an interdisciplinary background which crosses medicine, ethics, and law. This is reflected in her research which focuses on the philosophical analysis of law and policy in medicine and the biosciences. Her research in the last 5 years has focused on three main areas: (1) bodies and biomaterials, (2) bodies and (bio)technologies, and (3) the use of the behavioural sciences in law and policy. She has received funding from a number of bodies for her work including the Leverhulme and Wellcome Trusts. Her current research focuses on the legal and philosophical challenges arising from the joining of persons and bodies with attached and implanted medical devices.

Abstract

In recent years a range of attached and implanted medical devices have become, to greater or lesser degrees, ‘smart’. Many can store data and transfer that data to external repositories. Depending on the device’s particular capabilities, this could be via hard links, Bluetooth, Near Far Communication, or wifi. Significantly, these devices contain software enabling complex functionalities. Often, as with the example just given, medical device software comes integrated as part and parcel of a piece of hardware; that is, as software in a medical device (SiMD). Increasingly, however, software is being developed and made available independently of any particular device; to be downloaded and used, for instance, as an application (app) on a smart phone. Whilst there is much promise of improved care from such ‘smart’ medical devices, their complexity and risk profile present serious issues for regulators, developers, and end-users alike.

Of interest in this paper is the fact that there are a number of gaps and uncertainties regarding the application of the medical devices regulations in the case of software (as a medical device). These gaps and uncertainties are laid bare when we consider instances of open source (OS) software (as a medical device). Our contention is that many of the ambiguities and difficulties which we set out in this paper stem from the intangible nature of software. For us, this immateriality is rendered problematic within a body of law which has been predominantly constructed with (systems relating to) physical goods at its core. As such, using the example of open source automated insulin delivery systems as a case study, we examine how the law makes ‘matter’ matter and how software in general and SaMDs in particular challenge its material focus. Whilst we do not suggest wholesale solutions to the complexities identified, we make the case that the law should seek to make software ‘material’, and in so doing, bring it more comfortably within the existing legal and regulatory frameworks and systems.

(Based on a working paper by Muireann Quigley and Laura Downey.)