Law & Futures 31 March

Software as a Medical Device Living in a Material World?, Prof Muireann Quigley

Based on a working paper by Muireann Quigley and Laura Downey

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.

Patents on Technologies Related to the Human Body: The Urgent Need for Greater Bioethics Scrutiny. Prof Aisling McMahon

A patent is an intellectual property right which allows rightsholders to control how others use a ‘technology’ under patent for twenty years. Patents are available in all fields of technologies, including health-technologies. Moreover, although the human body itself is not patentable, many ‘technologies’ that relate in significant ways to the form, functioning and modification of our human bodies are patentable. For example, under European law, patentable ‘technologies’ include: isolated elements which form the human body such as isolated human genes which are patentable in Europe; ‘technologies’ which impact the functioning of the body such as medicines, and elements of ‘technologies’ that can alter our human bodies, such as novel neuro-technologies or gene editing technologies.

This paper develops a novel taxonomy of patentable ‘technologies’ related to human body, and using this, it argues that such patents – and how they are used - can pose significant bioethical implications, including, impacting how we treat, use and modify our bodies. Yet, such bioethical issues, and this relationship of patentable ‘technologies’ with the form and functioning of our human body is not considered in a routine manner - bar limited exceptions – within the patent decision-making system. Instead, a patent on an engine part is viewed the same as a patent on an isolated element of the human body.  Accordingly, this paper argues that far greater scrutiny is needed over the bioethical issues posed by patents and how they are used over such ‘technologies’ related to the human body.