As technology increasingly blurs the boundaries between the biological and the synthetic, law struggles to keep up
Increasing numbers of people worldwide rely on medical devices to help them to function. These devices range from the relatively simple, like hip replacements and aesthetic prostheses, to the complex, such as insulin pumps, pacemakers, and the total artificial heart. Increasingly, medical devices are smart devices. They run software and have wifi capabilities. They collect, analyse, and transmit data. However, the integration of medical devices – especially smart medical devices – with persons creates difficulties for the law.
Unanswered questions include: (1) should internal medical devices which keep the person alive be viewed as part of the person or mere objects (or something else)?; (2) is damage to neuro-prostheses personal injury or damage to property?; (3) who ought to control/own the software in implanted medical devices?; and (4) how should the law deal with risks around unauthorised third party access and hacking?
These questions may, at first, appear abstract but the issues they raise have serious implications for our everyday lives. For example, whether we treat damage to people’s (internal) medical devices as personal injury or damage to property matters because, in general, personal injury is treated more seriously by the law than property damage. We also need to take device cybersecurity seriously. The increasing sophistication of medical devices brings a number of risks, including the possibility of unauthorised remote access, interference with device functioning, and data theft.
As technology advances and implantable medical devices become more prevalent, these questions will become increasingly pressing. If the law is to keep up with societal change, is crucial we anticipate these. Here at the University of Birmingham we are trying to answer such questions as part of a 5 year Wellcome Trust-funded project: Everyday Cyborgs 2.0: Law’s Boundary-work & Alternative Legal Futures.
The Person-Thing Distinction
Why does the law struggle to answer such questions? At the heart of the matter is the way the law conceives of persons and things. English common law considers something to be either a person or a thing. The boundary between these two categories forms the basis of much of law’s structure, as well as its practical application. A good deal of law is divided in to law relating to persons (e.g. personal injury) and law relating to things (e.g. damage to goods). However, once attached or implanted, the boundary between medical device and person may not be clear. Devices can become incorporated into or integrated with persons in several ways.
First, they may take on a mechanical or physiological role becoming a literal physical and functional part of the person; e.g. joint replacements for osteoarthritis or insulin pumps for diabetes. Second, they may become part of the person psychologically, becoming part of their life and identity. The person might think of themselves as someone ‘with a pacemaker’. Third, the medical device may become part of how the person experiences and interacts with the world. A lower limb prosthesis, for example, is literally the means by which its recipient walks through the world. Fourth, in the case of life preserving devices such as pacemakers or internal cardioverter defibrillators, the very existence of the person relies on their integration with the device. Such devices keep the person alive by regulating their heart rhythm so that it is not too slow, too fast, or too disordered.
Part of our project will be investigating the difficulties and challenges which the joining of integrated persons (those with attached and implanted medical devices) with medical devices creates for the law. Drawing on work by Gill Haddow, we use the term ‘everyday cyborgs’ – both metaphorically and literally – to draw attention to the assemblage of persons with technology. In this respect, we have special interest in medical devices which are integrated goods; devices with both a physical existence and which can run software. Preliminary research conducted as part of a Wellcome Trust Seed Award (Jan 2017 – Jan 2018) gave us an initial understanding of the difficulties and revealed some of the challenges ahead.
The Need to Reimagine the Law
The first area relates to medical device law and regulation. Both at the UK and EU level, it is the devices themselves and not the subject (the person the device is attached to or implanted into) which are often the focus of the relevant law and regulation. Devices are framed as goods within the technology and innovation market. Thus, the emphasis of regulations and directives is on safety, and on how to balance and manage risk with the need for innovation. Whilst attention to safety and risk is necessary, the danger when the law constructs and utilises overly object-focused frames of reference is that medical devices become conceptually distant from the person in whom they are (to be) implanted. As a result we may end up with an inadequate and inappropriate conception and account of the subject; one that is alienated from the realities and experience of daily living with a particular medical device.
This relates to a second issue and that is that the law displays and outmoded, unjustified, and problematic reliance on dichotomies and boundaries. These include: (1) subject-object (i.e. person or thing); (2) internal-external (e.g. implanted vs. wearable device); (3) biological-synthetic (e.g. human origin vs. artificial); and (4) material-immaterial (e.g. property rights in tangible goods vs. intellectual property rights in those goods or software). However, the very literal transgression of the bodily boundary, represented by various everyday cyborg technologies, poses a problem for how and why law constructs, incorporates, and utilises different boundaries (including supposed ontological and moral ones).
In the biotechnological world objects move in and out of bodies, and parts and devices become incorporated into or integrated with persons to greater or lesser degrees. By not taking account of this, the law disregards how boundaries, especially bodily boundaries are unmade and re-made when persons and medical devices become conjoined. It belies the lack of fixity of persons and bodies.
Governing Data & Intellectual Property Rights
Another difficulty which we are grappling with is that there is a lack of a coherent and justified framework (conceptual, normative, and practical) for dealing with the assemblage of integrated persons and integrated goods. The ‘smart’ functionalities of many devices, along with the integration of hardware (tangible) and software (intangible), raise novel issues which have received inadequate scrutiny. In particular, there are challenges relating to data and privacy, intellectual property rights, and security and biohacking which warrant close scrutiny.
Healthcare data, such as electronic records, have received a reasonable amount of attention, but data in the everyday cyborg context has not. For example, there are pressing questions about how different types of data (e.g. physiological vs. device functionality) ought to be conceived of and treated, and of who should control and have access to different data types. There are also questions to be asked about how issues around intellectual property rights in implanted medical devices (including in their software) ought to be managed. What kinds of terms and conditions are manufacturers placing on the use of these devices and to what extent (if any) are/ought patients to be bound by these? Lastly, smart capabilities render devices – and thus the everyday cyborg themselves – susceptible to malicious attacks and data theft. The phrase ‘internet of bodies’ has been used to describe the linking of persons’ bodies with wearable smart devices, something which takes on an even more literal meaning here.
The Challenge Ahead
Given the increasing use of attached and implanted medical devices, it is imperative that appropriate legal principles are developed for dealing with the challenges which everyday cyborgs and their technologies pose. To do this, we need to look beyond current law and existing legal ontologies (perceived realities – e.g. separation between persons and things – which get built into law’s structure and operation). In particular, we need to look beyond boundaries, both legal and bodily ones, towards future alternatives. Unless we do this, the law will struggle to adequately and justifiably deal with the increasing sophistication of medical devices and the thorny issues raised by their integration with persons.
Work on this project is generously supported by a Wellcome Trust Investigator Award in Humanities and Social Sciences 2019-2024 (Grant No: 212507/Z/18/Z). Initial research in this area was supported by a Wellcome Trust Seed Award in Humanities and Social Science 2017-2018 (Grant No: 201675/Z/16/Z).