by Beth Chalcraft
The distinction between humans and technology is becoming increasingly blurred. This is particularly apparent with ‘smart’ medical devices. These are devices implanted into or attached to the body (such as pacemakers and insulin pumps) that run software capable of collecting, analysing and transmitting data. These medical devices pick up on physiological changes in the body and in some cases, can respond immediately to correct the issue. For example, internal cardioverter-defibrillators (ICDs) can deliver electric shocks to the heart when abnormal heart rhythms are detected. As these devices become more technically complex, legal questions inevitably arise: who owns the data in smart devices? Can patients legally ‘hack’ their own devices? Is the development and use of smart devices being appropriately regulated?
During my project with Professor Muireann Quigley, I set out to investigate these questions by delving into the largely unexplored legal side of smart medical devices.
I started the project by examining the licensing agreements for smart medical devices and smart household devices, such as TVs, laptops and iPhones. Essentially, license agreements are the terms and conditions set out by the device manufacturer that tell the patient how they can use the software. I mapped the similarities between the licences of different devices in order to identify trends in the language. I was surprised to find that both medical and non-medical licenses used much of the same language, especially regarding the copying, modifying and selling of the software. Initially, I was nervous about exploring the technological side of this project as I had no prior knowledge of technology law. However, starting with this task was extremely useful as it meant I quickly got my head around the kind of language being used.
Next, I conducted a literature review. This involved analysing a range of academic articles relating to smart medical devices. I started by researching broad legal issues but as the project progressed, I was drawn towards the specific area of emerging diabetes technology, which includes devices like insulin pumps and continuous glucose monitoring (CGM) devices. I became fascinated by the ‘Nightscout project’, an online tool for visualising glucose levels in diabetic patients. Users of the system exploit security loopholes in their insulin pumps to enable their phones or mini-computers to ‘talk’ to their insulin pumps and CGMs. I was even able to get in contact with the doctors working directly with these patients. I enjoyed the freedom that Professor Quigley gave me to follow my interests, as it meant I was able to investigate the most recent developments in diabetes software.
I also explored broader medical law issues, such as the prescribing of unlicensed drugs and the off-label use of medical devices. This was my favourite part of the project because I examined a variety of literature, such as White Papers, policy statements from patient groups and scientific studies. What surprised me the most was the lack of official literature published in this area. It appeared that most of the studies and investigations were conducted by independent bodies; there was little governmental guidance and there were no court cases from England and Wales dealing with these issues specifically. This made me realise how new this area of law is and it illustrated the importance of continuing research in order to understand where the law truly lies on these issues.
One aspect that I was particularly struck by was the dilemma faced by the parents of children with diabetes. On the one hand, parents are motivated to hack their child’s device to gain more control over the system and subsequently improve their child’s quality of life. Yet on the other hand, the legal consequences of doing this are currently unknown, meaning these parents are stuck in an untested gap in the law. It was very exciting to find issues like this where technological advancements have surpassed legal developments. This illustrated to me how far the law has to develop to adequately account for the issues arising from new technology.
Working on this project gave me the unique opportunity to conduct in depth research into an emerging and untested area of medical law. I have thoroughly enjoyed developing my legal research skills and I am keen to see how some of the insights gained can inform ongoing research in this area.