Wearable devices in medicine: ethical and legal implications

Hishaam Saumtally


Back in 2012, the Google Glass project created a huge buzz all over the internet. It has captured the curiosity of a lot of people, despite its unknown released date and price. Other companies, such as Nike, Sony and Jawbone have been striving with their electronic bracelets (respectively Fuelband, SmartBand and Up) that can track your exercise, sleeping and eating patterns.

These devices are examples of a new trend in technology: wearable devices. By nature, they differ from portable devices in the sense that they are non-obtrusive. It is no longer about needing to take a device out of your pocket to use, but a device that is part of your everyday life and that does its purpose without the user even noticing it.

It is a growing market, estimated at $2bn (¤1.46bn) in 2011 and estimated to reach $6bn (¤4.38bn) in 2018. Biosensors, which are at the heart of this trend, represent an even greater market, predicted to reach $17bn (¤12.41bn) in 2017. Applications for these devices include various sectors, such as fitness, infotainment, medical, industrial and military. But surprisingly enough, despite the popular excitement around the products previously mentioned, healthcare represents the largest share of this industry, with a 35% market share.

In the medical field, the demand for these devices can be explained by several intertwined factors. Overcrowded hospitals, longer hospital stays leading to rising health costs, prevalence of chronic diseases such as diabetes which cannot be treated in the hospital setting and the ever ageing population has created the need for ambulatory health monitoring, which these devices embody. The trend towards wearable devices really started with the invention of the Holter cardiac monitor back in the 1940s, but further development for other conditions has been impaired by the then-current technologies. In the past decades however, amazing progresses were made in terms of biosensors, smaller and more power efficient microelectromechanical systems (MEMS), miniature operating systems and software, and of course wireless technologies such as Wi-Fi, Bluetooth or even just the internet.

Currently, the best selling device remains the continuous glucose monitor (as commercialised by Medtronic) due to the high prevalence of diabetes in developed countries.  A sensor is implanted just below the skin and continuously measures glucose levels. This information is then directed to a non-implanted transmitter that communicates either to a pager that displays glucose levels or even an insulin pump. Another area where wearable devices have great potential is the treatment of Parkinson’s disease. In these patients, the monitoring of motor fluctuations between intakes of medication by a physician remains impractical. The wearable system, by the Motion Analysis Laboratory at Spaulding Rehabilitation Hospital in the US, allows access to gathered data using web application and provides clinicians with a means to interact remotely with patients in the home setting, configure the sensor nodes, and record annotated data. This technology can also help monitoring of treatment compliance. A 2013 study utilizing a monitor by Proteus Digital Health assessed the adherence to tuberculosis (TB) medication in 30 patients and sent it to a physician through a data server. The study found that 99.7% of the sensors positively detected patient ingestion of TB medication, which makes it very reliable.

Through these different examples, it is easy to see how technology can change the way physicians practice medicine and this can raise a few ethical concerns but also reinforce some key concepts in modern medicine, the first of which is autonomy. With this up-to-date information, patients will have the ability to make informed decisions when choosing the appropriate management for their condition. Since an individual can only be considered autonomous if their decisions are not limited by inadequate information or understanding, this is a great tool towards a better autonomy of the patient. Patients become therefore more active and this subsequently reduces paternalistic trends in medicine. From the physicians’ point of view, it can be argued that we get a better understanding of how the patient deals with his condition outside of the hospital setting, as demonstrated with the Parkinson’s and TB devices.

However, according to a paper by Bauer published in Cambridge Quarterly of Healthcare Ethics in 2007, such technology could create a gap between the patient and the doctor. Part of the art of medicine resides in the physical interaction between the patient and the physician. This is where a proper trust bond can be established between the two parties. By taking this away, one also risks a DIY approach to medicine. So while office visits and hospital stays are decreased, so is the confidence in physicians on one side and a depersonalisation of patients to physicians might occur on the other.

Another important aspect is how confidentiality can be affected by new technologies. In Ireland, under the Data Protection Acts, healthcare professionals are required to keep personal data, including medical records, secure.  Since complete security cannot be guaranteed for information transmitted digitally, it is important for patients to be informed of this potential lack of privacy.

Naturally, these concerns should be dealt using law. As technology is advancing at an ever-increasing pace, so is the need for regulation. Laws need to be technology neutral, that is to say they cannot favour a certain technology over another, and make sure that users of one technology are not at a disadvantage.

In Ireland, it is the Irish Medicines Board (IMB) who is in charge of the regulation of new medical devices. It makes sure that devices follow European Directives, indicated by the CE label. They follow three EC Directives that are constantly revised. The latest technical revision was in 2007 and the latest proposal was in 2012 – a new text which should replace all three Directives. Another amendment is scheduled for 2015, but the IMB was unable to let us know what these changes would be.

When it comes to the transmission of electronic data, privacy is the elephant in the room. A lot of our personal data is currently on our laptops, smartphones and remote servers and is prone to hacking. This can be used not only for identity theft purposes, but also for data corruption. The data sent to the physician or the patient can be withheld or worse, modified, which could for instance send a wrong flag or deliver a drug that should not have been delivered. It has been suggested (by Al Ameen and co-workers) that safeguard methods should be implemented at three levels: administrative (by granting permissions), physical and technical levels (encryption).

From a legal point of view, according to the Data Protection Acts, the physician has the legal responsibility to keep the patient’s record confidential, but now that a third party is involved (the server through which data transits), should the law be changed to now involve this third party?

The Health Information Bill from 2008 emphasises that informed consent from patient is important for use and sharing of information, and that a unique identifier should be used to improve patient care and safety. It is interesting to note that this bill addresses issues related to the use of new technology, but has yet to be enacted. Given the potential of this technology and the reasons why it is needed nowadays, this discrepancy of speed between technological evolution and law enactment could be a future source of controversy.