Technology is revolutionising healthcare. One example is the use of virtual reality (“VR”) in healthcare, which has been playing a growing role in recent years, especially since the COVID-19 pandemic, contributing to the sector’s boom in remote services and digitalisation. In fact, VR in healthcare was worth around 2.3 billion U.S. dollars worldwide in 2022 and is expected to reach over 25 billion U.S. dollars by 2030.
VR usually uses a device – typically a headset – to create immersive virtual environments. It differs from augmented reality, which enhances real-life environments through computer-generated sounds and graphics.
This technology is already used in multiple domains. The entertainment industry is probably the first to come to mind, but VR’s potential is increasingly being explored by a variety of other sectors, notably in medical fields. Healthcare was identified as one of the top three sectors that will lead the way in the adoption of VR technologies and, by 2025, the healthcare sector is expected to be the second-largest user of VR technology, following closely behind the electronic entertainment industry.
One of the areas where VR has the most significant impact is in the recovery and rehabilitation, both physical and mental, of patients. It can be used to treat patients who have suffered strokes to improve their upper and lower limb functions, as well as their balance, motor coordination and strength. It also helps in the rehabilitation of patients with multiple sclerosis, Parkinson’s disease or traumatic brain injuries.
Markedly different from traditional physical rehabilitation, the 3D environment created through VR can help the recovery process by boosting a patient’s interest and motivation, as there are endless possibilities. Scenarios can be customised to the specific needs of each patient, while distracting them from the pain and repetitiveness associated with rehabilitation processes.
VR has also shown to be very useful in the field of pain management, be it for chronic or acute cases, as well as for terminally-ill patients in palliative care. It helps in reducing the pain, discomfort, and anxiety patients may feel in these cases.
Likewise, VR can be an effective tool for mental health treatment. For instance, post-traumatic stress disorder rehabilitation, anxiety management and the treatment of addiction disorders are made easier, as healthcare professionals can expose patients to certain controlled virtual environments which would, otherwise, be very difficult or impossible to recreate in real life. The fact that these scenarios are perceived as safer by patients, also facilitates their confrontation with triggering situations.
Apart from being a very useful tool for treatment, VR also enhances medical education and training, by simulating, for instance, complex surgeries, allowing students to practice their skills in an engaging way, while avoiding the potential risks and expenses of a real-life scenario. The large-scale dissemination of VR applications and devices across various sectors has had the effect of decreasing their economic value, making them more accessible to the general public at a relatively low price. It has also optimised healthcare provision outside medical establishments, bringing telemedicine to a whole new level, all while reducing healthcare costs.
Looking at the above, VR is clearly here to stay and is full of opportunities for the healthcare sector. However, like everything that is new and ground-breaking, it poses a range of challenges, notably from a legal perspective.
One potential issue is the property of the virtual 3D worlds – their textures, sounds, and artworks – constituting the scenarios explored by patients. They will always be the product of someone’s work and, as such, intellectual property (“IP”) and copyright issues may arise. Unauthorised use of protected elements in VR content may result in (complex) legal disputes. It is crucial that laws not only protect IP rights owners, but also evolve in a way that allows for innovation in VR.
The use of VR technologies may also bring up privacy and data protection concerns. These applications have to be adjusted to each person’s medical situation, implying that certain personal and even sensitive data, such as clinical data, will be collected. Moreover, in the context of the treatment, these VR systems may track patients’ movements, location, and behaviour to adapt their treatment accordingly. Thus, even though there are rules already in place to protect users’ data and privacy, such as the General Data Protection Regulation, new specific guidelines should be created to address the challenges potentially resulting from the use (and misuse) of VR, especially in healthcare. As everything will be online and virtual, new cybersecurity threats may also arise.
From a regulatory point of view, and given that the use of VR technology is still quite recent in the healthcare sector, its legal classification may bring additional challenges. VR devices, including their hardware and software, may be classified as medical devices when they are “intended by the manufacturer to be used, alone or in combination, for humans beings for one or more of the following specific medical purposes: diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, (…) or compensation for an injury or disability […]” (see Article 2(1) of the Medical Devices Regulation, “MD Regulation”). However, VR devices used for educational or informational purposes will not fall under the MD Regulation.
In Europe, some VR rehabilitation equipment is already certified as a medical device (such as Bended). There are, however, many VR devices freely available on the market that can potentially be used for therapeutic purposes, but which were not originally designed for such use. One of the questions that may come up is whether the use of these devices should be regulated in similar terms to those already classified as medical devices. What further specificities should the law consider for VR devices used in healthcare?
To the best of our knowledge, no specific guidance from the European Medicines Agency has yet been issued on this topic. In this regard, the U.S. Food and Drug Administration is clearly in the forefront, having already published a list of medical devices that incorporate VR technology, along with several other guiding documents specifically addressing this issue. Lastly, safety and liability rules related to these products may also be an issue. On the one hand, VR users may potentially suffer harm when using these devices. They could, for instance, lose their balance and collide with something, or simply fall, possibly leading to real-world injuries and even litigation. On the other hand, how will medical negligence be delimited considering the new risks arising from VR technology? And what are the duties of the healthcare provider when recommending these options? Standards of best practices should be established in that regard. All in all, VR technology is booming and healthcare will be one of the sectors to benefit the most from this development. VR has an incredible potential to transform how healthcare services are provided and the change will happen faster than one may think. However, and as is often the case with technological progress, new challenges arise faster than the law is able to adapt. It remains to be seen whether and when such adaptation will happen.
