Healthcare VR and Regulatory Challenges
By Simon Portman, Marks & Clerk
Virtual reality used to be associated solely with entertainment (mainly games) and the provision of virtual walk-throughs and immersive environments for product designers, architects, archaeologists and the like. Furthermore, apart from the need to accommodate the psychological and visual disorientation and other side effects such an immersive 3D environment has the potential to provoke, the legal, contractual and intellectual property ramifications of the technology were little different from those thrown up any other product combining hardware, software and audio-visual content.
Now, however, the VR/AR sector is colliding with the healthcare sector (which has historically been very different in terms of technology, culture and regulatory framework) as it is beginning to develop and roll out new alternatives in terms of diagnosis and treatment. These new solutions are attractive and potentially game-changing not just because of their novelty but because, insofar as they offer alternatives to filling patients with drugs or putting them under the knife, they could, if fully-realized and properly implemented, be lower risk, more cost-effective and less time-consuming for patient, healthcare professional and primary career alike. All this presses the right buttons with a cash-strapped NHS. Examples of particular note include:
- Training doctors and nurses in a virtual environment and recording their performance for subsequent analysis.
- Allowing medical students to experience operations for learning purposes in a far more immediate and immersive way than if they were just looking over the surgeon’s shoulder.
- Using 3D virtual mapping of organs for pre-op diagnosis as an alternative to opening the patient up to take a look.
- Treating autism and phobias by means of exposure to a bespoke virtual or augmented environment.
- Diagnosing and treating Alzheimer’s, Parkinson’s and other neurodegenerative diseases.
- Using games technology to improve cognitive abilities, hand-eye coordination and physical dexterity as part of rehabilitation after, say, a stroke or surgery.
- Using VR to train athletes and treat sports injuries.
The list goes on and is always growing.
However, all this innovation presents a challenge. The increased use of AI in the medical field gives rise to dilemmas in the form of, for example, who bears the risk in the event of a catastrophic misdiagnosis or a surgical robot going haywire and shredding the patient, and how the risk of those things happening should be allocated between manufacturer and user. The regulatory framework and insurance industry will need overhauling to accommodate these challenges and NHS policy makers are already on it. The advent of VR/AR on the healthcare scene presents similar problems. For example:
- VR/AR methods of training, diagnosis and treatment could entail the creation, storage and manipulation of the subject’s image (or images of part of that individual’s body). What waivers will the subject need to provide and who will have the rights to that image?
- Inevitably patient data will be stored and created. Will it be stored securely? Who will have access to it? Has the patient given the requisite informed consent to such storage and creation?
- Who will be liable if the virtual assistance tool malfunctions and ends up being a hindrance rather than a help to surgery or if, due to an inherent defect or misuse, the therapeutic VR environment makes the schizophrenic patient worse, not better?
In these circumstances the regulations may not need reinventing as much as they do to accommodate the new AI applications already mentioned but the risks listed above will certainly need mitigating through the adoption of technical safeguards built into hardware and software, strict operating procedures and well-drafted contracts and consent forms to be signed by manufacturers, users and patients – an intriguing challenge for a technology everybody once thought was only good for playing games on.