THE VALUE OF VR
Pediatric Intervention
Managing pain, fear, and anxiety remain difcult in the pediatric population as they are often under-recognized and undertreated. Patient distress is common during treatment and procedures. This can especially be true with the intense pain experienced by burn and cancer patients who endure ongoing testing and treatment.42 Additionally, immediate pain and distress are not the only concerns. It is well documented that patients experience long term sequelae from inadequate pain management creating a negative impact on their future psychological health, including increased pain sensitivity over the course of their lives.43 Managing pain with the use of sedation and analgesia have been routinely used over the last 40 years, but experts have voiced serious concerns about the adverse efects of combining opioids with benzodiazepines for pain and anxiety control.44 Non-pharmacologic interventions have been somewhat efective including cognitive behavioral therapy (CBT), guided imagery, relaxation techniques, toy distraction, and hypnosis, but new and efective interventions are needed. Multiple clinical trials demonstrate that pediatric patients receiving VR intervention have statistically signifcantly reduced pain and anxiety as opposed to those treated with standard care.
Recent studies examining VR intervention as a tool for pain and anxiety reduction in the pediatric population include a study comparing the efectiveness of VR intervention to conventional care in children receiving peripheral intravenous catheter placement, and a study examining the use of VR intervention among hematology, oncology, and blood marrow transplant patients undergoing painful and distressing procedures.,45, 46 Both studies suggest VR intervention can be clinically signifcant in reducing pain and anxiety.
The use of VR is increasingly applied in children’s hospitals, such as Stanford Children’s Health where AR and VR software are part of a patient’s care plan to engage and distract them during painful procedures. The Childhood Anxiety Reduction Through Innovation and Technology (CHARIOT) program at Lucile Packard Children’s Hospital Stanford has composed a team of physicians, engineers, researchers, and child life professionals in an efort to implement new non-traditional immersive technologies for young patients.47 The hospital uses VR during treatment as a means to decrease pain and stress, for example, by ofering AR goggles for patients in the pre-op so they can watch movies and play games prior to being wheeled back for surgery, and by using VR games in the intensive care unit (ICU).
A study published in the Journal of the American Medical Association (JAMA) in June of 2021, suggests VR may be efective in reducing pain during dressing changes for pediatric burn patients. The intense pain associated with burn dressing changes is often worse than the initial burn injury and highdose opioids are routinely required. As well, a direct relationship between pain and anxiety exists amid pediatric burn patients leading to increased anxiety over the course of treatment and creating long-term challenges.48
Amidst the increased application and positive outlook of VR in the pediatric population, there is a lack of clinical professional guidelines and quantitative studies looking at the efects on children. Preliminary results show improvements in anxiety and pain symptoms with little side efects, but the possible impact on vision, brain development, and issues with stimulus intensity are all considerations for further investigation.49, 50 This is a greater concern in younger children given brain neuroplasticity for development in the early years of life. Evidence shows excessive exposure to screen time negatively impacts brain development, including a connection between increased screen time and diminished language, literary, and executive functions of the brain in preschool-aged children.51 Coordination may be negatively impacted due to VR’s infuence on the brain’s interpretation of sensory stimulus such as vision and vestibular balance.52 Additionally, studies have investigated electronic media use and sleep disturbances, depression, and anxiety.53 Age appropriateness is likely to be more critically reviewed as utilization grows and more studies are completed. Currently, some manufacturers of VR headsets do not recommend them for children younger than 13 years.54, 55 Furthermore, cau-
tion should be used regarding material that may be inappropriate or harmful to children. Meta Quest recently announced VR parental supervision tools to be implemented over the next several months while using the Quest headset. A paper published in Pediatrics suggests instead of using VR to fx a child’s impairment, it could be utilized as a tool to gain more insight and awareness of the difculties the child may experience due to the impairment.56
Mental Health Treatment
An estimated 52.9 million adults sufer from mental illness, according to a 2020 survey by the Substance Abuse and Mental Health Services Administration (SAMHSA). This equates to 1 in 5 American adults. Moreover, US young adults, ages 18 to 25 years old, were reported to have the highest prevalence of mental health illness.57 One of the biggest challenges today is the rising demand for mental health treatment and a shortage of available providers.58 As the pandemic unfolded, the need to provide continuity of care remotely quickly became a necessity and telehealth appointments ofered mental healthcare delivery outside of a traditional face-to-face setting. In fact, early studies show the potential benefts of this viable option, including improved accessibility for low-income, racial, and ethnic minority adults and children.59 Mental health treatment at a distance has the potential to break down the barriers of high cost and limited accessibility. As virtual-based treatment moves into mainstream medicine, more is understood about its potential as a mental health treatment.
One of the advantages of VR in mental health treatment may be utilization of VR for mental health assessment and exposure therapy, which is traditionally performed in a lab or clinic rather than a real-world setting. Through VR software, real-world settings designed to closely resemble surroundings of daily life ofer insight into triggering stimuli such as anxiety, paranoia, fear, and cravings. This gives therapists the ability to provide highly controlled environments for assessment and obtain real-time feedback to implement therapeutic strategies.60
Virtual reality exposure therapy (VRET) shows promise as a scalable tool for anxiety disorders and is already being used in panic disorder and phobia treatment.61, 62 Considerable research indicates efcacy for exposure-based therapy for anxiety, but it remains a treatment gap and is underutilized due to patient fears and therapists’ concern for only having limited control in real-life stimuli scenarios.63 A virtual environment allows more control regarding the insertion of stimuli, contexts, and tasks not possible in in vivo exposure therapy. Smartphone-based VR apps such as EASYHEiGHTS (created to treat Acrophobia) are low cost and can be accessed with a VR headset and conventional smartphone, enabling patients to receive treatments in a therapist’s ofce or even in their own home. This option removes the difculty of patients, for instance, having to stand on a tall building for acrophobia treatment, also removing the extra liability for clinicians conducting treatment in a real-world setting. Evidence shows patients are more willing to receive exposure therapy when they can do so in the comfort of a therapy ofce or their home rather than in the physical world.64
There is activity in PTSD using exposure therapy. PTSD, caused by traumatic life events, afects 3.6% of US adults.65 Studies show VRET produced a signifcant reduction in PTSD symptoms, including sustained improvements at 6- and 12-month follow-ups.66 Created at the University of Southern California (USC) Institute for Creative Technologies, BraveMind, a clinical, interactive, and VR based exposure therapy tool is currently being used by numerous hospitals and universities to treat PTSD.67
Autism Spectrum Disorder (ASD) researchers and therapists have been using VR since the mid-1990’s in an efort to help patients with autism practice being in stressful situations, combat phobias, and prepare for public speaking.68 A research initiative recently investigated the efcacy of VR incorporated with CBT resulting in marked improvements in specifc phobias among children with ASD.69
With hopes of reducing depression and loneliness, Rendever has created an innovative engagement VR platform to assist seniors sufering from social isolation.70 They are currently working with senior living communities and hospitals including the University of Cincinnati (UC) and the National Institute on Aging (NIA) to help bridge the distance between seniors and family members living apart. Moreover, they have created platforms allowing seniors to explore far away cities, travel back to their childhood homes, and even fulfll lifelong bucket list items.71
Of notable importance to mental health practitioners is a small January 2022 published study that compared face-to-face interaction with VR interaction suggesting participants reported a slight preference to face-to-face interaction overall, but when asked to disclose negative information 30% of the participants preferred to interact with an avatar rather than a real person.72
Preliminary study results suggest VR can be an efective treatment for individuals sufering from certain mental health disorders. Notably, some users may require VR-created platforms with special accommodations, such as programs designed around impaired cognition, memory, and language skills, or for individuals with mental health conditions that involve dissociative states or hallucinations
Chronic Pain Treatment
According to a Centers for Disease Control and Prevention’s (CDC) survey in 2019, 20.4% of adults in the US reported having chronic pain.73 Persistent pain has also been linked to depression and anxiety and can become an overlapping symptom. The CDC and the Centers for Medicare & Medicaid Services (CMS) recommend non-opioid and non-pharmacologic therapies as frst-line treatments. Both agencies have raised concerns in response to the increasing rate of opioid abuse and overdose deaths.74 A randomized comparative efectiveness trial conducted at Cedars Sinai revealed VR signifcantly decreased pain in hospitalized patients and was most efective in patients experiencing severe pain. The patients, using VR goggles, engaged in virtual environments that included swimming with dolphins, and reported a 24% drop in pain scores.75, 76
Seeking non-pharmaceutical solutions for pain management, AppliedVR received De Novo approval from the US FDA in November 2021 for the frst VR therapeutic to treat chronic low back pain.77 RelieVRx (formally EaseVRx), a prescription-use medical device, is an immersive VR system based on cognitive therapy methods delivered in an 8-week program and has been proven to improve chronic pain outcomes.78 A trial conducted in 2020 looked at 179 adults experiencing non-malignant chronic low back pain and reported a substantial reduction in pain, mood, and stress suggesting that home-based VR programs could open up access to efective non-pharmacologic on-demand treatments for chronic low back pain.79
Access to treatment and therapists remain obstacles for patients with pain, further exacerbated by COVID-19. A new and promising option for chronic pain suferers is on-the-spot VR treatment, including automated behavioral programs. One such company, XRHealth, provides virtual treatment rooms inside the Metaverse. Patients can go to the website, choose a therapist, order a VR headset, and begin personalized occupational therapy (OT), physical therapy (PT), or mental health therapy. XRHealth is covered under some insurance plans and ofers out-of-pocket plans.80
Virtual Rehabilitation
Telerehabilitation, or rehabilitation through VR, has been gaining traction for a number of years due to the growing advancement of hardware and software technologies designed to treat patients with a range of conditions, including chronic pain associated with injury or illness, traumatic brain injury (TBI), spinal cord injury, stroke, Parkinson’s disease, multiple sclerosis (MS), Alzheimer’s disease and dementia, and cerebral palsy (CP).81, 82, 83
Telerehabilitation methods are being implemented as alternatives to multiple traditional therapies like PT and OT. Although the benefts of PT have long been established, between 50% and 70% of patients who would beneft from PT are unable to receive therapy due to limited access.84 This number is believed to have been higher during the COVID-19 pandemic. Traditional therapies are helpful for recovery, but novel approaches have been suggested to improve patient compliance and outcomes. The use of VR in rehabilitation may ofer potential positive advantages for patients.85
Noteworthy advantages of VR-assisted rehabilitation have been reported in the literature including, improved patient engagement and motivation, post-stroke functional recovery and increased mobility, and quality of life in Parkinson’s patients.86, 87 Multiple clinical trials demonstrating VR’s
efectiveness in treating symptoms associated with Parkinson’s disease have been completed with promising results, including studies focused on balance, postural control, and gait disorders to prevent falls.88 VR environments provide interactive and customized platforms that allow patients to elicit realistic reactions that can be used to track patient performance, which is essential in recording patient progress.89
MindMaze, a company specializing in neurorehabilitation and enhancing the recovery potential of patients with neurological diseases, received FDA clearance for 2 gamifed neurorehabilitation systems.90 MindMotion GO received FDA-clearance in May 2018 and can be used in inpatient, outpatient, or home settings and ofers rehabilitation through upper and lower limb, and hand or trunk exercises.91 MindMotion Pro received FDA-clearance in May 2017 and was designed exclusively for inpatient acute stroke patients with upper limb hemiparesis.92
VR in Training and Education
The complexity of the ever-changing healthcare system and pressure to ensure learning objectives are met through standardized medical training is an ongoing challenge and a potential opportunity for medical educators. The use of VR in training and education ofers the ability to train personnel in a controlled environment while minimizing risks to a real patient. Communication skills and simulation-based training have become increasingly more important as a part of the clinical learning experience.93 Dramatic developments have taken place in the drive for better educational tools, including internet and mobile device options.
A growing number of hospitals are implementing VR systems to train residents, assist surgeons in surgical planning, and educate patients. Partnering with hospitals and institutions such as Yale University and University Hospitals Cleveland Medical Center, PrecisionOS received FDA 510(k) clearance for the InVisionOS tool for surgical planning in November 2021.94, 95 Further, Stanford University, Department of Neurosurgery is now utilizing Surgical Theater’s medical visualization platform Precision XR. The platform transforms patient’s 2D scans and data into a 360-degree 3D view, allowing surgeons to explore a patient’s anatomy in a way never before possible. Stanford surgeons can reconstruct a patient’s brain through 3D imaging which allows greater visualization, surgical mapping, and planning to improve surgical accuracy and create safer procedures.96, 97
In 2019 George Washington University Hospital became the frst hospital in the US to perform surgery using the AR system OpenSight, ushering in what has been called a revolution in pre-surgical planning. This followed Microsoft’s release of a newer version of the HoloLens, the HoloLens 2, which was granted 501(k) clearance for use with OpenSight for surgical planning which renders 2D, 3D, and 4D images in an interactive display and directly onto a patient’s body allowing surgeons to more accurately plan and perform surgeries with precise accuracy.98, 99
According to a recent randomized controlled trial from University of California Los Angeles’s (UCLA) David Gefen School of Medicine, participants using the Osso VR platform improved their overall surgical performance by 230% compared to conventional training methods.100, 101 Osso VR technology combined with Oculus headsets uses customized training platforms to provide reimagined surgical training. The platform allows dozens of hospital staf to collaborate and train in virtual operating rooms and has been demonstrated to accelerate learning memorization.102 Doctors from around the world recently collaborated in a 24-hour surgery facilitated by Microsoft featuring 12 holographic surgeries, including a shoulder replacement in South Africa and a knee procedure in the United Arab Emirates (UAE).103
Moreover, VR is assisting medical students and practicing physicians to create awareness and a better understanding around the patient-doctor relationship, including patient empathy. A study published in 2018 demonstrated VR immersion training as an efective tool to help medical students and other healthcare providers (HCPs) develop empathy for older adults dealing with vision and hearing loss and Alzheimer’s disease.104 The training is currently being used at the University of New England. Additionally, the recently developed mobile app, HealthVoyager, is designed to help
physicians enhance medical comprehension for patients and families following surgery or medical procedures and is currently being used at the Boston Children’s Hospital.105, 106
Early studies demonstrate the importance and potential of VR in improving performance and decreasing medical training costs. While the advantages of VR come into focus, the possible limitations such as overdependence on technology, reduced classical training and standardization in training should be a part of the dialogue.
Inequities in Health
Structural racism in the healthcare system has been evidenced in multiple studies and continues to afect the wellbeing of all people, but specifcally those who have been historically marginalized in society. Socioeconomic status and long-established residential segregation remain two strong determining factors of racial health disparity.107 It is important to consider how evolving healthcare technologies like VR may impact the future of healthcare equality.
During the COVID-19 pandemic disparities in the healthcare system were profoundly visible as mortality and hospitalization rates were signifcantly higher among marginalized populations. As the healthcare system adapted to reach individuals who needed care amid the threat of a burgeoning pandemic, telehealth and remote care implementation exploded, emphasizing what is widely known as the digital divide: the inequality between those who have access to technology and those who do not.108 Access obstacles to digital health tools like video enabled smartphones and limited broadband access are common in vulnerable populations with low social economic status and limited health or English literacy and could create an even greater barrier to the potential benefcial application of VR in healthcare.109 Although the pandemic established telehealth as an efective way to reach patients that may have been unreachable otherwise, technology access and literacy remain a challenge. Thus a continued investment in broadband access is warranted.
The fact that VR technology is not widely available cannot be overlooked. Not only could individuals face barriers in obtaining access to the technology, but entire communities, including the healthcare organizations that serve them may lack the means to obtain or adopt the technology.
As these challenges and the solutions to them unfold, researchers are learning how VR could be used as a catalyst to understand racial bias. VR is currently being implemented as a training tool to better understand the cultural and social needs of patients, and although study in this area has just begun there is potential for VR to become a tool to increase empathy and give users a more positive perspective when interacting with people from diferent ethnic or social economic backgrounds. Stanford University recently conducted a preliminary study suggesting that individuals who were able to imagine themselves in someone else’s circumstances report feeling empathetic, however individuals who actually experience someone else’s circumstances through VR had longer lasting empathy and the experience even motivated prosocial behaviors.110 While promising, the feld is still underexplored regarding using technological means to bolster empathy as a step towards equality.
Although the benefts of VR are recognized in this paper, as the technology becomes more commonly used by HCPs it could inadvertently leave underserved populations vulnerable if they are unable to access the growing wave of technology, in lieu of traditional methods to see and treat patients. This discussion acknowledges current healthcare disparities and how new technologies such as VR may positively or negatively impact select populations.
CLINICAL TRIAL EVIDENCE
The products that are identifed as VR technology are quite broad. There is a proliferation of rapidly evolving development in this space, extending from VR, AR, and MR devices to software systems and digital applications. This paper looks at the spectrum of products that fall under these categories, but the primary focus is on physical devices using immersive and tracking features. A literature search was performed limited to FDA-approved devices. Studies considered most relevant for the analysis included free full-text studies with clinical endpoints, published in English. These studies are summarized below. This is not an all-inclusive list. Medications (drugs and biologics) have prescribing information readily posted to the FDA website. For medical devices though, the CDRH Freedom of Information (FOI) Reference Sheet outlines what is releasable through the FOI process from the FDA. For example, for 510(k) premarket notifcation, labeling is only releasable through the FOI staf after pre-disclosure notifcation.111 Further, bench and clinical data are not releasable. Hence, specifc prescribing information and evidence could not be accessed for evaluation. General device labeling provisions are summarized in the FDA’s General Device Labeling Requirements.112
MindMotion GO
Wiskerke, E, et al. (2022)
Longitudinal observational study This study sought to apply the Rasch model to create a hierarchical order of existing VR balance exergames and to relate these exergames to the abilities of patients with neurological disorders (Multiple Sclerosis [MS] and stroke) to deliver challenge and variation
MindMotion PRO
Perez-Marco D, et al. (2017)
Pilot study To evaluate the impact of a VR system for taskspecifc upper extremity training after stroke in outpatient; study examined the impact on rehabilitation dose and training intensity, functional improvements, and safety and tolerance
81
Participants performed a training program that consisted of performing VR balance exergames with a movement recognition-based system
Weekly for 3 weeks for MS patients, and 4 weeks for stroke patients
Primary Endpoint: VR exercise scores & Berg Balance Scale scores
10 Use of a novel VR system for taskspecifc upper extremity training after stroke
10-session VRbased upper limb rehabilitation program (2 sessions/week)
Primary Endpoint: Motor function (FuglMeyer Assessment for Upper Extremity)
785 observations were recorded; 47 exercises had sufciently good ft to the Rasch model; 6 items showed underft (outft mean square values > 1.5); 1 item showed underft but was kept in the analysis; 3 items had negative point-biserial correlations; the fnal model included 47 exercises for persons with low to moderate balance ability
Participants showed 5.3% improvement in motor function post intervention and 15.4% at 1-month follow-up relative to baseline, which was a clinically signifcant improvement for 3 participants. A signifcant improvement in active range of motion (AROM) for the shoulder was observed
No serious adverse events occurred during training; 2 falls from the chair (without injuries) occurred, which is comparable to conventional balance training
An adequately ftting Rasch model for the VR exercises was identifed with a hierarchical order of VR balance exercises for stroke and MS patients with low to moderate balance ability; results provide guidance in the selection of VR balance exercises for stroke and MS patients
No severe adverse events were reported, however, some participants did report very low levels of pain, stress, and fatigue following each training session
Demonstrated how the use of a dedicated VR system can be used to deliver high rehabilitation doses and intensive training in chronic stroke survivors; results indicated that task-specifc VR training may help with further functional recovery in the chronic stage of stroke
CLINICAL TRIAL EVIDENCE
ImmersiveTouch continued
Yudkowsky, R et al. (2013)
Pre-post Evaluate the impact of simulationbased practice with a library of virtual brains on neurosurgery residents’ performance in simulated and live surgical ventriculostomies
16 Neurosurgery
residents participated in individual simulator practice on the library of brains including visualizing the 3-D location of the catheter within the brain immediately after each insertion for a ventriculostomy
A single 2 to 3 hour practice session
Primary Endpoint: Performance of participants on novel brains in the simulator and during actual surgery before and after intervention was analyzed using generalized linear mixed models
Simulator cannulation success rates increased after intervention, and live procedure outcomes showed improvement in the rate of successful cannulation on the frst pass; however, the incidence of deeper, contralateral (simulator) and third-ventricle (live) placements increased after intervention; residents reported that simulations were realistic and helpful in improving procedural skills such as aiming the probe, sensing the pressure change when entering the ventricle, and estimating how far the catheter should be advanced within the ventricle
N/R
Simulator practice with a library of virtual brains representing a range of anatomies and difculty levels may improve performance; thereby, potentially decreasing complications due to inexperience
THE POTENTIAL RISKS OF VR
Although the barriers of cost and access to technology for underserved populations cannot be ignored, the latest breakthroughs have extended accessibility of some apps to anyone with a smartphone and a VR headset. Despite technological advances providing the impetus for a great expansion in studying the efectiveness of VR, there is still much to learn, including the limitations and possible adverse efects of the technology. Importantly, studies are beginning to emerge detailing research on the brain-health consequences of spending too much time using digital technology.113
Cybersickness
Patient tolerability can sometimes be an issue and cybersickness (simulator sickness) remains a challenge for some individuals. Symptoms include dizziness, headache, and nausea, notably more prevalent in women, children, and the elderly population.114, 115, 116 The exact etiology of cybersickness is unknown, but possible causes appear consistent with the causes of motion sickness including, a mismatch of sensory information between the eyes and the inner ear, loss of postural control (awareness of presence in space), and eye movement theory (excessive eye muscle movement).117 Evidence shows that 60% to 95% of users experience some degree of cybersickness.118
Headset Discomfort
The headsets can also be uncomfortable when worn for long periods of time. A typical headset weighs nearly 2 pounds and early studies show it may contribute to muscle strain and discomfort.119 Surgeons have reported headset weight and weight distribution as a limiting factor during long surgeries.120
Injuries
Injuries have also been reported, falling into two categories: overuse and accidents. Individuals may become disoriented and fall down or run into furniture, walls, or other people causing broken bones, concussions, and lacerations. Individuals can also experience overuse injuries such as musculoskeletal disorders of the neck, shoulder, and spine due to the weight of the device as mentioned above.121 The potential for unintended negative efects such as stimulus intensity, which could make a condition worse rather than better, are also being considered.122
Mental Health Impact
There is also caution about the possible addictive properties of VR use. The WHO has classifed video game addiction as an ofcial mental health disorder in January 2022.123
“Gaming Disorder” is in the 11th Revision of the Internat na ass fi at n D s as s D and defned as a pattern of ‘gaming behavior (“digital-gaming” or “video-gaming”) characterized by impaired control over gaming, increasing priority given to gaming over other activities to the extent that gaming takes precedence over other interests and daily activities, and continuation or escalation of gaming despite the occurrence of negative consequences. Furthermore those that sufer from photosensitive epilepsy could be at risk for seizures while using VR apps that require a greater feld of vision.124 VR stimulates the eyes whole feld of view, afecting a larger part of the brain, hence triggering a seizure.125
Privacy
Privacy protection is of concern as well. Since VR headsets are able to collect more data (eye movement, eye focus, and body movement) than a traditional screen, they may present further opportunities for profling, predatory behavior, and security breaches.126 Individual privacy as well as personal health information protection concerns can grow as virtual spaces become more common. Hence, safeguarding data and privacy and having appropriate frameworks are key. There are currently organizations working to ensure privacy and safety for MRX frameworks.127
There is more to learn and potential hurdles to overcome. This includes the possible repercussions of reduced face-to-face communication, technology illiteracy, HCP and student anxiety or reluctance to learn a new technology, and the possible negative impact of overuse. The impacts described for VR can also apply to AR.
REGULATORY TRENDS
While there is a plethora of digital health options such as wellness apps, Medical Extended Reality (MXR) such as VR/AR that undergoes regulatory review has to be validated through the US Food and Drug Administration (FDA) clearance process.128 The US FDA classifes medical devices based on the risk associated with the device. There are also diferent premarket pathways for a device to undergo regulatory review under the FDA’s Center for Devices and Radiological Health (CDRH).129
DEVICE CLASSIFICATION:
Class I
low risk devices that are generally exempt from premarket notifcation or clearance. General controls apply.
EXAMPLES
dental foss, nasal swabs, and manual stereoscopes
PREMARKET PATHWAYS:
De Novo Premarket Pathway
Class II
moderate risk devices with greater regulatory control than Class I. General and special controls apply. Premarket notifcation is generally required but is sometimes exempt.
EXAMPLES
endoscopes, powered wheelchair, and digital cognitive behavioral therapy
Class III
high risk devices and require a Premarket Approval (PMA) before they are marketed. General and special controls apply.
EXAMPLES
coronary stents and breast implants
• Intended for low to moderate risk devices of a “new” type where a predicate device does not exist. AppliedVR’s RelieVRx (formerly EaseVRx) is a Class II device that was cleared through the De Novo pathway.
º De Novo is a risk-based classifcation process, therefore beneft versus risk is described as an assurance of safety and efectiveness for the intended use.130
a s a r ar t t fi at n
• Used to show a device to be marketed is safe and efective and substantially equivalent to a legally marketed or predicate device. 510(k) is the most common type of premarket submission for medical devices. Most 510(k) submissions are for Class II devices.
º A 510(k) device is considered substantially equivalent to a predicate if it: » has the same intended use and same technological characteristics OR » has the same intended use, diferent technological characteristics and does not raise diferent questions of safety and efectiveness and submitted data shows device is as safe and efective as the legally marketed device.
º Once a 510(k) has been created for a device, subsequent companies can submit a 510(k).131
Premarket Pathway
(PMA)
• The FDA’s most stringent device marketing application. It is reserved for highest risk devices (Class III) and has the highest data requirements than any other premarket pathway.
º Given the level of risk associated with Class III devices, general and special controls alone are insufcient to assure safety and efectiveness. PMA has signifcant data requirements including clinical data and non-clinical laboratory studies.132
VR and prescription digital therapeutics are primarily Class II. Data requirements will depend on a number of factors including class, the premarket pathway, potential risk to patients, and any special controls. There is also another type of marketing application for a Humanitarian Use Device (HUD) called a Humanitarian Device Exemption (HDE). An HDE is a pathway to market medical devices for rare diseases or conditions.133
Of note, the FDA’s Breakthrough Device designation can be granted to VR. This designation is intended for devices that “provide for more efective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.”134 An example is RelieVRx (formally EaseVRx) which was granted Breakthrough Device designation.135 The FDA also ofers a Safer Technologies Program (STeP) for medical devices. STeP is a voluntary program for medical devices that are “reasonably expected to signifcantly improve the safety of currently available treatments or diagnostics that target an underlying disease or condition associated with morbidities and mortalities less serious than those eligible for the Breakthrough Devices Program.” SteP provides more timely access to medical devices and device-led combination products by expediting development, assessment, and review, while still preserving the statutory standards for the 3 premarket pathways.136
The Patient Engagement Advisory Committee (PEAC) is comprised of patients, caregivers, and patient organization representatives. This committee was established by the FDA to consider patient needs and experiences around medical devices. PEAC has provided considerations for VR/AR benefts, risks, and uncertainty.137
In addition to regulatory considerations, legislative authorities that allow for access to certain telehealth services are a notable trend. For example, during the pandemic the authority under the Ryan Haight Act was lifted so prescriptions for certain medications such as medication assisted therapies (MAT) for substance use disorders could be accessible via telehealth instead of an in-person visit. Looking ahead patient-centric digital health legislation can aid in fostering an environment of responsible access.138
MAGELLAN PERSPECTIVE – FOUR PILLARS
Magellan Health supports fair and balanced reviews for new devices to the market. We have four primary tenants of practice, including education, evidence-based, safety, and access. Our overarching perspectives for VR are summarized in these four pillars:
provide targeted education and increase health literacy for all stakeholders (patients, providers, payors, educators, etc.) in the private and public sectors, for multigenerational ages (young & old), increase patient engagement, and advance healthcare training
ensure future coverage decisions are grounded in high-quality, validated evidence for devices that have undergone regulatory clearance, provide scalable value
advocate for patients by encouraging responsible access to these technologies with security protections in mind and using privacy standards and vigilance for all, particularly for children and teens where studies show safety and efcacy
increase access to healthcare in a responsible manner, remove geographical, social, broadband, and language barriers, increase diversity in care by closing the healthcare equity gap for underserved communities, and improve healthcare stafng
SUMMARY
While an abundant amount of research is being conducted, questions remain regarding the scalability of VR, the ethical aspects, and the longitudinal efects of quickly embracing the technology. Additionally, although MXR technology has the potential to create improved access to individuals through virtual care, it could also exacerbate current healthcare inequities due to inadequate broadband or device access, costs, and limited digital literacy.
As VR technology becomes more accessible, the immersive and interactive learning environment is providing experiences never thought possible. The future of healthcare could look very diferent, greatly impacted by the digital age and VR technology potential. It is a rapidly changing landscape in part due to the rapid fow of technological advancement. The advancing technology spurring considerable interest in healthcare utility can be observed in the number of startup and established tech companies leading the market in research and development of potentially efective medical treatments.
Considering the potential positive impact already demonstrated in the areas of pain management, rehabilitation, mental health treatment, training, and education, it is imperative to understand the importance of proper infrastructure, potential risks, standardization, balancing privacy with innovation, and training in order to successfully integrate the technology into practice. Further, representatives of specifc user groups (such as pediatrics) could be involved in the design and development through interdisciplinary research teams to create appropriate VR interventions. As well, special attention to these groups should be considered since longitudinal and large randomized studies have not clearly defned the benefts and risks of the technology.
MXR technology is new and continuing to be studied. The rapidly evolving and widely varied hardware and software create an exciting yet challenging research environment as current research becomes quickly obsolete or irrelevant due to frequent introduction of new versions. There is keen interest in VR’s healthcare potential and research initiatives are currently benefting from increased funding. Larger randomized controlled, and longer studies will be required to fully determine safety and efcacy in a multitude of treatment areas. This will be key in determining the potential positive and negative impacts of MXR and fostering mindful use of the technology.
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138. Portman, Whitehouse Urge DEA and HHS to Extend Americans’ Access to Telehealth Once the COVID-19 Public Health Emergency is Terminated. Available at: https://www.portman.senate.gov/newsroom/press-releases/portman-whitehouse-urge-dea-and-hhs-extend-americans-access-telehealth-once. Accessed May 18, 2022.
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