As of 2026, Medical Extended Reality (MXR) has transitioned from experimental pilot phases to an integrated component of the regulated medical device landscape. It is already part of the regulated medical device landscape in the United States, and the FDA now maintains a public list of AR and VR devices authorized for marketing. Some of those products are procedural or surgical, but others are clearly therapeutic, which means immersive care has moved beyond theory and into real clinical use.
While this adoption expands therapeutic modalities, it necessitates a rigorous evaluation of clinical safety protocols and longitudinal monitoring.
Healthcare organizations are getting better at talking about the promise of therapeutic VR. They are still far less prepared to document what happens when immersive treatment is difficult to tolerate, emotionally destabilizing, poorly matched to the patient, or clinically ineffective. In many systems, usage is being tracked more carefully than safety. That is the wrong order.
Therapeutic VR does not behave like ordinary health software. It acts on perception, attention, breathing, body awareness, movement, and emotional state at the same time. When it works, that can be clinically useful. When it does not, the problem is not limited to a technical glitch or a poor user experience. Patients may experience Adverse Events (AEs) including cybersickness (VIMS), depersonalization/derealization (DPDR) symptoms, and autonomic overarousal. The clinical response to immersive care therefore needs more than a dashboard. It needs a safety ledger.
The proposed “Safety Ledger” constitutes a structured clinical framework for documenting exposure, tolerability, adverse events, escalation triggers, and outcome response. It should answer simple questions that any health system should be able to answer before scaling immersive therapy. Who was screened in or out? What kind of content was used? How long was the session? Was the patient supervised? What symptoms appeared during or after use? Did those symptoms resolve? What triggered follow-up? What changed clinically over time?
The need for that record is not theoretical. The FDA’s own XR materials say the long term effects of medical XR are still being studied, and the agency directs patients, caregivers, and professionals to weigh benefits and risks carefully. It also points users toward Medical Device Reporting and the MAUDE adverse-event system, which is a reminder that immersive tools belong inside the same safety culture as other medical devices.
We are already seeing why that matters. In a 2023 systematic review of VR and AR interventions in psychiatry, researchers found inconsistent adverse-effect reporting across the literature. Some studies documented worsening symptoms or fall risk. Others reported “no adverse effects” despite describing symptoms such as cybersickness. Many did not mention adverse effects at all. That is a research problem, but it is also a warning for providers. If harms are underdescribed in studies, they will be even easier to miss in routine care unless organizations deliberately build for detection.
The implementation literature points in the same direction. A 2024 scoping review in JMIR XR and Spatial Computing found growing evidence that VR therapy can help pain and physical function, but it also found limited knowledge about implementation barriers and facilitators in health care settings. The barriers most often clustered around environmental context and patient skills, which is exactly where health systems fail when they treat immersive care as a novelty instead of a workflow. A separate qualitative JMIR study in academic, community, and safety-net settings reached a similarly practical conclusion. Readiness depends on staffing, acceptability, cost, operational fit, and whether the intervention actually works in diverse real-world populations.
This is why I believe the next phase of therapeutic VR will not be won by better visuals alone. It will be won by better clinical governance.
The case for governance becomes even clearer when you look at what is already on the market. AppliedVR’s EaseVRx received FDA De Novo authorization for chronic lower back pain after a randomized sham-controlled trial involving 188 subjects. Smileyscope’s Therapy Mode was cleared for children aged 4 to 11 to help reduce pain and relieve acute procedural anxiety during needle procedures. These are different use cases, different populations, and different care settings. What they share is more important than the indication. Once immersive therapy enters clinical care, organizations need a repeatable way to capture tolerance, safety, and response.
A useful safety ledger should include five elements.
First, screening. Pre-intervention screening must utilize validated instruments to assess vestibular sensitivity, seizure threshold, and propensity for dissociative states.
Second, exposure. Session length, frequency, content type, level of immersion, and whether the session happened in clinic or at home all matter. Without exposure data, benefit and harm are hard to interpret.
Third, tolerability. Health systems should capture nausea, dizziness, panic, sensory overload, fatigue, confusion, early termination, symptom worsening, and delayed negative effects after the session. In immersive care, tolerability is not a side note. It is part of the treatment response.
Fourth, escalation logic. A patient who repeatedly stops sessions, reports distress, or shows worsening symptoms should trigger a defined clinical follow-up, not disappear into a utilization report.
Fifth, outcomes. If the therapy is prescribed for pain interference, anxiety during procedures, or another defined target, that outcome should be measured over time. Otherwise a high-engagement intervention can look successful even when it is not clinically helping.
This is also where Nargiz’s own body of work matters. In her July 2025 paper on digital embodiment, she argued that immersive environments can strengthen bodily self-awareness but also carry risks including cybersickness, depersonalization, and blurred boundaries between the physical and digital self. That is exactly why therapeutic VR deserves clinical oversight that is sensitive not only to software performance, but to the patient’s perceptual and emotional state.
Advancing immersive therapeutics requires moving past technical ambition and reaching clinical maturity. This means establishing standardized records and clear escalation protocols, grounded in a real understanding of how these tools affect patients physically and psychologically. While therapeutic VR is a major part of modern care, it can only scale sustainably if we shift from engagement metrics to a clinical framework that prioritizes safety data.
About Nargiza Noimann-Zander:
Nargiza Noimann-Zander is the founder of X-Technology and a researcher with 25+ years in neuroscience and psychotechnology. She leads research programs on emotional and cognitive recovery after cancer, dementia, and other chronic conditions, and collaborates with clinicians to design and evaluate evidence-based, AI-supported virtual- reality interventions. She is currently partnering with UAE clinics to integrate these tools into routine care pathways, with a focus on measurable outcomes and patient dignity.
References
- FDA. Augmented Reality and Virtual Reality in Medical Devices
https://www.fda.gov/medical-devices/digital-health-center-excellence/augmented-reality-and-virtual-reality-medical-devices - FDA. Augmented Reality and Virtual Reality Medical Devices: Questions to Consider
https://www.fda.gov/medical-devices/digital-health-center-excellence/augmented-reality-and-virtual-reality-medical-devices-questions-consider? - FDA. DEN210014 Decision Summary, EaseVRx
https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN210014.pdf - FDA. K230825, Smileyscope System Therapy Mode
https://www.accessdata.fda.gov/cdrh_docs/pdf23/K230825.pdf - Lundin RM, Yeap Y, Menkes DB, et al. Adverse Effects of Virtual and Augmented Reality Interventions in Psychiatry: Systematic Review. JMIR Mental Health, 2023.
https://mental.jmir.org/2023/1/e43240 - Elser A, Pfeifer AC, Kohlmann T, et al. Barriers and Facilitators to the Implementation of Virtual Reality Interventions for People With Chronic Pain: Scoping Review. JMIR XR and Spatial Computing, 2024.
https://xr.jmir.org/2024/1/e53129 - Sarkar U, Gourley GI, Lyles CR, et al. Barriers and Facilitators to the Implementation of Virtual Reality as a Pain Management Modality in Academic, Community, and Safety-Net Settings: Qualitative Analysis. Journal of Medical Internet Research, 2021.
https://www.jmir.org/2021/9/e26623 - Noimann-Zander N. Digital Embodiment: How VR Helps Restore Self-Contact During Chronic Stress and Burnout. Universum: Psychology and Education, 2025.
https://7universum.com/ru/psy/archive/item/20483
