Immersive Technologies: The Uncertain Regulatory Landscape

Early Immersive Technologies

Immersive technologies are at the forefront of innovation in the consumer technology and life sciences industries, but regulators are struggling to fit these devices, which blend clinical software with commercial headsets, squarely into the already existing framework. As immersive technology innovation continues to outpace development of existing regulatory frameworks, companies need to be diligent in their efforts to keep up with and predict best practices and regulatory questions.

These digital tools—which allow people to enter and interact with an enormous range of dynamic, life-like environments—have expanded beyond their traditional application in the gaming and entertainment industry and now hold a great deal of promise for everything from education to manufacturing and healthcare. Exciting new applications are being explored and offer huge potential for increased product design and use cases.

To better understand this new landscape, it can be helpful to distinguish four key terms and categories:

• Virtual Reality (VR): Virtual reality replaces the real world with a virtual one by taking over your vision and superseding your physical surroundings.
• Augmented Reality (AR): Rather than replacing your vision, augmented reality adds to it by projecting virtual content over your real-world view.
• Mixed Reality (MR): Mixed reality is the term used to describe technology that incorporates both virtual reality and augmented reality—for example, a VR headset that incorporates AR features.
• Extended Reality (XR): Extended reality is a catch-all term that encompasses all types of immersive technologies, including VR, AR, and MR.

The Consumer Products Industry

The Emergence of VR/AR in the Consumer Products Space

With the growing digitalization of everyday life, XR headsets and goggles represent a major trend in the consumer product space. Several different types of VR, AR, and MR headsets and goggles digitally immerse the user to varying degrees, and companies are deploying these technologies in a variety of consumer-facing applications.

Educators are using these XR headsets to enhance students’ professional development. Examples of these offerings include:

• Practical experience in nursing programs: In the midst of COVID-19 and online learning, nursing students were still able to develop necessary practical skills by entering virtual emergency rooms and assisting in medical emergencies that mirror real-life situations via VR headsets.
• VirtualSpeech: An app called VirtualSpeech combines VR and AI to further enhance the learning environment by creating AI-powered avatars to simulate job interviews and act as tutors and mentors.
• The Giza Project: Using a social VR software called rumii, students at Harvard University and Zhejiang University in China studied anthropology by using virtual characters in a VR-equipped classroom. The students worked together to identify hieroglyphics and study ancient Egyptian characters and the Giza pyramids.

Retailers are also finding creative ways to experiment with immersive technologies to reach and engage consumers. Examples include:

• Virtual try-on: Fashion retailers use VR to create a digital version of the consumer’s appearance, enabling the consumer to “try on” products such as clothing, jewelry, makeup, and other accessories.
• View-in-room AR: Furniture and home decor retailers use AR to allow consumers to virtually place a product in a room or other environment in the consumer’s house, apartment, or office.
• 3D product configurators: Car retailers and shoe brands use VR to provide consumers with an interactive and instantaneous way to customize a product to their liking.

Regulatory Compliance

As immersive technologies become more prominent, organizations and agencies are starting to focus on creating regulatory processes and guidance for these novel products.

On April 28, 2023, the Underwriters Laboratory published an early safety standard dedicated to extended reality equipment: UL 8400 Safety Standard for Virtual Reality, Augmented Reality, and Mixed Reality Technology Equipment. Devices covered by this standard include VR/AR/MR headsets, goggles, and smart glasses, as well as holographic displays and interactive virtual simulators. The goal is to provide best practices and set out risk-reduction testing and design requirements to mitigate against potential adverse effects associated with these devices, such as skin sensitization, heat exposure to the eyes, motion sickness, and neurological effects on the visual systems.

The U.S. Consumer Product Safety Commission (CPSC) has also shown interest in this new technology. On January 17, 2024, the Skin Compatibility Task Group for the UL 8400 standard held its first of several meetings dedicated to updating the requirements in UL 8400 to address skin and other biocompatibility concerns for XR products. CPSC staff were also in attendance.

Finally, UL 8400 is intended to supplement the voluntary standards set out in the existing safety standard for wearable equipment (UL 62368-1), which addresses the general potential risks associated with wearables.

The Healthcare Industry

VR/AR Expanding into the Healthcare Space

VR and AR technologies have the potential to transform the healthcare industry in at least two important ways. First, they can accelerate diagnosis and help develop new approaches to treatment. Second, they can expand healthcare services to groups who otherwise would have difficulty accessing these services in person.

This expansion is already beginning. VR and AR systems are now being used for in-home treatments, for physical therapy, and even in operating rooms. Examples include:

• An AR surgical navigation system that superimposes 2D or 3D medical images over a patient’s body during surgery.
• A VR stroke rehabilitation therapy used to improve a patient’s physical and motor functions.
• A VR system used to treat post-traumatic stress disorder in veterans by placing them in the setting where the events happened.

In November 2021, the FDA issued a news release, authorizing marketing of EaseVRx (now called, “RelieVRx”), the world’s first at-home, prescription-use VR system designed to treat chronic lower back pain with cognitive behavioral therapy, rather than opioid pain medication. This eight-week treatment program uses a VR headset to target the physiological symptoms of pain through established principles of behavioral therapy, such as attention-shifting, deep relaxation, distraction, healthy movement, and interoceptive awareness, among other skills-based treatment methods.

Regulatory Compliance

As immersive technologies begin to blur the lines between consumer products and medical devices, regulatory agencies may need to work together to develop guidelines for safety and oversight of these dual devices.

Like CPSC, FDA is also working quickly to create a regulatory framework in this new space. On January 6, 2023, FDA published 21 CFR 890.5800, which governs virtual reality behavioral therapy devices for pain relief, such as the RelieVRx device discussed above. The regulation sets out a list of required special controls for these class II devices, in addition to mandatory labeling requirements, including warnings regarding the risk of nausea, motion sickness, and discomfort from the device and a summary of the clinical testing with the device.

Additionally, FDA recently issued a final rule adding the Digital Health Advisory Committee (DHAC) to its list of standing advisory committees. The DHAC is tasked with advising the Commissioner on issues related to digital health technologies (DHTs), for instance, the regulation of these technologies, their benefits and risks, and their application in clinical trials or post-market studies.

Analogous to the emergence of artificial intelligence in the healthcare industry, the regulation of DHTs is quickly evolving. While we expect to see similar data privacy and product security concerns, other facets of the regulatory scheme will continue to evolve as these products continue to come to market and experience industry growing pains.

Looking Ahead

We expect to see immersive technologies impact a wide variety of industries, even beyond the consumer product and healthcare realms. For now, manufacturers of XR systems should continue to monitor updates to regulatory guidelines and consult with counsel as they work to refine and create these novel offerings.