Facebook previously announced its $2 billion acquisition of Oculus VR, Inc. The announcement touts Oculus as being “the leader in immersive virtual reality technology,” having built “strong interest among developers” for its virtual reality (VR) headset, the Oculus Rift. The press release also reports that “Facebook plans to extend Oculus’ existing advantage in gaming to new verticals, including communications, media and entertainment, education and other areas.”
What if the “other areas” include applications of virtual reality in the healthcare field? Chris Wiltz, writing for Medical Device and Diagnostic Industry, wrote about such an application last July. In his article, Wiltz reported that “[t]he idea behind using VR for healthcare is to completely immerse patients in a computer-generated world where they can undergo therapy and training in a safe, artificial environment controlled by a clinician.” Wiltz interviewed a number of researches investigating the application of virtual reality to various medical fields, including Skip Rizzo. Wiltz reported that “Rizzo, a clinical psychologist and associate director for medical virtual reality at the University of Southern California’s Institute for Creative Technologies . . . , works to implement VR into a variety of clinical psychology applications – most prominently enhancing what is known as exposure therapy to treat soldiers with PTSD.”
In addition to helping the treatment of patients directly, virtual reality applications can be used as a tool to better train healthcare providers. For example, the Department of Neurosurgery at Mount Sinai School of Medicine announced in October 2012 that it would be “the first in the United States to use the NeuroTouch virtual-reality simulator designed to improve outcomes and reduce complications in patients undergoing brain surgery.” Joshua B. Bederson, MD, Professor and Chair of Neurosurgery at Mount Sinai, stated that “[w]e believe the new brain surgery simulator could potentially revolutionize the way we train and evaluate our surgeons.”
The ability to provide what Wiltz reported as “the strongest immersion experience seen in VR, all at a price point circling $300,” puts Facebook in a unique position to develop healthcare applications for the Oculus Rift for consumers. What Facebook must keep in mind, however, is the potential to find itself subject to FDA regulations. The FDA’s Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff, issued on September 25, 2013, provides some examples of how the FDA might regulate certain mobile medical applications. For example, Appendix A to the FDA guidance document provides examples of mobile apps that are not medical devices, including those “that are intended for health care providers to use as educational tools for medical training or to reinforce training previously received.” Appendix B, on the other hand, provides examples of mobile apps for which the FDA intends to exercise enforcement discretion, including apps “that help patients with diagnosed psychiatric conditions (e.g., post-traumatic stress disorder (PTSD), depression, anxiety, obsessive compulsive disorder) maintain their behavioral coping skills by providing a ‘Skill of the Day’ behavioral technique or audio messages that the user can access when experiencing increased anxiety.”
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