FDA launches extended reality-enabled initiative for home health care

The Food and Drug Administration (FDA) announced the launch of a new initiative, Home as a Health Care Hub, that focuses on using augmented reality and virtual reality to improve health equity by reimagining the home environment as part of a healthcare system. 

The FDA contracted with an architectural firm that designs buildings with health and equity in mind to consider what will be needed to transform a home into a healthcare setting. 

The Agency, alongside patient groups, care providers and the medical device industry, will build the hub by considering structural and critical elements of a home that are required to enable an adequate home healthcare environment. 

“The hub will be designed as an augmented reality/virtual reality (AR/VR)-enabled home prototype and is expected to be completed later this year,” Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health (CDRH), and Dr. Michelle Tarver, deputy director for transformation at CDRH, said in a statement. 

The lab aims to connect the populations most affected by health inequity and provide medical device developers, providers and policy makers with ideas for developing home-based offerings that consider health equity. 

The prototype will initially focus on creating structures in rural locations and lower-income communities with diabetes as its main disease focus. 

THE LARGER TREND

The FDA’s Home as a Health Care Hub is the latest example of how extended reality (i.e., virtual reality, augmented reality, and mixed reality) has entered the healthcare space. 

California-based AppliedVR, a long-time player in the medical extended reality (medical XR) space, garnered the first FDA De Novo clearance for an immersive experience in 2021 for its offering RelieVRx, formerly EaseVR.

RelieVRx is a self-guided, eight-week, in-home virtual reality program in which patients can participate in VR sessions that use cognitive behavioral therapy to treat pain. The sessions offer content like breathing, mindfulness, relaxation-response, and executive function exercises.

Other medical XR companies include Boston-based VR-enabled mental health company XRHealth, virtual training company OssoVR, digital mental health company Headspace that launched its new virtual reality app Headspace XR in March, New Zealand-based virtual reality and cognitive behavioral therapy company oVRcome and VMocion, a technology company focused on allowing users to “feel” the motion they see in XR experiences. 

Even tech giant Apple’s augmented reality headset released earlier this year, the Apple Vision Pro, has entered the healthcare space and is being utilized by companies like diagnostic imaging and multimedia company Visage Imaging, California-based healthcare system Cedars-Sinai and San Diego-based healthcare group Sharp HealthCare.

Still, experts argue that although extended reality is a game changer for healthcare, especially psychiatric care, concerns exist about the implementation of XR into mental health too quickly.