FDA Laws and Regulations About The Metaverse

The “metaverse” is the hot new work in technology and innovation. The metaverse holds promise for many new applications in many industry sectors – including healthcare. According to Healthviva, the metaverse combines AR, VR, artificial intelligence, “the Internet of Medical Devices, Web 3.0, intelligent cloud, edge and quantum computing along with robotics to provide new directions to healthcare.”

Metaverse – general applications

Metaverse applications generally involve the following:

• Virtual reality (VR). This technology replaces a person’s physical work with a virtual world through the use of headgear devices and software. While wearing the headset, the virtual reality user accesses a software-crated world through LCD screens inside the lenses of the headsets. The headsets are connected to a smartphone or PC that displays virtual images. These images can be duplicates of the real world or fictional worlds.
• Augmented reality (AR).  This technology combines the real and digital worlds. “It uses computer vision to recognize real-world surfaces and objects using technologies such as object recognition, plane detection, facial recognition, and movement tracking, among others. The computer then overlays computer-generated data like graphics, sounds, images, and messages on these previously recognized planes.”
• Mixed reality (MR). This is a combination of VR and AR. “The most appealing technology is the lifelike interaction between users and digital items.”
• Extended reality (XR). This term encompasses AR, VR, and MR. This immersive technology “either merges the virtual and “real” worlds or creates a totally immersive experience, extending our perception of reality.” Many people think XR will become mainstream in five years.

According to Sagentia Innovation, the term metaverse is believed to date back 30 years to a science fiction novel where humans interact with each other through software in a 3D virtual space. Early visions of the metaverse begin with the idea of human headsets used for work and leisure.

The newer version of the metaverse includes virtual reality (VR) and augmented reality (AR) in a 5G world. Many companies are already developing applications which are attracted investors and tech companies. A few examples illustrate the trends in the metaverse universe:

• Facebook rebranded its company name to Meta so the company could move from being a social media company to a metaverse company.
• Roblox, a game company, now describes itself as a metaverse company.
• Nvidia, which designs graphics processing units for the gaming and professional markets, has announced the launch of Omniverse, described as a metaverse for engineers. Omniverse will be available as an enterprise service later this year.

While the metaverse may take a decade or more to reach maturity, there are already indications that healthcare is already taking advantage of the metaverse. VR and AR are being used in the following ways:

• Medical education. VR is training doctors and medical staff by taking a 360-degree view of the human body and diseases – and helping physicians work online in real-world procedures. AR is being used for hands-on learning to simulate patient and surgical relationships and show students can practice new medical techniques.  The metaverse could even be a training ground for surgical robots where the robots along with artificial intelligence will perform surgeries on humans. Already, some robot technology is being used for surgeries that require infinitesimal movements.
• Surgical procedures and pre/post-surgical healthcare. Possible applications that are being explored include removing cancerous tumors and performing spinal surgery – through surgical precision and the ability to perform complex procedures. AR is currently helping surgical staff access information “that is more compatible with surgical workflows and the sterile field of the operating room, for example, real-time guidance is provided in the surgeon’s field of view of the surgical site through integration with surgical navigation systems and fusion of data from multiple imaging sources.” Before-surgery and after-surgery reviews can use AR to improve outcomes using more “personalized intervention rooted in data analytics.”
• Wellness and fitness. Game mechanics are being used to better connect patients with their healthcare providers. For example, AR is being used to deliver better workouts with guidance from visual teachers. AR is helping better the lives of people with dementia. “One study equipped patients with a VR headset to ‘visit’ one of five virtual environments, including a cathedral and a sandy beach. After 16 monitored sessions, researchers found the patients were better able to retrieve old memories, which improved mood and provided positive mental stimulation.”

Investments in healthcare companies working in the metaverse

Other examples of healthcare in the metaverse include:

• VR and AR are being used for intravenous injections and to draw blood – using technologies like that of Accuvein which projects a map of a patient’s veins onto the skin.
• Zimmer Biomet recently announced the purchase of OptiVu™ Mixed Reality which leverages the Microsoft HoloLens to merge real and virtual worlds. According to Insights2Techinfo, surgical assistive tools include technology like the Microsoft Hololens. “In addition to pre-operative pictures from CT, MRI, and 3D scans, AR headsets are used to view crucial real-time patient data such as heart rate, body temperature, blood pressure, and respiration rate.”
• Veyond Metaverse is another med-tech company that focuses on education, training, and collaborative medical procedures. The company claims that “it uses advanced cloud and real-time communication technology to ‘empower clinicians to practice their skills with the utmost precision to ensure everyone receives the best healthcare delivery anytime and anywhere.’”

The investments by large med-tech companies along with numerous AR and VR startups – are expected to alter how surgeries are performed for years to come.

According to a report by GrandView Research, the global augmented reality market size was valued at USD 17.67 billion in 2020. The market is expected to expand at a compound annual growth rate (CAGR) of 43.8% from 2021 to 2028.

A recent example of augmented surgeries

John Hopkins University recently announced that Johns Hopkins neurosurgeons performed the institutions’ first augmented surgery on June 8, 2020, in living patients. The doctors

“placed six screws in a patient’s spine for spinal fusion surgery to fuse three vertebrae in order to relieve the patient’s chronic, debilitating back pain. In a second surgery, two days later, surgeons removed a cancerous tumor known as a chordoma from the spine of a patient. The doctors report that both patients are doing well.”

FDA Proposed Guidelines for the Medical Device Metaverse

According to Ryortho.com, the FDA recently sought input for new medical device guidance documents for 2022. FDA has the authority to regulate medical devices. Many of the healthcare applications that take advantage of the metaverse may qualify as medical devices which means the manufacturers and sellers of these products need to be in compliance with FDA’s medical device regulations.

The FDA defines a medical device as:

• “An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory which is: recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
• Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
• Intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.”

There are numerous registration, listing, and other compliance requirements which med-tech companies should review with an experienced healthcare lawyer. For example, “certain medical devices may need to comply with Premarket Submission requirements (Premarket Notification or Premarket Approval).”

The list is divided into an A-list for priority documents and a B-list of texts FDA intends to publish. The lists include many med-tech devices that rely on artificial intelligence, machine learning, and “smart” devices, software and clinical decision software (CDS).

The guidelines also express concerns about medical device cybersecurity. FDA “plans to issue two draft documents regarding transition plans for devices covered by COVID-19 enforcement policies or emergency use authorizations. Test developers will need to get diagnostics authorized using traditional premarket review processes to support post-pandemic use.”

The A List. This list includes the following documents:

• Clinical Decision Support Software
• Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act
• Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order
• Remanufacturing of Medical Devices
• Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices
• Electronic Submission Template for Premarket Notification (510(k)) Submissions

The draft guidance topics on the A list include:

• Computer Software Assurance for Production and Quality System Software
• Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program
• Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
• Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
• Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
• Content of Premarket Submissions for Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD)
• Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers
• Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care
• Medical Device Shortages – Implementation of Section 506J of the Federal Food, Drug, and Cosmetic Act
• Clinical Considerations for Medical Device Premarket Submissions Targeting Opioid Use Disorder

The B List. The agency’s B-list of lower priority guidance documents also features two software-related drafts. The agency plans to release drafts on Marketing Submission Recommendations for A Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions and Risk Categorization for Software as a Medical Device in its next fiscal year.

Additional regulatory concerns

The FDA and FTC monitor advertising and marketing claims to determine if the claims violate the FD&C Act and whether the claims are misleading to consumers.

According to Business Insider, there are also concerns about personal safety and free speech. Some women have complained about being “harassed, groped or made to feel uncomfortable in various metaverses.” Moderation and enforcement in the metaverse are expected to be very difficult.

The metaverse’s universe of virtual, augmented, mixed, and extended reality offers exciting new opportunities for medical technical companies. Medical technical companies are now working to help educate healthcare providers, to care for patients, and assist in surgeries. Many of these devices may qualify as medical devices and thus regulated by the Federal Drug Administration.

Medical technical companies should contact Cohen Healthcare Law Group, PC to discuss FDA compliance issues involving medical devices and metaverse applications. Our experienced healthcare attorneys help healthcare companies and healthcare providers understand their compliance requirements.