In the Metaverse, Existing Healthcare Rules Apply

The metaverse uses technologies such as artificial intelligence (AI), augmented reality (AR), and virtual reality (VR) to create immersive, interactive environments that can feel very realistic. It may be the next generation of the internet, creating new ways to play, work, shop — and potentially access healthcare.

Delivering healthcare in these new digital spaces could lower costs while increasing access to health services and improving patient outcomes. Success could depend on the ability to realize the potential of technologies in three areas:

• Telepresence: technologies that bring people together virtually even when they are physically distant
• Digital twinning: technologies that create digital copies of a person’s unique biology or physiology for the purpose of treatment or diagnosis
• Blockchain: technologies that create distributed networks for storing and exchanging information

But healthcare applications in the metaverse will not be exempt from the laws and regulations that already apply “in the real world.” Below, we talk about some of the legal and regulatory considerations providers and platforms should keep in mind as they develop healthcare services for the metaverse.

Telepresence

Social distancing measures implemented during the COVID-19 pandemic accelerated the adoption of telemedicine. Now, many people routinely connect with providers online using technologies such as real-time video chat or store-and-forward secure messaging. This is a boon for patients — especially those who live in areas with insufficient numbers of providers — because it expands their options for care.

The metaverse could further expand access and potentially make virtual care more effective. Patients could use VR to connect with healthcare providers in ways that feel more like being in the same room, which could help them feel more comfortable while making it easier for providers to diagnose and treat them.

Laws and regulations related to telemedicine and virtual care will apply in the metaverse. That could be challenging for providers who operate in the metaverse and expect to serve patients across the country, given that laws vary state by state.

A majority of states restrict or prohibit the corporate practice of medicine (CPOM), which means companies often cannot practice medicine or employ physicians to practice medicine on their behalf. But most restrictions include exceptions that allow physicians to practice medicine through partnerships, professional service corporations, or limited liability companies that are owned exclusively by physicians. Any entity that provides care in the metaverse would have to ensure it complies with the CPOM laws in each state where it operates.

Licensing is another challenge. Nearly every state requires telehealth providers to be licensed in the state where the patient is located, although many states have waivers related to COVID-19 care.

Digital Twins

A digital twin is a complex virtual model or simulation of an object, process, or system. It uses real-world data and AI to develop a virtual replica of a real-world object that can be used to model possible scenarios and outcomes for its real-world counterpart. In the healthcare context, researchers and healthcare professionals use digital twins to help determine whether surgery is warranted or too risky. Physicians also use digital twins to model clinical approaches and identify the best course of treatment for a patient.

Healthcare and life sciences organizations envision digital twins becoming an integral part of clinical research, especially as our ability to map and understand individual genetics improves. If we can use digital twins to predict how patients will recover from surgery or model how an intervention will affect a patient years after the fact, providers will be able to deliver more personalized care and patients will be able to make more informed decisions.

Regulations that apply to human subjects involved in clinical trials using digital twins in the real world also apply in the metaverse. Sponsors and investigators will need to consider whether they need approval from an institutional review board for any clinical research involving digital twins that they conduct in the metaverse. They may also have to obtain informed consent from the digital twin’s real-world counterpart.

Blockchain Technology

Blockchain technology could enable individuals to own and control their health records themselves, giving individuals more power to decide who can access their health information and when. In addition to increasing patient agency, the technology could unlock tremendous efficiencies, enabling patients to provide clinicians anywhere in the world with access to selected medical records with a click of a button.

Blockchain technology will also be subject to existing laws regarding healthcare information. These include the Health Information Portability and Accountability Act of 1996 (HIPAA), the Health Information Technology for Clinical Health (HITECH) Act, and various state privacy laws that provide protections related to the use and disclosure of protected health information.

In the metaverse, where blockchain applications may interact with VR, AR, and other technologies, the challenge of coordinating multiple hardware and software components adds complexity to compliance.

Technology companies and developers that deal with health information may be required to comply with the information-blocking provisions (Information Blocking Final Regulation, or Final Rule) of the 21st Century Cures Act, which were issued by the Centers for Medicare & Medicaid Services and the Office of the National Coordinator for Health Information Technology.

These provisions are meant to ensure the secure exchange of electronic health information and interoperability between health information technology platforms. Interoperability requirements should be considered in the design of blockchain applications for the metaverse, particularly if the application would enable the use of electronic health records. Information-blocking prohibitions, even if they don’t apply directly, may otherwise be relevant in the design of a blockchain application.

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Existing rules apply in the metaverse, but how they are enforced may become clear only over time. Some rules will need to be adapted to the new context, and regulators may have to develop new rules as metaverse-native healthcare solutions emerge. This is an exciting frontier for healthcare, but it is likely to change rapidly as it develops.