Healthcare in the metaverse: The legal framework for medical treatment and the use of medical devices in the Medical Extended Reality
The metaverse is where the digital world fuses with the real world – and that is certainly true in the realm of healthcare. Of course, you can’t cure patients by treating their avatar. Nevertheless, according the view shared by most industry observers, medical extended reality (MXR) is able to offer fundamentally new ways for doctors to treat their patients using software-assisted medical devices in a virtual setting.
Providing healthcare in the metaverse raises a host of legal questions, especially questions about differentiations that need to be made:
- What treatments does the metaverse make possible, and how can existing, non-virtual treatments be combined with MXR?
- Which law governs cross-border MXR treatments?
- What medical interactions between avatars in the metaverse have to be performed by doctors?
- When is the software used in the metaverse to treat patients via avatars considered a medical device?
- How can MXR applications be integrated into Germany’s statutory health insurance system?
Dr. Enno Burk and Dr. Xiao Chen from our Berlin office, who specialise in advising on the digitalisation of healthcare, offer answers to these questions.
I. Medical extended reality
1. Inpatient medicine in the metaverse
- Companies are already opening “health cities” in the metaverse in which doctors and hospitals lease space and set up clinical pathways for virtual patients to get real treatment – where medically necessary – at real-world practices or hospitals.
- In August 2022, Essen University Medical Centre presented its Avatar Hospital pilot project, a virtual hospital with personalised avatars, which aims to save patients from travelling to the hospital and waiting a long time to be seen – all for short, hectic appointments. Instead, patients can interact with doctors through their avatars.
- Doctors can use a patient’s digital twin – an exact, three-dimensional model of the patient – not only to practice a surgical procedure before performing it, but also to ascertain what treatment has the greatest chance of success for a given patient.
- Surgical teams can run through procedures in advance from different locations using VR headsets. Patients can also be present to gain better insight into the procedure – allowing them to base their consent to the procedure on broader understanding.
- However, the procedures themselves still have to take place in physical hospitals.
2. Outpatient medical treatment in the metaverse
- The metaverse provides a new platform for outpatient interaction between doctor and patient – for example, in psychotherapy, where virtual reality (VR) technology provides a greater sense of being in the same room, and therefore familiarity, than regular video calls; conversely, the anonymity of VR avatars may also provide a greater sense of security.
- MXR also enables simulations that can be used in exposure therapy, for example, where patients face fear-inducing situations through their avatars without actually endangering themselves.
- For post-surgical care and physiotherapy, MXR can be used to better monitor recovery without requiring the patient to travel – and with artificial intelligence, using fewer personnel and at lower cost. The “gamification” of medical treatment achieved with the help of avatars is already being used with success in pain management.
Please find the overview in high resolution here.
3. Medical devices in the MXR
- As a virtual space, the MXR offers ample opportunity to use digital medical devices and medical device software. Software applications have previously been considered medical devices if
they are “intelligent”, i.e. they use the vital data measured to provide therapeutic recommendations on which the user can base medical decisions,
the manufacturer offers them for this intended purpose.
- Whether an MXR application qualifies as standalone medical device software likely depends on whether the intended medical purpose is treatment outside the metaverse. That means that if the device being used in the MXR has therapeutic or diagnostic impact on the patient’s real-world treatment, the metaverse application would be considered a medical device.
- In future, hardware components (e.g. networked measuring devices on the human body) will be connected to the components in the metaverse, which may then have to undergo conformity assessment as a single unit.
- Given the large number of treatments and associated products that are possible in the metaverse, each MXR application will need to be evaluated separately to establish whether it can be classified as a medical device or as a lifestyle product. For example, a VR headset that is not advertised using healthcare-related claims – but instead using only references to its VR functions – does not become a medical device simply because doctors and patients can use it to interact for medical purposes.
- If medical device software requires a VR headset to access the metaverse, however, the integration of this headset and its suitability must also be considered in the software’s conformity assessment.
- Advertising claims about MXR applications addressing the German market must be supported by reliable scientific studies (strict standard for health-related advertising).
Please find the overview in high resolution here.
II. Which law applies in the MXR?
- Even if the setting in which doctor and patient avatars interact is a global one, there are restrictions on the choice of law applicable to medical treatment contracts. The mandatory provisions of German civil law concerning patient protection also apply to such contracts between patients residing in Germany and doctors based abroad – and cannot be waived.
- While foreign law on medical treatment contracts generally applies if doctors based in Germany offer treatment to foreign patients, it does not apply if the level of protection afforded by the foreign law in question (e.g. regarding medical liability) is lower than that under German law.
III. Are only doctors allowed to provide treatment to avatars?
- In Germany, only licensed doctors may practise medicine and treat patients – but what about patients’ avatars?
- Outside the metaverse, medical care must be provided by a doctor if it requires a doctor’s/medical expertise and if the treatment – generally and typically – could be harmful to the patient’s health.
- This means that not every “treatment” of an avatar is considered medical care that only a doctor can provide. But making diagnoses or therapy recommendations in the metaverse with the aim of having the avatar’s user actually apply these to treat illnesses in real life does qualify as practising medicine; accordingly, only doctors can do this.
- Following the liberalisation of the professional code for doctors, treatment is however allowed in the metaverse if it meets medical standards of care and patients are informed about the specifics of MXR-only medical advice.
IV. Integrating MXR components into Germany’s statutory health insurance system
- One way of integrating MXR components into statutory outpatient care is via special healthcare contracts under section 140a Social Security Code, Book V (Sozialgesetzbuch, Fünftes Buch, “SGB V”). For this to work, both patients and doctors must have the technical means to interact in the metaverse. Special healthcare contracts involving digital medical devices can however also be executed without doctors as contracting parties.
- An MXR application that enables a patient’s avatar to communicate with an AI doctor in the metaverse – for example to describe their symptoms and receive suggestions for treatment (section 140a (4a) SGB V) – is therefore already conceivable. Fundamental diagnoses, however, must still be made by real-life doctors.
- Digital health applications – i.e. digital medical devices approved by the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimitel und Medizinprodukte, “BfArM”) for use in statutory healthcare, normally as smartphone apps – can also be combined with MXR components (see here for the BfArM’s Digital Health Applications Directory).
- Under section 68a SGB V statutory health insurance funds can support the development of digital innovations, especially MXR applications, by cooperating with third parties on content and technical aspects and by acquiring shares in innovation investment projects.
- The health data exchanged in the metaverse must be protected, however. The German healthcare system has particularly strict requirements for the protection of social data, for example in telemedicine. While these requirements cannot be directly applied to MXR components, specific security requirements will be developed as these applications gain importance – as was the case when telemedicine platforms began to be certified for the German healthcare system a few years ago.