Extended Realities and RegulationMay 19, 2021 Dr. Ella Sheiman RA & QA Project Manager
Extended Realities and Regulation
May 19, 2021
Dr. Ella Sheiman RA & QA Project Manager
What is reality?
In the past, the answer to this question for most people was very obvious- it is the reality that we can approach with our physical senses. Today, the evolution of human consciousness and technology has brought us to a place where we can choose a substitution for the limited physical reality. Today there are alternative and extended realities with Augmented Reality (AR) and Virtual Reality (VR) to name a few.
As with any other innovative technology, the healthcare industry is quick on adopting those extended realities as part of their arsenal and the regulatory bodies have to keep up with the industry. As a matter of fact, the extended realities have so much potential that the regulation harnessing it for its aid also! Just to emphasize the enormous growth of this field, it is estimated that by 2022, the extended realities market is expected to reach $209 billion, which is eight times what it is today .
Topics in this article:
What is the Extended Reality?
Extended Reality (XR) is an emerging umbrella term for all immersive technologies. The ones we already have today—Augmented Reality (AR), Virtual Reality (VR), and Mixed Reality (MR) plus those that are still to be created. All immersive technologies extend the physical reality we experience by either blending the virtual and “real” worlds or by creating a fully immersive experience.
VR and AR devices first made headlines in the consumer sector. Does Pokémon Go rush ring a bell? However, healthcare was quick to spot the potential of the technology, leading to explorations of its use in areas such as doctor-patient communication, surgery training, rehabilitation, and digital cognitive behavioral therapy such as chronic insomnia, for example [2, 3].
AR differs from its most known “relative”, VR since the latter creates a 3D world completely detaching the user from reality. There are two respects in which AR is unique: users do not lose touch with reality and it puts information into eyesight as fast as possible. These distinctive features enable AR to become a driving force in the future of medicine.
There’s plenty of potential for VR and AR in healthcare, but how might people use it, specifically?
- Patient experience – the regular checks and visits, classic telemedicine. Patients can describe their symptoms better through augmented reality. Additionally, with the help of AR, patients can see how the drug works in 3D in front of their eyes instead of just reading long descriptions on the bottle.
Researchers have investigated using VR to educate patients before their surgeries, too. For example, a person can see a digitized version of their brain, along with the problem a surgeon needs to fix and how they will do it.
- Diagnostics and surgical planning and simulation- One of the most pronounced advantages of this technology is that it allows healthcare professionals to learn new skills as well as retrain existing ones in a safe environment, without causing any danger to the patients. Surgeons planning their interventions, make them less likely to encounter surprises or feel unprepared.
- Surgery itself:
- Education and training in surgery, dentistry etc.- Surgical planning could become easier. Even the most experienced surgeons sometimes encounter surprises when operating on patients, but these high-tech solutions may make those instances less common.
These technologies could also improve training in medical school. Researchers at Johns Hopkins University embarked on an AR project that could see medical students trade their anatomy apps for AR. An augmented reality tool displayed an internal view of the body on top of a student’s physique. The technology also included a gesture-sensitive user interface, allowing people to interact with the AR representation.
- The main VR&AR enhanced surgery- The most common use of these technologies nowadays as they show digital information appearing on top of a patient’s body in real-time. Furthermore, this can help the assisting team in the operating room. For example, Nurses can find veins easier with augmented reality.
- The post-surgery patient care:
- Rehabilitation, for example, after a stroke and dementia. Augmented reality can save lives through showing defibrillators nearby
- Treatment and therapies for depressions, PTSD, autism, phobia, pain management, addictions.
Although the benefits of the XR in the use of healthcare speak for themselves there are also several risks associated with it. If we refer to the regular use of this technology in gaming, for example, Pokémon Go mentioned earlier, by now, it is officially conquered the world. It was reported that on the day when the game was launched, it immediately surpassed the daily time usage of Facebook, Snapchat or Twitter by the average iOS user on mobile phones. The side effects were soon to follow. For example, there were people who quit their job to become full-time Pokémon hunters. In Central Park, herds of Pokémon Go players almost caused a stampede as they tried to capture a rare type of imaginary animal. Car crashes due to the game application became a common phenomenon.
Beyond the daily life risks this technology imposes, there are several specific risks related to the healthcare field. The main risks being:
- Cyber-risk- since these technologies change the way people interact with data, the environment, and with each other, this risk implications become even more complex.
- The privacy of one's personal health information has escalated as a matter of significant concern for the public . Where does the limit for such information disclosure held?
- These technologies distract users from full awareness of their physical surroundings . Operators have reported being dizzy, disoriented, or nausea similar to motion sickness . This can be crucial in the operating room. The risk benefit balance therefore should be tightly monitored and maintained.
- Miss-registration between the real world being viewed and the superimposed virtual object. This can be risky when mentally unstable patients use these technologies . Furthermore, for an at-home patient who may become disoriented during a self-administered VR therapy session, the risk of injury is to be regarded seriously.
Surely there are also additional minor risks associated with each specific application.
Regulation of XR devices
The first step in determining the extended XR place among medical devices is by determination of its nature by analogy with existing legally regulated categories. Main medical device regulators in the US, Europe, Japan, and other markets have begun addressing some of the challenges through the expansion of guiding documents for the development and evaluation of the Software as Medical Device (SaMD), under which the XR is currently categorized.
The regulatory bodies around the globe are adjusting to the rapidly changing landscape of the technologies available to the end-users. Due to that adjustment, major attention was allocated to the Software as Medical Device field, including revision of the existing regulations and guidance documents and issuing new additional documents to support and expand the regulatory coverage of this field. Furthermore, the US FDA has established the Digital Health Center of Excellence, which goal is to empower stakeholders to advance health care by fostering responsible and high-quality digital health innovation.
The XR technologies are one of the catalysts for the special attention described above. For example, the US FDA held several meetings to discuss virtual and augmented reality in medicine as these technologies are becoming a major part of the healthcare landscape, currently in the surgical training and planning and therapy for pain, anxiety, and post-traumatic stress disorder .
Moreover, the US FDA is so interested in making these technologies available to the end-user in the safest and effective way that it supports the companies that develop XR devices by actual involvement in the development process using the Breakthrough Devices Program . For example, in October 2020, the FDA has granted breakthrough designation to AppliedVR's platform that treats chronic lower back pain and by doing so opened the door for broader use of virtual reality technology in healthcare .
The XR technologies outstand also in the FDA’s Software Precertification Pilot Program. One of the nine companies taking part in the FDA’s Pilot Program, Pear Therapeutics, is an XR developing company. The company products are currently FDA cleared with one of the products being the first product submitted through FDA’s traditional 510(k) pathway while also reviewed as part of FDA’s Software Precertification Pilot Program to help build and test FDA’s Digital Health Precertification Working Model 1.0. The company has been working closely with the FDA and volunteered to undergo the first-ever Excellence Appraisal in May 2019, which consisted of an onsite evaluation of the company’s commitment and execution across product quality, patient safety, cybersecurity responsibility, clinical responsibility, and a proactive culture 
Pear’s products are also part of a specific group of products designated by the FDA as the Prescription Digital Therapeutic (PDT)- a prescription-only software that delivers evidence-based therapeutic intervention(s) to prevent, manage or treat a medical disorder or disease. Designation of a specific characterization to a group of XR devices represents the emphasis the FDA is putting into these technologies.
The European (EU) regulation is pretty up-to-date as well when it comes to adapting to the rapid advances in technology. The rules on the approval of new medical devices have been updated relatively recently (in May 2017), and the EU is investing a lot in innovation. After a public consultation in 2017, the European Commission confirmed that one of the three priorities of the Digital Transformation of Health and Care in the Digital Single Market is “citizen/patient empowerment with digital tools for user feedback and person-centered care”. This ambition has been reconfirmed with the launch of a new instrument, the Digital Europe program. The European Union will invest €9.2 billion from 2021 to 2027 on several key digital challenges, including (e)healthcare & citizen empowerment .
Software Verification & Validation:
Interestingly, although the XR technologies are covered under the SaMD (Software as Medical Device) umbrella, currently approved devices are verified and validated using the harmonized EN 62304 standard and the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. This situation may change though when the new guidance documents and regulation of SaMD will be released and updated.
While no organization is immune to a cyber breach, organizations are expected to secure virtual and physical worlds. This is true especially when the technology is being deployed in critical situations, such as surgical procedures. Rather than viewing these issues as obstacles, meeting them head-on early in the process can help mitigate cyber risks, enable faster deployment and innovation, and reduce brand and reputational risks, both during development by the solution providers as well as during deployment at life sciences and health care organizations 
The first step for risk mitigation is the identification of the specific risks. Therefore, risk management should be considered the initially expected standard of care to be evaluated by the regulatory bodies. The risk assessment should begin with the fundamental issues such as identity and authentication in the virtual world that should differ from logging into a laptop with a user name and password to mitigate the risk due to cyber-attack. Embedding risk management throughout the process is crucial for digital transformation.
XR solution developers should incorporate security by design into their product lifecycle, and life sciences and healthcare organizations adopting these technologies should enhance their vigilance by monitoring related technology stacks on a real-time basis through integration to their overall security strategy in areas such as their Security Operations, Vulnerability Management, and Technical Resilience programs, among others. It is essential to integrate robust controls into the product or platform. It is expected by the customers and pursued by the regulatory bodies.
XR submissions are very in-depth and the amount of supporting clinical data. The requirements depend on the specific application of this technology varying from large, multi-centered, controlled studies, through retrospective evaluation, to no supporting clinical data at all.
Soon, we will be able to choose which reality we wish to live in, and regulation is here to make sure we use the benefits of this situation safely and wisely.
This article Prepared by:
Dr. Ella Sheiman, RA & QA Project Manager
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