The Medical XR Privacy & Safety Framework aims at developing recommendations, tools, and practices for better personal data management in the critical area of Medical XR.

San Francisco, CA, August 10th, 2021 – The XR Safety Initiative (XRSI) launched today a new effort to build a safer, more private, and transparent immersive medical domain.

XR, a term standing for Extended Reality, is not just the sum of Virtual and Augmented Reality but represents the intersection of all the emerging technologies contributing to extending or augmenting the human experience in everyday life. 

XR Industry is moving fast, so is the urgency to create standards, guidelines, and awareness. Recent news about data, privacy, and safety concerns are growing as technological advancements take place. 

When XR is used in safety-critical domains, such as healthcare and law enforcement, privacy and safety must be ensured.

New opportunities…

Extended reality can be a critical added value for the whole medical device development process, ultimately speeding up the creation and testing of the product. Further, XR in the medical device development process can also help enable more efficient individuals’ feedback during research and testing. For instance, virtual feedback can inform changes to the ergonomics of a device and the surgical suite in a more efficient way before testing in the physical space.

Extended reality provides students and young physicians opportunities to participate in more practice scenarios than would typically be the case. Specific procedures or opportunities are extremely difficult to set up and execute. With XR, these rare offerings are now available with a click of a button. Practice is crucial to perfecting medical procedures, and XR is one way for clinicians to refine their techniques.

Beyond device development and training, XR can benefit the patient’s experience by pulling from the consumer and gaming industry’s focus on XR as an entertainment vehicle. Hospitals could adopt VR entertainment as a playful distraction for children undergoing stressful procedures. Virtual reality is already being explored for use in psychiatric care, such as treating phobias and an analgesic effect.

…and new challenges

This revolutionary era is made possible by the massive amount of data we generate, track, transmit, store, and process today. The growing data processing power of neural networks and machine learning models, relying on faster and more reliable network protocols such as 5G, makes this transformation quicker and more extensive. 

According to XRSI’s founder & CEO, Kavya Pearlman, “This convergence takes us into the era of Constant Reality Capture. With Software as a building material, it has already begun revolutionizing the healthcare domain. With COVID-19 putting a crippling amount of pressure on global healthcare systems, we are in dire need of building trust in these new ecosystems, applications, platforms, and devices. XRSI being in the business of building and enhancing trust is well-positioned to ensure we understand traditional threats and learn about novel issues. No matter what, we must protect patient data and build a safe and inclusive immersive healthcare domain.”

Principles and Scope

The Medical XR Privacy & Safety Framework is a free, globally accessible baseline rulebook.

Started as a spin-off of the XRSI Privacy & Safety Framework 1.1, it brings together a diverse set of experts from various backgrounds and domains. This includes privacy and cybersecurity, cloud computing, immersive technologies, artificial intelligence, legal, artists, product design, engineering, and many more. 

It is based on some fundamental principles: a patient-first approach, priority to patients’ data protection, the idea that patient data belongs to the patient, and their health and safety are the primary purpose for its collection, except where they have fully consented to its use to promote general healthcare for all as in research. On top of that, the idea is that all patients deserve access to the care they need. When healthcare providers utilize immersive equipment, the data collected on them also needs the same level of protection. 

“As an XR-based medical device developer – said Ryan Cameron, co-chair of the Medical XR Privacy & Safety Framework – it is obvious that XR-specific safety and security standards are critical to ensuring our systems support patient rights and safety and getting ahead of where regulators will be headed soon. Participating in the Medical XR Privacy & Safety Framework is a great opportunity to help make that happen.”

Starting today, XRSI is extending the invite to stakeholders and experts to participate in developing this framework. During the initial phase, a dedicated team will collect use cases to understand the types of novel personal data being tracked, stored, and processed in the ecosystem around this data’s lifecycle and the level of awareness in the industry of the privacy concerns regarding this data. Subsequent phases will build upon this knowledge to create a practical guide to XR data privacy to supplement XR-based healthcare systems’ current efforts for effectiveness and safety. 

The Medical XR Privacy & Safety Framework by XRSI will focus on the privacy and security aspects of patient data, helping to ensure the patient is informed to be qualified to consent to how it is used and ensuring data is only collected and transmitted in the interest of patients’ health. XRSI does not provide guidelines for designing or creating healthcare devices or any standard for the efficacy of assessments, treatments, or therapies. XRSI’s approval does not indicate nor endorse any medical product or service’s effectiveness, safety, or benefits outside its use and protection of patient data.

How to get involved

This project, completely unbiased and impartial, is currently ramping up and recruiting community participants. XRSI is collaborating with University of California San Diego researchers on this project. 

You can visit https://forms.gle/7FifHhxD61FxFwNTA to take the survey and become part of this development effort! 

You can get involved in many different ways: participating in the above survey, emailing medical@xrsi.org, or visiting medical.xrsi.org.

Development Timeline

August 10th, 2021 – OFFICIAL KICK-OFF

November 1st, 2021 – END OF CONTENT CURATION

December 7th, 2021 – FRAMEWORK LAUNCH

Notes to Editors

For interviews with the XRSI curators or further information, contact:

Ryan Cameron
ryancameron@xrsi.org
XRSI, Co-chair of the Medical XR Privacy & Safety Framework

Marco Magnano
marco@xrsi.org
XRSI, Director of Communications

About XRSI

XR Safety Initiative (XRSI) is a 501(c)(3) worldwide not-for-profit  Standards Developing Organization(SDO) that promotes privacy, security, and ethics in immersive environments. XRSI’s mission is to help build safe and inclusive experiences so that XR stakeholders can make informed and pragmatic decisions. XRSI does this by discovering novel cybersecurity, privacy, and ethical risks and proposing potential new solutions to mitigate them. XRSI, being the first such global effort, is uniquely positioned to provide impartial, practical information about XR and Spatial Computing-related risks and opportunities to individuals, corporations, universities, government agencies, and other organizations worldwide. In 2020, XRSI launched a novel XRSI Privacy Framework for the XR and Spatial Computing domain that was well received and has been a point of discussion among XR stakeholders worldwide.

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