HOW IT WORKS
Community and Stakeholders Involvement
XRSI will invite key stakeholders and experts to participate in creating our framework in support of keeping XR based medical services, processes, products, ecosystems and devices safe and secure for patients, helping to ensure they are in the best interest of patient health.
Medical XR and Related Technologies
The resulting series of checkpoints are queried against an XR based medical service, process, or device.
XR based medical service, processes, or devices achieving a certain score based on compliance will be eligible to display the XRSI approved logo on their products and in their public communication.
Evaluation and Compliance
XRSI approved products will undergo regular audits and re-evaluations to ensure continued compliance.
Build Trust and Safety
Products or services meeting the XRSI requirements will enjoy the benefit of trust by patients and health care professionals world wide.
SCOPE OF THE FRAMEWORK
Privacy and Data Protection
XRSI will be focused 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 patient health.
XRSI does not provide guidelines for designing or creating healthcare devices, or any standard for efficacy of assessments, treatments or therapies.
Limited to Specific Data Protection Use Case
XRSI’s approval does not indicate nor endorse the effectiveness, safety, or benefits of any medical product or service outside of its use and protection of patient data.
Confidential Internal Reporting and External Facing Certification
The auditing process is targeted to audience whereas compliance and certification is made open and public. XRSI endeavors to ensure compliance but is not responsible for misuse of our logo. We encourage everyone to check our website regularly for updates on compliance of all applicants.
Here are some of the Frequently Asked Questions about this project
Why Should I Participate?
This is a chance to help shape the first specification of its kind. We see a great need for this in the industry and being an early adopter and a contributor will help the reputation of your company
What is My Expected Time Commitment?
Two hours a week on average for approximately six months.
What Will Be Expected of Me and My Company?
Participation in technical meetings regarding the data flow of your use cases, document reviews. Adherence to XRSI Code of Conduct is expected during participation.
Do I Get Paid for My Participation? Do I Have to Pay to Participate?
No payments of any kind are expected.
Will Participation Help My Product Meet Regulatory Requirements? Is there Support for This Project from Regulatory Agencies?
Participation will at a minimum increase you awareness of regulatory requirements compliance, both existing and upcoming. XRSI has secured participation from certain regulatory bodies to ensure alignment with the upcoming legislature. Additional regulatory bodies may join. Check back soon for the current list of partners. However, participation in this project will not directly help achieve approval from a regulatory agency..