Confidentiality {27}
All data handling is in accordance with the European Union General Data Protection Regulation (GDPR) 2016/679 and the Canadian Personal Information Protection and Electronic Documents Act (PIPEDA). By fulfilling PIPEDA, the device also covers the Alberta Freedom of Information and Protection of Privacy Act and Health Information Act. All study data submitted to the sponsor will be de-identified. An identification list of participants will be kept separately and securely in password-protected, encrypted computer files.