The app can only be used with a login.
The review login is “thegreatestappreviewer”. (without quotes)
Bluetooth demo video can be found here (download the file to play): https://evoleen.sharepoint.com/:v:/s/Dropbox/EfV_GGXrpW9Ft6325DvP6QsBlCjLO6bHMP14kP46sBKioQ?e=bNpagT
Video shows:
The app is NOT a COVID-19 app, the app is unrelated to the pandemic.
The app is intended to accompany a clinical study validating a wearable cough monitor for patients who are in treatment for chronic cough (these patients are NOT COVID-19 patients).
The app’s purpose is to transmit data from the wearable (such as charging state and number of coughs detected) to the cloud and ask the user to fill out a daily questionnaire according to the study protocol.
The app is used in an approved clinical study. The approval documents are linked below:
Ethics Committee Approval (https://evoleen.sharepoint.com/:b:/s/Dropbox/EZpp-eB1d3RDmTfRM-tzRPEB0uPrkFGtqqr45WudKraH2Q?e=6TkUen)
Swissmedic Approval (https://evoleen.sharepoint.com/:b:/s/Dropbox/Eb5lbN9GVAZIoYjslHHwiqoBpN9unxpdCI_-hGA1vi3n6w?e=TVR8RR)
The target audience are patients who are enrolled in the clinical study. Patients who are not enrolled in the study cannot use the app because a) they do not possess a valid study pseudonym to log in and b) they do not have the required wearable.
The app asks for Bluetooth permissions (to connect to the wearable) and for local notification permissions. The permission strings are:
Notification permissions are optional, Bluetooth is required to use the app.
There are no other uses of the requested permissions beyond those stated in the permission string.
The app does not require and does not collect any personal information.
The app does not require and does not collect any personal information.
Access is only possible to persons who have been explicitly granted access in the approved study protocol.
Data is only shared with parties who are part of the study protocol.
The app asks the user to share crash reports to enable field monitoring for unexpected bugs. This step is entirely optional and the app is fully functional without sharing crash reports.
The app is intended to be used in Switzerland. The study hospital attracts patients from neighbouring countries so users may have their app store account in Switzerland, Germany, Austria, Italy or France but the study is performed by a Swiss hospital according to Swiss regulations.
It is not intended to change or expand the intended jurisdiction.
The use of the app is not mandatory, not required by the government and participation in the clinical study is entirely voluntary. There are no consequences of not using the app or not participating in the study.
The study is officially approved.
Ethics Committee Approval (https://evoleen.sharepoint.com/:b:/s/Dropbox/EZpp-eB1d3RDmTfRM-tzRPEB0uPrkFGtqqr45WudKraH2Q?e=6TkUen)
Swissmedic Approval (https://evoleen.sharepoint.com/:b:/s/Dropbox/Eb5lbN9GVAZIoYjslHHwiqoBpN9unxpdCI_-hGA1vi3n6w?e=TVR8RR)
This app does NOT provide any COVID-19 related services.
No, the app is independent of any company and not intended for users of a specific company.
The app is intended to be used by patients participating in a clinical study.
No, the app is independent of any company. The app is intended to be used by patients participating in a clinical study.
All features of the app are intended for participants of a clinical study. Any patient can ask to be enrolled but the enrollment decision is made by the study hospital according to the enrollment criteria of the approved clinical study protocol.
The study hospital is the University Hospital of Zurich, Switzerland. Patients are typically from Switzerland and neighboring countries, so the app needs to be accessible for users from Switzerland, Germany, Austria, France and Italy. (ideally for users in Europe)
The study hospital enrolls a patient and assigns an anonymous code to them. The study hospital then submits the anonymous code to us, for which we create a corresponding account. This is done so that we cannot identify the patient.
Once the patient has logged in, the app secures the account so nobody else can access it.
Any individual may apply but the enrollment decision is made by the medical staff of the study hospital according to the approved study protocol.