At the start of the study, the study site will assign you with a study participant number / study reference number. Only this study reference number will be shared with us by your clinical trial site, to allow us to track and link your data within our system. OKKO Health will not receive your name, date of birth, email address or any other personal identifiers. OKKO Health will not hold nor have access to the key which allows you to be identified from this reference number and so we will only know you by this number.
This means that your Personal Data that is processed at OKKO Health is what is called pseudonymised (further information on what this means can be found on the ICO website (ico.org.uk)) to provide additional protection for your data. That said, this data remains Personal Data and as such, will still be processed, stored and managed within the same level of care and security as all other Personal Data processed at OKKO Health.
As a user of the OKKO Health App, we will also collect sensitive Personal Data about your health. This is described in further detail below. The purpose of data collection is written next to each.
General health information (sensitive):
- Details of diagnosis: to provide a tailored experience, for example, by recommending articles relevant to your eye condition.
- Treatment details: to provide a tailored experience, for example, by recommending articles relevant to your eye treatment and to understand your response to treatment.
- Symptom details: to provide a tailored experience, to capture symptoms over time for you and your Healthcare Provider to review and keep a record of how your symptoms change over time.
- Healthcare Provider details: to access the application you will be provided with an organisation code. The purpose of this code is to link you to your Healthcare Provider (Clinical trial site) and ensure that they are able to access your data.
App captured vision data (sensitive):
- Data about how your vision functions which may include data relating to your visual acuity, sensitivity to low contrast, sensitivity to colour contrast, and sensitivity to distortions: to fulfil the expected use of the OKKO Health medical device software designed to acquire and visualise objective quantifiable data related to visual function in an ambulatory or a clinic setting, used as an adjunct to decision making at the next clinician visit. This information will be made available to your linked Healthcare Provider (research / study site) via the OKKO Health Platform.
Other app captured data:
- Details about your device:
- App version: to ensure you are running the latest version of the app
- Device model and physical status of the device (e.g. screen brightness): to ensure your phone has the minimum requirements to run our app to the appropriate standard and to ensure the quality and consistency of the results
- Unique Device Identifier: to enable us to send push notifications to you to remind you when to play, to highlight updates to the app and the resources available to you.
- Details about how you interact with the device and app:
- Time of gameplay session: to allow us to understand how your vision varies at different times of the day.
- Measurements on how far you are from the screen, using the front-facing camera: to help give the most accurate vision results. We do not collect or store any images or any data that could identify your face.
- Data points about the position and orientation of your head while playing the games, using the front-facing camera: to determine how far you are from the screen only during active gameplay. We do not collect or store any images or any data that could identify your face.
- Information about what and where you tap on the screen and when: to help us understand the limits of your vision and how accurately you respond.
Please note that the information you provide and that which is captured via the app in relation to your vision will be available to the Healthcare Provider (research / study site) through which you are using the application on the OKKO Platform.
As part of the study, you may be invited to participate in an online or paper based survey. As above, in such a survey the only personal identifier we will request is your study reference number; name, email address, etc. is not requested. Surveys may cover questions relating to your health and/or to your experience of using our app.
Lawful basis for processing this data:
Consent
Any information about your health is classed as sensitive Personal Data and we ensure that additional safeguarding measures are in place to protect this information. Our lawful basis for processing this sensitive Personal Data is your consent. You can withdraw your consent at any time - for more information, please email [email protected].
Consent is given (by confirming your agreement to this Privacy Notice) at the time of informed consent for inclusion in the study at the research / study site and within the app sign-up process.