Mobile APP Privacy Policy

This App privacy policy is intended to inform you of the collection and use of your personal data via this App developed by Medable or from a linked study device.

In providing this App supporting the study in which you are participating, Medable will be acting as a “Data Processor” (or a service provider) on behalf of the study Sponsor, Vertex Pharmaceuticals, who directs Medable and acts as the “Data Controller.”

This App will collect and process your personal data in order to facilitate your access to study activities. The App will only collect and process data that is deemed necessary by the Sponsor for the completion of the study and assessment of study endpoints or is required to enable the functioning of the App, and in all cases only as directed by the Sponsor.

Types of personal data

Personal data

Participant’s first and last name;
Participant’s telephone number of their mobile device onto which they downloaded the study App (for mobile device users)
Participant’s email address; and the password associated with the user account.
Patient-Reported Outcomes (PROs) via the Medable application. These PROs typically include a patient diary, patient survey, and any specific questionnaires supplied by the Sponsor. In these PROs, the Participants are typically prompted to provide: (i) health status (ii) daily activities (iii) Participant experience of the study.
Medable does not have access to the identity of Participants.

Purpose

Facilitating the usage of the App to complete study activities helpdesk support request has been initiated by the Participant.

For further information please see the Privacy Note for Technical Support that you can find in the Resources section of the App.Helpdesk support will be provided by Stefanini NV (subprocessor). Personal data will be stored in the European Union.

Capturing data points relevant to the primary/secondary/exploratory endpoints of the study

For users of TeleVisit functionality, Medable does not have access to the audio or video content of the TeleVisit. Recording of video, audio, and/or image capture is not enabled for the TeleVisit service.

Access to your personal data collected through the App

When you use the App, your personal information may be shared with:

Sponsor and investigators involved in the study (Patient-Reported Outcomes via questionnaires, diary and surveys).
Medable. Medable will not contact you unless you request helpdesk support.
Study Device vendors who provide services in connection with the operation of the App: Participant email addresses and phone numbers are only shared with third parties which require such information to fulfil functions on behalf of Medable: for example, device vendors who may assist Participants with a study device, or to the operators of reminder services which will send automated messages to Participants. Such third parties are utilized by Medable as subcontractors and are subject to equivalent data usage restrictions as Medable has agreed with the Sponsor.

Storage and security

Medable has established physical, technical, and administrative safeguards to protect the information collected. These safeguards are used to protect against unauthorized access, disclosure, and improper use of your personal data and to maintain the accuracy and integrity of that data.

Medable further commits to notify Sponsors about: (i) any legally binding request for disclosure of the Participant Data by a law enforcement authority (unless prohibited by applicable law); (ii) any accidental or unauthorized access to Participant Data of which Medable becomes aware; (iii) any request received directly from a Participant.

Retention

Your personal data collected through the App will be stored by Medable in the US and retained for as long as necessary to fulfill the purposes described in this privacy policy as directed by the study sponsor.

Questions about this Privacy Policy

If you have any questions or would like to exercise any rights you may have under applicable privacy laws regarding the personal data collected through the App, please contact the study doctor.