Document control:

ID TD 2.1 Status Final
Owner Thomas Timmers Classification External
Version 1.0 Date 29-07-24
Prepared by Anne Sophie Dil (NAALA) Date 17-2-2022
Approved by Management Team Date 12-08-2024

| Applicable standard / regulation | • Regulation (EU) 2017/745 on medical devices  | | --- | --- |

Review log:

Version Changes Reviewer Date
0.1 Checked and finalized the document in new style, added references and synced content. PS 29-07-2024

Instructions for Use (IFU) for Patient Journey App (PJA) (EN)

Welcome to Patient Journey App (PJA), a cloud-based platform designed to revolutionize remote healthcare management. This platform empowers healthcare professionals to provide seamless and efficient care to patients from the comfort of their homes. Through PJA, healthcare professionals can create personalized patient journeys that include data collection, educational content, notifications, and communication tools. For patients, PJA offers timely and relevant information, reminders, and a convenient way to stay connected with their healthcare providers. This Instructions for Use (IFU) document provides comprehensive guidance on setting up and using the Patient Journey App to ensure optimal performance and user satisfaction.

Manufacturer Information

Interactive Studios BV

Parallelweg 27

5223 AL Den Bosch

Netherlands

Website: www.patientjourneyapp.com

Email: [email protected]

Interactive Studios BV is committed to providing innovative digital solutions that enhance patient care and streamline healthcare workflows. For any support or inquiries, please contact us through our website.

1. Intended Use

Patient Journey App is a cloud service intended to support healthcare professionals in offering remote care and monitoring services.

Healthcare professionals can develop their own patient journeys within the platform. These journeys may include data collection (e.g., PROMS, PREMS, vital parameters, photos), signals based on decision trees/algorithms, educational content (e.g., disease and treatment information, self-management competences, pre- and rehabilitation exercises), push notifications, reminders, and communication functionality (e.g., chat of video conference). Healthcare professionals may configure such a journey in a timely manner, meaning patients receive all of the above at a time that is most appropriate given the phase, state or duration of their treatment.

Patients are linked to one or more journeys by their healthcare professional and can download the app. From the app, they receive the requests from data, educational content, push notifications and reminders on their personal timeline. In addition to the timeline, the app offers an information library, contact and communication functionalities and a personal profile in which they can configure the app.