GENERAL TERMS AND CONDITIONS FOR USE
LIH Sonar Application

GENERAL TERMS AND CONDITIONS FOR USE OF THE LIH SONAR APPLICATION

1. Purpose

These General Terms of Use (“GTU”) govern access to and use of the mobile application LIH SONAR (the “App”), developed and provided by Luxembourg Institute of Health (hereinafter referred to as “LIH”), a public institute, having its registered office at 1A-B rue Thomas Edison, L-1445 Strassen, Luxembourg. (the “Institute”).

The App is made available exclusively for use within the clinical research study on vocal biomarkers for health monitoring (the “Study”) and shall be used solely in accordance with Study Protocol [V1.3 19/03/2026], as duly approved by the competent ethics and regulatory bodies pursuant to the laws and regulations applicable in the Grand Duchy of Luxembourg

The App is a companion research tool and does not provide medical advice, diagnosis, or treatment, nor does it replace interactions with healthcare professionals.

For the avoidance of doubt, the App is not intended by the LIH to serve any medical purpose within the meaning of Article 2(1) of Regulation (EU) 2017/745 on medical devices. The App does not perform diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of disease, and consequently does not fall within the scope of the Medical Device Regulation.

2. Eligibility and restricted Use

Use of the App is strictly limited to individuals enrolled in the Study who meet the following eligibility conditions:

2.1. Inclusion Conditions

The App may be used by adult individuals who:

• are 18 years of age or older;
• are able to understand the Study, provide informed consent, and comply with Study procedures, with reasonable accommodation where appropriate;
• speak at least one of the Study languages (French, English, German, or Portuguese);
• own and use a smartphone compatible with the App.

Study participants may be hospitalised or not and may be included with or without a specific disease, provided they meet the inclusion conditions.

2.2. Accessibility

Motor, sensory, or other functional impairments do not, in themselves, preclude participation or use of the App.

Where necessary, reasonable accommodation may be offered, including assistance with App use, adapted scheduling, or support with access to recording environments, insofar as compatible with the Study.

2.3. Exclusion and Restrictions of Use

Use of the App may be restricted or suspended if, at the time of screening or during the Study:

• a participant presents acute clinical instability such that Study procedures could reasonably interfere with medical care (e.g. need for immediate treatment, severe respiratory distress, or restrictions related to hospitalisation);
• or any other condition exists which, in the judgment of the Study’s medical leadership or qualified staff, would place the participant at unreasonable risk or prevent meaningful participation, despite reasonable accommodation.

2.4. Restricted Purpose

The App is provided solely for participation in the Study and may not be used for any personal, medical, or commercial purpose outside the Study framework.

3. Eligibility and restricted Use

The App provides two separate access profiles with role‑based permissions.

3.1. Study Nurse Access

Authorised study nurses may:

• manage participant lists and study visits;
• manage informed consent documentation;
• collect study data during visits, including questionnaires and standardised voice recordings.

3.2. Participant Access

Participants may:

• schedule study visits;
• complete at‑home monitoring tasks (health evaluations; medical and daily‑life diaries; voice journaling; standardised or free‑speech recordings);
• use an optional menstrual cycle tracking module;
• view graphs of the evolution of their own data.

4. Measurements and procedures

All Study‑related data, whether collected during on‑site visits or between visits are collected through the App.

4.1. At‑Home Monitoring (Optional)

Participants may complete, at any time and according to preference:

• self‑assessment of overall health status (0 -100 scale);
• mood description using a visual selection;
• Symptom ratings (0 – 10 Likert scale) (including stress, pain, fatigue);
• medical and daily‑life diary;
• voice journaling.

4.2. Scheduled and Adaptive Assessments

To limit burden, more in‑depth assessments may be proposed at an adaptive frequency (e.g., weekly, bi‑weekly, monthly), including:

• ad‑hoc questionnaires;
• cognitive tests (e.g., PROMIS v2 Cognitive Function 8a);
• additional health questionnaires and Patient‑Reported Outcomes (PROs) relevant to the participant’s health status;
• voice tasks such as sustained /a/ vowel phonation, DDK rate tests, reading a randomly selected sentence, and brief free speech on health status.

4.3. Notifications

The App may send notifications/reminders for tasks or assessments. Participants may deactivate notifications at any time within the App.

5. Optional Connection with External Health Applications

If the participant activates the function, the App may indirectly collect sleep duration, heart rate, weight, and physical activity data from Apple Health, Google Health linked to the participant’s devices.

This is optional, may be disabled at any time, and depends on the participant’s devices and the third‑party services. The Institute is not responsible for the availability, accuracy, or functioning of third‑party services.

6. Development Standards and Testing

The App has been developed with reference to the 2016 “Référentiel de bonnes pratiques sur les applications et les objets connectés en santé” (HAS, France). Before Study start, the App is tested by study nurses and test users to detect and correct potential technical issues.

7. Data Protection and Confidentiality

Data collected through the App is handled by LIH in the strictest confidence, limited to what is strictly necessary for the purposes of advancing scientific and medical knowledge in the field of voice biomarkers, whether for scientific purposes or to provide services.

Such data is treated with due care as confidential information relating to the user who provided it. LIH implements all appropriate technical and organisational measures required under applicable law to protect personal data against unauthorised access, disclosure, alteration, or loss.

Access to personal data is limited to authorised personnel involved in the Study or to service providers acting under LIH’s instructions, subject to confidentiality and data protection obligations. Personal data shall not be disclosed to third parties except where:

• required for the conduct of the Study,
• required by applicable law or a competent authority, or
• authorised by the user, where such authorisation is required under applicable law.

In the event that data is made available for secondary use to public or private partners, such use shall at all times remain compatible with the original purposes for which the data was collected, as described in the Informed Consent Form.

Under no circumstances shall LIH disclose data that directly identifies users of the application. Any data sharing shall be subject to appropriate contractual, technical and organisational safeguards designed to ensure that users cannot be directly identified from the information made available.

Users’ personal data is processed in accordance with:

• Regulation (EU) 2016/679 of 27 April 2016 (General Data Protection Regulation – GDPR), and
• Luxembourg law of 1 August 2018 on the organisation of the National Commission for Data Protection and the implementation of the GDPR, as amended (together, the “Data Protection Laws”).

For detailed information on the processing of personal data, including categories of data processed, purposes, legal bases, data retention periods, data subject rights, and contact details, users are invited to consult the Information for the Patient on the Processing of Personal Data / Data Protection Notice for the LIH SONAR App, which forms an integral part of the Study documentation

8. User Obligations

The user acknowledges that access to and use of the App:

• takes place within the framework of the Study and under the user’s responsibility;
• is subject to compliance with these GTU and applicable law.

The user undertakes to:

• use the App solely for participation in the Study;
• provide information that is accurate to the best of their knowledge;
• keep access credentials confidential and secure their device;
• refrain from any misuse, unauthorised access, interference, reverse engineering, or attempt to disrupt the App or its functioning.

The user remains responsible for any breach of these obligations and for the consequences thereof.

The user acknowledges that any health data or other information provided through the App will be processed by LIH in accordance with the GDPR and applicable Luxembourg law, and agrees that LIH may use, store and process such data for the purposes of the Study and for other scientific research purposes permitted under applicable data protection laws, including research activities that may lead to developments with potential commercial applications. The App is provided free of charge and for research purposes only. To the extent permitted by applicable law, LIH shall not be liable for any direct or indirect damage arising from:

• the use of, or inability to use the App;
• temporary unavailability, interruption, suspension, maintenance, or updates;
• technical incidents, network failures, or communication disruptions;
• acts or omissions of third parties providing infrastructure or communication services.

No guarantee is given that the App will be continuously available or error‑free. Nothing in these GTU excludes or limits liability that cannot lawfully be excluded, including liability for willful misconduct or gross negligence.

9. Intellectual Property

LIH SONAR is an application developed and owned by LIH.

LIH is the exclusive owner of all intellectual property rights, including copyrights, relating to the App, in particular to the application, its structure, architecture, source code, interfaces, databases, and content.

Nothing in these GTU shall be interpreted as transferring or granting to the user any intellectual property rights in or to the App or its services. Users are granted a limited, personal, non‑exclusive, non‑transferable, and revocable right to access and use the App solely for the purposes of participation in the Study, as defined in Article 2.

Users undertake to:

• respect LIH’s intellectual property rights and comply with all applicable laws, regulations, and provisions relating to intellectual property;
• refrain from using the App in any manner that may constitute infringement, counterfeiting, unfair competition, or parasitic use of information;
• refrain from representing, reproducing, extracting, exploiting, or making available, in whole or in part and on any medium, any content or data accessible via the App, including texts, images, audio samples, videos, logos, icons, and technical materials.

Users shall not:

• modify, adapt, translate, merge, decompile, reverse‑engineer, disassemble, or otherwise attempt to derive the source code of the App;
• create derivative works based on all or part of the App or its components.

Any breach of the obligations set out in this Article may give rise to personal liability of the user and may result in the termination of the right to use the App, without prejudice to any other remedies available to LIH under applicable law.

10. Limitation of Liability and Disclaimer of Warranties

“As Is” Basis: The App is provided “AS IS” and without any warranties of any kind, either express or implied, including fitness for a particular purpose.

To the maximum extent permitted by law, LIH shall not be liable for any direct, indirect, or consequential damages arising from your use of the app, including inaccurate health data, system downtime, or failure to follow professional medical advice.

11. Availability, Updates, Deactivation and Uninstallation

The App is provided free of charge for the duration of the Study. Updates may be deployed for security or functionality purposes.

At the end of the Study, the App will be deactivated and no longer accessible. Participants may uninstall the App at any time. Uninstallation does not, in itself, constitute withdrawal from the Study.

12. Governing Law and Jurisdiction

These GTU are governed by Luxembourg law. Any dispute shall fall under the jurisdiction of the competent courts of Luxembourg, without prejudice to mandatory legal protections.

13. Contacts

Publisher / Data Controller: Luxembourg Institute of Health

Address: 1A-B rue Thomas Edison, L-1445 Strassen, Luxembourg

Support: sonar@lih.lu

Data Protection Contact / DPO: dpo@lih.lu

14. ePrivacy and Device-Based Technologies

The App does not use cookies, or comparable tracking tools. The App may however send data through electronic communications networks when the user enables the optional coupling with external health applications, (such as Apple Health or Google Health via their respective APIs), and it may use push notifications to remind users of Study tasks.

In accordance with Article 5(3) of the ePrivacy Directive and applicable Luxembourg telecommunications rules, LIH shall obtain the user’s prior consent where required for the use of push notifications and for any functionalities involving the transmission of data via electronic communications networks. Users may deactivate push notifications at any time directly within the App through a dedicated on/off control.

All other consent settings relating to App functionalities may be modified directly within the App, and such changes are recorded accordingly. Withdrawal from the Study remains subject to the dedicated in‑App withdrawal process or, alternatively, the contact methods indicated in the Study documentation. These ePrivacy requirements apply irrespective of whether the transmitted information constitutes personal data and operate in parallel with the GDPR.

Contacts

Publisher / Data Controller:
Luxembourg Institute of Health

Address:
1A-B rue Thomas Edison,
L-1445 Strassen, Luxembourg