TERMS OF USE OF THE CARAMEL Self-Assessment App

Last updated: APRIL 2026

1. General Provisions
1.1 These Terms of Use (“Terms”) govern access to and use of the CARAMEL Self-Assessment App.
1.2 The CARAMEL Self-Assessment App is developed and operated within the Horizon Europe research project “CARAMEL”, aimed at supporting cardiovascular disease prevention in menopausal women through research and data-driven analysis.
1.3 The CARAMEL Self-Assessment App is a publicly accessible component. The CARAMEL Self-Assessment App is intended for use by the general public. This component is not limited to study participants and may be accessed outside the strict framework of the CARAMEL clinical study, subject to applicable terms of use and data protection requirements.
1.4 By accessing or using the CARAMEL Self-Assessment App, you acknowledge that you have read and understood these Terms and agree to comply with them. If you do not agree, you must not access or use the CARAMEL Self-Assessment App.

2. Research Context
2.1. The CARAMEL Self-Assessment App is part of a scientific research project funded under the Horizon Europe programme. Its purpose is to support research activities, including data collection and analysis. The CARAMEL Self-Assessment App may provide research-based indicators or visualisations but:
• does not provide medical diagnosis,
• does not replace professional medical advice,
• does not replace consultation with qualified healthcare professionals, and
• does not constitute a medical device intended for clinical decision making.
2.2 Any outputs generated within the system are for research and informational purposes only.
2.3. No solely automated decision producing legal or similarly significant effects within the meaning of Article 22 GDPR takes place.
2.4 The CARAMEL Self-Assessment App is not intended for use in emergency situations. In case of medical emergency or urgent health concerns, users must immediately contact a qualified healthcare professional or the competent emergency services.

3. Eligibility and Access
3.1. Access to the CARAMEL Self-Assessment App is restricted as follows:
• The CARAMEL Self-Assessment App is available to the general public.
3.2 The Self-Assessment App is intended for use by the general public and does not require participation in the CARAMEL Study.
3.3. Access may be suspended or revoked if:
• participation in the Study ends,
• consent is withdrawn,
• misuse is detected,
• access is no longer required for project purposes,
• the Study period expires.
3.4 The CARAMEL Self-Assessment App is intended to be available and supported beyond the study period.

4. Acceptable Use
4.1. Users of the Self-Assessment App agree to use this tool:
• in accordance with the present Terms,
• in compliance with applicable law.
4.2 Users of the CARAMEL Self-Assessment App must not:
• attempt to access data of other participants,
• interfere with or attempt to bypass the CARAMEL Tools’ security measures,
• reverse engineer the software,
• upload malicious code,
• use the system for unlawful purposes.
4.3. Any violation of these Terms or misuse of the CARAMEL Self-Assessment App may result in the suspension or permanent termination of access to this App.

5. Intellectual Property 5.1 All intellectual property rights related to the CARAMEL Self-Assessment App, including software, databases, algorithms, models, documentation and underlying research results, remain the property of the respective CARAMEL consortium partners or the CARAMEL consortium as defined in the Project agreements.
5.2 Users are granted a limited, non-exclusive, non-transferable right to use the CARAMEL Self-Assessment App in accordance with these Terms.
5.3 Except for the limited right of use described above, no intellectual property or ownership rights are transferred to the users.

6. Data Protection
6.1 Processing of personal data in connection with the CARAMEL Self-Assessment App is governed by the CARAMEL Privacy Notice (available here).
6.2 Use of the CARAMEL Self-Assessment App is not conditional upon participation in the CARAMEL Study, and this tool may be accessed by the general public. Where personal data are processed in this context, such processing shall be carried out in accordance with applicable data protection law and based on an appropriate legal basis, which may include user consent where required.
6.3 Nothing in these Terms modifies or supersedes the allocation of roles and responsibilities defined in the Joint Controllers Agreement concluded between the CARAMEL consortium partners.

7. Service Availability and Security
7.1 The CARAMEL Self-Assessment App is a research system. Continuous or uninterrupted availability is not guaranteed.
7.2 Access may be temporarily suspended for:
• maintenance,
• security updates,
• technical reasons,
• regulatory compliance.
7.3. Users are responsible for maintaining the security of their devices and credentials when accessing the CARAMEL Self-Assessment App.
7.4 Access to the CARAMEL Self-Assessment App may also be suspended or restricted where necessary to address suspected security incidents, (suspected) data breaches, regulatory requirements, or instructions issued by competent authorities.

8. Limitation of Liability
8.1 To the extent permitted by applicable law:
• the CARAMEL Self-Assessment App is provided as research tools;
• no warranty is given regarding accuracy, completeness or fitness for a particular purpose;
• no medical guarantee is provided.
8.2 The consortium partners shall not be liable for:
• medical decisions taken based on system outputs,
• indirect or consequential damages,
• temporary unavailability due to technical reasons,
• misuse of the system by users.
8.3 Nothing in these Terms excludes liability where exclusion or limitation is not permitted under applicable law.
8.4 Each consortium partner is responsible solely for the components and functionalities operated under its control within the CARAMEL Tools. Nothing in these Terms shall be interpreted as establishing joint and several liability among consortium partners beyond what is required under applicable law.

9. Duration and Termination
9.1 Access to the Self-Assessment App is not limited to the study period and may be available beyond the duration of the CARAMEL Study, subject to these Terms.
9.2 Termination of access does not affect retention and processing of research data where such retention is required under:
• the study protocol,
• Horizon Europe funding obligations,
• applicable law.

10. Force majeure
The consortium partners shall not be held liable for any failure or delay in the performance of their obligations under these Terms resulting from events beyond their reasonable control, including but not limited to natural disasters, acts of government, regulatory restrictions, technical infrastructure failures, cyber incidents not attributable to gross negligence, or other force majeure events.

11. Amendments
11.1 These Terms may be updated to reflect, inter alia, changes in:
• project structure,
• technical infrastructure,
• regulatory requirements.
11.2 Users will be informed of material changes to these Terms by publication of the updated version within the relevant CARAMEL Tool or on the project website. Users are encouraged to review the Terms periodically.
11.3 Continued use of the CARAMEL Self-Assessment App after notification constitutes acceptance of the updated Terms.

12. Governing Law, Interpretation and Dispute Resolution
12.1 These Terms are governed by Portuguese law in relation to the CARAMEL Self-Assessment App without prejudice to mandatory provisions of EU law applicable to research participants.
12.2 Whenever possible, the provisions of these Terms and Conditions shall be interpreted in such a manner as to be valid and enforceable under the applicable law. However, if one or more provisions of these Terms and Conditions are found to be invalid, illegal or unenforceable, in whole or in part, the remainder of that provision and of these Terms and Conditions shall remain in full force and effect as if such invalid, illegal or unenforceable provision had never been contained herein.
12.3 The user agreed to try and solve any dispute regarding the use of the Platform and these Terms and Conditions through negotiations. Should negotiations fail, then all disputes concerning the validity, interpretation, enforcement, performance and termination of these Terms shall be submitted to the Jurisdiction of the Court indicated at 11.1.

13. Contact
The user agrees to contact the CARAMEL partners responsible for the CARAMEL Self-Assessment App via the following email addresses:

PARTICLE

• Marco Manso: marco@particle-summary.pt
• Bárbara Guerra: barbara@particle-summary.pt

MODULE A

Specific Provisions for the CARAMEL Self-Assessment App

A1. Operator
The CARAMEL Self-Assessment App is developed and hosted by PARTICLE SUMMARY, Lisbon, Portugal.

A2. Functionality
The CARAMEL Self-Assessment App enables users to:
• perform a structured cardiovascular self-assessment,
• visualise a risk indicator based on the provided responses,
• access CVD risk awareness and prevention materials in the CVD Prevention Portal.

A3. Nature of Outputs
Risk indicators:
• are generated using statistical or algorithmic models,
• are not diagnoses,
• do not constitute medical advice,
• must not be used as a substitute for consultation with healthcare professionals.
The outputs of the App shall not be relied upon for medical, therapeutic or diagnostic decision-making. Any health-related decisions must be made in consultation with a qualified healthcare professional.

A4. No Third-Party Commercial Components
The App does not incorporate third party analytics tools, marketing trackers or advertising technologies.