INSAFEDARE Open Training Platform for Synthetic Data and Digital Health Regulation

INSAFEDARE Training Platform

Terms of Use

Effective date: 20 October 2026

1. Introduction and Acceptance of Terms

Welcome to the INSAFEDARE Training Platform, accessible at https://training.insafedare.org.

The platform has been developed within the framework of the INSAFEDARE project, partly funded by the European Union's Horizon Europe Research and Innovation Programme under Grant Agreement No. 101095661.

The platform provides educational resources and online training activities relating to regulatory decision-making in digital health and medical devices.

These Terms of Use govern access to and use of the platform, including publicly accessible learning materials, registered user accounts, training activities, assessments and certificates.

By accessing or using the platform, users agree to comply with these Terms of Use. Registered users may be required to explicitly accept these Terms during account registration.

If users do not agree with these Terms, they should not register for an account or use services that require acceptance.

2. Platform Administration and Contact

The INSAFEDARE Training Platform is operated as part of the educational and dissemination activities of the INSAFEDARE project.

Platform administration: EFMI - European Federation for Medical Informatics

Contact email: insafedare@gmail.com

Website: https://training.insafedare.org

The allocation of responsibilities among the participating organisations is subject to the applicable project arrangements.

3. Eligibility and User Registration

The platform is intended exclusively for individuals aged 18 years or older.

Users who register for an account must:

• Be at least 18 years old.
• Provide accurate and up-to-date registration information.
• Maintain the confidentiality of their account credentials.
• Use their accounts only for their own educational participation.
• Refrain from sharing account credentials with other individuals.

Accounts are personal and may not be transferred to another individual.

The platform administrator reserves the right to suspend or deactivate accounts where there is reasonable evidence of misuse, inaccurate eligibility declarations, security concerns or serious violations of these Terms, subject to applicable law.

4. Access to Learning Materials and Courses

Certain educational materials may be accessed without registration.

Registration may be required to enrol in courses, complete assessments, monitor learning progress, participate in restricted learning activities or obtain certificates.

Access to the INSAFEDARE training programme is provided free of charge.

The platform administrator may modify course availability, technical features or learning activities where reasonably necessary for educational, operational, security or project-related purposes.

5. Training Programme Structure and Accreditation

The INSAFEDARE training programme, titled "Regulatory Decision-Making in Digital Health and Medical Devices", consists of a foundational module and specialised learning modules.

The training programme is based on an EFMI-accredited training syllabus, titled “Regulatory Decision-Making in Digital Health and Medical Devices”.

This accreditation concerns the educational programme and its approved syllabus. It should not be interpreted as regulatory approval of medical devices, authorisation to perform regulated professional activities or certification of an individual's professional competence.

Module 1 introduces fundamental concepts and serves as a prerequisite for participation in the specialised Modules 2–5.

Users are responsible for completing the applicable learning activities and assessments according to the requirements published within each course.

Specific assessment criteria, completion requirements and learning outcomes are communicated through the relevant course pages.

The platform administrator may correct technical or administrative errors affecting enrolment, assessment results or completion records.

6. Assessment and Certificates

Certificates of completion may be issued to registered users who successfully fulfil the applicable course requirements. These certificates confirm successful completion of the relevant training activities delivered under the EFMI-accredited training syllabus.

Certificates reflect successful completion of the specified training programme or specialisation, delivered within the framework of an EFMI-accredited syllabus.

The exact issuing organisation, authorised signatory and certificate wording are determined by the arrangements approved for the training programme.

Unless expressly stated in the certificate or accompanying official accreditation documentation, a certificate:

• Does not constitute a professional licence.
• Does not authorise the holder to perform regulated professional activities.
• Does not constitute approval or certification of a medical device.
• Does not replace conformity assessment or other regulatory procedures.
• Does not independently establish professional competence beyond the learning outcomes assessed by the programme.

Users must complete assessments independently and must not misrepresent their identity, participation, results or qualifications.

Certificates may be corrected or withdrawn where they were issued as a result of demonstrable administrative error, fraudulent activity or material violation of the assessment rules, following appropriate review.

7. Disclaimer – Use of Learning Materials

This learning material has been developed within the framework of the INSAFEDARE project, which was partly funded by the European Union's Horizon Europe Research and Innovation Programme under Grant Agreement No. 101095661.

As part of the project dissemination and educational activities, the consortium has developed learning content based on publicly available project results.

The materials made available through this platform are provided for information and educational purposes and are subject to the intellectual property rights of the relevant INSAFEDARE project partners and other applicable rights holders.

Users are permitted to access, download and retain copies of the learning materials for their own personal, non-commercial educational use and skills improvement, subject to any specific licence or restrictions indicated for individual materials.

This permission does not authorise the redistribution, public publication, commercial exploitation, adaptation or modification of protected materials without prior authorisation from the relevant rights holder(s), except where permitted by applicable law or an existing licence.

Users are responsible for ensuring compliance with applicable copyright, licensing and intellectual property requirements when using the materials.

While reasonable efforts have been made to ensure that the learning materials and information contained herein are accurate, the materials may contain errors, omissions or information that becomes outdated. The INSAFEDARE project partners do not guarantee the completeness, accuracy or continued applicability of the materials.

Nothing in these Terms excludes or limits liability where such exclusion or limitation is prohibited by applicable law.

8. Intellectual Property Rights

Unless otherwise indicated, educational content, texts, presentations, graphics, assessment materials and other resources available through the platform remain subject to the intellectual property rights of their respective owners.

Access to the platform does not transfer ownership of any intellectual property rights to users.

Users may:

• Access publicly available educational materials without registration, where permitted by the platform.
• Download learning materials made available for download.
• Store copies on personal devices for individual educational use.
• Consult the materials for personal learning, professional development and skills improvement.

Users must not, without appropriate authorisation or another applicable legal permission:

• Redistribute protected materials to third parties or upload them to publicly accessible repositories.
• Commercially exploit protected learning materials.
• Reproduce substantial portions of the materials in other publications or training programmes.
• Adapt or modify protected content for redistribution.
• Remove or alter copyright notices, acknowledgements or attribution information.
• Present INSAFEDARE materials as their own original work.
• Use project names, logos or branding in a manner that falsely suggests endorsement or authorisation.

Where specific materials are made available under an open licence or separate reuse terms, those terms apply to the relevant materials.

9. Acceptable Use and User Conduct

Users must use the platform responsibly, lawfully and respectfully.

Users must not engage in activities that:

• Disrupt or compromise platform security or availability.
• Attempt to gain unauthorised access to accounts, data or administrative functions.
• Introduce malicious software or harmful content.
• Infringe the intellectual property, privacy or other rights of third parties.
• Involve harassment, threats, discriminatory abuse or unlawful content.
• Manipulate assessments or misrepresent training achievements.
• Use automated methods to extract platform content or personal data without authorisation.

Where discussion forums or other interactive features are available, users must communicate professionally and avoid disclosing confidential, sensitive or third-party personal information without an appropriate lawful basis.

10. Privacy and Personal Data Protection

Personal data collected through the platform are processed in accordance with the INSAFEDARE Training Platform Privacy Policy and applicable data protection legislation, including the GDPR.

The Privacy Policy explains the categories of personal data processed, purposes and legal bases of processing, retention periods, applicable rights and contact procedures.

Users are encouraged to review the Privacy Policy before registering.

Privacy Policy: [Link to published Privacy Policy]

11. Platform Availability and Technical Requirements

The platform is provided using the Moodle learning management system.

Reasonable efforts are made to maintain its availability, accessibility and technical reliability. However, uninterrupted or error-free access cannot be guaranteed.

Temporary interruptions may occur due to maintenance, software updates, technical failures, cybersecurity incidents or circumstances outside the reasonable control of the platform administrator.

Users are responsible for maintaining suitable internet access, compatible devices and appropriate browser settings.

12. Educational and Regulatory Disclaimer

The educational materials are intended to support knowledge development and professional learning.

They do not constitute individual legal, medical, clinical or regulatory advice.

References to medical device regulation, digital health technologies, regulatory frameworks or conformity assessment procedures are provided for educational purposes and must be interpreted in the context of the applicable legislation and official regulatory guidance.

Users remain responsible for consulting authoritative sources and obtaining appropriate professional advice before making decisions with legal, clinical, technical or regulatory consequences.

Participation in the training programme does not imply endorsement, approval or certification by any regulatory authority.

13. Third-Party Content and External Links

The platform may contain references or links to external websites, publications, standards, regulatory resources or other third-party materials.

Such resources may be governed by their own terms of use, privacy policies and intellectual property arrangements.

The inclusion of external resources does not necessarily imply endorsement of their content by the INSAFEDARE project partners.

14. Suspension and Termination of Access

The platform administrator may restrict, suspend or terminate access where reasonably necessary to address serious violations of these Terms, security risks, fraudulent activity or legal obligations.

Where appropriate, users will be informed of the reason for such action and given an opportunity to seek clarification or correction.

Account termination and the handling of associated personal data will be governed by the Privacy Policy and applicable law.

15. Changes to These Terms

These Terms of Use may be updated to reflect changes in platform functionality, educational activities, applicable law or organisational responsibilities.

The current version will be published on the platform with its effective date.

Where changes materially affect registered users, appropriate notice will be provided and renewed acceptance may be requested where necessary.

16. Contact

For questions about these Terms of Use, access to the platform, educational materials or training activities, please contact:

INSAFEDARE Training Platform

Email: insafedare@gmail.com

Website: https://training.insafedare.org