General Terms of Service of the INCISIVE Platform (General ToU)

1. Definitions
   1. ‘AI Models’ – Artificial intelligence models (AI models) available for use on the Platform.
   2. ‘Central Node’ – Central data storage space that will host Data from the Data Providers, technically acting in the same way as the Federated nodes. The Central Node can be used as one node of the several INCISIVE Federated Nodes and/or as a centralised data repository where AI training can take place.
   3. ‘Central infrastructure’ – The cloud infrastructure of INCISIVE, provided using Azure technology, comprised by 4 Virtual Machines, located in Central France that contains the centralized services required to make the INCISIVE platform work.
   4. ‘Consortium Agreement’ – Consortium Agreement signed between INCISIVE Beneficiaries on 15 July 2020, and any future amendment of this agreement that will be signed.
   5. ‘Data Protection Laws’ – GDPR and any additional locally applicable data protection legislation.
   6. ‘Data Provider’ – An entity which contributes Data to the INCISIVE repository. Data Providers include INCISIVE Data Providers, on the basis of internal data sharing agreement between INCISIVE Beneficiaries, and third-parties, on the basis of respective Data Sharing Agreements.
   7. ‘Data Subject’ or ‘Subject’ – The patient or another person from whom the Data was obtained.
   8. ‘Data User’ – The entity or a person who uses the Data available in the INCISIVE repository for Federated Learning and/or AI training. During the term of the Project, Data Users will be INCISIVE Data Users. In time, INCISIVE repository will become open to cooperation with external Data Users
   9. ‘Data’ – Medical data and images made available in the INCISIVE repository, once made available for sharing.
   10. ‘Federated Learning’ – Means that AI model is trained in a distributed way using the required Federated nodes, i.e., the nodes that have the Data that matched with the user query. Each Federated or Central node contains a particular set of Data that may be required for training, and it will not leave the node to ensure privacy. The model is trained in each Federated node, including Central node, and then it is sent to the Central infrastructure to be merged to gather ‘central knowledge’. This training-merging process can be repeated more than once for the same model as the more times this is done, the more robust is the solution.
   11. ‘Federated Node’ – Dedicated infrastructure (cloud or local) in which the Data Provider stores the Data which they contribute to the INCISIVE repository.
   12. ‘GDPR’ – Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation).
   13. ‘General ToU’ – These General Terms of Service.
   14. ‘Grant Agreement’ – grant agreement number 952179 – INCISIVE signed by the INCISIVE Beneficiaries being Consortium Members and the European Union as the funding authority, and any future amendment of this agreement that will be signed.
   15. ‘INCISIVE Beneficiaries’ – Consortium Members under Grant Agreement; full list of INCISIVE Beneficiaries provided on the INCISIVE website.
   16. ‘INCISIVE Data Provider’ – Data Provider who is an INCISIVE Beneficiary.
   17. ‘INCISIVE Data User’ – The following INCISIVE Beneficiaries acting as the Data Users in during the INCISIVE Project:
       1. AI developers working in INCISIVE Project for the training and validation of AI solutions: INSTITUTE OF COMMUNICATION & COMPUTER SYSTEMS, CENTER FOR RESEARCH AND TECHNOLOGY HELLAS, ARISTOTLE UNIVERSITY OF THESSALONIKI, FUNDACIO TSCALUT, SQUAREDEV, UNIVERSITY OF HELSINKI, UNIVERSITY OF NOVI SAD, CENTRO REGIONALE ICT SCRL, VISARIS D.O.O.
       2. Beneficiaries working on INCISIVE development and testing of the repository: MAGGIOLI S.P.A., CENTRO REGIONALE INFORMATION AND COMMUNICATION TECHNOLOGY SCRL, BARCELONA SUPERCOMPUTING CENTER – CENTRO NACIONAL DE SUPERCOMPUTACION, EUROPEAN DYNAMICS LUXEMBOURG SA, TELESTO IOT SOLUTIONS LTD.
   18. ‘INCISIVE Project’ or ‘INCISIVE Action’ – project conducted in accordance with Grant Agreement no. 952179; details of the INCISIVE Project and INCISIVE Beneficiaries can be found at INCISIVE website.
   19. ‘INCISIVE Repository’ or ‘Repository’ – Pan-European repository of medical images and data, where each Data Provider maintains (stores) their data locally at chosen location, which includes either a Federated Node set up at own premises or premises selected by the Data Provider, or Central node, or both. The term encompasses both federated and hybrid data sharing.
   20. ‘INCISIVE website’ – Webpage available at https://incisive-project.eu/.
   21. ‘Platform’ – Platform (technical infrastructure integrating several components) provided by the Project which includes the INCISIVE repository, AI development workspaces for AI training, AI Models and the Inference services.
   22. ‘User’ or ‘user’ – Any person making use of the Platform or any services offered on the Platform, including the INCISIVE Data Providers and the INCISIVE Data Users as well as external users.
   23. ‘User Institution’ means organization or institution where individual Users are employed or otherwise members of.
2. General obligations
   1. These General ToU apply to all Users of the Platform, including Data Users and Data Providers.
   2. Users are required to provide accurate, complete and truthful information about themselves, their organization, their Data and AI Models and other details relevant to the use of Platform tools and services.
3. Technical requirements to use the Platform
   1. Minimal technical requirements to the use of the Platform:
      1. To make use of the INCISIVE platform on any system, an active internet connection is required.
      2. To use the INCISIVE platform through a browser on Windows, User will need: Windows 7 (or later) or Mac.
      3. To use the INCISIVE platform through a browser on Mac, User will need: MacOS High Sierra 10.12 (or later) or Linux.
      4. To use the INCISIVE platform through a browser on Linux, User will need: 64-bit Ubuntu 16.04+, Debian 10+, openSUSE 15.2+, or Fedora Linux 32+.
   2. Minimum Hardware requirements:
      1. Pentium 4 or newer processor that supports SSE2
      2. 512MB of RAM / 2GB of RAM for the 64-bit OS
      3. 200MB+ of hard drive space
   3. Recommended Hardware
      1. Pentium 4 or newer processor that supports SSE3
      2. 2GB of RAM / 8GB of RAM for a 64-bit OS
      3. 500MB+ of hard drive space
4. Registration in the INCISIVE Platform
   1. User can only use Platform after having registered, and upon registration, the user accepts these General ToU, on behalf of himself (herself) and – when acting as an administrator – on behalf of their organization, in their entirety and without reservation, as well as he/she acknowledges the Privacy Policy. In addition, depending on the applicable role, the user needs to accept the terms of the Data Sharing Agreement, terms applicable for the Data Users or specific conditions of the AI tool provided on the Platform.
   2. In order to use the Platform, the potential user must apply for access to the Platform. The approval of the user will be provided in accordance with the requirements and processes defined by the INCISIVE Project. This may include a process agreed to by IINCISIVE Project with EU funded initiatives, such as EUropean Federation for CAncer IMages (EUCAIM).
   3. In order to use the Platform the person representing the User Institution (acting as the administrator) will need to register, create an account and appoint users from the User Institution. By registering a user, the individual declares that they are legally competent in their own jurisdiction to enter into binding agreements, are at least 18 years and that they are the person whose details are provided in connection with their user account.
   4. User is not allowed to transfer their rights and obligations under these General ToU to any third party.
5. Rights and obligations of users of the Platform
   1. User must only use the Platform in good faith and in compliance with the applicable law.
   2. User must use all reasonable security measures when using the Platform.
   3. User must follow good practice within their institution in relation to the disclosure of (confidential) information on or through the Platform.
   4. User must keep their login credentials for gaining access to their account confidential and may not share them with others. Any unauthorised use of user’s login credentials not resulting from a security breach at the Platform side, shall be the user’s own responsibility and happen at their own risk. User is responsible to keep their information up-to-date and to back up any information they may require in the future.
   5. User is solely responsible for the use of the Platform through their account, whether or not authorised by the user, by any employee or co-worker of the user, any person to whom the user has given access to the services and/or any person who gains access to user’s Data or services as a result of a failure by the user to use reasonable security precautions.
   6. Notwithstanding any provisions of Consortium Agreement applicable between INCISIVE Beneficiaries, the user shall only use information obtained through the Platform for their own lawful purposes and with respect to any limits set in relation to that particular piece of information. Data Users shall observe limitations of the use of Data, as provided for in these General ToU and the Data User Terms.
   7. Unless otherwise provided for in the General ToU or the Consortium Agreement (when applicable), the user cannot share any information obtained through the Platform without the prior, explicit and written consent of all involved parties, including Data Providers.
6. Restrictions on the use of the Platform
   1. When using the Platform, the users must do so for lawful purposes only and cannot:
      1. use the Platform to share information and material infringing on anyone else’s rights;
      2. use the Platform or share any information or Data in a manner that would constitute a breach of other persons intellectual property rights or individual’s privacy (including uploading Data Subject’s private or personal information without a legal basis) or any other legal rights;
      3. attempt to re-identify any Data Subject’s whose Data is available on the Platform;
      4. use the Platform in any way that is or may be damaging to other users, INCISIVE Beneficiaries or in any way contrary to applicable laws and regulations, or that may cause harm to the Platform, or to any person or entity using the Platform;
      5. use the Platform to use, extract or disclose another user’s or third party’s data in any manner that is beyond or contrary to the General ToU, Data User Terms or any other terms and conditions of the Platform or to harm the intellectual property rights of INCISIVE Beneficiaries or third parties;
      6. modify, reverse engineer, decompile, or create derivative works from the Platform, or any of its elements (contrary to these General ToU, Data User Terms or without a specific permission) nor to remove or alter any copyright or other proprietary notices in the Platform, unless specifically authorized by the provider of the service or the tool;
      7. tamper with or modify the Platform, use or instal any viruses, spyware, malware, data gathering tools or any other malicious code or programming routines that may damage or interfere with the Platform, or any of its Data or tools, in connection with use of the Platform;
      8. disrupt the functioning of the Platform or make any changes to the Data shared in the Platform; this does not prevent conducting AI Model training on the Data, as long as the original Data hosted in the Federated Node or the Central Node (depending where the Data is stored) is not modified nor copied outside the relevant node;
      9. copy, modify, download, sell or exploit the Data or other content of the Platform (including and not limited to text, images, logos, etc.) in any other manner than permitted in these General ToU or Terms and Conditions for the Users without INCISIVE Project consent;
      10. take any action that imposes an unreasonable burden upon the infrastructure used to support the Platform, including but not limited to unsolicited e-mail, also called SPAM;
      11. facilitate or assist a third party to do any of the above acts.
7. Rights and obligations of the INCISIVE Beneficiaries
   1. INCISIVE Project and/or respective INCISIVE Beneficiaries reserve the right to:
      1. To remove or modify any of the Data, AI models or guidelines or other content that is infringing or otherwise deemed to be inappropriate or outdated. Data shared by an external Data Provider will not be modified by the INCISIVE Beneficiaries, however INCISIVE Project may decide to remove this Data from the Repository;
      2. To change or update the functionalities of the Platform;
      3. To restrict user’s access to their account or to suspend or delete their account in the event of infringement of these General ToU, other applicable terms or justified suspicion of the infringement;
      4. To change these General ToU, however the changes will not contradict the requirements of the INCISIVE project as provided for in the DoA (in particular, will not pertain to the core functionality of the Platform or the agreed use of Data);
      5. To record and monitor data traffic generated by users to verify compliance with the conditions of use as well as to track the use of the Data on the Platform. The activity of the users will be monitored in accordance with the Privacy Policy.
   2. INCISIVE Beneficiaries can take any of the above actions at any time and at their full discretion. User will be informed about these actions, as appropriate.
   3. INCISIVE Project is a research and innovation action and its results will be prototypes and not fully deployable technologies. In particular, AI Models, Inference Services or any other tools available on the Platform are research results and have not been the subject matter of clinical evaluation or conformity assessment. Platform or any of its services or tools must not be used for diagnostic or therapeutic decisions.
   4. The content or outcomes generated on the Platform (including predictions of the AI Models available on the Platform or Inference Services) cannot be construed as a legal, medical or other professional advice. The information or materials on this Platform are made available to provide general information only and no reliance should be placed upon it for any specific purpose. While care has been taken to ensure that such information on this Platform is accurate and complete INCISIVE Beneficiaries do not accept any liability where this is found not to be the case.
   5. The accuracy of the information and outcomes provided by the Platform and/or each respective tool or service is the result of best effort but cannot be guaranteed. Any use of the Platform, Data, AI Models, other tools and services or information provided through the Platform by INCISIVE Beneficiaries, or another party is at user’s sole discretion and at user’s own risk. INCISIVE Beneficiaries cannot be held liable for any damage caused by external user content, Data or information, as well as for the unless damage was caused by their wilful act or gross negligence.
   6. INCISIVE platform may be periodically unavailable, due to development work, maintenance or other unforeseen circumstances. INCISIVE will strive to inform the users in advance of the scheduled maintenance work. If the Data is stored in the Federated Node by its Data Provider, the Beneficiaries cannot guarantee uninterrupted access to Data. User is responsible for backing up any information for long term storage.
8. Liability
   1. All users and INCISIVE Beneficiaries are liable for their respective obligations under the GDPR and/or other Data Protection Laws applicable to them. External users shall be responsible and liable for any damages, losses and fines resulting from its own actions or failures to adhere to these terms and applicable Data Protection Law and shall indemnify and hold harmless INCISIVE Beneficiaries for any of such damages. For the purposes of this sub clause, actions or omissions of co-workers, or other employees contracted by users, shall be attributed to the user.
   2. Neither INCISIVE Beneficiaries nor the external Data Providers:
      1. are liable for any use by the Data User of the Data and/or Results created with the use of the Data, or any loss, claim, damage or liability of whatsoever kind of nature, which may arise from or in connection with the use, handling, storage or deletion of the Data and/or Results mentioned above, unless damage was caused by a wilful act or gross negligence;
      2. warrant or guarantee that the Data will be accurate, be merchantable or useful for any particular purpose, including the Data User’s research purpose.
   3. Should any liability arise, each INCISIVE Beneficiary shall be solely liable for any loss, damage or injury to third parties (including external Data Providers, Data Users or other users of services provided on the Platform) resulting from the performance of that Partner’s obligations by them or on their behalf under the Consortium Agreement or from its use of Results or Background.
   4. INCISIVE will make every effort to operate the Platform with reasonable care and skill, however these services and tools of Platform are brought by INCISIVE Beneficiaries, ‘as is’ and ‘as available’. INCISIVE Beneficiaries make no warranties as to the Results that may be obtained by using the Platform or the correctness of the information shared on the Platform. INCISIVE Beneficiaries are not responsible for verifying the Data provided by the external Data Providers. To the extent permitted by law, the INCISIVE Beneficiaries will not be liable for any damage, direct or indirect that the user may suffer in relation to their use of the Platform, any of its tools or services, or Data, unless the damage has been caused intentionally or by gross negligence. In the event of any default or liability between the INCISIVE Beneficiaries, the terms of Consortium Agreement will apply.
   5. The Platform may contain links to one or more third party websites. Those links are provided solely as a convenience to users and INCISIVE Beneficiaries are not responsible for the content or practices of third party websites or their operators and are not liable or responsible in any way for any loss or inconvenience in connection with use of a third party website.
9. Additional terms of use of the AI Models
   1. The User is responsible for reviewing the guidelines and terms and conditions of use of each AI Model which may be provided by the AI Model owner.
   2. User may use the AI Models available in the Platform only for purposes described below. User may not copy the AI Models.
   3. When uploading the AI Models to the Platform, unless otherwise specified, AI Model owner hereby grants to permitted Users a non-exclusive, perpetual and royalty free right to use Models for non-commercial research, teaching and patient care purposes within the Platform, for as long as the AI Model is available on the Platform.
10. Data Access Committee
    1. INCISIVE Project may establish a Data Access Committee to streamline the management and governance of the Data in the Platform. In particular, the Data Access Committee may verify the user requests and provide recommendations to the Data Providers on the user requests approval.
    2. Data Access Committee will act in accordance with the instructions of the Data Providers.
    3. INCISIVE is planning to connect to the pan-European infrastructure developed by the EUropean Federation for CAncer IMages (EUCAIM) and may cooperate or delegate certain administrative functions (such as maintaining of DAC) to this infrastructure to the extent that such functions will cover the required ethical and legal requirements at the local (Data Provider level), national and EU level. Further details of this cooperation will be developed and shared with the Data Providers and Users.
11. Termination
    1. The user may use the Platform for indefinite time, unless otherwise stated in his/her research proposal or in case the Platform services or operation are terminated or discontinued.
    2. If the user is violating the General ToU or Data User Terms, their account will be terminated with or without notice. INCISIVE Beneficiaries may pursue claims related to infringement of the General ToU by the user.
12. Governing Law and Jurisdiction
    1. These General ToU are governed by the Belgian Law. Whenever possible, the provisions of these General ToU 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 General ToU are found to be invalid, illegal or unenforceable, in whole or in part, the remainder of that provision and of these General ToU shall remain in full force and effect as if such invalid, illegal or unenforceable provision had never been contained herein.
    2. The user agrees to try and solve any dispute regarding the use of the Platform and these General ToU through negotiations. Should negotiations fail, then all disputes concerning the validity, interpretation, enforcement, performance and termination of these General ToU shall be submitted to the jurisdiction of the courts of Brussels.
13. Miscellaneous
    1. During the Project term, INCISIVE Platform is financed by the European Union’s Horizon 2020 research and innovation programme under grant agreement No 952179 and the use of the INCISIVE Platform by the approved Users is free of charge.
    2. INCISIVE Beneficiaries reserve the right to update these General ToU; therefore, the user should consult them regularly. The Platform content (including the Data) is subject to change without notice.
    3. The use of the Data provided by the INCISIVE Data Providers and used by the INCISIVE Data Users is governed by the Consortium Agreement and INCISIVE data sharing agreements (data processing agreement and joint controller agreement as amended from time to time) as concluded between those Beneficiaries. These General ToU terms do not modify the terms of those Agreements.