Annex II. Dataset Access Request Template

This annex shows the details of the documents required by the negotiator when requesting access to existing datasets, which are already exposed in the catalogue.

APPLICATION DOCUMENTS (Data User-Researcher, Innovators, Members):

The documents has 6 main sections

1. Request summary, automatically filled with the dataset requested.

2. Contact Details. This section

• Organization name and acronym (Applicant organization name and acronym).

• Title, Name and Surname of the Principal Investigator.

• Expected timeline for the realization of the use case (maximum 2 years)

• Phone Number (including the country code)

• Role of the applicant in the organisation.

1. Scientific Relevance

• Title of the use case

• General description of the use case, including main objectives, expected results, expected technical and/or clinical impact, methodology (max 600 words)

• Expected timeline for the realization of the use case (maximum 2 years)

• Please provide a description of the intended use and expected benefit related to the use of the EUCAIM data, including a description of the AI algorithm(s) you wish to train/validate (max 600 words)

• Please provide an estimation of the period during which the electronic health data is needed for processing in secure environment

• Additional comments

1. Ethical and legal requirements

• Available (or not) ethical approval, selecting one of the following options:

  • A certificate of ethics approval by an ethics committee is available for your Project

  • You have already applied for an ethics approval from an ethics committee

  • No action has been taken yet to obtain an ethics approval from an ethics committee

  • o need for approval of an Ethics Committee according to national law

• Law Obligations, selecting one of the following options:

  • You are able to demonstrate the due diligence in complying with the GDPR.

  • You are currently not yet able to demonstrate the due diligence in complying with the GDPR, but are working towards it.

  • You are not able to demonstrate the due diligence in complying with the GDPR and have not started working on it yet.

  • Use case not subjected to specific obligations related to GDPR.

• Due diligence, selecting one or more of the following options:

  • A certification or statement issued by your Data Protection Officer

  • A Data Protection Impact Assessment report or independent Audit.

  • Membership of codes of conduct or certification schemes or equivalent documentation.

• Medical Device Regulation, selecting one of the following options:

  • Yes

  • No

  • N/A

• AI tools validation, selecting one of the following options:

  • An AI risk analysis (preferably using the ALTAI tool) for assessing AI-based technologies is already available.

  • An AI risk analysis (preferably using the ALTAI tool) for assessing AI-based technologies is not available yet, but you are working towards it

  • An AI risk analysis (preferably using the ALTAI tool) for assessing AI-based technologies is not available.

  • N/A

• Legal compliance. Confirm the acceptance that you will be committed to provide further information and documents about the compliance with the legal and ethical requirements and to sign all the relevant agreements.

• Additional comments

• Confidentiality clause, confirmation of the confidentiality clause, which indicates that the information disclosed by the applicants will be kept confidential, shall be exclusively used for participation in EUCAIM. IPR developed by the applicants is exclusively owned by the applicants.

1. Confirnation, which confirms that by submitting the form, the personal data of the user will be electronically processed for the purpose of the Data Access application, confirming the applicant allow EUCAIM to share this information with other partners for this purpose.