1 Introduction
XpanDH – ‘Expanding Digital Health through a pan-European EHRxF-based Ecosystem’ is a project that aims to mature and accelerate a sustainable and scalable interoperability environment for digital health innovations based on the EEHRxF, around 5 Goals:
- To develop robust technical specifications and resources for the EEHRxF building;
- To establish the X-Bundle Readiness model;
- To verify the usefulness of the X-Bundle in real-world with a set of early adopters grouped under selected adoption domains;
- To mature a pan-European digital health ecosystem of solution providers and end-users,
- To develop a framework for sustainable ecosystem (X-Nets).
In order to expand the XpanDH network and increase the capacity of development of their work, the project is opening a call that intends to include partners able to contribute with the project as associated partners on the following activities:
- Support the development of the EEHRxF technical specifications
- Support the experimentation on the X-bubbles
- Support the ethical/cybersecurity transversal specifications
The interested entities will demonstrate their interest to integrate the project by a process described below to provide their information and their inclusion on the project will be conditionate by voting process.
1.1 Objectives
The inclusion of new partners on XpanDH project intends to strength the project development by the addition of the partners expertise that can contribute directly with one or more tasks of the project, and also expand the X-Nets of the project.
1.2 Scope
This document intends to present the concept behind the inclusion of the new partners on XpanDH project as well specify the process required to integrate new associated partners to the XpanDH project.
1.3 Concepts
1.3.1 Associated Partner
An Associated Partner[1] in Horizon Europe is an international partner in Horizon 2020. An Associated Partner (AP) is an entity that works for the EU project but cannot declare costs and needs to have its own budget. It can be linked to one beneficiary or more beneficiaries. It can also be linked to the entire consortium. They are not eligible for funding.
- Associated Partner does work but cannot declare costs
- Associated Partner can be linked to the whole consortium or to a particular beneficiary
- The beneficiaries must ensure that relevant MGA obligations are also extended to AP (e.g. through the consortium agreement)
- They do not access the Funding & Tenders Portal
1.3.2 X-Net XpanDH partner
The XpanDH X-Nets – are networks of stakeholders (EU or MS organisations) that, linked by similar interests, form the existing pan-European (Digital) Health space and can potentially use or benefit from the widest adoption of the EEHRxF. Ten such networks will be promoted throughout the CSA, inspired by the Hospitals-on-FHIR initiative set out in March 2022 to network all Hospitals and Healthcare Providers (HCP) across Europe11. The following 10 XpanDH X-Nets have been established in the proposal stage, engaging already and just in a few days, around 20 organisations (local, regional, or national in nature) in total, out of 461 invited, and will be further enlarged and nurtured by the X-Net Agitators, throughout and beyond the project duration.
The X-nets can be seen on the table below:
| X-nets | Description |
| Patient association | Network of patient associations, particularly supported by WP1 and engage particularly with WP3/4/5 |
| SDOs & Industry Board | Network of Digital Health Industry players (companies, and associations) as well as relevant SDOs (e.g., SNOMED Int) |
| Hospitals-on-FHIR X-Net | Network of organisations affiliated with the HL7 Europe Hospital-on-FHIR Initiative and interested parties |
| BioMedical Research | Network of Researchers and Research collaboration initiatives in the life sciences and biomedical areas |
| Professionals Associations | Network of Health professionals’ chambers, associations and unions national and European |
| Citizens and Society | Network of citizen associations, consumer groups, and other representatives of civil society, including media |
| Health Mgt & Regulators | Network of health management professionals and associations, as well as healthcare regulators and financers |
| Innovation Hubs | Network of partners of the innovation cycle (e.g., venture capital and innovation funds, incubators, innovation hubs) |
| ERNs and PerMed | Network of all EU ERNs established and projects/initiatives in personalised medicine (e.g., ICPerMed) |
| Health Regional Authorities | Network of all health regional authorities responsible for healthcare provision or oversight/planning healthcare |
1.4 Benefits to be in line with XpanDH
Be a XpanDH partner presents some benefits that should be useful for a broad range of stakeholders that’s compose the eHealth ecosystem. Within this call we will focus on the ‘Associated Partner’ role and also the ‘X-Net’ role. Below is described the advantages for being a XpanDH partner.
1.4.1 As an Associated Partner
The associated partners are directly integrated on the project and will develop some tasks in agreement with the WP leaders and beneficiaries. To develop their activities, they have access to the project documentation and outputs before the publication, in addition to support the development of the specific activities. It can beneficiate directly the associated partners because they will be updated within the beneficiaries about the new technologies and developments of the project, also they will have access to the European Commission information as soon it is communicated with the project members.
1.4.2 As a X-Net member
As a X-Net member, the partner does not have allocated activities inside the project, however it will be in line with the development of the project by the direct consultation regarding specific thematic in which it has expertise, presentation of preliminary results in order fine tune the project developments, also, have the opportunity to experiment the developments with the project support.
2 Process
- The WP1 will open a call for the associated partners that will be available on the XpanDH website and social media with the information for the new organisations get onboard as associated partners (no budget)
a) We intend to open 2 calls in this regarding, on M5 and M13 (May 2023/Jan 2024).
b) Additionally, there is the possibility to integrate the interested partner on the X-nets. As XpanDH is meant to be an open project to participation, is possible to participate in these 2 roles: X-nets or associated partners
c) There will be a selection, with agreement of all partners, of the inclusion as associated partners that follows some criteria to this finality. The entities that doesn’t fits on it will be integrate on the respective X-Net. - The interested institutions shall send an email to xpandh@iscte-iul.pt to manifest their interest and receive the Letter of commitment to be fulfilled.
- The call will be open for 90 days to receive the candidatures
- The project Leadership Council (LC) will evaluate the entities that candidate to it and analyse the provided documentation on each 30 days to ensure their eligibility on the Associated partners criteria
a) The partners that fits on the Associated partners criteria will receive the description of the WPs and tasks to identify in which they can collaborate and the effort on it, in alignment with the WPs leaders and the coordination. They shall provide a structured Letter of intentions describing their interest to be part of the project and the respective tasks and effort.
b) The partners that are not eligible for associated partners will be to the best-fit X-nets. - After the open call, the Steering Council (SC) will be consulted by a written procedure (10 days to reply) to accept or not the eligible partners to became Associated on XpanDH. The partners that did not manifest any reaction will be considered accept the proposal (see D1.1.1 for more details on written procedure)
a) After be accepted by the SC, the entities have 30 days to prepare and deliver the documents that will be analysed by the coordination and LC to ensure their eligibility
b) Once approved by the SC, the selected associated partners can initiate the development of the indicated project activities, in line with the respetives WP leaders, even before the submission of the amendment. - The coordination will initiate the amendment process
- The coordination will submit the amendment to the EC Project Officer
2.1 Timeline
The proposed calendar is:
- 11/05/2023 – the call will be open on the XpanDH website and social media
- 22/05/2023 – 1st SC evaluation
- 26/06/2023 – 2nd LC evaluation
- 24/07/2023 – 3rd LC evaluation and close the call and send the written procedure for vote procedure (Deadline 04/08/2023)
- 04/09/2023 – deadline to the candidates provide the documentation and initiate the amend process with other project requests
2.2 Required documents
There is required from the associated partners the following documents:
- PIC number (Participant Identification Code)
- (available through email: xpandh@iscte-iul.pt)
2.3 Specific responsibilities for Associated Partner(s) accordingly XpanDH Consortium Agreement
For the avoidance of doubt, the Associated Partners do not sign the Grant Agreement and do not receive funding from the Granting Authority and therefore do not have a right to charge costs or claim contributions from the Granting Authority. Associated Partners must ensure their own funding for the implementation of the Project. However, certain terms and conditions of the Grant Agreement and its Annexes are applicable to the Associated Partners. The Coordinator will share a copy of the signed Grant Agreement and information on any amendments with the Associated Partners.
The Associated Partners hereby commit to implement the Project tasks attributed to it/them in Annex 1 of the Grant Agreement.
In addition, the Associated Partners hereby commit especially to the following articles of the Grant Agreement and related regulations of Annex 5 (see annexes below):
- Proper implementation of the action (Article 11)
- Conflicts of interest (Article 12)
- Confidentiality and security (Article 13)
- Ethics and values (Article 14)
- Visibility (Article 17.2)
- Specific rules for carrying out the action (Article 18)
- Information obligations (Article 19)
- Record-keeping (Article 20)
The Associated Partners support the Beneficiaries regarding their exploitation, dissemination and Open Science obligations and commit to contribute to the technical and continuous reporting during and after the implementation of the Project.
Furthermore, the Associated Partners hereby explicitly agree to cooperate with and grant access to bodies according to Article 25 of the Grant Agreement (the Granting Authority, the European Anti-Fraud Office (OLAF), the European Public Prosecutor’s Office (EPPO), the European Court of Auditors (ECA)), so that these bodies can carry out checks, reviews, audits and investigations also towards the Associated Partner(s).
Any Associated Partner from a non-EU country undertakes to comply additionally with any other obligation arising from Art. 10.1 of the Grant Agreement.
In case of termination or being declared a Defaulting Party, an Associated Partner shall, within the limits specified in section 5.2 of this Consortium Agreement, bear any reasonable and justifiable costs occurring to the other Parties for performing this Associated Partners tasks and the costs for additional efforts necessary to implement the Project.
Moreover, an Associated Partner is obliged to indemnify the other Parties for any claim of the Granting Authority against them, caused by this Associated Partner´s actions or omissions during Grant Agreement preparation, Project implementation or after Project end. Regarding such claims the Associated Partner´s special liability is limited to 10.000€ Should the Associated Partners be obliged to sign a separate agreement concerning its funding for the Project, it is the responsibility of the Associated Partner to ensure such agreement is not in conflict with this Consortium Agreement.
Annex – Grant Agreement articles
Proper implementation of the action (Article 11)
11.1 Obligation to properly implement the action
The beneficiaries must implement the action as described in Annex 1 and in compliance with the provisions of the Agreement, the call conditions and all legal obligations under applicable EU, international and national law.
11.2 Consequences of non-compliance
If a beneficiary breaches any of its obligations under this Article, the grant may be reduced (see Article 28).
Such breaches may also lead to other measures described in Chapter 5.
Conflicts of interest (Article 12)
12.1 Conflict of interests
The beneficiaries must take all measures to prevent any situation where the impartial and objective implementation of the Agreement could be compromised for reasons involving family, emotional life, political or national affinity, economic interest or any other direct or indirect interest (‘conflict of interests’).
They must formally notify the granting authority without delay of any situation constituting or likely to lead to a conflict of interests and immediately take all the necessary steps to rectify this situation.
The granting authority may verify that the measures taken are appropriate and may require additional measures to be taken by a specified deadline.
12.2 Consequences of non-compliance
If a beneficiary breaches any of its obligations under this Article, the grant may be reduced (see Article 28) and the grant or the beneficiary may be terminated (see Article 32).
Such breaches may also lead to other measures described in Chapter 5.
Confidentiality and security (Article 13)
13.1 Sensitive information
The parties must keep confidential any data, documents or other material (in any form) that is identified as sensitive in writing (‘sensitive information’) — during the implementation of the action and for at least until the time-limit set out in the Data Sheet (see Point 6).
If a beneficiary requests, the granting authority may agree to keep such information confidential for a longer period.
Unless otherwise agreed between the parties, they may use sensitive information only to implement the Agreement.
The beneficiaries may disclose sensitive information to their personnel or other participants involved in the action only if they:
(a) need to know it in order to implement the Agreement and
(b) are bound by an obligation of confidentiality.
The granting authority may disclose sensitive information to its staff and to other EU institutions and bodies.
It may moreover disclose sensitive information to third parties, if:
(a) this is necessary to implement the Agreement or safeguard the EU financial interests and
(b) the recipients of the information are bound by an obligation of confidentiality.
The confidentiality obligations no longer apply if:
(a) the disclosing party agrees to release the other party
(b) the information becomes publicly available, without breaching any confidentiality obligation
(c) the disclosure of the sensitive information is required by EU, international or national law.
Specific confidentiality rules (if any) are set out in Annex 5.
13.2 Classified information
The parties must handle classified information in accordance with the applicable EU, international or national law on classified information (in particular, Decision 2015/444[1] and its implementing rules).
Deliverables which contain classified information must be submitted according to special procedures agreed with the granting authority.
Action tasks involving classified information may be subcontracted only after explicit approval (in writing) from the granting authority.
Classified information may not be disclosed to any third party (including participants involved in the action implementation) without prior explicit written approval from the granting authority.
Specific security rules (if any) are set out in Annex 5.
13.3 Consequences of non-compliance
If a beneficiary breaches any of its obligations under this Article, the grant may be reduced (see Article 28).
Such breaches may also lead to other measures described in Chapter 5.
Ethics and values (Article 14)
14.1 Ethics
The action must be carried out in line with the highest ethical standards and the applicable EU, international and national law on ethical principles.
Specific ethics rules (if any) are set out in Annex 5.
14.2 Values
The beneficiaries must commit to and ensure the respect of basic EU values (such as respect for human dignity, freedom, democracy, equality, the rule of law and human rights, including the rights of minorities).
Specific rules on values (if any) are set out in Annex 5.
14.3 Consequences of non-compliance
If a beneficiary breaches any of its obligations under this Article, the grant may be reduced (see Article 28).
Such breaches may also lead to other measures described in Chapter 5.
Visibility (Article 17.2)
Unless otherwise agreed with the granting authority, communication activities of the beneficiaries related to the action (including media relations, conferences, seminars, information material, such as brochures, leaflets, posters, presentations, etc., in electronic form, via traditional or social media, etc.), dissemination activities and any infrastructure, equipment, vehicles, supplies or major result funded by the grant must acknowledge EU support and display the European flag (emblem) and funding statement (translated into local languages, where appropriate):
The emblem must remain distinct and separate and cannot be modified by adding other visual marks, brands or text.
Apart from the emblem, no other visual identity or logo may be used to highlight the EU support.
When displayed in association with other logos (e.g. of beneficiaries or sponsors), the emblem must be displayed at least as prominently and visibly as the other logos.
For the purposes of their obligations under this Article, the beneficiaries may use the emblem without first obtaining approval from the granting authority. This does not, however, give them the right to exclusive use. Moreover, they may not appropriate the emblem or any similar trademark or logo, either by registration or by any other means.
Specific rules for carrying out the action (Article 18)
18.1 Specific rules for carrying out the action
Specific rules for implementing the action (if any) are set out in Annex 5.
18.2 Consequences of non-compliance
If a beneficiary breaches any of its obligations under this Article, the grant may be reduced (see Article 28).
Such a breach may also lead to other measures described in Chapter 5.
Information obligations (Article 19)
19.1 Information requests
The beneficiaries must provide — during the action or afterwards and in accordance with Article 7 — any information requested in order to verify eligibility of the costs or contributions declared, proper implementation of the action and compliance with the other obligations under the Agreement.
The information provided must be accurate, precise and complete and in the format requested, including electronic format.
19.2 Participant Register data updates
The beneficiaries must keep — at all times, during the action or afterwards — their information stored in the Portal Participant Register up to date, in particular, their name, address, legal representatives, legal form and organisation type.
19.3 Information about events and circumstances which impact the action
The beneficiaries must immediately inform the granting authority (and the other beneficiaries) of any of the following:
(a) events which are likely to affect or delay the implementation of the action or affect the EU’s financial interests, in particular:
(i) changes in their legal, financial, technical, organisational or ownership situation (including changes linked to one of the exclusion grounds listed in the declaration of honour signed before grant signature)
(ii) linked action information: not applicable
(b) circumstances affecting:
(i) the decision to award the grant or
(ii) compliance with requirements under the Agreement.
19.4 Consequences of non-compliance
If a beneficiary breaches any of its obligations under this Article, the grant may be reduced (see Article 28).
Such breaches may also lead to other measures described in Chapter 5.
Record-keeping (Article 20)
20.1 Keeping records and supporting documents
The beneficiaries must — at least until the time-limit set out in the Data Sheet (see Point 6) — keep records and other supporting documents to prove the proper implementation of the action in line with the accepted standards in the respective field (if any).
In addition, the beneficiaries must — for the same period — keep the following to justify the amounts declared:
(a) for actual costs: adequate records and supporting documents to prove the costs declared (such as contracts, subcontracts, invoices and accounting records); in addition, the beneficiaries’ usual accounting and internal control procedures must enable direct reconciliation between the amounts declared, the amounts recorded in their accounts and the amounts stated in the supporting documents (b) for flat-rate costs and contributions (if any): adequate records and supporting documents to prove the eligibility of the costs or contributions to which the flat-rate is appl
[1] Commission Decision 2015/444/EC, Euratom of 13 March 2015 on the security rules for protecting EU classified information (OJ L 72, 17.3.2015, p. 53).
[1] https://eufunds.me/what-is-an-associated-partner-in-horizon-europe/