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Grant Analysis

Purpose & Target

Core objective: This grant aims to foster innovation in how health data is used for secondary purposes within the European Health Data Space (EHDS), ensuring strong intellectual property (IP) protection while enabling data-driven advancements in healthcare.
Target recipient type and size: The opportunity targets a broad range of organizations, including public and private entities, the healthcare industry, hospitals, academic institutions, and public authorities. It is geared towards collaborative projects.
MUST state if grant is 'SECTOR-SPECIFIC' or 'SECTOR-AGNOSTIC': SECTOR-SPECIFIC (Healthcare, Data Science, Digital Health).
Geographic scope and any location requirements: Applicants must be established in EU Member States, Horizon Europe Associated Countries, or specific low- and middle-income countries. Project activities focus on improving healthcare within the EU.
Key filtering criteria for initial grant screening: Focus on secondary use of health data, EHDS, data protection (IP, RDP, trade secrets), data sharing, ethical/legal standards, and fostering trust in digital health ecosystems.
Grant frequency and program context: This is part of the Innovative Health Initiative Joint Undertaking (IHI JU) Call 10, which is a recurring program under Horizon Europe. This specific call operates on a two-stage application process.

Financial Structure

Funding type: This grant provides a budget-based, mixed actual cost grant, meaning it reimburses specific eligible costs that are genuinely incurred for the project.
Funding rate: The grant will cover 100.0% of your project's eligible costs, as it is classified as a Research and Innovation Action (RIA).
Indirect costs: A flat-rate of 25.0% will be applied to your total eligible direct costs, excluding costs for subcontracting, financial support to third parties, and any unit costs or lump sums that already include indirect costs.
Budget categories: Eligible costs can fall under various categories, including actual personnel costs (or unit costs), subcontracting, purchase costs, and financial support to third parties (if applicable). Unit costs (e.g., for SME owners or average personnel costs) and lump sums may also be used.
Pre-financing: Typically, you'll receive an advance payment (pre-financing) equal to 160.0% of the average EU funding expected per reporting period, to help you start the project. This amount may vary.
No-profit rule: The grant aims to cover costs, not to generate profit. Any surplus of revenues plus the grant over costs will be deducted from the final grant amount.
No double funding: You cannot receive funding from another EU grant for the same costs. Your accounting must clearly separate costs if you combine this grant with other EU funding.

Eligibility Requirements

Organizational Type

Any legal entity is eligible to participate, regardless of its place of establishment, including non-associated third countries or international organizations.
SME (Small and Medium-sized Enterprises) and ENTERPRISE (larger private companies) are eligible, especially those in healthcare and technology sectors.
PUBLIC bodies (e.g., public institutions, Member State agencies, hospitals) are eligible.
UNIVERSITY (academic institutions, research organizations) are eligible.
NGOs (Non-governmental organizations) may be eligible if they represent civil society or similar interests.
Entities without legal personality may participate if their representatives can undertake legal obligations and offer equivalent financial guarantees.

Geographic Location

To be eligible for funding, organizations must be established in one of the following:
EU Member States: AT, BE, BG, HR, CY, CZ, DK, EE, FI, FR, DE, GR, HU, IE, IT, LV, LT, LU, MT, NL, PL, PT, RO, SK, SI, ES, SE.
Horizon Europe Associated Countries: AL, BA, GE, IS, IL, MD, ME, MK, NO, NZ, RS, TR, UA, UK.
Specific low- and middle-income countries: AF, DZ, AR, EG, MY.
Affiliated entities must also meet these geographic establishment requirements to receive funding.
Exclusion Criteria:
Legal entities subject to EU restrictive measures are not eligible.
Legal entities established in Russia, Belarus, or non-government controlled territories of Ukraine are not eligible to participate in any capacity.
Hungarian public interest trusts established under Hungarian Act IX of 2021 are not eligible for funded roles as long as Council measures are not lifted.

Consortium Composition

A consortium is required, consisting of at least three independent legal entities.
These entities must be established in different eligible countries.
At least one legal entity must be established in an EU Member State.
At least two other independent legal entities must be established in different EU Member States or Associated Countries.
Affiliated entities do not count towards meeting the minimum consortium composition requirements.

Financial and Operational Capacity

Applicants must demonstrate stable and sufficient financial resources to successfully implement the project and contribute their share. This is generally checked for the coordinator if the requested grant is EUR 500,000 or more.
Applicants must possess the necessary know-how, qualifications, and resources (human, technical, other) to perform their tasks effectively.
Public bodies, Member State organizations, and international organizations are typically exempt from financial and operational capacity checks.

Other Conditions

Projects must focus exclusively on civil applications and adhere to strict ethical principles (e.g., no human cloning for reproductive purposes, no heritable genetic modification of humans except for specific treatments, no human embryo creation solely for research).
Projects must comply with all applicable EU, international, and national laws and policies (e.g., environment, social, security, industrial policy).
Public bodies, research organizations, and higher education establishments from EU Member States and Associated Countries must have a gender equality plan (GEP) that meets specific minimum process-related requirements (publication, dedicated resources, data collection, training). A self-declaration is required at the proposal stage. Private for-profit organizations, including SMEs, are exempt from this specific GEP requirement.

Application Process

The application follows a two-stage submission procedure.
All proposals must be submitted electronically through the Funding & Tenders Portal's online system; paper submissions are not accepted.
Your application will consist of two main parts: Part A (administrative information, filled out online) and Part B (technical description of your project, uploaded as a PDF).
You must include all mandatory annexes and supporting documents, which are available for download in the submission system.
The coordinating organization must confirm they have the authority to act for all applicants and that the information provided is accurate and complete, ensuring all participants meet the EU funding conditions.
Before the grant agreement is signed, each participant will need to submit a formal Declaration of Honour.

Deadlines and Timeline

First stage application deadline: 2025-04-23T00:00:00+0200.
Second stage (full proposal) application deadline: 2025-10-14T00:00:00+0200.
You can expect to receive the evaluation outcome for the first stage approximately 3 months after the first stage deadline.
For the second stage, evaluation results are typically provided around 5 months after the second stage deadline.
The indicative timeframe for signing the grant agreement is approximately 8 months after the second stage deadline.

Required Documentation

For the 1st Stage (Short Proposal):
Proposal template - Part A (generated by the IT system).
Proposal template Short proposal - Part B.
Compulsory Annex: Type of Participants (an Excel template with instructions, must be uploaded as a separate document).
For the 2nd Stage (Full Proposal):
Proposal template - Part A (generated by the IT system).
Proposal template Full proposal - Part B.
Compulsory Annex: Annex to the budget and type of participants (Excel template, complements Part A budget figures).
Compulsory Annex: Declaration of in-kind contribution commitment (Word document template).
Compulsory Annex: Essential information for clinical studies (if your proposal does not include clinical studies, you must upload a statement declaring this).
Optional Annex: In-kind contributions to additional activities (IKAA) (Excel template).
Optional Annex: Ethics (if detailed ethics issues exceed Part A's character limit).

Support and Guidance

Various resources are available to assist applicants, including:
The Online Manual for procedures from submission to grant management.
The Horizon Europe Programme Guide for detailed program guidance.
Funding & Tenders Portal FAQs for common questions.
The Research Enquiry Service for general European research inquiries.
National Contact Points (NCPs) for country-specific guidance and assistance.
The Enterprise Europe Network for business advice, especially for SMEs.
The IT Helpdesk for technical portal issues.
The European IPR Helpdesk for intellectual property advice.
CEN-CENELEC Research Helpdesk and ETSI Research Helpdesk for standardization advice.
Partner Search tools to help find consortium partners.

Evaluation Criteria

Excellence

Does the project clearly state its objectives, and are they relevant?
Is the proposed work ambitious and does it go beyond current practices or knowledge?
Is the methodology sound, including the concepts, models, assumptions, and inter-disciplinary approaches?
How well does the proposal consider gender differences in its research and innovation content?
What is the quality of open science practices, including sharing research results and engaging with citizens or relevant groups?

Impact

Is it credible that the project will achieve the expected outcomes and impacts mentioned in the grant details (e.g., fostering data-driven healthcare innovation, improving IP protection, balancing data use and access, establishing best practices for data sharing and security, recommending legal and ethical standards, and increasing industry confidence in the EHDS)?
What is the likely scale and significance of the project's contributions?
Are the proposed measures to maximize outcomes (like dissemination, exploitation of results, and communication activities) suitable and of high quality?

Quality and Efficiency of Implementation

How well-planned and effective is the overall work plan?
Are potential risks identified and adequately assessed?
Is the effort assigned to different work packages appropriate and are resources allocated efficiently?
What are the capabilities and roles of each participant, and does the consortium collectively possess all necessary expertise?

Scoring and Thresholds (for full application, Stage 2)

Each of the three criteria ('Excellence', 'Impact', 'Quality and Efficiency of Implementation') will be scored out of 5 points.
To pass, a proposal must achieve at least 3 points for each individual criterion.
The total score (sum of all three criteria) must be 10 points or higher.

Scoring and Thresholds (for first stage application)

Only two criteria are evaluated: 'Excellence' and 'Impact'.
To pass the first stage, a proposal must achieve at least 4 points for each individual criterion.
The total score (sum of 'Excellence' and 'Impact' scores) will typically need to be 8 or 8.5 points or higher.

Compliance & Special Requirements

Ethical and Legal Compliance

Your project must strictly adhere to the highest ethical principles, including research integrity, and comply with all relevant EU, international, and national laws.
You are required to complete an ethics self-assessment as part of your application. Projects with identified ethical issues will undergo a specific ethics review and may be subject to additional ethics requirements that become part of the grant agreement.
The project must be exclusively for civil applications. Activities such as human cloning for reproductive purposes, heritable genetic modification of humans (with a narrow exception for cancer treatment of gonads), or creating human embryos solely for research/stem cell procurement are prohibited.

Security Requirements

If your project involves classified or sensitive information, it will undergo a security appraisal and may be subject to specific security rules.
Projects involving information classified as 'TRES SECRET UE/EU TOP SECRET' (or equivalent) cannot be funded.
Handling of EU classified information (e.g., 'CONFIDENTIEL UE/EU CONFIDENTIAL') may require a Facility Security Clearance (FSC) and personnel security clearance (PSC).
Beneficiaries must ensure that their projects are not subject to national or third-country security requirements that could jeopardize the grant's implementation or award.

Data and Intellectual Property (IP)

Standard provisions for Intellectual Property Rights (IPR) will apply.
The granting authority may object to any transfer of ownership or exclusive licensing of project results for up to 4 years after the action ends, as outlined in specific provisions.
You are required to practice open science: deposit research outputs in a repository and provide open access (under CC BY licence, CC 0, or equivalent), unless legitimate interests are jeopardized.
In the event of a public emergency, you may be required to immediately deposit research output in a repository and provide open access, or grant non-exclusive licenses under fair and reasonable conditions to entities addressing the emergency.
The IHI JU specifically reserves the right to object to the transfer or exclusive licensing of results.

Other Compliance

Public bodies, research organizations, and higher education establishments (from EU Member States and Associated Countries) must have a gender equality plan (GEP) to be eligible for funding. This GEP must meet specific process-related requirements.
Entities subject to EU restrictive measures are not eligible.
Legal entities established in Russia, Belarus, or non-government controlled territories of Ukraine are not eligible for funding.
Specific Hungarian public interest trusts established under Act IX of 2021 are ineligible for funded roles as long as related Council measures are in place.

Grant Details