FAQ

What is an Excellence Hub?

Excellence hubs play a pivotal role in fostering innovation by enabling innovation ecosystems in both widening countries and beyond to collaborate.

Thereby, they establish stronger connections between academia, business, government, and society. This cultivates a genuine culture of place-based innovation in widening countries, guided by a strategic agenda that aligns with regional or national smart specialization strategies.

These excellence hubs are designed to enhance the accessibility of excellence for Research and Innovation (R&I) entities in widening countries. They strive to develop collaborative R&I strategies that harmonize with national, regional (particularly RIS3), and/or European strategies or policy priorities, such as the Green Deal and Digital transition.

These strategies will be supported by concrete action plans and an investment strategy that extends beyond the project’s duration. This comprehensive approach aims to leverage national, regional, and European funds, as well as private (venture) capital, ensuring sustained impact beyond the project’s lifespan.

What is a Health Data Space?

According to OPEN DEI (2021), “A data space can be defined as a federated data ecosystem within a certain application domain and based on shared policies and rules.”

The users of such data spaces are enabled to access data in a secure, transparent, trusted, easy and unified fashion. This access and usage right can only be granted by those persons or organisations who are entitled to dispose of the data.

The European Health Data Space is a health-specific ecosystem comprised of rules, common standards and practices, infrastructures and a governance framework. The framework aims to:

  • empower individuals through increased digital access to and control of their electronic personal health data, at national level and EU-wide
  • support their free movement
  • foster a genuine single market for electronic health record systems, relevant medical devices and high-risk AI systems (primary use of data)
  • provide a consistent, trustworthy and efficient set-up for the use of health data for research, innovation, policy-making and regulatory activities (secondary use of data)

As such, the European Health Data Space is a key pillar of the strong European Health Union. Also, it is the first common EU data space in a specific area to emerge from the European strategy for data[2].

Read more about the health data space VELES will create here.

[1] https://www.opendei.eu/wp-content/uploads/2022/03/Position-Paper-Design-Principles-for-Data-Spaces.pdf

[2] https://health.ec.europa.eu/ehealth-digital-health-and-care/european-health-data-space_en

How will a Health Data Space help me?

The Health Data space will:

  • Empower me as an individual to have control over my health data
  • Enable health professionals to have access to relevant health data which will lead to better diagnosis and treatment, improved patient safety, continuity of care and improved healthcare efficiency
  • Assist policymakers and regulators in accessing relevant non-identifiable health data
  • Facilitate access to non-identifiable health data for researchers and innovators
  • Better health policy, greater opportunities for research and innovation

What does “widening country” mean?

Widening countries are characterized by low participation rates in FP7 and H2020 projects. This indicates varying capacities across the European Union to successfully undertake transnational research and innovation endeavors.

Disparities arise due to factors such as inadequate scientific infrastructure, challenges in establishing or accessing networks, difficulties in recruiting and retaining talent, and structural barriers at the institutional, regional, or national levels.

Within the framework of Horizon Europe, the European Commission aims to address these disparities by literally ‘Widening’ the scope of funding to strengthen research and innovation across Europe as a whole. This approach involves providing specific support to countries with low participation rates in FP7 and H2020 projects, enabling them to strengthen their research and innovation systems. This collective effort contributes to the overall advancement of the European Research Area in alignment with the policy objectives.

To fully realize the potential of the European Research Area and foster collaborative progress in research and innovation across the EU, particular attention and support are directed towards widening countries under Horizon Europe. This group encompasses 15 member states (Bulgaria, Croatia, Cyprus, Czechia, Estonia, Greece, Hungary, Latvia, Lithuania, Malta, Poland, Portugal, Romania, Slovakia, and Slovenia), all outermost regions, and associated countries sharing equivalent characteristics in terms of research and innovation performance (Albania, Armenia, Bosnia & Herzegovina, the Faroe Islands, Georgia, Kosovo, Moldova, Montenegro, North Macedonia, Serbia, Tunisia, Turkey, Ukraine, and Morocco).

What does RSHDS mean?

RSHDS is the shortened version of the Regional Smart Health Data Space. The RSHDS is aimed to be created in the 4 widening countries participating in the project: Bulgaria, Romania, Greece and Cyprus.

VELES sets the grounds for the establishment of RSHDS and its seamless integration within the EU Smart Health Data Space. The project will research and set up a common methodological framework comprising all the relevant aspects – ecosystem, legal, technological, organisational and business. 

The establishment of the RSHDS will:

  • support the personalised and more precise healthcare delivery
  • enable the deployment of new technologies
  • advance research and research results taken up in the domain
  • provide for evidence-based decision-making and policy development
  • improve the environment for R&I investment
  • accelerate the development of data-driven health innovations and their adoption in the economy and society.

What does RIS3 mean?

RIS 3 stands for regional research and innovation strategies for smart specialization (according to The Guide on Research and Innovation Strategies for Smart Specialisation, issues by EC, JRC)

RIS 3 are integrated, place-based economic transformation agendas that do five important things

  • They focus policy support and investments on key national/regional priorities, challenges and needs for knowledge-based development, including ICT-related measures;
  • They build on each country’s/region’s strengths, competitive advantages and potential for excellence;
  • They support technological as well as practice-based innovation and aim to stimulate private sector investment;
  • They get stakeholders fully involved and encourage innovation and experimentation;
  • They are evidence-based and include sound monitoring and evaluation systems.

What does personal data mean?

Personal data concerning health should include all data about the health status of a data subject which reveals information relating to the past, current or future physical or mental health status of the data subject.

This includes:

  • information about the natural person collected in the course of the registration for, or the provision of, health care services as referred to in Directive 2011/24/EU of the European Parliament and of the Council to that natural person;
  • a number, symbol or particular assigned to a natural person to uniquely identify the natural person for health purposes;
  • information derived from the testing or examination of a body part or bodily substance, including from genetic data and biological samples;
  • and any information on, for example, a disease, disability, disease risk, medical history, clinical treatment or the physiological or biomedical state of the data subject independent of its source, for example from a physician or other health professional, a hospital, a medical device or an in vitro diagnostic test.

[Regulation (EU) 2016/679]

What does electronic health data mean?

‘Electronic health data’ means personal or non-personal electronic health data.

What does personal electronic health data mean?

‘Personal electronic health data’ means data concerning health and genetic data as defined in Regulation (EU) 2016/679, as well as data referring to determinants of health, or data processed about the provision of healthcare services, processed in an electronic form.

What does real-world data mean?

Real-world data (RWD) are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources.

Examples of RWD include data derived from electronic health records, medical claims data, data from product or disease registries, and data gathered from other sources (such as digital health technologies) that can inform on health status.

What does primary use of electronic health data mean?

‘Primary use of electronic health data’ means the processing of personal electronic health data for the provision of health services to assess, maintain or restore the state of health of the natural person to whom that data relates. It includes the prescription, dispensation and provision of medicinal products and medical devices, as well as for relevant social security, administrative or reimbursement services.

What does secondary use of electronic health data mean?

‘Secondary use of electronic health data’ means the processing of electronic health data for purposes set out in Chapter IV of this Regulation. The data used may include personal electronic health data initially collected in the context of primary use, but also electronic health data collected for the purpose of secondary use.

What is data Governance framework?

A data governance framework is a set of rules, processes, and responsibilities that dictate how an organization collects, organizes, stores, and uses its data. The goal of a data governance framework is to set a standard on how data is managed (to ensure its integrity), leveraged by internal teams, and protected from security risks.