OpenLobby.EU
Explore

EIT Health

EIT Health was established in 2015, as part of the European Institute of Innovation and Technology (EIT).

Lobbying Activity

Response to Biotech Act

11 Jun 2025

EIT Health welcomes the commitment to reinforce Europes competitiveness through the Biotech Act. The European biotech sector has the potential to transform health outcomes, strengthen Europes strategic autonomy, and drive competitiveness. Small start-ups and SMEs require specific policy support and are disproportionately impacted by a number of issues. A European approach to supporting them would involve business accelerators, grants, hubs paired with wide, open networks and quality data access. With over 120 members across the healthcare ecosystem, eight regional innovation hubs (Co-Location Centers) across Europe with a footprint in 18 Member States, EIT Health stands ready to support the development and implementation of the strategy, and to work alongside the European Commission, Member States, and the healthcare ecosystem to ensure that the European Biotech sector becomes more competitive, rapidly developing, translating and commercialising innovative ideas and solutions.
Read full response

Response to EU Life sciences strategy

17 Apr 2025

EIT Health welcomes the European Commission's commitment to reinforce Europes competitiveness through A strategy for European life sciences. A European Life Sciences strategy should address better support for start-ups and SMEs, de-risking mechanisms for private investment, stronger academic-industry collaboration, enabling public-private partnerships, reducing market fragmentation, and addressing the talent gap through upskilling and reskilling. With over 120 members across the healthcare ecosystem, eight regional innovation hubs (Co-Location Centers) across Europe with a footprint in 18 Member States, EIT Health stands ready to support the development and implementation of the strategy, and to work alongside the European Commission, Member States, and the healthcare ecosystem to ensure that the European Life Science sector becomes more competitive, rapidly developing, translating and commercialising innovative ideas and solutions.
Read full response

Meeting with Annukka Ojala (Cabinet of Executive Vice-President Roxana Mînzatu), Triinu Volmer (Cabinet of Executive Vice-President Roxana Mînzatu)

19 Mar 2025 · Relevant policy developments on EU level

Response to EU Start-up and Scale-up Strategy

17 Mar 2025

EIT Health welcomes the European Commissions initiative to develop a comprehensive EU Startup and Scale-up Strategy. Please find attached two documents outlining EIT Health's response to this call for evidence: 1) Response to the European Commission Call for Evidence: Hurdles Facing Startups and Scaleups in the EU Single Market 2) Access to Talent & Hiring Barriers in HealthTech Scaleups
Read full response

Meeting with Fulvia Raffaelli (Head of Unit Health and Food Safety)

6 Mar 2025 · Meetings with stakeholders in Brussels to inform partners about relevant policy developments on EU level, and to enhance the contribution of EIT Health Innostars and its partners to relevant EU policies.

Meeting with Eszter Lakos (Member of the European Parliament)

5 Mar 2025 · Health innovation

Meeting with Olivér Várhelyi (Commissioner) and

13 Feb 2025 · Food

Response to Interim evaluation of the EU4Health Programme 2021-2027

8 Jan 2024

EIT Health welcomes the opportunity for to provide feedback on the interim evaluation of the EU4Health programme 2021-2027. EIT Health ask the European Commission to consider the following points as they proceed with the next phase of the programme: Continue to build upon best practices identified by previous projects, and where appropriate foresees the utilisation of established networks and ecosystems such as EIT Health to implement and disseminate these best practices on the ground. Use tools such as guidelines or networks of stakeholders in order to ensure smooth implementation and societal change at Member State/EU level. This approach ensure maximum positive impact on EU4Health priorities, by ensuring themes are supported from research/best practice identification to country level implementation. Allocate additional resources to educate, train and upskill key stakeholders, including patients, civil society, healthcare professionals, local and regional health authorities. Prioritise education initiatives to smoothly execute the necessary actions as we prepare for the green and digital transitions. Ensure that future programme calls are developed with a view to ensuring continuity in initiatives. This requires a long-term, ecosystem approach which takes priorities from the identification of challenges, needs and best practices to the development of pilot projects, to the large-scale rollout and implementation of best practices and/or new solutions across Europe. Foresee the use of EIT Health, as a well-established network of key stakeholders (working closely with EU and national health policy-makers, healthcare industry, healthcare providers, universities and training organisations), to support awareness raising implementation and implementation of EU health policies and legislation. This should include support for the implementation of the European Health Data Space, through the facilitation of a coordinated approach that aligns existing knowledge and expertise and addresses key challenges in each Member State. Explore opportunities for future collaboration and knowledge exchange, to leverage best practices and innovative solutions from other sectors, regions, educational institutions, businesses and start ups. About EIT Health EIT Health is one of nine Knowledge and Innovation Communities (KICs) of the European Institute of Innovation and Technology (EIT), an EU body. EIT Health is also an Institutionalised Partnership under Horizon Europes Pillar III Innovative Europe.
Read full response

Response to European Year of Skills 2023

14 Dec 2022

The EIT (European Institute of Innovation and Technology) KICs (Knowledge and Innovation Communities) welcome 2023 as the European Year of Skills. The EIT KICs appreciate the European Unions intention to invest and catalyse efforts in education and lifelong learning. As EU partnerships invested in the creation of a European knowledge economy, EIT KICs are ready to contribute to a successful outcome of this initiative. They call for a greater, explicit recognition of the direct link between education, innovation and Europes competitiveness and for the acknowledgement of EITs role in achieving this endeavour. EIT KICs also caution about the need to earmark budget to fund dedicated action towards upskilling and reskilling for a successful outcome.
Read full response

Response to A New European Innovation Agenda

10 May 2022

EIT Health welcomes the Commission’s commitment to reinforcing Europe’s innovation potential. It calls for a ‘New European Innovation Agenda’ powerfully centred on the use and integration of existing initiatives. This will avoid dispersion of past and current investments. It will also ensure that new plans benefit from lessons learned and have a higher likelihood of generating societal impact. EIT Health and its network are a unique resource capable of supporting the development and implementation of the new innovation agenda. As such, EIT Health wishes to offer the following concrete building blocks for incorporation in the future framework: Access to finance: Scale-up Gap EIT Health and the European investment Fund (EIF) jointly operate the Venture Centre of Excellence (VCOE), a public-private co-investment programme to empower finance for European health small and medium size enterprises (SMEs). The programme encompasses 1.7 € billion of investment capabilities and should be further leveraged among EU instruments. Framework conditions Within the EIT Health network, ~150 partner organisations and institutions from academia, business, research and healthcare delivery collaborate across disciplines, borders and sectors to reinforce excellence, create knowledge and innovation and encourage greater investment in innovation that delivers the outcomes that matter to patients. As a result, EIT Health represents a unique match between a sustainable innovation ecosystem model gathering and leveraging different partners and funding sources, and a change agent with extensive capacity to generate real-world data for evidence-based decision-making and the transformation of health care. These are clear assets for the strengthening of the EU’s innovation base and the achievement of EU strategic objectives and policy priorities. Fragmentation of the EU innovation ecosystem EIT Health has developed a highly integrated and inclusive partnership model to leverage the innovation and entrepreneurial potential of society as a whole. In addition, the participation and contribution of citizens & patients throughout the entire health innovation pathway is firmly embedded within EIT Health’s core principles and meaningful relations are pursued with European civil society organisations. EIT Health thus embodies EU’s capacity to overcome fragmentation and build integrated innovation ecosystems across sectors and borders. As such, it should be used as a model and centre piece for further integration. More cooperation opportunities with EIT Health – including co-funding options - should be embedded in EU instruments to foster a cohesive innovation environment and fulfil synergies. Innovation performance EIT Health’s regional programmes, among which InnoStars which is active in 13 Central, Eastern and Southern European countries, showcase best practices to stimulate innovation in regions that have high growth potential. Increasing cross-border cooperation between innovation actors, including through interconnecting European innovation hubs and creating and supporting pan-European ‘marketplaces’ to connect ideas between entrepreneurs across Europe, will stimulate these regions and reduce the information and innovation gap. EIT Health’s platform is a solid foundation upon which further regional efforts can be built. Talent The EIT Health WorkInHealth Foundation sets to federate collective action to address the skills gap, attract talent to the HealthTech industry, support the acceleration of upskilling and reskilling of talent by linking industry & academia and boost the growth, autonomy and competitiveness of the European health industry. The initiative is in full alignment with the EU Pact for Skills. As such, it should be taken into consideration for the design of the new Innovation Agenda, and synergies should be fostered with the EU Skills Agenda, Digital Strategy etc
Read full response

Response to A European Health Data Space

6 May 2022

EIT Health welcomes the publication of EHDS proposal, a key building block for the creation of a sustainable and resilient European Health Union, and an unprecedented opportunity to leverage the European power to innovate. The EHDS creates a much-needed balance between the rights of patients to control and access their own data and the needs of healthcare professionals, providers, industry, researchers and decision-makers to use health data both for health care delivery and for public health, scientific and R&D purposes. Importantly, the ability for innovators to use high-quality health data is an indispensable requirement to transform health care and deliver more value to patients. EIT Health will be closely monitoring the development of the proposal through the European Parliament and Council of the European Union. As outlined in its Report report ‘Learning from health data use cases: Real-world challenges and enablers to the creation of the EHDS’ it invites policymakers to consider the following elements for the creation of a truly operational EHDS: 1.The EHDS governance framework should effectively address the different roles that health data users may hold, and work with all stakeholders The way in which data can be accessed and used is determined by the user’s role in the healthcare system. Roles are not static: a healthcare professional may also be a researcher, a public health insurance body can also be a policy maker, and a citizen may be a patient, a carer and also a data provider. It is important to ensure a regulatory landscape that embraces and effectively addresses the ‘changing nature’ of roles while keeping the rights and interests of patients front and centre. This demands that the legislators work collaboratively with all stakeholders. 2. Compliance with the new EHDS requirements on data interoperability should be facilitated and supported Practices and standards applied to health data collection, processing and storage vary among sectors and borders. This poses a challenge of interoperability – i.e., the ability of organisations and technologies to interact meaningfully without altering the content of data – which will not be easily surmounted given the currently fragmented landscape. As the EHDS legislation sets to establish common rules and obligations for interoperability, support should be foreseen for stakeholders to comply with the new requirements so that these represent an opportunity rather than a new challenge, particularly for smaller players such as start-ups and SMEs. If interoperability is not met, data will remain significantly under utilised. 3.Clarity on the interplay between the EHDS and connected legislation must be ensured, and compliance simplified as much as possible Unleashing the ‘data economy’ is paramount to accelerate Europe’s digital transformation towards a Digital Single Market. Yet, challenges persist regarding the commercialisation of digital health solutions. In the evolving field of digital health, innovators often face difficulties in achieving widespread adoption, due to regulatory, reimbursement and procurement processes which are difficult to navigate and fragmented across Europe. Such barriers delay impactful solutions from reaching patients and citizens. Legal complexity and overlap between other legislation impacting the health sector must be addressed to ensure that overregulation is avoided and that the legislative landscape is as understandable and user-friendly as possible for innovators and early adopters of new technologies. EIT Health and its network are a unique resource capable of supporting the development and implementation of the EHDS. Together, we are keen to make available the knowledge of our experts as well as best practice examples throughout the process so that the final EU law is fit for purpose, and that the resulting EHDS can bring real benefit in terms of empowering patients and unleashing the full European innovation potential.
Read full response

Response to Requirements for Artificial Intelligence

29 Jul 2021

• EIT Health welcomes the proposed AI Regulation and its ambition to create horizontal legislation overseeing AI and to maximise the safety and trustworthiness of this technology. We welcome the creation of a risk-classification of AI and prohibition of certain AI in alignment with the OECD, as this type of risk management is vital to ensuring uptake of this important technology. • With the importance of AI in the healthcare context in mind, the AI Act should support – not supress – innovation. Additional requirements and conformity assessments imposed by the foreseen legislation should therefore be combined or simplified to the greatest extent possible, and accompanied by clear guidance and support to innovators of all sizes to provide certainty and ensure they are not inhibited by additional regulatory requirements. • To avoid delays both in terms of innovations coming to market and patient access to new technologies and treatments, notified bodies and other authorities should be supported by the EU to ensure they are able to assess AI coming to market quickly whilst complying with the necessary safety assessments. • We welcome the European AI Board but stress the need for cohesion with other EU level boards to ensure complete harmonisation of legislation to reduce regulatory burden. The proposed independent expert group is a positive inclusion, and EIT Health would welcome the opportunity to participate to provide insight and real-world evidence generated from its network of health innovators. • Other stakeholders within the healthcare ecosystem need to be supported in the uptake and use of AI, notably patients and healthcare professionals. Appropriate education and upskilling on all the relevant aspects of AI and its utility in healthcare should be incorporated within existing and future curricula, and continued professional education for healthcare professionals is a vital foundational step. EIT Health’s education pillar has trained or educated 43,000 graduates and professionals, through activities including Summer Schools, Fellowships and Master’s/PhD programmes. On AI specifically, the EIT Health project HelloAI RES Online (https://eithealth.eu/project/helloairis/) was designed to introduce medical professionals to AI and equip them with the skills needed to allow them to benefit from the ongoing evolution of the healthcare field. • The proposed Regulation must have appropriate flexibility to accommodate sector specific issues, notably in health, where the risks are greater and the level of regulation already high. The proposal finds itself overlapping with many health sector specific and horizontal legislation (DGA, EHDS, MDR, IVDR, EHDS) and appropriate measures must be taken to ensure that health innovation is still allowed to thrive whilst of course ensuring patient safety. • Further clarity is needed on how healthcare AI outside of the scope of the MDR and IVDR will be regulated, notably when used for research purposes. • Finally, EIT Health welcomes the assurances created by looking at the whole value chain, and calls upon the Commission to find the right balance between support for innovation and building public trust in clear regulation, enabling safe and secure exchange of data and the development of new innovative AI.
Read full response

Response to European Health Emergency Response Authority

24 Feb 2021

The COVID-19 public health emergency highlighted the need for a proactive approach to health emergency response in Europe. EIT Health therefore welcomes the European Commission’s ambition to create a Health Emergency Preparedness and Response Authority (HERA) to ‘advance science and trigger innovation to the healthcare systems’ and prompt ‘proper preparedness, quick and efficient crisis response and management of medical countermeasures’ in the face of health crises with pandemic potential. EIT Health recognises the critical issues identified by the European Commission in the Initial Impact Assessment on this topic. In particular, fragmentation of efforts in the EU and the need for more effective development, financing and deployment of new countermeasures in times of crisis are topics that EIT Health recognize as being absolutely fundamental to address to ensure HERA’s success and effectiveness, and also as areas that EIT Health are actively working to promote and support. This includes our Headstart Programme, which in 2020 helped support 21 start-ups to develop health solutions in response to the pandemic, and our Rapid Response Initiative, which provided €7 million to 15 projects to help combat clinical challenges related to the pandemic, focusing on immediate and impactful solutions built in line with clinical needs. EIT Health would be happy to discuss these initiatives in more detail and to provide key learnings and best practices as HERA defines its role and structure. EIT Health welcomes the proposed scope for HERA, and looks forward to a degree of centralised architecture to focus on knowledge anticipation, generation and dissemination; development capacity; production capacity; resources and financing and procurement capacities that are flexible and fit-for-purpose; distribution capacity, and; training, which EIT Health view as vital to ensuring Europe develops and maintains the necessary knowledge and skills to be able to rapidly respond to future health emergencies. Regarding the options for regulatory involvement, EIT Health welcomes the establishment of a stand-alone authority with a permanent structure, to ensure a central point of oversight and to foster seamless cooperation between Member States on the crucial topics outlined above. EIT Health would like to indicate its preference for policy option 2.2, namely the establishment of a stand-alone authority which covers operational and infrastructural elements. To stimulate such innovation and maximise efficiency, HERA should aim for a flexible and agile setup that encourages collaboration, establishes effective decision-making and execution processes whilst eliminating redundant bureaucratic procedures and governance complexity. EIT Health believes that a simple governance structure is pivotal to ensure that HERA will be immediately capable of emergency activation in the event of a health crisis. Within this structure, EIT Health would like to emphasise the importance of a strong partnership mindset and collaborative culture. To enhance the attractiveness and overall performance of the authority, HERA should aim to integrate with the existing preparedness and response ecosystem, and to work closely with key partners. EIT Health would like to be closely aligned with agency objectives and priorities, and is ready to contribute to the development and realisation of the HERA objectives as soon as is practical. EIT Health foresees several opportunities to contribute to projects under HERA’s mandate, and is ready to explore how EIT Health’s broad network across Europe, and its vast experience in funding innovation and delivering education and training, can be utilised within the context of HERA’s scope of work.
Read full response

Response to Evaluation of patient rights in cross-border healthcare

11 Feb 2021

• EIT Health welcomes the consultation on the Cross-border healthcare (CBHC) Directive and the European Commission’s recognition of the importance of cross-border cooperation in healthcare, and fully endorses the recognition that COVID-19 has highlighted the need for cross-border sharing of capacity and expertise. • EIT Health notes that the eHealth provisions of the Directive will be evaluated in the context of the EHDS, and urges the Commission to work closely with both internal and external stakeholders to gain input to foster close compatibility between CBHC Directive and EHDS. This should include ensuring that CBHC can be supported to secure sharing of fully interoperable patient records, prescriptions, lab reports, images and other data needed to ensure a high standard of care. • The European Reference Networks (ERNs) have been successful for diagnosis and treatment and have been well accepted by healthcare professionals. We urge the Commission to explore how such sharing of expertise could be properly financially supported through the CBHC Directive to foster greater uptake, and to explore extension of the expertise sharing platform, the Clinical Patient Management System (CPMS), beyond rare diseases. EIT Health also calls for further action in regards to collaboration beyond diagnosis and treatment, particularly regarding development of new drugs, medical devices, care models and eHealth solutions and tools, as set out on https://ec.europa.eu/health/ern/work_en. • We welcome the focus on assessing how effective the CBHC Directive is in meeting patients’ needs, and urge the Commission to actively seek feedback from patient and consumer groups to better assess the level of public awareness of rights under the Directive. In this context, Member States (MS) should be encouraged to undertake thorough reviews of the operation of the National Contact Points (NCPs) and the extent to which they are able to offer advice to patients. MS should also be encouraged to assess HCPs knowledge of the Directive and their capacity to advise patients on its use. • It is well known that the Directive can pose a financial barrier for patients, as in most cases care has to be funded out of pocket at the point of care with reimbursement following later. Options for other funding modalities should be explored in the review of the Directive. • It is noted that the review will include the interaction with Regulation 883/2004. EIT Health urges the Commission to work in close collaboration with the MS and their NCPs to assess the extent to which the NCPs can and do help patients evaluate the best mechanism for accessing care in another MS. • EIT Health would welcome the opportunity to support the Commission in its assessment of CBHC. Through our network we could provide examples of cross border healthcare operating both within and outside the Directive, including experiences in Germany where we know NCPs have some problems in reporting data. Our close relationships with key hospitals as well insurers could be further explored to help identify challenges to reporting data, and help provide a better understanding of specificities of CBHC for German patients and other citizens living in German border regions. • Our strong network and relationships with key stakeholders in CBHC, including major hospitals and insurers, could also be a useful tool for supporting further understanding of the realities of CBHC in other regions, which we would be delighted to explore with the Commission.
Read full response