EU consultation · Commission Proposal
226 submissions from 185 organizations told the European Commission what they think about this file. Here is what each of them said, in their own words.
The Commission lists 1,600 submissions on this file. Shown here: the 226 from organizations. Not shown, by design: submissions from private individuals, which we never publish, and anything filed since our last weekly refresh.
74 submissions from industry — companies and their trade associations — against 70 from civil society: NGOs, consumer organizations, environmental groups and trade unions.
Groupings use the respondent type each organization selected when filing. Counting submissions, not organizations — a body that filed twice is counted twice.
What the room declares
Self-declared to the EU Transparency Register (snapshot 2 Sept 2026). The cost figure sums band floors, so the true total is higher.
The file, right now
The consultation closed on 28 Jul 2022 — it ran from 4 May 2022.
How it got here
Also on the Commission’s pipeline for this file, with no date recorded: Initiative planned, Communication.
Showing 25 of 226 submissions.
The DLR-DocSWISS Space2HealthTec consortium agreed with the following comments The reason for a specific sectoral health data initiative is not: sufficiently explained. The difference between secondary use and data altruism is not clear and this is: creates confusion between the different consent mechanisms. The report does not adequately reflect the different views of stakeholders.
Filed in German · English published by the European Commission
Thank you for the possibility to comment the EHDS draft proposal! Please find ESiOR’s comments attached as a PDF file. ESiOR Oy offers expert solutions for value demonstration, as well as the expertise to improve efficiency and cost-effectiveness in social and healthcare.
· · filed 28 Jul 2022 · source
The European Digital Peer Citizen Patient Alliance (EuDiPPA)/DLR-DocSWISS Space2HealthTec agree with the following comments. (1) the reason for having a specific sectoral initiative on health data is not: sufficiently explained. (2) the difference between secondary use and data altruism is not clear and this is: leads to confusion in the different authorisation mechanisms.
Filed in Dutch · English published by the European Commission
Flatiron Health, Inc. (Flatiron), a pioneer in the generation and use of real-world evidence (RWE) for oncology, appreciates the opportunity to provide feedback on the Proposal for a Regulation on the European Health Data Space (EHDS).
· · filed 28 Jul 2022 · source
The Avicenna Alliance welcomes the proposal for the EHDS. The Alliance is a multistakeholder group with the mission of accelerating medical innovation and its practical implementation to ensure safe, affordable and cost-effective health care through the large-scale adoption of in silico medicine and computer modelling and simulation (CM&S).
IDF Europe, representing both people living with diabetes (PwD) and healthcare professionals (HCPs) through a network of 70 national diabetes associations across Europe, strongly welcomes the Commission’s European Health Data Space (EHDS) proposal, which we believe, could make a meaningful difference to the health and well-being of the 32 million adults (one in 10) living with diabetes in the European Union (EU) as…
Siemens Healthineers welcomes the European Commission’s goal of creating a framework enabling access to health data and health data sharing across the European Union. It is a timely and highly anticipated initiative which empowers patients, while setting the building blocks for a European single market for (digital) health and tackling barriers which impede sharing of (health) data.
The German Social Insurance Agency welcomes the objective of creating a common health data space (EHDS). It offers an opportunity for an added value for patients and healthcare systems, both through digital, cross-border access to health data for medical treatment and its meaningful integration for research.
Filed in German · English published by the European Commission
· · filed 28 Jul 2022 · source
In light of the increasing digitalisation accelerated by the COVID-19 pandemic, the Austrian Social Insurance welcomes the European Commission’s proposal on a regulation establishing a European Health Data Space (EHDS) which is safe, accessible and transparent.
· · filed 28 Jul 2022 · source
HIMSS, the Healthcare Information and Management Systems Society, welcomes the European Commission’s proposal for the European Health Data Space (EHDS). As a global advisor, thought leader and member-based society committed to reforming the global health ecosystem through the power of information and technology, we are pleased to see that the European Union is nurturing the ongoing digital health transformation to a…
DIGITALEUROPE is a great supporter of the ambitions outlined in the Commission’s proposal for a regulation on the European Health Data Space (EHDS) which in our view is not a mere regulation but rather a holistic vision for the future of health and care for Europe. More effective use of health data is necessary to address diseases impacting often vulnerable communities.
Johnson & Johnson welcomes the EU Commission Regulation on a European Health Data Space (EHDS) intended as a patient- and consumer-centric data ecosystem based on the full respect of ethics, privacy and security principles.
European Lung Foundation (ELF) appreciates the opportunity to give feedback on the proposal on the European Health Data Space for better healthcare, research and policy-making. Supporting the submission of the European Respiratory Society, ELF endorses their recommendations and would like to provide additional patient perspective on this proposed legislation.
· · filed 28 Jul 2022 · source
The European Federation of Allergy and Airways Diseases Patients' Associations (EFA) welcomes the Commission initiative for a European Health Data Space, and especially its provisions related to the primary use of data. Regarding particular aspects of the proposed regulation, EFA fully agrees with the contribution of the European Patient Forum (EPF) on the need to put in place a policy framework that ensures: 1.
Insurance Europe welcomes the European Commission’s (EC) efforts to create an EU policy framework that unlocks the value of the data economy and creates a beneficial European Health Data Space (EHDS). The initiative has the potential to empower individuals and create new ways of communication between health care professionals and patients.
Accompany enhanced data sharing with necessary (digital) literacy programs AESGP welcomes the European Commission’s proposal for a regulation on the European Health Data Space and its ambition to support innovation, take advantage of digital technology developments and deliver concrete results to improve healthcare in Europe.
· · filed 28 Jul 2022 · source
The European Alliance of Medical and Biological Engineering and Science (EAMBES) is a non-profit scientific society focusing on Biomedical Engineering (BME) that brings together representatives most of Europe’s most renowned academic institutions, scientific BME societies, hospitals and universities.
The Bundesverband der Arzneimittel-Manufacturers e.V. (BAH) represents the interests of the pharmaceutical and medical devices industry both at federal and regional level vis-à-vis health policy, authorities and institutions. With around 400 member companies, it is the largest association in the pharmaceutical and medical devices sector.
Filed in German · English published by the European Commission
Please find attached the feedback on the European Commission proposal for a Regulation on the European Health Data Space (EHDS) by GIRP, the European Healthcare Distribution Association. GIRP is the umbrella organisation for full-service healthcare distributors in Europe.
The European Health Data Space (EHDS) could be a game changer for the healthcare and research sectors. If properly implemented, EHDS represents the opportunity to bring much-needed efficiencies to healthcare, by facilitating health data sharing, use for primary and secondary purposes, improve efficiency in delivery of (cancer) care.
· · filed 28 Jul 2022 · source
The legislative proposal on a European Health Data Space (EHDS) and respective horizontal proposals provide an unprecedented opportunity to shape the future health data and digital ecosystem. Digital transformation has the potential to increase the innovation and productivity of the EU economy and ensure that Europe remains an innovator and world leader in the development and manufacture of medicines, supporting…
· · filed 28 Jul 2022 · source
Digestive Cancers Europe (DiCE) applauds the European Commission for the proposal on European Health Data Space. DiCE believes that health data can improve health systems and advance research, especially in area of cancers such as digestive, where better diagnostic tools and treatment are urgently needed. In relation to EHDS we would like to share the following reflections. 1.
MedTech Europe welcomes the opportunity to provide feedback on the proposed European Health Data Space (EHDS) regulation, please find our full answer attached. • The EHDS regulation is meant to complement other EU laws, including existing sectoral and horizontal legislation.
· · filed 28 Jul 2022 · source
EHDS -- Comments to the European Parliament -- in behalf of the Co-Leaders of the Health Domain of the Gaia-X Spanish Data Hub 1. The proposed model of treatment of Health Data, in Article 37 of the Bill, contemplates that the institution that grants the Permits to access the Health Datasets, is the same that processes this information to make it available to the applicants that request access to this information…
· · filed 28 Jul 2022 · source
The European Blood Alliance (EBA) welcomes this proposal on the European Health Data Space (EHDS). European blood establishments represented by EBA have regularly asked for more and better data to increase donor protection and reinforce patient care; we believe that the EHDS can be a fundamental tool in working towards these goals.
The VYV Group (Harmonie Mutuelle, MGEN, MNT, Mutuelle Mare-Gaillard, etc.) set up in 2017 is the 1st mutual health and social protection actor in France. With its three jobs (Insurance, Care and Support, Housing), we protect almost 11 million people, 69 000 health and welfare client companies, more than 26 000 local and regional authorities and 11 ministries and public institutions.
Filed in French · English published by the European Commission
· · filed 28 Jul 2022 · source
The Holomedicine® Association is the first global association for holographic technology used in medicine, comprised of individual experts from medicine, science, technology, and policy. The Association warmly welcomes the EHDS initiative as well as the Commission's efforts towards a streamlined approach to the primary and secondary use of patient data.
The Bundesverband der Pharmazeutische Industrie e.V. (BPI) represents more than 270 companies from the entire range of the pharmaceutical industry, from multinationals to SMEs, mid-caps and start-ups. These companies ensure a timely and safe supply of medicines to all patients in Germany, the EU and worldwide.
Filed in German · English published by the European Commission
The proposal for a Regulation on the European Health Data Space (EHDS) is a welcome attempt to strengthen patients’ rights in relation to their elec-tronic health data and to foster sharing and use of electronic health data for the public benefit. However, vague definitions and the resulting inadvertent-ly extensive scope of several provisions are likely to impede the uptake of the EHDS.
GSK welcomes the proposal for a European Health Data Space (EHDS). We support the EU’s efforts to enable citizens and patients to access and control their health data, whilst enabling researchers and innovators access to health data in a secure way. Privacy of patient data is a critical issue.
The Pharmaceutical Group of the European Union (PGEU), the organization representing community pharmacists in 32 European countries, welcomes the European Commission’s proposal for a Regulation on European Health Data Space and the possibility to provide feedback. Please kindly find PGEU feedback attached hereto.
Bayer strongly supports the European Union’s (EU) efforts to increase patient and citizen access to and control of their health data through the proposal for a Regulation on a European Health Data Space (EHDS). In addition, the removal of barriers to the use of health data for scientific research will mean that patients will benefit from the discovery of innovative treatments, medical devices, and diagnostics.
· · filed 28 Jul 2022 · source
The European Social Insurance Platform (ESIP), representing statutory social security institutions, welcomes the intention to establish the European Health Data Space (EHDS). We endorse two separate infrastructures for primary and secondary use as well as a twofold governance mechanism, where access is granted by national competent bodies, networked at EU level.
France Assureurs supports the objective of improving healthcare delivery by ensuring that EU citizens have greater control over their electronic health data, but also to promote better exchange and access to different types of electronic health data in a private and secure environment for the common good. Therefore, we would like to highlight the following points which are detailed in the position paper attached.
· · filed 28 Jul 2022 · source
CIOMS supports the arguments for the EHDS with tailored rules beyond the scope of the existing legislation. The following need clarification: 1. Respecting the necessity of privacy. Whereas the proposal recognises the different competing interests of medical science in the public interest and individual fundamental rights, this discussion needs greater conceptual depth, particularly to ensure the essential public…
The European Society of Radiology (ESR) welcomes the European Commission’s proposal for the European Health Data Space (EHDS), a crucial way towards ensuring patient-centered healthcare, by using patient data to continuously improve patient care and health outcomes.
Label2Enable is a HORIZON-HLTH-2021 project in which 14 consortium partners from 7 countries collaborate to implement concrete actions on the integration and use of security and quality assured health and wellness apps, using the CEN-ISO 82304-2 label, in specific health care settings, covering the entire EU. The objectives of the project are to: 1.
As the Association representing the voice of leading online pharmacies in the EU and EEA, the EAEP welcomes the opportunity to provide its feedback on the adoption of the European Commission’s (EC) proposal “European Health Data Space (EHDS)”.
Access to data and data systems’ interoperability are the cornerstone of the digital transformation of healthcare in EU member states. A robust regulatory sectorial framework is needed to provide certainty to all actors for the digital technologies use for electronic health records, as well as exchange of health data within and among Member States for primary and secondary use.
· · filed 27 Jul 2022 · source
Research is global and therefore access to data, with appropriate safeguards, should be global. Cancer Research UK (CRUK) is the world's largest charitable funder of cancer research. We draw on the strength of our network and collaborate with partners around the world to save and improve many more lives than we could alone, bringing hope to people affected by cancer everywhere.
EATRIS-ERIC is the European infrastructure for translational medicine, mandated by 14 European Members States to bring together resources and services for research communities to translate scientific discoveries into benefits for patients.
The European Health Data Space (EHDS) aims for “making the most of the potential of digital health to provide high-quality healthcare and reduce inequalities”. EuroHealthNet has supported the establishment of the EHDS as it could improve monitoring and prevention systems, as well as enhance the ability of people to better understand and engage in their own wellbeing via multiple applications and tools.
· · filed 27 Jul 2022 · source
WMA supports the arguments for the EHDS with tailored rules beyond the scope of the existing legislation. The following need clarification. 1. Respecting the necessity of privacy. Whereas the proposal recognises the different competing interests of medical science in the public interest and individual fundamental rights, this discussion needs greater conceptual depth, particularly to ensure the essential public…
· · filed 27 Jul 2022 · source
EUREC supports the arguments for the EHDS with tailored rules beyond the scope of the existing legislation. The following need clarification. 1. Respecting the necessity of privacy. Whereas the proposal recognises the different competing interests of medical science in the public interest and individual fundamental rights, this discussion needs greater conceptual depth, particularly to ensure the essential public…
With its values of proximity and accessibility, La Poste has been engaged for several years in the health data and digital services sector. It has put itself at the service of the health system by adapting its know-how in logistics and in securing trade, promoting sovereignty and enhanced digital security.
Filed in French · English published by the European Commission
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world’s leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives.
· · filed 27 Jul 2022 · source
There are 6000 various rare diseases affecting over 30 million people across Europe, but only 6% of all known rare diseases have curative treatment. The rare disease community has many unmet needs. The limited number of patients alongside the scarcity of available knowledge and expertise on these diseases, make rare diseases a field that could greatly benefit from the European action.
· · filed 27 Jul 2022 · source
The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) welcomes the proposal on the European Health Data Space (EHDS). It recognises the importance of EU-level data collection standards and the promotion of data interoperability and exchange protocols. However, such a domain-specific common data space is expected to face challenges. Therefore, we submit the following recommendations.
SPECTARIS - the German Industry Association for Optics, Photonics, Analytical and Medical Technologies – welcomes the European Commission’s proposal for a Regulation on the European Health Data Space (EHDS). Due to the increased relevance of using and exchanging health data, the EHDS aims at strengthening EU citizens’ control over their own data, while also improving data access for research and innovation.
BioMed Alliance vision on the EHDS: The European Health Data Space could have a transformative effect on the healthcare and research sectors by facilitating health data sharing and use for primary and secondary purposes.
· · filed 27 Jul 2022 · source
Novartis commends the Commission for suggesting regulation around a European Health Data Space (EHDS), which could be a game changer for the digital transformation of healthcare in the EU. The regulation has many benefits for patients, who will have the right to control and share their personal electronic health data.
The proposal for a European Health Data Space (EHDS) promotes the EU-wide exchange of health data, removes access barriers and supports health research, in particular on new prevention strategies, but also for scientific research, on treatments, medicines, medical devices, as well as removing barriers to the cross-border use of digital health services and products to allow building more resilient and sustainable…
CSC strongly agrees with the need to make better use of electronic health data both in primary healthcare and secondary uses, such as research and policy-making, as this will bring tangible benefits to all Europeans in the form of more efficient healthcare systems, development of new treatments and personalised medicine as well as better informed decision-making in the health sector.
Bitkom welcomes the opportunity to give feedback on the Commission’s proposal. We are convinced that a uniform European health Data Space with transparent, efficient and innovation-promoting conditions is the central component of a connected and learn-as-you-go health sector. Our position paper provides an initial assessment of the proposal and highlights a number of points, which should be critically reviewed.
EuropaBio welcomes the European Commission’s bold ambition to make Europe the most competitive data economy globally. The power of data in the healthcare sphere is evident and realising the potential of healthcare data is a crucial step to ensure the EU is a leader in the development of next generational medicines.
Roche welcomes the opportunity to provide feedback to the European Commission’s Proposal for a Regulation of the European Parliament and of the Council on the European Health Data Space (EHDS). As the first sectorial area for Common Data Spaces, the success of the EHDS is key to realising the “European strategy for data” (the “Data Strategy”). Please find our full response attached.
On 3 May 2022 the European Commission published a proposal for a Regulation on the European Health Data Space (EHDS). As the current version would have a major impact on the medical device industry, the Bundesverband Medizintechnologie e.V. (BVMed) — representing over 240 manufacturers of medical devices — is using the opportunity to comment. BVMed e.V. welcomes the introduction of the EHDS.
Filed in German · English published by the European Commission
· · filed 26 Jul 2022 · source
The EORTC (European Organization for Research and Treatment of Cancer) very much welcomes the initiative to create a European Health Data Space (a “common health data space”), as there is an unmet need to facilitate health data sharing across borders and at international level.
· · filed 26 Jul 2022 · source
The legislative proposal is overall suitable to address the existing barriers to the secondary use of health data at the national and European level. In particular, it should result in a reduction in the time required to access data in France and in a harmonization of the rules.
The Medical Device / AI Expert Group (MD-AIG) established by the Netherlands Normalisation Institute (NEN) welcomes the European Commission’s (EU) proposal for a Regulation laying down harmonised rules on the European Health Data Space (‘EHDS’).
ResMed welcomes the proposal for the European Health Data Space (EHDS) and considers it has great potential to facilitate sharing and using health data, improve primary & secondary care and enhance the secondary use of health data. We would like to point out the following issues that could impact the promise of the EHDS.
The Association of European Cancer Leagues (ECL) welcomes the European Commission’s proposal to create a European Health Data Space (EHDS) to unleash the full potential of data cooperation across borders for the benefit and improvement of care, research, care and health policy.
We are three researchers involved in EU-funded research projects related to digitalization in health and medicine (ERC, Horizon 2020). We support the effort of the European Commission to stimulate safe access to up-to-date and accurate medical dossiers throughout the European Union.
The Council of European Dentists (CED), a European not-for-profit association representing 340,000 dentists across Europe welcomes the European Commission’s Proposal for European Health Data Space (EHDS) Regulation. It is important to ensure that the proposal and its future implementation are truly workable and beneficial for healthcare professionals (HCPs), dentists included.
EUPHA welcomes the establishment of the EHDS, and feels that the regulation proposal provides a solid basis for further discussion and development. In that further development, we urge to Commission to take into consideration various issues that, when not considered well and mitigated, could hamper the practical implementation and effectiveness of the EHDS.
· · filed 25 Jul 2022 · source
Representing more than 25,000 oncology professionals from over 160 countries, the European Society for Medical Oncology (ESMO) welcomes the proposal for the European Health Data Space (EHDS) and its intention to improve patient access to their health data and facilitate the use of health data for research and innovation.
Please find enclosed a document consolidating the full comments made in connection with an event promoted by the Faculty of Medicine of the University of Porto on 8 July 2022. The theme was "Access, Economy, and Sharing: the European Health Data Space ", and its main objective was to raise awareness of multiple stakeholders (clinicians, nurses, technology developers, administrators, students from various levels of…
Filed in Portuguese · English published by the European Commission
The European Respiratory Society appreciates the opportunity to give feedback to the proposal on the European Health Data Space (EHDS) for better healthcare, research and policy-making. The COVID-19 pandemic has shown the need of electronic health data for the development of policy response to health emergencies, better preparedness of healthcare services and for fostering research and innovation.
The EFN welcomes the EHDS legislative proposal and its key objectives as a logical next step in the digital transformation of health and care ecosystems. The EFN is part of Smart4Health and Interopehrate, both EU projects empowering citizens to use and donate their health data.
Comment of the Association of Clinical Research Organizations (ACRO) ACRO represents the world’s leading clinical research and technology organizations, which among them conduct or support the conduct of a majority of industry-sponsored clinical trials in the European Union.
Consultation of the Regulation for the creation of the European Health Data Space Comments from AMETIC • The document adequately reflects the EU’s intention to build a European Health Data Space, considers primarily eHealth data. HCE, Electronic Recet and Radiological Imaging, but data from other sources such as population health or interaction with patients should also be considered.
Filed in Spanish · English published by the European Commission
· · filed 22 Jul 2022 · source
In principle, the choice is made to let the system work with self-declarations. Ensuring a level playing field will imply great supervisory pressure for supervising authorities. The question is whether this is feasible (in practical sense) for all member states.
· · filed 22 Jul 2022 · source
In a previous (not officially published) version of the EHDS, references to ‘harmonized European standards’ were included. Surprisingly, in the current version the ‘harmonized European standards’ are deleted from the text and only ‘national and international standards’ are mentioned. This is not in line with the Standardization Strategy of the European Commission (see https://ec.europa.eu/docsroom/documents/48598).
RWE4Decisions welcomes the Commission’s EHDS proposal: it is an ambitious step forward that can contribute to a sustainable real-world data (RWD) ecosystem by addressing the current fragmentation and lack of health data infrastructure within and across Member States, making sure the data are interoperable and of high-quality.
· · filed 20 Jul 2022 · source
TEHDAS WP8 welcomes the new proposal from the European Commission of elaborating a European Health Data Space and defining a framework for primary and secondary use of health data in Europe. However, we would like to draw the attention of the Commission to the following. There is a general tendency to increasingly involve citizens in policy-making processes.
· · filed 20 Jul 2022 · source
The European Patients’ Forum (EPF) welcomes the ambition to establish an overarching framework for the exchange and sharing of health data. Appropriate use of health data can improve health systems’ sustainability, increase the quality, safety and patient-centredness of healthcare, and transform care into a more participatory process.
European Doctors (CPME) represents national medical associations across Europe. We are committed to contributing the medical profession’s point of view to EU and European policy-making through pro-active cooperation on a wide range of health and healthcare related issues.
The Flemish Agency for Care and Health recognises the potential of the evolution of digitalisation in healthcare, both in terms of developing and integrating digital tools and applications, as well as in terms of digitalisation of data and electronic data sharing. Subject to further scrutiny reservations, we provide the following feedback on the European Health Data Area (EHDS) proposal in annex.
Filed in Dutch · English published by the European Commission
· · filed 19 Jul 2022 · source
The European Hospital and Healthcare Federation (HOPE) welcomes the EHDS legislative proposal and its key objectives as a logical next step in the digital transformation of health and care. However, based on our preliminary analysis, a number of legal and technical clarifications will be required - in particular regarding some of the terminologies, operational requirements and standards, and links with other…
I am opposed to seeing my medical report by the EU Commission, taking udaje mozuvati lecturers for my state of health, apart from the fact that they have also produced a statistic that sends you to your statues, health care, insurance and other bodies, including in the EU
Filed in Slovak · English published by the European Commission
AmCham EU speaks for American companies committed to Europe on trade, investment and competitiveness issues. It aims to ensure a growth-orientated business and investment climate in Europe. AmCham EU facilitates the resolution of transatlantic issues that impact business and plays a role in creating better understanding of EU and US positions on business matters.
The International Association of Mutual Benefit Societies (AIM) is an international umbrella organisation of federations of health mutuals and other not-for-profit healthcare payers, which provide compulsory/and/or supplementary health coverage to around 230 million people around the world, including close to 200 million people in Europe, on a not-for-profit basis.
The European Heart Network (EHN) welcomes the publication of the EHDS proposal, one of the central building blocks for a strong European Health Union We welcome the aim to strengthen patient rights for primary use of electronic health data with the introduction of the new rules.
· · filed 12 Jul 2022 · source
Care4everyBody (C4EB) welcomes the Commission’s proposal for a Regulation on the European Health Data Space and is pleased to provide input. C4EB is an international NGO bringing together a multidisciplinary group of medical professionals. Advocating for sex- and gender-specific healthcare across Europe, C4EB takes a broad, interdisciplinary approach to women’s health.
ScanBalt - an international association of research clusters from the Baltic Sea Region and Scandinavia - has been accompanying the digitalisation and digitisation of healthcare and health research in Europe for many years. We would like to comment on this proposal from a cluster perspective and with a special focus on patient-centred care.
· · filed 5 Jul 2022 · source
The Slovak Patients’ Union strongly opposes the proposed initiative to create a common digital space for sharing data on the health status of EU citizens. This initiative grossly violates patients’ rights. The initiative is in direct violation of the right to privacy and confidentiality of the patient’s personal information in general.
Filed in Slovak · English published by the European Commission
· · filed 3 Jul 2022 · source
We strongly disagree with the creation of a common digital space with EU citizens’ health data. We consider such an effort by the European Commission to be questionable and inadequate. By joining the EU, citizens of the Member States have not waived their rights, which include the right to privacy.
Filed in Slovak · English published by the European Commission
· · filed 1 Jul 2022 · source
The World Federation of Hemophilia would like to congratulate the European Commission on Public Consultation on the European Health Data Space for this innovative program. Patient data are the foundation of clinical and regulatory decisions and health policies and can play a transformative role in the lives of patients.
· · filed 30 Jun 2022 · source
In general, Dansk Erhverv works for an efficient healthcare system in which citizens have a high level of trust and receive the highest quality of care, whether public or private. In this context, Dansk Er is a representative of the Danish health and life science industry in a broad sense, including pharmaceutical companies, media and diagnostic companies, biotech, health IT companies and other life science…
Filed in Danish · English published by the European Commission
The Deutscher Anwaltverein (DAV) is the professional association for lawyers in Germany; membership is optional. The DAV brings together more than 61 000 lawyers and notaries of lawyers, organised in 253 local lawyers’ clubs in Germany and abroad. He represents the interests of the German Bar at national, European and international level. Please find attached our opinion.
Filed in German · English published by the European Commission
CZ The European Commission’s efforts, i.e. a bureaucratic apparatus without real scrutiny, to create a “European Health Data Space” is legally and absolutely unacceptable for a number of reasons: — oversight of the public health of citizens of the Member States does not fall within the competence of the European Union (this is the sovereign competence of the citizens of the elected bodies of the Member States).
Filed in Czech · English published by the European Commission
· · filed 28 Jun 2022 · source
- Czech version - English version CZ Snaha Evropské komise, tedy byrokratického aparátu bez reálné kontroly, o vytvoření „Evropského prostoru pro data z oblasti veřejného zdraví“ je právně i lidsky absolutně nepřijatelná z řady důvodů: - mezi pravomoci Evropské unie nespadá dohled nad veřejným zdravím občanů členských států (to je výsostná kompetence občany volených orgánů členských států) – snaha o rozšiřování…
VIATRIS is committed to providing access to medicines, advancing sustainable operations, and developing innovative solutions to improve patient outcomes. Our portfolio comprises more than 1,400 molecules across major therapeutic areas including brand medicines, generics, OTC medicines, and APIs.
· · filed 13 Jun 2022 · source
Personal data is digital gold. The larger the dataset, the higher the risk of attack. — 500 million Facebook user records stolen in 2021 — 700 million LinkedIn user records were stolen in 2020-2021 https://www.mojandroid.sk/linkedin-unik-dat/ — The German insurance company Haftpflichtkasse was challenged in July 2021 The processing of personal health data in a large centralised database is likely to result in a high…
Filed in Slovak · English published by the European Commission
· · filed 13 Jun 2022 · source
We "Europeans for Safe Connections" are against this initiative as a whole. Personal data is digital gold. The bigger the dataset - the higher risk of the attack. - 500 million Facebook user records were stolen in 2021 - 700 million LinkedIn users records were stolen in 2020-2021 - German insurance company Haftpflichtkasse was attacked in July 2021 Processing of personal medical data in a big centralised database is…
· · filed 8 Jun 2022 · source
Our Italian Electrosensitive Association is opposed to this initiative as a whole. Personal data is digital gold. The larger the data set, the higher the risk of attack. It is known to everyone that many hundreds of millions of dative-users have been stolen by platforms (considered ‘extremely secure’) such as Facebook or Linkedin, as well as by many highly protected sites such as NASA and many others across the…
Filed in Italian · English published by the European Commission
· · filed 17 May 2022 · source
European Podiatry would like to warmly welcome you to the initiative proposed by the European Commission on Public Consultation on the European Health Data Space. Thanks to this proposal, the capacity of digital health will be able to be increased to reduce inequalities and be able to offer better medical attention to European citizens.
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.
Very important topic, approached in great detail. Interoperability is a key aspect in data science and health. Also patient access to own data is critical and not often accounted for in the health data management systems. This issue listed in the text is critical: "potential administrative burden and complexity linked to the implementation of this legislation will be assessed".
The ECHAlliance is a global network of Digital Health Alliances that connects 78 countries in Europe, USA, Canada, China, Africa, Asia, the Caribbean and Americas and the Pacific, including stakeholders from government, health & social care providers, companies and start-ups, researchers, insurances, patient groups and citizens.
· · filed 4 Feb 2021 · source
The Vereniging Innovatieve Geneesmiddelen (VIG) is positive towards the proposal of the European Commission to establish a European Health Data Space (EHDS). This proposal enables the EU to better grasp the potential of health data for research and innovation on new preventive strategies, as well as on diagnosis and treatment of diseases to improve health outcomes.
The initiative aims to promote access to health data for research and innovation on new preventive strategies, as well as on diagnosis and treatment of diseases to improve health outcomes while ensuring that citizens have control over their own personal data.
· · filed 4 Feb 2021 · source
The Belgian Federal Health(care) administrations welcome the initiative and the efforts that are made towards achieving better access, sharing and re-using of health data in Europe. There needs to be improved visibility on how to access EU-level health data supported by a tailored governance framework, by open and exhaustive metadata catalogues, and by the adoption of common European data quality and…
The initiative aims to promote access to health data for research and innovation on new preventive strategies, as well as on diagnosis and treatment of diseases to improve health outcomes while ensuring that citizens have control over their own personal data.
· · filed 4 Feb 2021 · source
The VYV Group (Harmonie Mutuelle, MGEN, MNT, MGEFI, Mutuelle Mare-Gaillard, SMACL Assurances, etc.), established in 2017, is the 1st mutual health and social protection actor in France. All the components of the group and their 45 000 staff, protect around 10 million people and propose solutions tailored to more than 89 000 health and welfare companies and more than 84 000 legal entities in IARD.
Filed in French · English published by the European Commission
Seqirus is one of the world’s largest influenza vaccine providers, a major contributor to influenza prevention and a key partner in pandemic preparedness. We believe evolving data innovations in health technology can help unlock particular challenges associated with influenza and improve influenza prevention.
· · filed 4 Feb 2021 · source
The European Health Data Space (EHDS) will definately promote the development of cloud-computing healthcare platforms, where the patient data will be shared and stored under secure federated cloud databases fulfilling the data protection requirments (legal or ethical) which are posed by the GDPR (General Data Protection Regulation).
The following comments are issued by the members of the reasearch Project BioDat (http://biodat.proyectoscebes.es/): The impulse of a strategy to create an EHDS, in the frame of the European strategy for data, must be regarded as very positive, given the particular characteristics of the health sector and the sensitive character of the information handled in its context.
Orphanet welcomes and support the ambition of the EHDS to make the most of the use of digital technologies as a means to provide high-quality healthcare as well as reducing inequalities while ensuring that citizens have control over their personal data. Further to this primary use and major aim, EHDS will enable secondary use of health data for research and evidence-based policy making purposes.
· · filed 3 Feb 2021 · source
IDF Europe is a pan-European not-for-profit organisation, representing people living with diabetes and healthcare professionals in 70 associations across 44 countries in Europe. Diabetes is an incurable and complex disease, which currently affects more than 33 million people across the European Union.
· · filed 3 Feb 2021 · source
The European Cancer Organisation congratulates the European Commission for taking bold initiative to better harness the power for improvement that stronger coordination of health data at the European level can achieve. In this sense, the proposed European Health Data Space offers great potential.
In general, BBMRI-ERIC welcomes the initiative for a European Health Data Space (EHDS). The roadmap/impact assessment correctly identifies problems hindering the creation of a single European market for data (section “Problems the initiative aims to tackle”) and discriminates health data between health care and health research data, including the peculiar issues with data privacy, sharing, and interoperability…
· · filed 3 Feb 2021 · source
In general, BBMRI-ERIC welcomes the initiative for a European Health Data Space (EHDS). The roadmap/impact assessment correctly identifies problems hindering the creation of a single European market for data (section “Problems the initiative aims to tackle”) and discriminates health data between health care and health research data, including the peculiar issues with data privacy, sharing, and interoperability…
· · filed 3 Feb 2021 · source
NFDI4Health Input to the European Health Data Space initiative Summary: NFDI4Health – the German National Research Data Infrastructure for Personal Health Data – strongly supports the goals of the European Health Dataspace (EHDS). We see the necessity to promote flexible, GDPR-compliant, and maximally privacy preserving sharing of data.
The American Chamber of Commerce to the European Union (AmCham EU) shares the European Commission’s view that EU-level action is required to address the fragmented environment of European health data, the lack of data available for (re-)use in scientific research and the need for increased uniformity in Member States’ applications of data regulations.
The health insurance funds and not-for-profit health insurers of AIM agree with the huge potential that a flexible use of health data has for patient centeredness as well as improving healthcare quality and outcome.
· · filed 3 Feb 2021 · source
In light of increasing global cancer burden, with breast cancer estimated to be the most commonly occurring cancer in the world, a multi-stakeholder initiative Transforming Breast Cancer Together (TBCT) commends the European Commission's ambitious initiative - Europe’s Health Data Space (EHDS).
· · filed 3 Feb 2021 · source
The initiative is a fundamental step for the transformation of health systems and their sustainability. The document clearly highlights the need for regulatory actions at European level, requiring Member States to implement specific actions regarding GDPR, data quality and interoperability.
· · filed 3 Feb 2021 · source
Forum’s views on the proposed European Health Data Space (EHDS) Forum, the Slovenian innovative pharmaceutical association, which represents 21 global research companies, supports the Commission's efforts to generate a legal environment providing for a wide-ranging use, re-use and exchange of health data, acknowledging the value of such data and promoting the harmonization of digital standards, both at the EU and at…
The European Health Parliament (EHP) is a movement connecting and empowering the next generation of European health leaders to rethink EU health policies. During the 5th session of the EHP, the Interconnected Care Committee developed a set of policy recommendations focused on the ever-growing demand for interconnected healthcare services and more efficient care.
Bitkom strongly welcomes the European Commission’s efforts to create a European Health Data Space (EHDS) to unlock the potential of health data for sustainable and resilient healthcare systems. Access and (re)use of health data are preconditions to a digital transformation of healthcare systems and set the cornerstones for patient-oriented and data-driven health ecosystems for the future.
Microsoft appreciates the opportunity to comment on the European Commission’s inception impact assessment on the European Health Data Space (hereinafter “EHDS”). Fostering greater access and sharing of health data across the EU, for both primary and secondary uses, is a goal we strongly share at Microsoft.
LET THE KNOWLEDGE CONTAINED IN DATA OPEN DOORS TO THE FUTURE OF HEALTHCARE AESGP welcomes the European Commission’s Combined Evaluation Roadmap and Inception Impact Assessment on A European Health Data Space and its ambition to introduce innovation, to take advantage of digital technology developments and to deliver concrete results to improve healthcare in Europe.
The German Association of Private Health Insurers has 42 ordinary and 10 extraordinary members. Its member companies cover almost the entire private comprehensive and supplementary health insurance market in Germany. We welcome the European Commission’s plans for a European Health Data Space (EHDS).
EuropaBio welcomes the EC's plan to begin a discussion with stakeholders to develop the EHDS. Science is evolving fast and digital tools are accelerating our ability to conduct research. For the biotechnology industry, it is imperative quality data sets are collected and analysed, while protecting privacy and maintaining trust in how the data are used.
· · filed 3 Feb 2021 · source
The European Molecular Biology Laboratory (EMBL) is supportive of the European Commission’s efforts to establish the European Health Data Space. EMBL-EBI (Hinxton, UK site) maintains the world’s most comprehensive range of freely available molecular data resources.
· · filed 3 Feb 2021 · source
The International Federation of Anthroposophic Medical Associations (IVAA) welcomes this initiative and the effort by the Commission to coordinate health data collection. We believe this will improve efficiency and efficacity of healthcare and health research across the EU.
· · filed 3 Feb 2021 · source
The Digital Health and Data Network (DHDN) of the European University Hospital Alliance (EUHA, an association of nine leading university hospitals in Europe) welcomes the initiative of a European Health Data Space and looks forward to working together on its design and implementation.
· · filed 3 Feb 2021 · source
SIOP Europe welcomes the European Health Data Space Roadmap with its focus on eradicating inequalities, facilitating research, and empowering patients. The roadmap objective 1: ‘Legal and governance framework to cover the access to and exchange of health data’ is particularly relevant for addressing the challenges and opportunities in the paediatric sector.
The European Respiratory Society appreciates the opportunity to input to the proposal on the European Health Data Space for better healthcare, research and policy-making. The COVID-19 pandemic has clearly shown the benefits that better sharing and use of health data could bring to healthcare in the EU.
· · filed 3 Feb 2021 · source
HIMSS warmly welcomes the roadmap and inception impact assessment on the EHDS, which will be a core tool in allowing the European partners to collaborate to build more sustainable and resilient healthcare systems. We note and welcome the recognition of the fragmentation of digital standards and limited digital interoperability in the health sector.
Rare Cancers Europe (RCE), a 40-partner strong multi-stakeholder partnership, welcomes the EU efforts towards the creation of a European Health Data Space (EHDS). Rare cancers are a neglected area deserving dedicated attention as 24% of all new cancer diagnoses, including all paediatric cancers, are rare.
Health data is a key enabler for the digital transformation of healthcare. The rapidly expanding corpus of health data holds clear potential to improve citizens’ health as well as care systems. However, leveraging health data is faced with the double challenge of balancing citizens’ need for privacy and security with regulatory frameworks that promote research, innovation and patient empowerment through the use of…
The BioMed Alliance welcomes the European Health Data Space (EHDS). We believe it can play an important role in facilitating health data sharing to improve the health of European citizens. The 35 members of the BioMed Alliance contribute to this mission in multiple ways; they conduct health research, provide information and education to healthcare professionals and strive to improve European healthcare in general.
· · filed 3 Feb 2021 · source
A connected and interoperable European Health Data Space (EHDS) is essential to unlock the potential of health data in Europe. The initiative will first and foremost benefit societies in Europe – including patients and healthcare providers – as it can play a crucial role in developing innovative technologies and treatments. Standard protocols can be replaced by personalised, data-driven insights and interventions.
· · filed 3 Feb 2021 · source
All.Can welcomes the European Health Data Space (EHDS) initiative which seeks to ensure access and optimal use of health data as well as digital health products and services. Efficient healthcare systems that deliver the best possible outcomes for patients are evidence-based learning systems that incorporate meaningful input from healthcare users, make continuous assessments of products and processes, and report the…
To whom it may concern, Roche welcomes the opportunity to provide feedback to the European Commission’s combined evaluation and roadmap/Inception Impact Assessment for A European Health Data Space (EHDS) as an important step towards informing the legislative proposal for the EHDS and realising the European Commission’s “A European strategy for data” released in 2020.
· · filed 3 Feb 2021 · source
Huawei supports the EU’s initiative on the creation of health data space and welcomes the opportunity to comment on the combined evaluation roadmap and inception impact assessment. The coronavirus pandemic has highlighted and accelerated the importance of health data for research, and we fully support this Commission priority.
Bayer welcomes the European Commission’s agenda to create a European Health Data Space (EHDS) that will promote access to health data, foster the European digital health market, and enable the use of AI in health. Bayer actively participates in several data sharing projects, because we believe in the value of electronic health records (EHR) and patient-generated health data (PGHD) to promote scientific advances.
The EHDS Inception Impact Assessment sets out ambitious objectives linking together the need for secure and trusted health data sharing for what will be the creation of the first European data space. The EHDS has the potential to be the single market for digital health products and services, and the global centre of development of secure AI powered digital health.
Orange Business Services' Health Subsidiary – Enovacom - fully agrees and supports the European Commission initiative “Digital health data and services – the European health data space”. We strongly believe that it is of paramount importance to design a European Health Data Space that respects the core European principles and values, especially on Data privacy, GDPR and equal access to healthcare innovation to…
· · filed 3 Feb 2021 · source
EPHA welcomes the European Health Data Space as a Commission priority and is pleased that it is seen as a way to increase the ability of digital health to reduce inequalities and provide high-quality healthcare.
· · filed 3 Feb 2021 · source
We welcome the initiative of the European Commission to setup a European Health Data Space (EHDS). As the voice of 200 million people living with allergy, asthma, and chronic obstructive pulmonary disease (COPD) in Europe, the European Federation of Allergy and Airways Diseases Patients’ Associations (EFA) fully acknowledges the immense benefits that data sharing applied to health can bring to people’s diagnosis…
COCIR welcomes the opportunity to provide feedback on the combined evaluation roadmap/inception impact assessment on the European Health Data Space. COCIR is fully supportive of the European Data Strategy that aims to establish common European data spaces.
· · filed 3 Feb 2021 · source
The European Health Data Space (EHDS) covering the exchange and access of primary and secondary use of good quality health data is eagerly awaited by the Avicenna Alliance to pursue scientific research and innovations, including the use of computer modelling and simulation (CM&S) in healthcare.
· · filed 3 Feb 2021 · source
The ERN RARE-LIVER welcomes the EU initiative to create a European Health Data Space (EHDS). Digitization has driven technological advancements over the past decade. Adopting to this development, facilitating the secure exchange of health data between EU member states is nothing but the next logical step.
· · filed 3 Feb 2021 · source
EFHPA, the European Federation of Homeopathic Patients’ Associations, welcomes and supports this important initiative, which aims for patients to have greater access to their health records and allow researchers and policy-makers greater access to health data, which will ideally mean citizens receive the best and most appropriate care.
EUCOPE welcomes the opportunity to participate in the evaluation process of the European Commission proposal for a European Health Data Space (EHDS). Representing small and medium-sized companies active in pharmaceuticals, biotechnologies and medical technologies, EUCOPE shares the Commission’s ambition to see the EU becoming a leader in digital innovation.
DigitalHealthEurope is a CSA supporting the EC Communication on the DTHC. In 2020 DHE held multiple stakeholder consultations on the acceptability of reusing health data, especially for research, and on the potential opportunities from the EHDS. The key requests for the EHDS highlighted through the project are: 1.
EIT Health European Health Data Space Consultation Response • The EHDS will be an important part of Europe’s health research and innovation landscape which will support the development of many innovative treatments and interventions which will improve outcomes, health and quality of life.
ERNICA supports the proposed aims and objectives of the EHDS. ERNICA also welcomes the development of the 24 ERN registries and believes that they can be a very important building block for the EHDS. The EHDS was discussed with the EC during the ERN Coordinators Group meeting on 27 November 2020 where there was broad support for the initiative.
· · filed 3 Feb 2021 · source
CSC agrees with the objectives of the planned regulatory framework for a European Health Data Space and supports its establishment. However, it must be ensured that the sector-specific data spaces and their respective legislative frameworks do not become silos but are developed in coherence, making them interoperable and thus supporting the ultimate goal of creating one unified European data space.
ERN CRANIO supports the proposed aims and objectives of the EHDS. ERN CRANIO also welcomes the development of the 24 ERN registries and believes that they can be a very important building block for the EHDS. The EHDS was discussed with the EC during the ERN Coordinators Group meeting on 27 November 2020 where there was broad support for the initiative.
· · filed 3 Feb 2021 · source
VITO is an independent Flemish research organization in the areas of Health, cleantech, and sustainable development. As an international research organization, VITO creates innovative technological solutions and actively shares its knowledge with businesses and government bodies across the globe.
The BAH welcomes the European Commission’s initiative on European Health Dataspace (EHDs) and has the following expectations and requirements: 1. The Commission should collect the status quo in order to obtain a concrete overview of the individual countries and of the main obstacles to a common data space in order to target the legal framework in the most targeted and efficient way.
Filed in German · English published by the European Commission
· · filed 3 Feb 2021 · source
The Association of Innovative Pharmaceutical Industry (AIFP) shares the EFPIA’s view expressed in its input into this Inception Impact Assessment. Further to this, we would like to stress some of our main concerns and observations.
· · filed 3 Feb 2021 · source
The European Society of Intensive Care Medicine (ESICM) welcomes the initiative of the European Commission to engage the digital transition in the health sector while making the most of the potential of digital health.
· · filed 3 Feb 2021 · source
We welcome this initiative. The future of new prevention, diagnostics, therapies and the overall development of the health care system highly relies on both data quantity and quality. There is a necessity to ensure that generated data can be used (and re-used) to benefit the most but without compromising each citizens personal integrity.
· · filed 3 Feb 2021 · source
The European Society of Oncology Pharmacy welcomes the start of the European Health Data Space and congratulates the European Commission for taking this ambitious step towards improving health care service delivery and outcomes for European citizens. We would like to take this opportunity to express our hope that the European Health Data Space will address the needs of our oncology patients.
BEUC, The European Consumer Organisation appreciates the opportunity to provide input to the European Commission’s ongoing evaluation of the need for a legislative proposal on a European Health Data Space. We consider that the evaluation provides a timely opportunity to ensure that sensitive data of European patients and consumers used for scientific advancements is well protected and serves societal interests.
· · filed 3 Feb 2021 · source
The Council of European Dentists (CED) welcomes the opportunity to provide feedback on the assessment by the European Commission on the need for a legislative proposal on the European Health Data Space (EHDS). A robust and secure EHDS is long overdue and has the potential to create new ways to communicate between health care professionals and patients and to empower the latter.
Biogen is one of the world’s leading biotechnology companies, with a focus on discovering, developing, and delivering innovative therapies and digital solutions for people living with serious neurological diseases.
The German Medical Association (Bundesärztekammer) is the central organisation in the system of medical self-administration in Germany. As the joint association of the State Chambers of Physicians (Landesärztekammer), it represents the interests of more than 526,000 physicians in matters relating to professional policy, and plays an active role in opinion-forming processes with regard to health and social policy and…
· · filed 3 Feb 2021 · source
EFPIA welcomes the proposal to create sectoral and horizontal legislative frameworks to unlock the value of data, support the use, re-use and exchange of health data at the EU level and ensure coherence between the operation of the different legislations contributing to the functioning of the Data Space.
The Spanish Federation of Rare Diseases (ERDF), aligned with the European Alliance representing these diseases (EURORDIS), welcomes this consultation, recognising first of all the opportunity of this review for research and addressing this group.
Filed in Spanish · English published by the European Commission
· · filed 3 Feb 2021 · source
The European Society for Blood & Marrow Transplantation (EBMT) warmly welcomes the EU's EHDS strategy. As the largest registry holder of its kind in Europe (>700k transplants reported), EBMT is rightly recognised as a key resource for not just scientific research in the field of cell therapy but for regulatory and other purposes.
In the field of rare diseases (RD), typified by limited knowledge and data on each specific disease, needs and benefits of capturing, using, sharing and federating health data to advance scientific research and improve care are very strong.
· · filed 3 Feb 2021 · source
The European Social Insurance Platform (ESIP) welcomes the Commission’s intention to improve access to and exchange of health data, via the establishment of a European Health Data Space (EHDS). We support a reinforcement of the legislative and governance framework to ▪ Increase cooperation among Member States on the exchange of health data for primary use, also as a preventive measure for future cross-border health…
· · filed 3 Feb 2021 · source
Towards a European Health Data Space Socioeconomic concerns: 1. Differences between levels of digitalisation between countries → integration 2. Differences between national IT regulatory frameworks → integration 3. Differences between individuals’ IT skills, financial background (e.g. lack of devices), access to the Internet → long-term: creation of a pan-EU health digital platform? 4.
Endo-ERN Response To Consultation On The EHDS In general we support the development of the EHDS and the ERNs should be involved in informing its development and implementation. By using platforms such as CPMS and rare disease registries, ERNs have first hand experience of using common platforms across a wide range of health care providers in several member states.
· · filed 3 Feb 2021 · source
CEN Technical Committee 251 Health Informatics is very positive on the initiatives around a European Health Data Space. We see an important role for the standards that CEN/TC 251 produces in the problem area identified in the third bullet of the section “Problems the initiative aims to tackle”, as well as on the “Preliminary Assessment of Expected Impacts”. We have documented our input in attached document.
MedTech Europe supports the project of the European Health Data Space (EHDS). The medtech industry is at the heart of the health data ecosystem. The industry’s digital health solutions annotate and enrich data to turn raw data into datasets of high value. Innovation in the development of new treatments and protocols is highly dependent on its ability to access and appropriately utilise health data.
· · filed 3 Feb 2021 · source
ELIXIR welcomes and supports the initiative of the European Health Data Space (EHDS) and related regulatory framework, as it will be essential to realise the full potential of personalised medicine. The work outlined in this proposal, especially the ability to share genomic, phenotypic, and biomolecular data across borders aligns closely with ELIXIR’s work on development of federated networks generally and in the…
· · filed 3 Feb 2021 · source
The objevtives and policies outlined are a prominent need for boosting research, especially in case of rare diseases or emerging diseases and epidemics and are clearly defined. For what concerns adoption in clinical pracrice, besides the well known and well addressed issues of data interoperability and data reuse, the integration of new concepts in clinical research and in the conduction of clinical trials, that…
United European Gastroenterology (UEG) is a professional non-profit organization combining all the leading European medical specialists and national societies focusing on digestive health. Together, we act as the united and trusted voice of European Gastroenterology, promoting science, research, education, quality of care. We aim at reducing health inequalities across Europe.
On 2 February 2021, the CPME Executive Committee adopted the ‘CPME Statement on the Combined Evaluation Roadmap/Inception Impact Assessment on a European Health Data Space’ (CPME 2021/005 FINAL). CPME Statement on the Combined Evaluation Roadmap/Inception Impact Assessment on a European Health Data Space The Standing Committee of European Doctors (CPME) represents national medical associations across Europe.
· · filed 3 Feb 2021 · source
The Irish Blood Transfusion Service welcomes the proposal to create legislation in support of an EU Health Data Space particularly with regard to the potential for using health data to optimise healthcare delivery and for appropriate healthcare research purposes.
· · filed 3 Feb 2021 · source
The Irish Blood Transfusion Service welcomes the proposal to create legislation in support of an EU Health Data Space particularly with regard to the potential for using health data to optimise healthcare delivery and for appropriate healthcare research purposes.
· · filed 3 Feb 2021 · source
Governance – a shared vision based on trust • The 24 ERN registries should be one of the fundamental building blocks of the EHDS * The former UK ERN Full Members are part of the ERN Registries and should therefore have access as well • The ERN CG can build on the recent experience of setting up registries to actively work with the EC to create the EHDS - we would like to be involved in the development, discussions…
· · filed 3 Feb 2021 · source
Edwards Lifesciences is a global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring for critically ill patients. More specifically, for the management of critically ill patients, Edwards Lifesciences develops predictive monitoring solutions.
The German Insurance Association (GDV) welcomes the European Commission’s plans for a European Health Data Space (EHDS). Effective and secure use and re-use of health-related data has the potential to create immense benefits for the well-being of patients and society. The roadmap shows that a plethora of issues and barriers currently persist which prevent us from fully exploiting that potential.
The Alliance for Regenerative Medicine (ARM, www.alliancerm.org) is the leading international advocacy organisation dedicated to realizing the promise of advanced therapy medicinal products (ATMPs). ARM promotes legislative, regulatory and reimbursement initiatives in Europe and internationally to advance this innovative and transformative sector, which includes cell therapies, gene therapies and tissue-based…
· · filed 3 Feb 2021 · source
Thanks first of all for the opportunity to provide feedback on the proposed Regulation on the European Health Data Space (EHDS). Cancer Control is a disease-fighting patient association that has, among other things, just over 200 researchers carrying out cancer research at a high international level.
Filed in Danish · English published by the European Commission
Sense (Societal impact of gENetic SciencE) is the Dutch consortium of bringing genetic science to citizens. Please find attached the feedback from our Consortium. Feedback was send by the Coöperatie 4LifeSupport U.A. one of the members of the Sense consortium.
Governance: The ERN Coordinator Group can build on the recent experience of setting up registries to actively work with the European Commission to create the EHDS, European Health Data Space. The 24 ERN registries should be one of the fundamental building blocks of the EHDS, providing a wealth of global patient date for rare diseases.
The Heart Failure Policy Network (HFPN) is an independent multidisciplinary group of healthcare professionals, patient organisations, policymakers and other key stakeholders from across Europe working to raise awareness of unmet needs surrounding heart failure and its care.
· · filed 2 Feb 2021 · source
I am based at Heidelberg University Hospital, and I am the Coordinator of the EC-H2020 funded ReCoDID project (www.recodid.eu; Reconciliation of Cohort Data on Infectious Diseases), with a focus on harmonization and data sharing for ID-related cohorts, especially emerging viral diseases. We have embarked on data sharing for Arbovirus cohorts (acute febrile illness, Dengue/Zika) and COVID-19 cohorts.
Please find attached comments of ACT | The App Association (Transparency Reg. # 7202951387754) on the European Commission’s Roadmap "A European Health Data Space" (Ref. Ares (2020)7907993). Anna Bosch Policy Associate ACT | The App Association (Transparency Reg. # 7202951387754) Rue de Trèves 45 B-1040 Brussels
Statement by ELIXIR-Luxembourg on the European Health Data Space (EHDS) Please see the attached document for our complete feedback. The following consists of a brief point-by-point summary. Scope: The IIA has a strong emphasis on primary healthcare and data driven services (e.g. in the justification section). It is strongly recommended to put a major emphasis on secondary use for research as well.
1)Data governance, access, sharing, use and re-use The EHDS should build on F.A.I.R. (findable, accessible, interoperable, reusable) data principles to ensure maximum value and trust from the data collected. Given the specificities of the health sector, J&J welcomes the intent to complement the Data Governance Act proposal by establishing sectoral bodies, namely national digital health bodies and sectoral bodies…
· · filed 2 Feb 2021 · source
The European Cancer Patient Coalition (ECPC) welcomes the initiative of the European Commission of setting up the European Health Data Space (EHDS) as a tool to strengthen cooperation, improve cancer research and ensure more equality for patients.
· · filed 2 Feb 2021 · source
Digital Health Society & the European Institute for Innovation Through Health Data Calls to Action on Health Data Ecosystems This contribution summarises the outcomes of two recent multi-stakeholder consultations to examine the acceptance criteria for societal trust in the use of health data and a recipe for trustworthy digital health: standards, architecture and value.
RWE4Decisions welcomes the set up of the EHDS to enable the cross-border sharing of real-world data (RWD) by healthcare decision-makers (regulators, HTA authorities, and payers). The EHDS should take into account the potential of RWD for learning healthcare systems and thereby support the development of a multi-stakeholder EU Learning Network on Real-World Evidence (RWE).
· · filed 2 Feb 2021 · source
The French authorities (FAs) welcome significant and structured progress made since the publication of the European Strategy for Data in February 2020, including the proposed legislative roadmap and available financial instruments such as the TEHDaS Joint Action, which have allowed to create a catalyst moment around the creation of a future European Health Data Space (EHDS).
· · filed 2 Feb 2021 · source
Allied for Startups welcomes the European Commission’s proposal to create the European Health Data Space (EHDS). Our members believe that the EHDS has strong potential to support the digitization of health and care, accelerate digital health innovation and boost the global competitiveness of European startups innovating in healthcare.
· · filed 2 Feb 2021 · source
HOPE welcomes this Roadmap as an opportunity to further clarify certain elements in particular as the Commission mentions its priority to reduce inequalities, which are particular important in terms of digital access and digital literacy. Specificities should be recognized instead of being ignored with a one-fits-all approach.
· · filed 2 Feb 2021 · source
02 February 2021 The Association of Clinical Research Organizations (ACRO) represents the world’s leading clinical research and technology organizations. Our fourteen member companies provide a wide range of specialized services across the entire spectrum of development for new drugs, biologics and medical devices, from pre-clinical, proof of concept and first-in-human studies through post-approval…
ERN-RND welcomes the opportunity to provide feedback on the roadmap published by the Commission on the European Health Data Space (EHDS). EHDS provides an excellent opportunity to align and integrate the data based activities of the European Reference Networks. This refers to both (cross-border) care data and research data.
· · filed 2 Feb 2021 · source
During the last two decades, much attention has been paid to the digitization and interoperability of health, healthcare, and medical data in EU member states separately and at the EU level in general. Still, achieving the seamless exchange of European citizens' healthcare data throughout the EU is not achieved. Also, the level of digitization and interoperability varies remarkably between the EU member states.
Health is an area where Europe can undoubtedly benefit from the data revolution. Proper use of health data can improve health systems’ sustainability, foster disease prevention, increase the quality, safety and patient-centredness of healthcare, decrease costs and transform care into a more participatory process.
Dear Sir or Madam, In the attachment I am sending you the position of the European Association of E-Pharmacies (formerly EAMSP) on the creation of a European Health Data Space. Please do not hesitate to contact us if you have any comments or questions. Kind regards [name removed] Secretary EAEP
· · filed 2 Feb 2021 · source
VCI welcomes the opportunity to provide feedback on the roadmap published by the Commission on the European Health Data Space (EHDS). The current Covid-19 pandemic particularly highlights the need for such an initiative to efficiently develop vaccines and treatments while monitoring the spread of the virus. The baseline scenario describes adequately the current situation in the EU.
EuroHealthNet welcomes the European Commission’s initiative to establish a European Health Data Space with the purpose of promoting access to health data for research and innovation on new preventive strategies, as well as on diagnosis and treatment of diseases to improve health outcomes, while ensuring that citizens have control over their own personal data.
We warmly welcome the much needed initiative of the European Health Data Space. Please find below the summary of recommendations from the EAU. A full explanation of our feedback is attached as a pdf. Governance – a shared vision based on trust - Ambitious resourcing and financing is needed to ensure strong engagement across the EU and with multiple stakeholders.
Sanofi is a global biopharmaceutical company focused on human health and a global leader in pharmaceutical research and development. Our ability to generate, access and use health and health-related data for research is critical to develop and launch new vaccines and treatments, address unmet medical needs, and optimize supply chain processes.
· · filed 2 Feb 2021 · source
The German social security umbrella organisations welcome the European Commission’s intention to shape a European health data space, in particular by: — a more binding cooperation between Member States to improve the availability and interoperability of health data with added value for patients; and — the creation of institutionalised data Governance Structure, research and development of innovation and the…
Filed in German · English published by the European Commission
The European Society of Cardiology welcomes the European Commission’s initiative to create a European Health Data Space for better healthcare, research, and policymaking. The COVID pandemic has clearly shown the weakness to overcome healthcare challenges and lack of collaboration between Member States and their data exchange due to national legal constraints.
Feedback to Digital health data and services – the European health data space 1 February 2021 EHTEL welcomes the initiative of the European Commission to create the European Health Data Space (EHDS) organized around an operational and regulatory framework which would bind Member States and change the tempo in order to develop and implement the much-needed building blocks.
· · filed 1 Feb 2021 · source
In light of the increasing digitalisation accelerated by the COVID-19 pandemic, the Austrian Social Insurances warmly welcome the Commission’s plan to establish a European Health Data Space (EHDS) which is safe, accessible and transparent.
· · filed 1 Feb 2021 · source
EHDS is a profound step towards health data integration within the European Union, harmonising primary and secondary data use, constituent stakeholders and ensuring complementarity of expectations for patients and citizens across Member States.
· · filed 1 Feb 2021 · source
McKesson Europe fully supports the European Commission’s initiative “Digital health data and services – the European health data space”. We would like to use this opportunity to contribute to the ongoing roadmap consultation and flag areas where EU policy action can further be improved.
The League of European Research Universities (LERU) are very enthusiastic about this proposal. We think it provides a very ambitious framework that will help the health sector to move forward in digitalisation. We very much approve of the federated approach. Furthermore, it pushes all member states to stop thinking and start acting. It has a high potential to facilitate research and healthcare across the EU.
aNewGovernance applauds the European Commission’s intention to create the European Health Data Space. The COVID-19 pandemic has the potential to be the catalyst to a long-awaited bold human-centered shift in the way we manage our Health, truly moving from sick-care to health-care (see document attached).
· · filed 30 Jan 2021 · source
On the proposal to create a common European health data space, a group of observers politically engaged in the formulation of a new policy proposal called “Together” (website: Www.insieme.per.it), which has as one of its founding values a European vision for the consolidation and development of the EU institutions, presents the following comment to the Commission: “Together, the political party expresses its…
Filed in Italian · English published by the European Commission
· · filed 29 Jan 2021 · source
The European Council of Optometry and Optics (ECOO) supports the objectives of the proposed EHDS. However, achieving these objectives will require significant changes by member states, health authorities and health professionals to ensure consistency of approach, practice and operation. The EHDS should apply to all health data.
The General Council of Spanish Official Associations (CGCOM) has ruled on the Digital Rights of Citizenship and on the Telemedicine platform T. Care. CGCOM supports the following projects in terms of trust and security for society in digital health services: • Private Electronic Collection Project, a successful case of data interoperability.
Filed in Spanish · English published by the European Commission
· · filed 28 Jan 2021 · source
ECHAMP welcomes and supports this important initiative, which will be an essential cornerstone for the Pharmaceutical Strategy. We are pleased to see that the proposal emphasizes the importance of allowing patients and citizens control over their own health data and of exploring how to facilitate the inclusion of citizen-generated data.
· · filed 27 Jan 2021 · source
Firstly, the Spanish National Pharmaceutical Industry Business Association (Farmaindustria) thanks the European Commission for opening the Inception Impact Assessment (IIA) on the forcing legislative proposal to create a European Health Data Space (EHDS). The necessary digital transformation of the health system has been highlighted during the recent COVID-19 crisis, with a strong boost to e-health solutions.
Filed in Spanish · English published by the European Commission
The 'Societal Impact of Pain' (SIP) platform is a multi-stakeholder partnership led by the European Pain Federation (EFIC) and Pain Alliance Europe (PAE). SIP aims to raise awareness of pain and to change pain policies. The scientific framework of the SIP platform is under the responsibility of EFIC, and the strategic direction of the project is defined by both partners.
Generally speaking, creating an EU environment where data are available, accessible and interoperable can only be welcome. Data are complex and need to be informative on the disease, the host and their respective evolution overtime. Data are not static must should be seen as dynamic set of varying inter-dependent information.
· · filed 26 Jan 2021 · source
GS1 Healthcare is a healthcare-specific, global user group bringing together both large and small healthcare stakeholders: pharmaceutical and medical device manufacturers, wholesalers and distributors, group purchasing organisations, hospitals, pharmacies, logistic and solution-providers, governmental and regulatory bodies, and industry associations.
I believe this initiative is an essential one. The objectives align with the recommendations of the SAPEA evidence review report Transforming the Future of Ageing. The report is linked below. We know that digital technology is already changing the experience of ageing, including wearable and assistive devices. Nevertheless, barriers to acceptance and practicality must be overcome.
The Commission’s initiative is to be welcomed. In particular, if, in the further stages of development — beyond the patient’s perspective — the development of the operational framework extends the exchange of information in a non-friction-free, structured and semantically interoperable manner to the perspective of doctors involved in the treatment process.
Filed in German · English published by the European Commission
· · filed 18 Jan 2021 · source
GS1 Healthcare is a healthcare-specific, global user group bringing together both large and small healthcare stakeholders: pharmaceutical and medical device manufacturers, wholesalers and distributors, group purchasing organisations, hospitals, pharmacies, logistic and solution-providers, governmental and regulatory bodies and industry associations.
· · filed 13 Jan 2021 · source
The nursing workforce, which is the largest healthcare professional of all, will be key in the deployment of the European health data space in healthcare settings. Its success in Europe will largely depend on end-users providing input to the health data space and using the data to better plan their services.
ERN-LUNG has access to a number of registries: own ERN-LUNG registries, disease specific local, regional, national, and European Registries. Personal cross-border data utilization (when travelling) should not be under the same roof as data sharing or data second use for research. This will only cause fears of unauthorized use of data. These personal and public data applications must be physically distinct.
Method. Every quote is verbatim from the organization’s own submission to the European Commission, trimmed to its opening passage and never summarized by a model. Where a submission was filed in another EU language we show the English text the European Commission publishes alongside it, labeled on the quote; the original is one click away at the source. Groupings use the respondent type the organization itself selected when filing. We deliberately do not label anyone “supportive” or “opposed” — you read what they wrote and draw your own conclusion. Organizations only, never individuals. Reused under Commission Decision 2011/833/EU; the European Commission is not liable for this reuse.