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A European Health Data Space

Public health

The European Health Data Space will promote safe exchange of patients’ data, also when travelling abroad, and citizens’ control over their health data. It will support research on treatments, medicines, medical devices and outcomes and encourage the use of health data for research, policy-making and regulatory purposes, with a trusted governance and respecting data protection rules. It will support digital health services and clarify safety and liability of Artificial Intelligence in health.

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Public consultation

ID: 12663

Lobbying Activity

145 responses

Consultation response

Bureau Européen des Unions de Consommateurs, 3 Feb 2021

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…

Microsoft Urges EU-Wide Legal Basis for Health Data Research

Microsoft Corporation, 3 Feb 2021

Microsoft requests EU-wide legislation establishing a specific legal basis for secondary use of health data in research. They want harmonized rules replacing fragmented national interpretations of GDPR Article 9. The company also seeks promotion of privacy-enhancing technologies and interoperability standards in procurement.
This would reduce legal uncertainty and liability risks when accessing third-party health datasets.

EuropaBio urges industry representation and strong intellectual property protections

American Chamber of Commerce to the European Union, 27 Jul 2022

EuropaBio requests industry representation on the governing board and strict intellectual property safeguards. They also support standardising electronic health records to facilitate data portability across Member States.
Access to cross-border data would enhance their ability to develop next-generation medicines.

Consultation response

American Chamber of Commerce to the European Union, 3 Feb 2021

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…

Consultation response

Bundesverband der Deutschen Industrie e.V., 3 Feb 2021

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…

DIGITALEUROPE Urges Regulatory Alignment for European Health Data Space

DIGITALEUROPE, 28 Jul 2022

They request alignment between the health data proposal and laws like GDPR. They demand clearer data holder definitions and protections for intellectual property. Certification should be simplified to avoid duplicative requirements with existing regulations.
Simplified rules would reduce compliance costs and administrative burdens for companies.
Broad intellectual property protections could limit data access for external researchers.

Consultation response

DIGITALEUROPE, 3 Feb 2021

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…

Bayer urges harmonized data access rules across EU health space

Bayer AG, 28 Jul 2022

Bayer requests harmonized implementation across Member States with common data standards and clear timelines. They want protection for commercially confidential clinical trial data and trade secrets. They seek unified interpretation of key terms like 'anonymisation' and 'scientific research' to enable cross-border research.
This would enable efficient global research operations and protect proprietary clinical trial information.
Public health authorities lose some immediate access to commercial clinical trial data.

Consultation response

Bayer AG, 3 Feb 2021

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…

Insurance Europe urges health data access for premium setting

Insurance Europe, 28 Jul 2022

Insurance Europe requests removing the prohibition on using electronic health data for premium setting. They seek clearer definitions to ensure private insurers are not burdened with data-sharing obligations.
Accurate data access allows insurers to calculate risks precisely and maintain competitive pricing.
Policyholders might face more expensive insurance due to pricing uncertainty from data gaps.

Consultation response

Orange, 3 Feb 2021

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…

MedTech Europe urges alignment of health data rules

MedTech Europe, 28 Jul 2022

The group seeks clear legal alignment between new data requirements and existing medical device laws. They demand stronger safeguards for trade secrets and intellectual property when sharing sensitive data. They advocate for using international technical standards to avoid creating unique European barriers.
This alignment would prevent redundant regulatory burdens and safeguard the industry's competitive technological innovations.
Stronger trade secret protections may restrict data access for independent researchers and smaller competitors.

Consultation response

MedTech Europe, 3 Feb 2021

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…

Consultation response

Huawei Technologies, 3 Feb 2021

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…

Novartis seeks uniform health data rules and protected IP

Novartis International AG, 27 Jul 2022

Novartis calls for uniform implementation across the EU to avoid fragmentation. The company requests that regulators accept evidence from patient records and protect clinical trial data.
Standardized rules and protected data sharing would reduce research barriers and costs.
EU patients might lose access to clinical trials if developers move research abroad.

German Insurance Association seeks clearer European health data rules

Gesamtverband der Deutschen Versicherungswirtschaft e.V., 28 Jul 2022

The association requests clearer definitions to ensure private insurers are excluded from heavy data-handling rules. They also demand the removal of a clause specifically banning insurers from using health data to adjust premiums.
Narrower definitions would help insurers avoid significant administrative burdens and potential legal disputes.
Policyholders could lose explicit legal protections that prevent companies from raising premiums based on health data.

Consultation response

Gesamtverband der Deutschen Versicherungswirtschaft e.V., 3 Feb 2021

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…

ACHIEVE Coalition urges EHDS to improve viral hepatitis tracking

FIPRA International SRL, 27 Jul 2022

The coalition wants better data collection on viral hepatitis and related liver diseases. They advocate for cross-border data sharing to ensure continuity of care and disease prevention.
Detailed patient data would help these companies market their treatments and diagnostic products more effectively.

Consultation response

EuropaBio, 3 Feb 2021

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…

German chemical industry urges intellectual property protection in EHDS

Verband der Chemischen Industrie e.V., 27 Jul 2022

The VCI calls for concrete mechanisms to protect intellectual property and confidential business information. They also request industry representation on the EHDS Board to ensure effective implementation.
Protecting commercial secrets helps maintain their competitive advantage and reduces administrative overhead.
Public health researchers lose access to datasets that companies classify as private property.

Consultation response

Verband der Chemischen Industrie e.V., 2 Feb 2021

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…

Sanofi urges industry access to EU health data infrastructure

SANOFI, 2 Feb 2021

Sanofi requests that industry be included as a key partner in the EHDS user group alongside public bodies. They want the private sector invited to contribute and access EHDS data for legitimate purposes under appropriate governance. They emphasize that EU-wide regulation should be the default position with limited national restrictions.
This would enable pharmaceutical companies to access real-world data for drug development and regulatory submissions.

Johnson & Johnson urges IP safeguards and industry board representation

Johnson Johnson, 28 Jul 2022

J&J requests healthcare industry representation on the EHDS Board. They advocate for federated networks and clearer protection for trade secrets and intellectual property. The company also seeks clarity on international data transfers and GDPR alignment.
This would protect proprietary assets while enabling more effective investment in innovative medical solutions.
European researchers and patients lose out on global innovation if data transfer rules are restrictive.

European Patients' Forum calls for patient control over health data

European Patients' Forum (EPF), 20 Jul 2022

The organization requests that patients control their electronic health data through a standardized format, that safeguards limit data reuse to clearly defined public benefits, and that patient representatives have formal roles in governance bodies. They argue vague innovation purposes erode trust, especially when private companies are involved.
This would give patient organizations formal influence over data governance and scale up education programs.
Private companies lose access to health data for broadly defined innovation purposes without clear public benefit.

European Patients' Forum calls for patient-centred Health Data Space

European Patients' Forum (EPF), 2 Feb 2021

The organization requests improved data access and control for patients, a clear framework for data use and re-use, better investments in infrastructure, and meaningful patient involvement in governance. They emphasize patients should have barrier-free access to their health records and control over how data is used.
This would give patients greater control over their health information and stronger participation in healthcare decisions.

European Cancer Organisation urges stakeholder inclusion in health data governance

European Cancer Organisation, 28 Jul 2022

ECO requests representation for patients and professionals on the European Health Data Space Board. They call for regulatory clarity to prevent fragmented data protection rules across Europe. The organisation also recommends a federated data structure.
This would simplify cancer research and accelerate the delivery of new patient treatments.

Consultation response

European Cancer Organisation, 3 Feb 2021

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.…

Philips Urges Alignment of Health Data Rules With Existing Laws

Koninklijke Philips, 19 Jul 2022

Philips requests that the proposal provide clear definitions and alignment with existing laws to avoid regulatory uncertainty. They urge the use of internationally recognized standards for interoperability rather than unique EU specifications. Additionally, the mandate to share data must include safeguards to protect intellectual property and trade secrets.
Clearer rules would prevent the company from undergoing three separate, costly certification processes for one product.
European technology companies could face higher costs and barriers when trying to export products globally.

Consultation response

Koninklijke Philips, 29 Jan 2021

Philips appreciates the opportunity to provide feedback on the European Commission initiative to create the European Health Data Space. Please see the detailed feedback attached.

GSK urges IP protections in European Health Data Space

GSK, 28 Jul 2022

GSK requests clear protections for intellectual property and trade secrets. They propose streamlined data access processes and industry representation on the EHDS Board.
Stronger intellectual property safeguards protect the company's massive annual research and development investment.

Rare Disease Patient Group Calls for Patient-Centred EU Health Data Space

EUROPEAN ORGANISATION FOR RARE DISEASES, 27 Jul 2022

The organisation requests that electronic health records use ICD-11 and ORPHA rare disease codes, implement strong data governance allowing patients to control their data, and establish the European Reference Networks as a testing hub for data governance models.
This would enable rare disease patients to share health information with specialists across borders more easily.

Consultation response

European Public Health Alliance, 3 Feb 2021

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. The Combined Evaluation Roadmap / Inception Impact Assessment appears to be well…

European rare disease alliance urges multi-stakeholder health data governance

EUROPEAN ORGANISATION FOR RARE DISEASES, 3 Feb 2021

EURORDIS requests a well-structured multi-stakeholder dialogue to co-create health data guidance and rules. They want ERNs used as testing environments for new governance models. They call for an EU-level agency to coordinate cross-border health data sharing with national agencies.
This would help them pool scarce expertise and data across borders for rare diseases.

Pharmaceutical SMEs demand uniform European Health Data Space rules

European Confederation of Pharmaceutical Entrepreneurs, 27 Jul 2022

The Commission must clarify data protection rules and streamline legislative overlaps to support innovation. Industry stakeholders should be involved in the new governance board to clarify their roles.
Harmonised standards will lower financial barriers and legal risks for pharmaceutical innovation.
National regulators may lose discretion over expanding health data categories independently.

Consultation response

European Confederation of Pharmaceutical Entrepreneurs, 3 Feb 2021

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…

Cardiology society demands clinical expert role in health data space

European Society of Cardiology, 28 Jul 2022

The ESC calls for medical societies to help define technical data standards. They want to avoid extra paperwork for doctors and use existing heart disease registries. The group also requests financial support for non-profit organizations to manage data systems.
Using their existing registry standards would reduce their compliance costs and administrative burden.
Public sector bodies would lose their exclusive legal priority for accessing electronic data.

Self-care industry calls for digital literacy in health data space

Association of the European Self-Care Industry, 28 Jul 2022

The association asks for digital literacy programs to help people understand their data. They also recommend including information on non-prescription medicines and wellness apps in health records. Finally, they advocate for using real-world data to improve healthcare delivery.
This would streamline the development and marketing of non-prescription medicines and supplements.

Consultation response

Association of the European Self-Care Industry, 3 Feb 2021

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…

COCIR urges legal alignment for European Health Data Space

European Coordination Committee of the Radiological, Electromedical and healthcare IT Industry, 27 Jul 2022

COCIR requests that the EHDS regulation be aligned with GDPR to ensure legal certainty. They also seek protection for intellectual property and want industry experts included in consultations.
Aligning these rules would reduce compliance risks and protect corporate intellectual property.
Vague definitions of data systems threaten to increase costs for national healthcare systems.

Medical imaging industry urges harmonised health data rules across EU

European Coordination Committee of the Radiological, Electromedical and healthcare IT Industry, 3 Feb 2021

The organization requests harmonized data protection rules across Member States to enable health data access and exchange. They argue fragmented GDPR implementation creates significant hurdles for machine learning and medical software development. They seek clarification that medical images without patient information should be considered anonymized data for scientific research.
This would reduce compliance burdens and enable companies to process large amounts of health data for AI development.

European Doctors warn health data rules increase administrative burdens

Standing Committee of European Doctors, 20 Jul 2022

CPME demands informed consent for sensitive data and exemptions for small enterprises. They call for financial support to manage new digital infrastructure and administrative tasks.
Excluding small practices would protect doctors from significant financial and administrative burdens.
Research organizations would have less health data available for secondary scientific studies.

Consultation response

Standing Committee of European Doctors, 3 Feb 2021

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…

La Poste urges sovereign cloud and unified health data certifications

LA POSTE, 27 Jul 2022

The group requests harmonized security rules and mandatory certifications for hosting medical records across Europe. They also advocate for using sovereign cloud solutions to protect sensitive information from foreign legal jurisdictions.
Mandatory EU-wide certifications would leverage their existing French expertise and protect their market leadership.
American cloud companies would face exclusion from the health sector under proposed sovereignty requirements.

German Bar Association demands exclusive health data rules

Deutscher Anwaltverein (German Bar Association), 30 Jun 2022

The association requests a specific regulation excluding the General Data Protection Regulation to ensure legal clarity. They argue for mandatory participation of patients and doctors to ensure the system's success.
Avoiding General Data Protection Regulation disputes would reduce litigation risks and legal uncertainty.
Citizens lose individual control as mandatory data sharing replaces rights-based participation.

Consultation response

ZVEI e.V. - Verband der Elektro- und Digitalindustrie, 26 Jan 2021

You will find ZVEIs statement attached in a separate document

App Association warns against burdensome health data certification rules

ACT | The App Association, 26 Jul 2022

The association wants the Commission to clearly distinguish between wellness apps and medical devices. They believe mandatory certification is overly burdensome and should be replaced by voluntary schemes. They suggest that standards should leverage leading standardisation efforts already in existence.
A move to voluntary certification would lower operational costs for small app developers.
Conflicting regulatory requirements could harm consumers by causing confusion and limiting innovation.

Siemens Healthineers Urges Harmonized Rules for Health Data Space

Siemens Healthineers AG, 28 Jul 2022

The company requests the EHDS clearly delineate the scope from other regulated product definitions to avoid inadvertent overlaps. They argue safeguards for the protection of intellectual property and trade secrets are insufficient. Finally, they suggest involving industry in the governance board to leverage expertise.
This would reduce its compliance cost and protect the business value of its research.
Independent researchers would lose access to valuable datasets if intellectual property safeguards are strengthened.

Finnish IT Center Calls for Practical EHDS Implementation Framework

CSC – IT CENTER FOR SCIENCE LTD., 27 Jul 2022

CSC requests emphasis on metadata interoperability, sufficient implementation time and resources, use of existing infrastructures, balanced security requirements, stronger stakeholder engagement including researchers, careful assessment of anonymisation rules, removal of automatic permit issuance, clearer publication requirements, Europe-wide consent mechanisms, and linkages with other data spaces.
This would allow them to leverage existing infrastructure investments and ensure workable technical requirements.

Health mutuals demand realistic timelines for EU health data space

Association Internationale de la Mutualité, 15 Jul 2022

AIM calls for delaying the 2025 implementation deadline and ensuring citizens have tools to manage data consent. They also propose reducing administrative burdens to prevent bottlenecks in data access permits.
Streamlined permit processes and extended timelines would lower administrative costs and organizational pressure.
Individuals with limited digital skills may lose control over their private health data.

Consultation response

Association Internationale de la Mutualité, 3 Feb 2021

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. A closer cooperation in the use of health data shall aim to improve patient’s…

Finnish IT Center Urges Federated Approach to EU Health Data Space

CSC – IT CENTER FOR SCIENCE LTD., 3 Feb 2021

The organization requests that health data remain in original locations using federated infrastructure, ensure interoperability with other data spaces, and leverage existing initiatives like 1+ Million Genomes. They emphasize data must stay within the European Economic Area.
This would allow them to utilize existing high-performance computing investments and maintain their role as infrastructure operator.

Diabetes Federation urges patient-centric governance in health data space

International Diabetes Federation European Region, 28 Jul 2022

Patient groups should be represented in EHDS governance as full stakeholders. The federation requests clearer definitions for data use and easier consent withdrawal. They call for structural actions to bridge digital literacy gaps across Europe.
This would improve diabetes prevention and empower patients through better health information.
Citizens in less digitally advanced nations risk exclusion from health technology innovation.

French insurance federation demands clear access to health data

Fédération Française de l'Assurance, 28 Jul 2022

The federation calls for better definitions ensuring insurers can access health data for contract execution. They seek alignment with data protection rules to provide legal certainty for the industry.
Access to health data allows insurers to offer more affordable rates and assess risks.
Ambiguity in the regulation could lead to legal disputes and reduce access to insurance.

Consultation response

Allied For Startups asbl, 2 Feb 2021

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…

French research giant CEA demands protection for health datasets

Commissariat à l'Energie atomique et aux énergies alternatives, 27 Jul 2022

CEA warns against rules that might dispossess research institutions of their valuable health data. They argue that the regulation should not increase administrative complexity for scientists or compromise digital sovereignty.
Public research bodies would maintain their exclusive rights to commercialize patient data.
Global technology companies might face stricter legal barriers to hosting European health data.

Pharma Deutschland Demands Equal Access to European Health Data

Pharma Deutschland e.V, 28 Jul 2022

The association demands that industrial research be explicitly recognized as a legitimate user of secondary health data. They request strict protections for trade secrets and a harmonized implementation across all member states to avoid regulatory fragmentation.
Explicit data access and IP protections will reduce development risks and costs.
Public health bodies may face increased costs due to market-rate data fees.

Social insurance bodies urge tighter controls on health data access

European Social Insurance Platform AISBL, 28 Jul 2022

ESIP requests that social security institutions be recognized as key data holders. Stricter criteria should be imposed for commercial access to health data. They argue for return on investment provisions and excluding wellness apps.
These measures safeguard the financial stability and operational control of public social security systems.
Commercial firms and wellness app developers face tougher restrictions and potential exclusion from the infrastructure.

Consultation response

Pharma Deutschland e.V, 3 Feb 2021

Der BAH begrüßt die Initiative der Europäischen Kommission zum European Health Dataspace (EHDS) und hat folgende Erwartungen und Anforderungen: 1. Die EU KOM sollte den Status quo erheben, um einen konkreten Überblick über die einzelnen Länder und darüber zu erlangen, welche wesentlichen Hemmnisse…

Consultation response

European Social Insurance Platform AISBL, 3 Feb 2021

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…

Consultation response

European Committee for Standardization, 3 Feb 2021

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…

Consultation response

League of European Research Universities, 1 Feb 2021

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…

Cancer leagues demand patient-centered European health data framework

Association of European Cancer Leagues, 26 Jul 2022

The organization calls for patient representation in governance to ensure patient-centeredness. They demand that data protection rules be unified to prevent research fragmentation.
Unified rules would reduce legal uncertainty for cancer research across borders.
Patients in less digitalized regions risk facing wider health inequalities.

Consultation response

European Society for Paediatric Oncology, 3 Feb 2021

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…

German pharma industry urges unbureaucratic access to health data

Bundesverband der Pharmazeutischen Industrie e.V., 28 Jul 2022

The association demands framework conditions allowing industry access to health data without high bureaucratic effort. They call for harmonizing fragmented data protection interpretations across the EU. Furthermore, national bodies must have sufficient resources to meet deadlines for data requests.
Efficient data access would accelerate the development of market-ready pharmaceutical products.
National regulators lose their ability to maintain stricter privacy interpretations.

European Federation of Nurses urges direct inclusion in digital design

European Federation of Nurses Associations, 25 Jul 2022

The EFN requests that nurses be involved in the design of digital health systems. They advocate for using standardized nursing terminology to ensure clinical data is accurately captured.
Standardized digital tools would significantly reduce the administrative workload for frontline nursing staff.
Taxpayers and developers lose if digital tools remain theoretical and waste European funding.

European Heart Network calls for patient-led health data governance

European Heart Network, 15 Jul 2022

They want the EU to define 'public interest' alongside patients and ensure meaningful involvement in governance. They also urge alignment with GDPR to reduce legal fragmentation across member states.
Harmonized data access would boost underfunded cardiovascular research and improve patient outcomes.
Citizens with low digital literacy risk facing greater health inequalities and exclusion.

Consultation response

Edwards Lifesciences, 3 Feb 2021

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…

Consultation response

European Federation of Nurses Associations, 13 Jan 2021

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…

Consultation response

Lääketeollisuus ry, 15 Jul 2022

See attached file for Pharma Industry Finland's comments.

Hospital pharmacists urge stronger privacy safeguards in health data plan

The European Association of Hospital Pharmacists, 22 Jul 2022

EAHP demands stricter oversight for secondary data use to prevent commercial exploitation. They argue hospital pharmacists must have direct access to patient health records. The association also calls for involving healthcare professionals in the implementation process.
Universal access to patient records allows pharmacists to improve medication safety and adherence.
Patients risk discrimination if data privacy safeguards fail to prevent commercial misuse.

Consultation response

All Policies for a Healthy Europe, 3 Feb 2021

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…

Consultation response

The European Association of Hospital Pharmacists, 2 Feb 2021

Attached please find the feedback of the European Association of Hospital Pharmacists (EAHP) on "Digital Health data and services-the European health data space".

Roche demands intellectual property safeguards in European Health Data Space

F. Hoffmann-La Roche Ltd, 27 Jul 2022

Roche advocates for strong private sector involvement and public-private partnerships in the framework. They emphasize the need to protect intellectual property and trade secrets during data sharing. Additionally, they urge the use of global standards over new EU-specific technical requirements.
This would protect their proprietary research while reducing the costs of technical compliance.
Public health researchers might face restricted access to data deemed commercially sensitive by corporations.

Consultation response

F. Hoffmann-La Roche Ltd, 3 Feb 2021

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…

Consultation response

Bundesärztekammer, 3 Feb 2021

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…

Consultation response

European Organisation for Research and Treatment of Cancer, 26 Jan 2021

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 …

European e-pharmacies urge creation of central EU medication database

European Association of E-Pharmacies, 27 Jul 2022

They request mandatory interoperability standards and a single EU medication database for online pharmacies. They also push for a European Digital Identity and harmonized cross-border reimbursement for telehealth.
Access to health data allows online pharmacies to compete equally with established local providers.
Restrictive national health systems and local pharmacies lose their exclusive control over medicine dispensing.

Consultation response

The European Society of Intensive Care Medicine, 3 Feb 2021

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. ESICM agrees with the Commission’s objective to promote access to health data…

Consultation response

Alliance for Regenerative Medicine, 3 Feb 2021

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…

Consultation response

European Association of E-Pharmacies, 2 Feb 2021

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 Sebastian Schulz Secretary EAEP

Consultation response

European Blood Alliance, 28 Jul 2022

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…

Consultation response

Stichting Open Future, 23 Jul 2022

Please see the attached document for the feedback by Open Future and Instrat Foundation on the data access and data sharing rules in Chapter IV of the proposed regulation.

Consultation response

United European Gastroenterology, 3 Feb 2021

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,…

EuroHealthNet Urges Digital Literacy Focus for Health Data Space

EuroHealthNet, 27 Jul 2022

The organization calls for digital health literacy programs for citizens and professionals. They also seek clearer definitions for the secondary use of health data to ensure inclusivity.
Enhanced health surveillance capabilities would allow their member organizations to perform duties more efficiently.
Tech companies lose operational flexibility under stricter requirements for data standardization and regulation.

SPECTARIS urges streamlined rules for European Health Data Space

SPECTARIS Deutscher Industrieverband für Optik, Photonik, Analysen- und Medizintechnik e.V., 27 Jul 2022

SPECTARIS requests avoiding regulatory overlaps with existing medical device frameworks. They advocate for equal data access for private research and the use of international cybersecurity standards.
This approach would prevent excessive regulatory burdens on small and medium-sized enterprises.
Public institutions would lose their priority status for accessing and using health data.

BioMed Alliance Urges Stakeholder Role in European Health Data Space

Biomedical Alliance in Europe, 27 Jul 2022

The group calls for structural stakeholder involvement and scientific advice in the health data space's governance. They emphasize the need for harmonized data protection rules to remove barriers to collaborative research.
Harmonized rules would reduce the time and administrative effort currently spent navigating overlapping national regulations.
Third-party researchers would lose immediate access to raw clinical data before primary research teams publish results.

Consultation response

BGP Products Operations GmbH – a Viatris Company, 28 Jun 2022

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. We…

Consultation response

Biomedical Alliance in Europe, 3 Feb 2021

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…

Consultation response

EuroHealthNet, 2 Feb 2021

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…

Austrian Social Insurance urges opt-out rights for health data

Dachverband der österreichischen Sozialversicherung, 28 Jul 2022

The organization calls for citizen opt-out options for primary and secondary data use. They advocate for strict data standards and public returns from private sector usage.
This allows them to maintain autonomy and avoid heavy administrative costs.
Private companies face limited data access and new requirements for providing public benefits.

Consultation response

Dachverband der österreichischen Sozialversicherung, 1 Feb 2021

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. The current crisis has shown the great importance of timely…

Consultation response

Verband der Privaten Krankenversicherung e.V., 28 Jul 2022

The German Association of Private Health Insurers welcomes the European Commission’s plans for a European Health Data Space (EHDS). In addition to the attached comments, we refer to the statement of Insurance Europe, which is fully supported.

Consultation response

Verband der Privaten Krankenversicherung e.V., 3 Feb 2021

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…

Consultation response

Consejo General de Colegios oficiales de Médicos, 29 Jan 2021

El Consejo General de Colegios Oficiales de España (CGCOM) se ha pronunciado sobre los Derechos Digitales de la Ciudadanía y sobre la plataforma de telemedicina T. Care. El CGCOM apoya los siguientes proyectos en términos de confianza y garantía para la sociedad en materia de servicios sanitarios…

Consultation response

ResMed, 26 Jul 2022

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…

Consultation response

European University Hospital Alliance, 3 Feb 2021

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. In addition…

Consultation response

European Public Health Association, 25 Jul 2022

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…

Consultation response

European Association of Urology, 25 Jul 2022

The European Association of Urology welcomes the Commission's Proposal. Please find attached our feedback and suggestions.

Consultation response

Center for Data Innovation, 4 Feb 2021

On behalf of the Center for Data Innovation (Transparency Register #: 367682319221-26), we are pleased to submit this feedback on the European Commission’s roadmap on “Digital health data and services—the European health data space.”

Consultation response

European Cancer Patient Coalition, 2 Feb 2021

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. Seeing the impact that the COVID-19 pandemic has…

Consultation response

European Association of Urology, 2 Feb 2021

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…

Consultation response

Digestive Cancers Europe, 28 Jul 2022

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…

European hospital federation urges stakeholder-led health data space governance

European Hospital and Healthcare Federation, 19 Jul 2022

Prioritize specific health data categories instead of an unrealistic broad vision. Ensure governance remains with healthcare stakeholders rather than the technology industry. Support the transition with EU funding to manage significant infrastructure costs.
Aligning digital tools with clinical needs avoids unnecessary economic pressure on hospitals.
The IT industry would lose influence over the system's design and management.

Consultation response

European Hospital and Healthcare Federation, 2 Feb 2021

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…

Consultation response

European Federation of Allergy and Airways Diseases Patients' Associations, 28 Jul 2022

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…

Consultation response

Cancer Research UK, 27 Jul 2022

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…

Consultation response

EIT Health, 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…

Consultation response

European Federation of Allergy and Airways Diseases Patients' Associations, 3 Feb 2021

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’…

Consultation response

aNewGovernance, 1 Feb 2021

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…

Consultation response

European Lung Foundation, 28 Jul 2022

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…

Consultation response

European Society of Radiology, 28 Jul 2022

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. ESR fully embraces the concept…

Consultation response

International Federation of Anthroposophic Medical Associations, 3 Feb 2021

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. IVAA also appreciates…

Consultation response

European Health Parliament, 3 Feb 2021

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…

Consultation response

Vlaamse Instelling voor Technologisch Onderzoek, 3 Feb 2021

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.…

Consultation response

European Society of Oncology Pharmacy, 3 Feb 2021

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…

Consultation response

Avicenna Alliance, 28 Jul 2022

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…

Consultation response

Stichting Koninklijk Nederlands Normalisatie Instituut, 28 Jul 2022

Please find enclosed the feedback of CEN TC 251 'Health Informatics'. CEN/TC 251 delivers and maintains health informatics standards for Europe.

Consultation response

Health Data Hub / Plateforme des données de santé, 26 Jul 2022

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. It will…

Consultation response

European Coalition on Homeopathic and Anthroposophic Medicinal Products, 28 Jan 2021

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…

Consultation response

The Holomedicine® Association, 28 Jul 2022

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…

Consultation response

Groupe VYV, 28 Jul 2022

Le Groupe VYV (Harmonie Mutuelle, MGEN, MNT, Mutuelle Mare-Gaillard,etc) créé en 2017 est le 1er acteur mutualiste de santé et de protection sociale en France. Avec ses trois métiers (Assurance, Soins et accompagnement, Logement), nous protégeons près de 11 millions de personnes, 69 000…

Consultation response

Council of European Dentists, 26 Jul 2022

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…

Consultation response

Groupe VYV, 4 Feb 2021

Le Groupe VYV (Harmonie Mutuelle, MGEN, MNT, MGEFI, Mutuelle Mare-Gaillard, SMACL Assurances...), créé en 2017, est le 1er acteur mutualiste de santé et de protection sociale en France. L’ensemble des composantes du groupe et leurs 45 000 collaborateurs, protège environ 10 millions de personnes et…

Consultation response

Biobanking and Biomolecular resources Research Infrastructure-European Research Infrastructure Consortium, 3 Feb 2021

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…

Consultation response

Avicenna Alliance -, 3 Feb 2021

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.…

Consultation response

Council of European Dentists, 3 Feb 2021

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…

Consultation response

Biogen Inc., 3 Feb 2021

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. We welcome the proposal to create sectoral and horizontal legislative frameworks to…

Consultation response

HIMSS Europe, 28 Jul 2022

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…

Consultation response

Biotechnology Innovation Organization, 27 Jul 2022

Comments from the Biotechnology Innovation Organization (BIO)

Consultation response

ScanBalt MTÜ, 11 Jul 2022

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…

Consultation response

Associazione Italiana Elettrosensibili, 8 Jun 2022

La nostra Associazione Italiana Elettrosensibili siamo contrari a questa iniziativa nel suo complesso. I dati personali sono oro digitale. Più grande è il set di dati, più alto è il rischio di attacco. E’ a tutti noto come molte centinaia di milioni di dati-utenti sono stati rubati dalle…

Consultation response

European Podiatry, 17 May 2022

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…

Consultation response

Connected Health Alliance CIC, 4 Feb 2021

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,…

Consultation response

Seqirus, 4 Feb 2021

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…

Consultation response

HIMSS Europe, 3 Feb 2021

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…

Consultation response

All.Can International, 3 Feb 2021

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…

Consultation response

European Society for Blood and Marrow Transplantation, 3 Feb 2021

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…

Consultation response

Associação Portuguesa para a Defesa do Consumidor, 3 Feb 2021

Our contributes

Consultation response

Coöperatie 4LifeSupport Europa U.A., 2 Feb 2021

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.

Consultation response

The European Institute for Innovation through Health Data, 2 Feb 2021

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…

Consultation response

Association of Clinical Research Organizations, 2 Feb 2021

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…

Consultation response

ScanBalt MTÜ, 2 Feb 2021

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…

Consultation response

European Health Telematics Association, 1 Feb 2021

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…

Consultation response

, 29 Jan 2021

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…

Consultation response

, 26 Jan 2021

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…