Brussels, 3 May 2022
“I am proud to announce the first common EU data space in a specific area. The European Health Data Space will be a ‘new beginning’ for the EU’s digital health policy, making health data work for citizens and science. Today, we are laying down the foundations for secure and trustworthy access to health data that is fully in line with the fundamental values underpinning the EU.”
Commissioner for Health and Food Safety, Stella Kyriakides, said:
“Today we are putting in place another pillar for the European Health Union. Our vision is becoming a reality . The European Health Data Space is a fundamental game changer for the digital transformation of healthcare in the EU. It places the citizens at its centre, empowering them with full control over their data to obtain better healthcare across the EU. This data, accessed under strong safeguards for security and privacy, will also be a treasure trove for scientists, researchers, innovators and policy-makers working on the next life-saving treatment.The EU is taking a truly historic step forward towards digital healthcare in the EU.”
Putting people in control of their own health data, in their country and cross-border
- Thanks to the EHDS, people will have immediate, and easy access to the data in electronic form, free of charge. They can easily share these data with other health professionals in and across Member States to improve health care delivery. Citizens will be in full control of their data and will be able to add information, rectify wrong data, restrict access to others and obtain information on how their data are used and for which purpose.
- Member States will ensure thatpatient summaries, ePrescriptions, images and image reports, laboratory results, discharge reports are issued and accepted in a common European format.
- Interoperability and security will become mandatory requirements. Manufacturers of electronic health record systems will need to certify compliance with these standards.
- To ensure that citizens’ rights are safeguarded, all Member States have to appoint digital health authorities. These authorities will participate in the cross-border digital infrastructure (MyHealth@EU) that will support patients to share their data across borders.
Improving the use of health data for research, innovation and policymaking
- The EHDS creates a strong legal framework for the use of health data for research, innovation, public health, policy-making and regulatory purposes. Under strict conditions, researchers, innovators, public institutions or industry will have access to large amounts of high-quality health data, crucial to develop life-saving treatments, vaccines or medical devices and ensuring better access to healthcare and more resilient health systems.
- The access to such data by researchers, companies or institutions will require a permit from a health data access body, to be set up in all Member States. Access will only be granted if the requested data is used for specific purposes, in closed, secure environments and without revealing the identity of the individual. It is also strictly prohibitedto use the data for decisions, which are detrimental to citizens such as designing harmful products or services or increasing an insurance premium.
- The health data access bodies will be connected to the new decentralised EU-infrastructure for secondary use (HealthData@EU) which will be set up to support cross-border projects.
Background
The COVID-19 pandemic has clearly demonstrated the importance of digital services in the health area. The uptake of digital tools increased significantly during this time. However, the complexity of rules, structures and processes across Member States makes it difficult to access and share health data, especially cross-border. In addition, health systems are now the target of increasing cyberattacks.
The EHDS builds further onthe GDPR, proposed Data Governance Act, draft Data Act and NIS Directive. It complements these initiatives and provides more tailor-made rules for the health sector. An open public consultation on the EHDS ran between 3 May and 26 July 2021 and gathered a wide range of views that contributed to the design of this legal framework.
The EHDS will make use of the on-going and forthcoming deployment of public digital goods in the EU, such as Artificial Intelligence, High Performance Computing, cloud and smart middleware. In addition, frameworks for AI, e-Identity and cybersecurity, will support the EHDS.
Next Steps
The proposal put forward by the European Commission will now be discussed by the Council and the European Parliament.
For More Information
Proposal for a Regulation on the European Health Data Space
Background and statements –>
Questions and answers – EU Health: European Health Data Space (EHDS)
1. What is the EHDS proposal about?
Every second, doctors, nurses, pharmacists, researchers and health regulators all over the EU generate and use large numbers of essential healthcare data that are critical to their lifesaving work. Health data are the blood running through the veins of our healthcare systems. The COVID-19 pandemic has shown thatup-to-date health data are key to take well informed public health measures and to respond to crises. The pandemic has also triggered a huge acceleration in the uptake of digital tools. Unfortunately, there are still complex obstacles that make it difficult to reach the full potential of digital health and health data.
The European Health Data Space will overcome these obstacles. It is a health-specific data sharing framework establishing clear rules, common standards and practices, infrastructures and a governance framework for the use of electronic health data by patients and for research, innovation, policy making, patient safety, statistics or regulatory purposes.
2. Who benefits from the EHDS?
The European Health Data Space will empowerindividualsacross the EU to fully exercise their rights over their health data. People will be able to easily access and share these data, while retaining greater control over them, fully in line with our overall EU approach to data protection.
At the same time, the work ofhealth professionals’will be made easier and more effective. With improved interoperability, health professionals will be able to access a patient’s medical history across borders, thus increasing the evidence base for decisions on treatment and diagnosis, including when the patients’ data is in another EU country.
By strengthening interoperability to support data exchange between healthcare providers within countries and across borders,healthcare providerswill avoid duplications of tests, with positive effects for patients and healthcare costs.
Researcherswill also benefit from a more direct way of obtaining access to data within a trusted and secure framework. Researchers will have access to larger amounts of high-quality data. They will be able to access the data in a more efficient and less expensive way, through a data access body that guarantees the privacy of the patients.
Regulatorsand policymakers will also have easier access to health data for policy making and for a better functioning of healthcare systems. This will lead to better access to healthcare, reduced costs, increased efficiency, more resilient health systems, new research and innovation and enable more evidence-based policymaking.
Industrywill benefit from an EU-wide market for electronic health record systems, with the same standards and specifications. Greater availability of electronic health data will improve people’s health, facilitate the production of innovative medicinal products and devices that offer better and more personalised care. Industry will be also able to develop new devices that use artificial intelligence technology.
3. What kind of governance system will be introduced?
The EHDS will reinforce governance at national and EU level. It builds upon the current cooperation for the primary use of data in healthcare (the use of data for the patients themselves) within the eHealth Network, which showed its value during the COVID-19 pandemic.
The EHDS extends the scope of this primary use and will now also regulate secondary use of health data (the re-use of aggregated health data by for example researchers, policy makers, innovators and industry).
The EHDS rules on the re-use of health data build on the framework introduced by the Data Governance Act. Anew European Health Data Space Boardwill be created, composed of the representatives of digital health authorities and new health data access bodies from all the Member States, the Commission and observers. It will contribute to a consistent application of the rules throughout the EU, including by advising the European Commission, while cooperating with other EU bodies and stakeholders such as patient organisations.
Member States will also cooperate at EU level on two cross-border digital infrastructures to enable data sharing (one for primary uses of health data and another one for secondary uses of health data).
4. What are the benefits and costs of the EHDS and how will it be financed?
Overall, the EHDS it is expected to save for the EU around €11 billion over ten years: €5.5 billion will be saved from better access and exchange of health data in healthcare and another €5.4 billion will be saved from better use of health data for research, innovation and policy making.
To make the EHDS a reality, further digitalisation is needed at national level. At the same time, it is necessary to set up interoperable EU-wide infrastructures to enable the cross-border use of health data in the EU. Both the Member States and the Commission will therefore support the EHDS under different EU funds and instruments. For instance,Member Stateshave budgeted €12 billion for investments in digital health under theRecovery and Resilience Facility. TheEuropean Regional Development FundandInvest EUoffer further opportunities for investment.
In addition,the Commission will provide over€810 millionto support the EHDS. €280 million will be available under the EU4Health Programme and the rest will be financed by the Digital Europe Programme, the Connecting Europe Facility and Horizon Europe.
5. What is the expected impact on other initiatives of the European Health Union – cancer, pharma, HERA?
The EHDS is a central component of a strong European Health Union.
It will help to boost the work underEurope’s Beating Cancer Plan. Pooling and sharing knowledge, experience and data helps developing practical solutions for cancer patients. The EHDS will also enable the development of innovative approaches to cancer registration, allowing for more timely and efficient collection of information on various types of cancers. This will help to provide a real-time state of play of cancers across the EU.
The EHDS will also allow health data to make a vital contribution to innovation, research and the development of new medicines, treatments, and medicinal products. As a result, it will strongly support thePharmaceutical Strategy for Europeand the work ofHERA.
6. What’s in it for me?
The Health Data Space, together with GDPR rights, will give yougreater control over your health data. You will in particular:
- have access to your health data in electronic formimmediatelyandwithout any cost
- be ableto shareyour datawith health professionalswithin the EU and across borders
- be ableto add information,rectifyerrors,restrictaccess andobtaininformation onwhat health professional accessed your data
- have certain categories of health data, such aspatient summaries, ePrescriptions, images and image reports, laboratory results and discharge reportsbe issued and accepted in aEuropean electronic health record exchange format.
Moreover,yoursecurity and privacy will be ensured:
- researchers, industry or public institutions will haveaccessto your health data only for specific purposes that benefit individuals and society
- but they can only access data that do notreveal your identity
- the data can only be accessed and processed inclosed, secure environmentsand only anonymised data can be downloaded.
7. Can you give concrete examples of how the EHDS will function?
Example 1: A woman living in Portugal is going on holidays to France. Unfortunately, she gets sick in France and therefore needs to see a local general practitioner. Thanks to the EHDS and MyHealth@EU, a doctor in France will see on his/her computer the medical history of this patient in French. The doctor can prescribe the necessary medicine based on the medical history of the patient, avoiding for instance products to which the patient is allergic.
Example 2: A health tech company is developing a new AI-based medical decision support tool that assists doctors to make diagnostic and treatment decisions following a review of the patient’s laboratory images. The AI compares the patient’s images with those of many other previous patients. Through the EHDS, the company is able to have efficient and secure access to a large number of medical images to train the AI algorithm and optimise its accuracy and effectiveness before seeking market approval.
Example 3: A man has a medical image of his lungs, taken in the public hospital where he was brought in by the emergency team. Shortly after, he visits his regular pulmonologist in another hospital. Thanks to the EHDS, his pulmonologist can see the medical image performed in the other hospital, thus avoiding a new, unnecessary test.
8. What impact will the EHDS have on health professionals?
Electronic health data will become available more easily for health professionals both within and across borders. With this improved interoperability, health professionals can access a patient’s medical history, thus increasing the evidence base for decisions on treatment and diagnosis.
Through easier and faster access to relevant health data, health professionals will be able to improve the continuity of care.
They will also be able to access health data from different sources more easily, reducing the administrative burden from having to manually copy records across different systems. This will also positively impact healthcare system efficiencies. If health professionals are involved in research, they will enjoy the benefits of easier access to health data for research and innovation.
9. How will the EHDS protect data privacy and security?
The EHDS builds on the General Data Protection Regulation (GDPR), proposed Data Governance Act, draft Data Act and NIS Directive. The EHDS complements these initiatives and provides more tailor-made rules for the health sector where needed.
Trustis an important element of the EHDS. The proposal introduces security criteria for interoperability and security of electronic health record systems and requires manufacturers to certify them. The EHDS also builds on the possibility offered by GDPR to put forward an EU law supporting the use of health data for diagnosis and treatment and for research, statistics or for public interest.
Moreover, processing electronic health data for secondary use of data is only possible for specificpurposesforeseen in the Regulation, based on apermitissued by adata access body. It will beforbidden to use the data to take decisions detrimental to individuals, or to market health products towards health professionals or patients.
Data processing can only take placein secure processing environments,which need to comply with very high standards of privacy and (cyber)-security and no personal data can be downloaded from such environments. Moreover, the researcher, company or public institution can only access non-identifiable data (offering information about the disease, symptoms and medication, without revealing the identity of the individual). It is forbidden for the user to re-identify the data subjects. Strict measures are paramount given the sensitive nature of health data.
10. To what extent are Member States ready for the EHDS?
Member States have different maturity levels when it comes to digital health.
As regardsprimary use of health data:the use of health data for health service provision, as illustrated in different studies, some Member States have achieved high levels of digitalisation and interoperability within their borders, while others are in the process of taking the necessary steps. Patient summaries and e-prescription services exist in two-thirds of all Member States and are most frequently accessed via an online portal, but only in a few countries can they be sent or received across borders and 11 countries are still using paper printouts for prescriptions. Today, only ten Member States support the sharing of patient summaries and ePrescriptions via MyHealth@EU. There are however plans for all Member States to join MyHealth@EU by 2025.
As regards thesecondary use of health datafor research, innovation, policy making and regulatory purposes: studies which inform regulatory decisions are currently often performed in a small set of databases clustered in a few EU Member States, limiting their geographical and demographic sample sizes. To overcome this fragmentation and the over-reliance on consent, some Member States started to adopt national laws. For instance, 13 Member States have started to put forward more centralised national systems to provide access to data, but there is no link between them at EU level, the system remains fragmented and there are differences between tasks, even though they share many commonalities. Some Member States have created Health Data Access Bodies such as Findata, French Data Hub, German Forschungsdatenzentren, and others.
The EHDS is ambitious in the sense that the proposal wants toadvance digital health for all Member Statesand to make the healthcare systems of the EU ready for the digital future.
11. Will the EHDS share health data with industry?
It is important that industry can use health data, to allow for innovation that will improve the prevention, diagnosis and treatment of diseases. The COVID-19 pandemic showed again the importance of such innovation to develop vaccines that helped saving millions of lives.
That is why industry will have the opportunity to make use of the health data access bodies, after they have been granted a permit for access to data. Only the data necessary for that specific research would be put at their disposal, without revealing individual’s identity, and it can only be accessible in the secure processing environment for the duration of their project.
In the context of healthcare, the EHDS only supports the access of health professionals to the data of their patients. Industry will not have access to such data.
More Information
Proposal for a Regulation on the European Health Data Space
Data Strategy of 19 February 2020
Remarks by VP Margaritis Schinas at the press conference on the European Health Data Space
3 May 2022
We are here today to present our proposal for a European Health Data space. This is revolutionary and it comes at a time that makes a big difference for Europe. Health Data is power and Health Data is the blood running through the veins in our healthcare systems.
Our proposal for a European Health Data space is the first of its kind worldwide. It is a milestone for our digital transformation; a real revolution in European medical history. With our proposal today we are addressing important health inequalities allowing all Europeans to have equal use, equal access and equal rights.
And this also means that the more health data we have, the better diagnosis and more treatments we can obtain for challenging diseases like cancer or Alzheimer’s.
The why of this proposal is obvious. We have an EU bank of data which is very rich, ultra-rich, but we are making an ultra-poor use of this wealth. We have difficulties for many citizens in exercising their rights over their electronic health data. We have uneven implementation and interpretation of these rules in different Member States. We have situations where natural persons cannot benefit from innovative treatments because of the lack of sufficient data.
Same thing for researchers and policy makers, we have different standards, we have limited interoperability, we have many shortcomings that we are correcting with the proposal that we are presenting today and there is no better timing for this than now. In this post pandemic world, now that we are switching from firefighting to construction work , constructing a true genuine robust European Health Union.
There is not only a health rationale, which is better diagnosis and better treatments, but there is also an economic rationale behind this proposal that can help bring significant savings. Just to give you an example, we spend 14 billion Euros for medical images in the EU and 10% of this is totally unnecessary because we don’t have this common space that will rationalize this type of expenses.*
Concretely, we mainly have two strands of work in this proposal.
The first one is what we call the proposal for the primary useof health data. This is when citizens will be able to access their own health data electronically in their language and share it with the doctor or the hospital of their choice. This means in practical simple terms that one can be on holidays and still be able to process his or her data with his or her doctors. It goes without saying that all of us individuals will retain control of all the data we share. We will be able to add, request changes, restrict access or even track who visited our data.
Second, health data could be re-used for research, policy-making, or personalised medicine. This is the so-called secondary use and will give access to researchers, policy makers, those who innovate, these re-users will be able to access these data in a way that will optimize their operations but always in a close and secure environment fully anonymised and in full respect with our data protection rules and privacy requirements.
Every time that a proposal on data is presented there is a lot of excitement around. We understand that. But this is big. It is important, it is necessary, it’s innovative and it comes at the right time. The Commissioner and I, we were very lucky to have the full and unanimous backing of the College and the President for this proposal.
We have to make this work, we have to build this capital of trust that is always necessary when we discuss data space and I am sure that this will be the case.
* Updated on 3 May 2022 at 19:57.
Remarks by Commissioner Stella Kyriakides at the press conference on the European Health Data Space
3 May 2022
Today we present another pillar of the European Health Union – I dare say its backbone. A European Health Union that since 2020 now includes a wealth of initiatives that always place patients at the centre, from strengthening the mandates of ECDC and EMA, the creation of HERA, the launch of Europe’s Beating Cancer Plan, the reform of the EU’s pharmaceutical legislation to come at the end of the year, and now the European Health Data Space.
What was then seen as a vision is slowly but surely becoming a reality.
A Union rendered more resilient and able to adapt to crises, address longstanding challenges, and which will offer citizens what they expect in the area of health.
The COVID-19 pandemic has shown us the importance of digital tools and how much they improved patient care.
The EU Digital COVID Certificate is a prime example of this, setting a global standard for safe travel.
Today, we propose a European Health Data Space. An initiative that brings us closer to making health data work for patients, people and innovation.
Our target is for the Health Data Space to start functioning by 2025.
For the first time, we will have a common EU data space connecting all Member States, for the benefit of all EU citizens.
The European Health Data Space has two basic aims.
The first is to enable citizens to share health data, for example their medical history, test results or prescriptions with hospitals and medical practitioners in and across Member States.
Let’s see what this means practically.
For example, if a person living in Portugal falls ill in Paris, a local doctor will be able to access her or his medical history in French and prescribe the right medicine. There is no need to repeat unnecessary medical exams, they can be shared digitally across the EU.
Likewise, if a cancer patient has to stay longer than expected away from their country of residence, but is running out of the medicine prescribed by their oncologist, he or she will be able to take the prescription to a pharmacy in the country they find themselves in and get the vital medication needed.
Or it will allow those for example with rare diseases to access doctors in other Member States. We have seen the value the European Reference Networks have brought to the treatment and care of patients with rare diseases. The European Health Data Space will help to further pool data, always in a safe way.
Sharing up-to-date, reliable health data is not only key to countering health threats like COVID-19, and developing effective treatments and vaccines, but it is also cost effective.
So, by sharing health data across hospitals and between medical practitioners across Member States, which will save further resources.
The European Health Data Space’s second aim is to revolutionise how we use health data for research, innovation and policy-making.
It will create a strong legal framework to allow public researchers, institutions, and industry to access, combine and re-use health data.
This data can lead, for example, to the development of new, revolutionary life-saving treatments, medicines, medical devices or next-generation antibiotics; and to make progress on personalised medicine.
Our researchers will have access to large amounts of health data – real-world, concrete data, with the higher quality that medical breakthroughs require.
Meanwhile, easier access to health data for regulators and policy-makers will benefit public health and healthcare systems.
For our European industry this means an EU-wide market for electronic health records will be available, with the same standards and specifications, and the use of data for the development of innovative medicines and devices.
Here I would like to use two key words, the first is trust and the other is respect.
The framework we have put in place for the European Health Data Space respects citizens’ and patients’ rights.
For all the above to work, trust is vital. Strong privacy and security protections is how we will build this trust.
When it comes to our citizens, they can be confident that their personal health data will be handled with the greatest care, underpinned by strong data protection rules and data security.
The European Health Data Space will give citizens complete control over their data.
They will be able to add information, rectify errors, restrict access and find out which health professionals have accessed their data.
When it comes to industry or researchers, they will require a permit from their national health data access bodies.
And even then, only the data needed for a specific project will be provided in a secure and controlled environment, and will not allow people to be identified. Complete anonymity is secured.
Ladies and gentlemen,
Bringing together the health data of almost 450 million citizens will be a fundamental game changer, making the EU a global leader in this area.
Ultimately, the European Health Data Space can only be a success if we move forward together. I am convinced that through the pandemic, where we have seen how much we can do when we work together, this proposal will be supported.
It shows the power of cooperation, and that there is nothing more valuable for citizens than their health. It is therefore crucial that they are able to access and share their health data, and to make the best use of it in a very safe way, while at the same time encouraging research and innovation in a safe space.
Thank you.