Strasbourg, 14 March 2024
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Citizens will be able to access prescriptions, imagery and lab tests electronically, also from different EU countries
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Aggregated health data can be shared for research purposes e.g. into cancer and rare diseases
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Strong privacy safeguards on the manner and the purpose of the sharing of sensitive data
EP and Council negotiators agreed on the creation of a European Health Data Space to ease access to personal health data and to boost secure sharing for the public interest.
The provisional political agreement on a European Health Data Space (EHDS), reached early on Friday by Parliament and the Belgian Presidency of the Council, outlines that patients will be able to access their personal health data electronically across the EU’s different healthcare systems. The bill also gives health professionals access to their patients’ data, based strictly on what is necessary for a given treatment, and patients will also be able to download their health record free of charge.
Electronic health records (EHR) would include patient summaries, electronic prescriptions, medical imagery and laboratory results (so-called primary use).
Each country would establish national health data access services based on the MyHealth@EU platform. The law would also create a European electronic health record exchange format, and outline rules on data quality, security and the interoperability of EHR systems that will be monitored by national market surveillance authorities.
Data-sharing for the common good with safeguards
The EHDS would allow anonymised or pseudonymised health data, including health records, clinical trials, pathogens, health claims and reimbursements, genetic data, public health registry information, wellness data and information on healthcare resources, expenditure and financing, to be shared for public interest purposes (so-called secondary use). These reasons would include research, innovation, policy-making, education and patient safety purposes.
The sharing of data for advertising or assessing insurance requests will be prohibited. During negotiations, MEPs ensured that secondary use would not be allowed concerning decisions on labour markets (including job offers), lending conditions and other types of discrimination or profiling.
Stronger safeguards for sensitive data
The law ensures patients will have a say in how their data is used and accessed. They must be informed each time their data is accessed, and they will have the right to request or correct incorrect data. Patients will also be able to object to healthcare professionals accessing their data for primary use, except where this is necessary for protecting the vital interests of the data subject or another person. MEPs secured the right for patients to opt out of secondary use, with certain exceptions for public-interest, policy-making or statistics purposes, and protections for intellectual property rights and trade secrets when relevant data is shared for secondary use.
National data protection authorities will monitor the enforcement of health data access rights and will be empowered to issue fines in the event of shortcomings.
Quotes
Tomislav Sokol (EPP, Croatia), Environment Committee co-rapporteur, said: “The European Health Data Space will put citizens in control of their health data by providing a safe framework for storing and accessing their personal health records that will be accessible anywhere in the EU – enhancing healthcare at a national and cross-border level. the EHDS will also facilitate the responsible sharing of health data to researchers – boosting research and innovation in the EU, and ensuring the development of new treatments.”
Annalisa Tardino (ID, Italy), Civil Liberties Committee co-rapporteur, said: “The EHDS will contribute to providing state-of-the-art healthcare to patients everywhere in the EU. We have succeeded in including in the text significant reinforcements regarding the protection of sensitive personal data, in particular with the possibility for patients to opt-out both for primary and secondary use of their health data. In that regard, Parliament’s mandate was stronger and provided even more safeguards, but the majority of LIBE political groups considers that the final agreement strikes a balance between exchanging health data for treatment and for life-saving research, and protecting the privacy of our citizens.”
Next steps
The provisional agreement still needs to be formally adopted by both institutions before it can enter into law.
Further information
European Health Data Space: EU Council background
15 March 2024, 01:10
The Council of the EU and the European Parliament have reached a provisional agreement on a new law making it easier to exchange and access health data at EU level. The agreement will now need to be endorsed by both the Council and the Parliament.
The proposed regulation for a European Health Data Space (EHDS) aims to improve individuals’ access to and control over their personal electronic health data, while also enabling certain data to be reused for public interest, policy support, and scientific research purposes. It provides for a health-specific data environment that will help foster a single market for digital health services and products.
Currently, cross-border access to health data varies across the EU. The new rules aim to make it possible for a Spanish tourist to pick up a prescription in a German pharmacy, or for doctors to access the health information of a Belgian patient undergoing treatment in Italy.
After months of hard work and dedication, we have a deal that will strongly support patient care and scientific research in the EU. The new law agreed on today will allow patients to access their health data wherever they are in the EU, while also providing scientific research for important reasons of public interest with a wealth of secure data that will greatly benefit the development of health policies.
Frank Vandenbroucke, Belgian Deputy Prime-Minister and Minister of Social Affairs and Public Health
Easier access to health data for individuals
Under the new rules, individuals will have faster and easier access to electronic health data, regardless of whether they are in their home country or another member state. They will also have greater control over how that data is used. EU countries will be required to set up a digital health authority to implement the new provisions.
Greater research potential
The EHDS will also provide researchers and policy-makers with access to specific kinds of secure health data, enabling them to tap into the vast potential provided by the EU’s health data to inform scientific research in the public interest.
Ensuring interoperability
Currently, the level of digitalisation of health data in the EU varies from one member state to another, making it more difficult to share data across member-state borders. The proposed regulation requires all electronic health record (EHR) systems to comply with the specifications of the European electronic health record exchange format, ensuring that they are interoperable at EU level.
Key elements of the provisional agreement
The provisional agreement reached today between the Council and the Parliament amends the Commission’s original proposal in a number of key areas, including:
- opt-out: member states can allow patients to opt-out on the use of their health data being accessed, whether by a healthcare professional (primary use) or for further use (secondary use, always under strict conditions), except for purposes of public interest, policy making, statistics and research purposes in the public interest
- restricted information: if patients choose to restrict information, healthcare professionals will only be able to access restricted health data in situations of vital interest
- sensitive data: member states may put in place stricter measures governing access to certain kinds of sensitive data, such as genetic data, for research purposes
- trusted data holders: in order to reduce the administrative burden, member states may establish trusted data holders that can securely process requests for access to health data
- clinically significant findings: if researchers inform health data access bodies (HDABs) about findings that may impact the health of a patient whose data was used in the scientific research, the HDAB may inform the trusted data holder who has to inform the patient or the relevant treating health professional about these findings
Next steps
The provisional agreement will now have to be endorsed by the Council and the Parliament. It will then be formally adopted by both institutions after legal-linguistic revision. The regulation will enter into force 20 days after publication in the EU’s Official Journal.
Background
On 3 May 2022 the European Commission published a proposal for a regulation creating a European Health Data Space (EHDS). The proposal is the first of nine European sector- and domain-specific data spaces set out by the Commission in its 2020 communication, ‘A European strategy for data’. The Council agreed on its mandate for negotiations on 6 December 2023.
The aim of the EHDS is to make it easier to access and exchange health data across borders, both to support healthcare delivery (‘primary use of data’) and inform health research and policy-making (re-use of data, also referred to as ‘secondary use of data’). It is considered a key pillar of the European Health Union.