The Council of the EU and European Parliament ended up being temporary agreement for a young man law which facilitates data sharing and access health at EU level.

The proposed regulation for one European Health Data Area (European Health Data Space) aims to improve people’s access to and control of their personal electronic health data, while allowing the re-use of certain data for public interest, policy support and scientific research purposes. It provides a health-specific data environment that will help promote a single market for digital health services and products.

“The European Health Data Space is a game-changing moment for health in Europe and for the care our citizens receive. It will allow patients to share health data such as their medical history, test results or prescriptions with hospitals and doctors within and between member states as they wish. At the same time, it will unlock the potential of health data for the development of innovative and life-saving treatments and devices, as well as for better health policy-making, all with strong data protection and security safeguards. Our Health Union is based on cooperation and the European Health Data Space will be one of the strongest and most emblematic examples of what we can achieve when we come together,” emphasized Health and Food Safety Commissioner Stella Kyriakidou.

Currently, cross-border access to health data varies in the EU. As the Council communication points out, for example the new rules aim to enable a Spanish tourist to pick up a prescription from a German pharmacy or doctors to access the health information of a Belgian patient undergoing treatment in Italy.

Easier access to health data

Under the new rules, citizens will have faster and easier access to electronic health data, regardless of whether they are in their home country or in another Member State. They will also have more control over how this data is used. EU countries will be asked 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 types of secure health data, enabling them to harness the enormous potential that EU health data provides to inform scientific research in the public interest.

Ensuring interoperability

Currently, the level of digitization of health data in the EU differs from one Member State to another, which makes 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 format for the exchange of electronic health records, ensuring that they are interoperable at EU level.

Key elements of the interim 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:

*member states may allow patients to opt out of the use of the health data they have access to, either by a healthcare professional (primary use) or for further use (secondary use, always under strict conditions), except for purposes of public interest, drawing policy, statistical and research purposes in the public interest

*restricted information: if patients choose to restrict information, healthcare professionals will be able to access limited health data only in situations of vital interest

*sensitive data: Member States may introduce stricter measures governing access to certain forms of sensitive data, such as genetic data, for research purposes

*trusted data holders: in order to reduce the administrative burden, Member States can establish trusted data holders who can securely process requests for access to health data

Next steps

The interim agreement will now have to be approved by the Council and Parliament. It will then be formally approved by both institutions after a legal-linguistic review. The regulation will enter into force 20 days after its publication in the Official Journal of the EU.