On Friday 15 March, negotiators from the Council of the European Union and the European Parliament reached a provisional political agreement on the proposal for a European Health Data Space.
Under a new regulation to be adopted by the two institutions, patients will be able to access their personal health data electronically in the various EU health systems (see EUROPE 13313/29). The text also allows healthcare professionals to access their patients’ data, strictly limited to what is necessary for a given treatment, and patients will also be able to download their medical records free of charge.
Electronic health records (EHRs) will include patient summaries, electronic prescriptions, medical imaging and laboratory results (known as primary use).
Each country will set up national health data access services based on the MyHealth@EU platform. The legislation also provides for the creation of a European format for the exchange of electronic medical records, as well as rules on data quality, security and interoperability of EHR systems, which will be monitored by national market surveillance authorities.
This space will allow anonymised or pseudonymised health data to be shared, including medical records, clinical trials, pathogens, health claims, genetic data, public health registry information, wellbeing data and information on healthcare resources, expenditure and funding for public interest purposes (known as secondary use). These include research, innovation, policy development, education and patient safety.
Sharing data for the purposes of advertising or evaluating insurance applications will be prohibited. During the negotiations, MEPs ensured that secondary use would not be permitted for labour market decisions (including job offers), loan conditions and other types of discrimination or profiling.
The legislation guarantees that patients will have a say in how their data is used and accessed. They will have to be informed each time their data is consulted 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, unless this is necessary to protect the vital interests of the data subject or another person. MEPs secured the right for patients to object to secondary use, with certain exceptions for reasons of public interest, policy development or statistics, and the protection of intellectual property rights and trade secrets when relevant data is shared for secondary use.
National data protection authorities will monitor the application of rights of access to health data and will be empowered to impose fines in the event of non-compliance.
“The new rules will make a real difference to the lives of some people who need urgent care abroad. If, for example, you suddenly have an allergic reaction and lose the ability to speak, this new legislation will enable doctors to quickly find the information they need in your electronic files”, Parliament’s rapporteur Tomislav Sokol (EPP, Croatian) explained.
For Sara Cerdas (S&D, Portuguese), this innovative regulation will improve the accessibility, efficiency and quality of healthcare, while stimulating scientific medical research, public health surveillance and policy development. “Importantly, it gives patients real control and choice over their electronic health data”, she added.
Lucia Ďuriš Nicholsonová (Renew Europe, Slovakian) spoke of the advent of a “new era for the healthcare sector”: the text will improve healthcare for patients in national and cross-border cases, and patient mobility will be made considerably easier.
The European Commission has welcomed the compromise, saying that citizens will have immediate and easy access to their digital health data, wherever they are in the EU. Health professionals will be able to access a patient’s medical records when necessary for treatment in another Member State. (Original version in French by Lionel Changeur)