Access your health data in electronic format even from a European Member State other than the one in which you live, and allow healthcare professionals to consult patient files with their consent also from other EU countries. All with the aim of making treatments more efficient and making a contribution to life-saving clinical research. It will be possible thanks to the creation of the European Health Data Area: the European Parliament definitively approved the interinstitutional agreement for its establishment on 24 April with 445 votes in favour, 142 against and 39 abstentions.
These electronic health records would include patient reports, electronic prescriptions, medical images and laboratory results.
The EU regulation will also allow health data to be transferred securely to healthcare providers in other European countries (with the MyHealth@EU platform), for example when citizens move to another country. It will be possible to download your health record for free. The anonymized health data, informs the European Parliament, can be shared for research, for example on rare diseases.
There will be strong privacy protections regulating how and for what purpose sensitive data is shared.
The anonymous data may be processed for purposes of public interest, including research, statistics and policy development (so-called secondary use). They could, for example, be used for
find treatments for rare diseases, where currently small data sets and fragmentation prevent progress in treatments. However, secondary use will not be permitted for commercial purposes, including advertising, evaluating insurance applications or loan terms, or making labor market decisions. Decisions on access will be taken by national data access bodies. The law also ensures people have a say in how their data is used and accessed. Patients will be able to refuse access to their health data by professionals (except where this is necessary to protect the vital interests of the data subject or of another person) or for research purposes, except for certain research purposes. public interest, political or statistical.
Patients will also have to be informed every time their data is accessed and will have the right to request the correction of incorrect data.
“With the health data space – explains Tomislav Sokol, co-rapporteur of the Committee on the Environment – we can exploit the data we have in a safe and secure way, giving a great boost to vital research into new treatments. Furthermore, gaps will be avoided in care by ensuring that healthcare professionals can access their patients’ medical records across national borders.
At the same time, the possibility to object will ensure that patients have a say and that the system is trustworthy. This is an important step forward for digital healthcare in the EU.” According to Annalisa Tardino, co-rapporteur of the Committee on Civil Liberties, “the Health Data Space will improve everyone’s access to healthcare. In future, doctors may be allowed to access their patients’ medical records and laboratory results in other regions or even in other EU member states, saving money and resources and providing better care. Even though we would have preferred even more incisive measures, we managed to find a position that can be accepted by the majority”. However, the timing is not immediate. The provisional agreement must in fact still be formally approved by the European Council. Once published in the Official Journal of the EU, will enter into force twenty days later. The regulation will apply two years later, with some exceptions, including primary and secondary use of data categories, which will apply 4 or 6 years later, depending on the category.
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