The Launch of the Electronic Health Record System Across the EU

Making healthcare more efficient and contributing to life-saving clinical research. This is the goal of the new electronic health record accessible throughout the European Union. With 445 votes in favor, the European Parliament has definitively approved the interinstitutional agreement for its establishment, to allow citizens and healthcare professionals to access data in electronic format even from a different European member state than the one they live in. People cared for by a female doctor survive longer: the new study on about 800,000 hospitalized patients. European health data space, it's a yes. With 445 votes in favor, 142 against, and 39 abstentions, on April 24, the European Parliament definitively approved the interinstitutional agreement for its establishment, thus facilitating citizens and healthcare professionals to consult their medical records in all European countries. These electronic medical records will include patient reports, electronic prescriptions, medical images, and laboratory results. The EU regulation will also allow the secure transfer of health data to healthcare operators in other European countries (with the MyHealth@EU platform), for example, when citizens move to another state. It will be possible to download one's health record for free. The anonymized health data, the European Parliament informs, can be shared for research, for example, on rare diseases. Strong privacy protections will regulate how and for what purpose sensitive data is shared. The data, anonymous, can be processed for public interest purposes, including research, statistics, and policy-making (the so-called secondary use). They could, for example, be used to find treatments for rare diseases, where currently small data sets and fragmentation prevent progress in treatments. Secondary use will not be allowed for commercial purposes, including advertising, evaluating insurance claims or loan conditions, or making labor market decisions. Decisions on access will be made by national data access bodies. The law also ensures that people have a say in how their data is used and consulted. Patients will be able to refuse access to their health data by professionals (except where necessary to protect the vital interests of the subject or another person) or for research purposes, except for certain public interest, political, or statistical purposes. Patients must also be informed whenever their data is accessed and have the right to request the correction of erroneous data. "With the health data space - explains Tomislav Sokol, co-rapporteur of the Committee on the Environment - we can safely and securely leverage the data in our possession, giving a significant boost to vital research on new treatments. Moreover, it will avoid gaps 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. It 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 the future, doctors may be authorized to access the medical records and laboratory results of their patients in other regions or even in other EU member states, saving money and resources and providing better care. Although we would have preferred even more decisive measures, we managed to find a position that can be accepted by the majority." However, the timing is not immediate. The provisional agreement must still be formally approved by the European Council. Once published in the Official Journal of the EU, it will enter into force twenty days later. The regulation will apply two years later, with some exceptions, including the primary and secondary use of data categories, which will apply 4 or 6 years later, depending on the category.