MEPs have approved the creation of a European Health Data Space, which will improve citizens' access to their personal health data and enhance the secure exchange of data in the public interest. With the new regulations, citizens across the EU will have access to their entire medical records with strong protection of sensitive data.
MEPs voted with 445 in favour and 142 against (39 abstentions) to approve the inter-institutional agreement on establishing a European Health Data Space. It will empower patients to access their health data in an electronic format, including from a different member state to the one in which they live, and allow health professionals to consult their patients’ files with their consent (so-called primary use), also from other EU countries. These electronic health records (EHR) would include patient summaries, electronic prescriptions, medical imagery and laboratory results. The law will also make it possible to transfer health data safely to health professionals in other EU countries (based on MyHealth@EU infrastructure), for example when citizens move to another state. It will be possible to download the health record free of charge.
Possible data sharing for research purposes
MEPs are also considering introducing special provisions to enable data sharing for scientific purposes. The sensitive data obtained would be fully anonymized, as envisioned by policymakers. 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, could be processed for public interest purposes, including research, statistics and policy-making (so-called secondary use). Data could, for example, be used to find treatments for rare diseases, where small datasets and fragmentation currently prevent advances in treatments.
Secondary use will not be allowed for commercial purposes including advertising, assessing insurance requests or lending conditions or making job market decisions. Access decisions will be made by national data access bodies.
"The Health Data Space can help us to leverage the data we have in a safe and secure manner, giving vital research into new treatments a major boost. It will prevent gaps in treatment by making sure health professional can access their patients’ records across borders. At the same time, opt-outs will ensure that patients have a say, and that the system is trustworthy. It will be a major step forward for digital healthcare in the EU” – said Tomislav Sokol (EPP, Croatia), Environment Committee co-rapporteur.
The new measures improve the security of sensitive data
The law ensures people will have a say in how their data are used and accessed. Patients will be able to refuse their health data being accessed by practitioners (except where this is necessary for protecting the vital interests of the data subject or another person) or processed for research purposes, apart from certain public-interest, policy-making or statistical purposes. Patients will also have to be informed each time their data are accessed, and will have the right to request corrections to incorrect data.
The provisional agreement still needs to be formally approved by the Council. Once published in the EU’s Official Journal, it will enter into force twenty days later. It will be applied two years after, with certain exceptions, including primary and secondary use of data categories, which will apply four to six years later, depending on the category.
Source of information: European Parliament.