Negotiators from the European Parliament and the Council have agreed on the creation of a European health data space to facilitate access to personal health data and promote secure sharing in the public interest.
The provisional political agreement on a European Health Data Space (EHDS), reached on Friday morning by the Parliament and the Belgian Presidency of the Council, provides that patients will be able to electronically access their personal health data throughout the country. EU of different health systems. The bill will also allow health professionals to access their patients’ data, strictly based on that necessary for a given treatment, and patients will also be able to download their health records free of charge.
Electronic health records (EHRs) would include patient summaries, electronic prescriptions, medical images, and laboratory results (known as primary use).
Each country would establish national health data access services based on the MaSanté@EU platform. The law would also create a European format for exchanging electronic health records and set rules on data quality, security and interoperability of EHR systems that will be monitored by national market surveillance authorities.
Data sharing for the common good with guarantees
The EHDS would enable the sharing in the public interest of anonymized or pseudonymized health data, including health records, clinical trials, pathogens, health claims and reimbursements, genetic data, health registry information public health, well-being data and information on health care resources, expenditures and financing. purposes (known as secondary use). These reasons would 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 allowed regarding decisions on labor markets (including job offers), loan conditions and other types of discrimination or profiling..
Strengthened guarantees for sensitive data
The law ensures that patients will have a say in how their data is used and accessed. They must be informed each time their data is accessed and they will have the right to request or correct incorrect data. Patients may also object to healthcare professionals accessing their data for primary purposes, except when this is necessary to protect the vital interests of the data subject or another person. MEPs secured the right of patients to refuse secondary use, with certain exceptions for reasons of public interest, policy development or statistics, as well as the protection of intellectual property rights and trade secrets when the data Relevant information is shared for secondary use.
National data protection authorities will monitor compliance with rights of access to health data and will be empowered to impose fines in the event of non-compliance.
Citations
Tomislav Sokol (EPP, Croatia), co-rapporteur of the Environment Committee, said: “The European Health Data Space will enable citizens to control their health data by providing a secure framework to store and access their personal health records which will be accessible anywhere in the EU. – improve healthcare at national and cross-border levels. The EHDS will also facilitate the responsible sharing of health data with researchers, thereby boosting research and innovation in the EU and ensuring the development of new treatments.
Annalisa Tardino (ID, Italy), co-rapporteur of the Civil Liberties Committee, said: “The EHDS will help provide cutting-edge healthcare to patients everywhere. EU. We managed to include significant reinforcements in the text regarding the protection of sensitive personal data, in particular with the possibility for patients to object to the primary and secondary use of their health data. In this regard, Parliament’s mandate was stronger and included even more guarantees, but the majority of LIBE political groups consider that the final agreement strikes a balance between the exchange of health data for treatment and research purposes vital, and the protection of the privacy of our citizens. »
Next steps
EuropeThe provisional agreement still needs to be formally adopted by the two institutions before it can enter into force.
Originally published in The European Times.
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