EU Health Data Space to support patients and research
Cezar Nita
Happy to make a difference / Business management / Healthcare Services / Legal / Operations
The European Parliament and Council have agreed on the creation of a European Health Data Space (EHDS) to support patients and research. The provisional agreement outlines that patients will be able to access their personal health data electronically across the EU's different healthcare systems, and health professionals will have access to their patients' data based on what is necessary for a given treatment. Patients will also be able to download their health record free of charge. The EHDS would allow anonymised or pseudonymised health 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, to be shared for public interest purposes (secondary use). This includes research, innovation, policy-making, education, and patient safety purposes. The sharing of data for advertising or assessing insurance requests will be prohibited. The law ensures patients have a say in how their data is used and accessed, with the right to request or correct incorrect data and object to healthcare professionals accessing their data for primary use, except where this is necessary for protecting the vital interests of the data subject or another person. Patients can opt out of secondary use, with exceptions for public-interest, policy-making or statistics purposes, and protections for intellectual property rights and trade secrets when relevant data is shared for secondary use. National data protection authorities will monitor the enforcement of health data access rights and issue fines in the event of shortcomings.
Quotes
Tomislav Sokol?(EPP, Croatia), Environment Committee co-rapporteur, said: “The European Health Data Space will put citizens in control of their health data by providing a safe framework for storing and accessing their personal health records that will be accessible anywhere in the EU - enhancing healthcare at a national and cross-border level. the EHDS will also facilitate the responsible sharing of health data to researchers - boosting research and innovation in the EU, and ensuring the development of new treatments.”
Annalisa Tardino?(ID, Italy), Civil Liberties Committee co-rapporteur, said: “The EHDS will contribute to providing state-of-the-art healthcare to patients everywhere in the EU. We have succeeded in including in the text significant reinforcements regarding the protection of sensitive personal data, in particular with the possibility for patients to opt-out both for primary and secondary use of their health data. In that regard, Parliament’s mandate was stronger and provided even more safeguards, but the majority of LIBE political groups considers that the final agreement strikes a balance between exchanging health data for treatment and for life-saving research, and protecting the privacy of our citizens.”
The Commission welcomes?the political agreement agreed today between the European Parliament and the Council of the EU on the European Health Data Space (EHDS), a key building component of a strong European Health Union. Commission guidelines proposed in May 2022 have two goals:
The goal is to:
1. empower citizens with data control to improve healthcare across the EU?
and to?
2. share data for research and public health purposes.
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The co-legislators' agreement sets clear norms for using health data to improve healthcare, research, innovation, and policymaking. The EU's high data protection standards will be met while the new laws enable safe and secure health data transmission, usage, and re-use.
Quote:
“The European Health Data Space is a game changing moment for health in Europe and for the care our citizens receive. It will enable patients to share health data, such as their medical history, test results, or prescriptions with hospitals and medical practitioners within and across Member States, as they wish. At the same time, it will unleash the potential of health data for the development of innovative and lifesaving treatments and devices, as well as for better health policy-making, all with strong data protection and security safeguards. Our Health Union is built on cooperation, and the European Health Data Space will be one of the strongest and most emblematic examples of what we can achieve when we come together.”
Stella Kyriakides, Commissioner for Health and Food Safety
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(The European Health Data Space is a health-specific ecosystem that aims to empower individuals by increasing digital access to and control of their electronic personal health data. It supports free movement, fosters a single market for electronic health record systems, medical devices, and high-risk AI systems, and provides a consistent, trustworthy, and efficient set-up for health data use for research, innovation, policy-making, and regulatory activities. Trust is a fundamental enabler for the success of the European Health Data Space, which builds on the General Data Protection Regulation, proposed Data Governance Act, draft Data Act, and Network and Information Systems Directive. More specific rules are developed in the European Health Data Space Regulation, considering the sensitivity of health data.)
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CEO | A Healthier Democracy | Physician
8 个月Well shared Cezar - Traian Nita ????- Traian Nita shares promising news from the European Parliament and Council negotiators: the creation of a European Health Data Space. This initiative aims to facilitate access to personal health data while ensuring secure sharing for the public good.