{"id":50301,"date":"2025-06-23T06:00:00","date_gmt":"2025-06-23T04:00:00","guid":{"rendered":"https:\/\/trendsanita.it\/?p=50301"},"modified":"2025-06-22T15:28:06","modified_gmt":"2025-06-22T13:28:06","slug":"european-health-data-space-more-rights-more-control-more-equity","status":"publish","type":"post","link":"https:\/\/trendsanita.it\/en\/european-health-data-space-more-rights-more-control-more-equity\/","title":{"rendered":"European Health Data Space: More Rights, More Control, More Equity"},"content":{"rendered":"\n

Immediate, Free, and Interoperable Access to Health Data Across the EU<\/h2>\n\n\n\n

Immediate, cost-free, and interoperable access to one\u2019s health data in any EU country is one of the key changes introduced by the new Regulation on the European Health Data Space (EHDS)<\/a>, published last Marchin the EU\u2019s Official Journal. Digital health was the focus of the European Patients\u2019 Rights Day, held in Brussels on Wednesday, May 15, and organized by Active Citizenship Network \u2013 Cittadinanzattiva, under the patronage of the Polish Presidency of the EU Council and the Polish Ombudsman for Patients’ Rights, with support from the MEPs Interest Group \u201cEuropean Patients\u2019 Rights & Cross-Border Healthcare<\/a>.\u201d<\/p>\n\n\n

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Fulvia Raffaelli<\/figcaption><\/figure>\n<\/div>\n\n\n

On the sidelines of the event, TrendSanit\u00e0<\/em> interviewed Fulvia Raffaelli, Head of Unit for Digital Health at DG SANTE, European Commission<\/strong>: \u201cWith the EHDS, we\u2019re introducing new rights for all European citizens, who will finally be able to access their clinical data wherever they are, free of charge and with strengthened guarantees.\u201d<\/p>\n\n\n\n

The right to access one\u2019s health data\u2014still fragmented or even nonexistent in many Member States\u2014will now be ensured for every EU citizen. \u201cToday, our data are scattered across hospitals, labs, and general practitioners,\u201d Raffaelli explains, \u201cand even within the same Member State it\u2019s often difficult to reconstruct a complete clinical history. With the EHDS, every citizen will be able to access all of their electronically recorded health data, regardless of their location in Europe.\u201d<\/p>\n\n\n\n

Not Just Access: More Transparency and More Control<\/h2>\n\n\n\n

Beyond access, the regulation also establishes the right to know who is accessing your data and for what purpose. \u201cPrivacy is protected<\/strong>,\u201d Raffaelli clarifies. \u201cData will not be available indiscriminately, but only to healthcare professionals directly involved in the patient\u2019s care<\/strong>. Moreover, every citizen will have the right to obscure specific sensitive information, such as a psychiatric diagnosis or a sexually transmitted disease.\u201d<\/p>\n\n\n\n

This enhancement of individual rights is accompanied by a principle of interoperability<\/strong>: data can also be used by the citizen for purposes beyond care, such as sports or insurance needs. \u201cThe data will be available to them, but always under their own responsibility.\u201d<\/p>\n\n\n\n

The regulation also establishes the right to know who accesses your data and for what purpose<\/p>\n\n\n\n

Among the most concrete examples of everyday impact, Raffaelli highlights the ability to use an electronic prescription across countries: \u201cEven in Italy, we still face barriers between different regions. The new system will allow, for example, an Italian citizen on vacation in Portugal to obtain their medication at a Portuguese pharmacy, simply by contacting their GP back home<\/strong>. It\u2019s a real revolution for frequent travelers, Erasmus students, or cross-border workers.\u201d<\/p>\n\n\n\n

The Strategic Value of Data for Public Health<\/h2>\n\n\n\n

But why should citizens trust the system and share their data? <\/strong>The answer, according to Raffaelli, is both simple and crucial: \u201cBecause data are the fuel of research and public health. They\u2019re essential for defining prevention strategies, preparing for health crises, and developing new drugs or devices. And it is important to clarify: data used for secondary purposes, such as research or innovation, will never be made available in an identifiable form<\/strong>. They must be provided in aggregated format, or be anonymised or pseudonymised, in accordance with strict safeguards. Re-identification of a data subject is explicitly prohibited under the EHDS Regulation.\u201d<\/p>\n\n\n\n

Data is the fuel of research and public health \u2014 essential for prevention, health emergencies, and the development of new therapies<\/p>\n\n\n\n

The new legal framework thus creates a unified system across the Union\u2014but without centralization<\/strong>: \u201cThere will be no massive European database of everyone\u2019s health records. Data will remain where they are\u2014under the control of hospitals and national authorities\u2014and can only be accessed in accordance with shared rules, step by step, as outlined in the regulation.\u201d<\/p>\n\n\n\n

From Clinical Research to Solidarity: A Paradigm Shift<\/h2>\n\n\n\n

The EHDS represents not only a technological shift, but also a cultural one<\/strong>. \u201cToday, most clinical data come from patients already receiving care. But if we could also involve healthy individuals, the resulting datasets would be more representative and complete, enabling more scientifically sound and robust use of data. This would ultimately enhance prevention efforts and promote greater equity in health policy development.\u201d<\/p>\n\n\n\n

The EHDS also introduces an underlying ethical principle: solidarity among citizens<\/strong>. \u201cI may be healthy today, but I could fall ill tomorrow. Sharing my data means helping to build better healthcare\u2014not just for others, but for myself in the future.\u201d<\/p>\n\n\n\n

Health innovation also stems from trust and shared data<\/p>\n\n\n\n

According to Raffaelli, this reflection is just as important as technical safeguards: \u201cIn healthcare, we risk falling into the same pattern we see in environmental issues: everyone wants clean energy, but no one wants a wind turbine in their backyard. Here, it\u2019s the same: everyone wants access to innovative therapies, but few are willing to share their data. This mindset must change, also through civic education in health.\u201d To be pursued \u2014 as emphasized by Mariano Votta, Head of European Affairs at Cittadinanzattiva\/Active Citizenship Network<\/strong>, in the closing remarks of the European Patients\u2019 Rights Day \u2014 also through public health literacy programs, which should of course include digital health literacy.<\/p>\n\n\n

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\"\"<\/figure>\n<\/div>\n\n\n

What\u2019s Next?<\/h2>\n\n\n\n

As for implementation, the EU is already taking action. \u201cOn June 16, the first meeting with the Member States was held to launch the phase of implementing decrees. We have two intense years ahead to define the technical standards<\/strong>, building on the progress already made by various countries.\u201d<\/p>\n\n\n\n

In the meantime, a voluntary initiative\u2014MyHealth@EU<\/a>\u2014is already paving the way for some of the future features: \u201cItaly isn\u2019t part of it yet, but is working toward joining the system. It\u2019s the best way to prepare, since there will be continuity between the voluntary and mandatory phases.\u201d<\/p>\n\n\n\n

And the future? \u201cI hope that in a few years, the EHDS becomes part of everyday life, just like the end of roaming charges<\/strong>,\u201d Raffaelli concludes. \u201cWhat once seemed complicated is now second nature. And maybe we\u2019ll look back and smile, remembering that it was Europe that made it possible.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"

With the new regulation on the European Health Data Space (EHDS), the EU strengthens citizens\u2019 digital rights. Fulvia Raffaelli (DG SANTE, European Commission) explains what changes in terms of access, control, and use of health data across Europe<\/p>\n","protected":false},"author":91,"featured_media":50298,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[544],"tags":[699,590,549,578,695,572],"rubrica":[],"speciale":[],"class_list":{"0":"post-50301","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-across-europe-en","8":"tag-acn-2","9":"tag-digital-health","10":"tag-europe-en","11":"tag-innovation","12":"tag-organisation","13":"tag-patients"},"yoast_head":"\nEuropean Health Data Space: More Rights, More Control, More Equity<\/title>\n<meta name=\"description\" content=\"Fulvia Raffaelli (European Commission) explains what changes in terms of access, control, and use of health data across Europe\" \/>\n<meta name=\"robots\" content=\"index, follow, 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