The Data Summit

From Paris to Barcelona with a health pass: how Italia prepares the EU Health Area

Next step for our country on 31 March with the first launch of the Health Data Ecosystem: tight schedule for the construction of the community 'platform' that will enable better care, disease prevention and cutting-edge research from privacy-protected information

by Barbara Gobbi

25 March 2026

5' min read

Translated by AI

Versione italiana

5' min read

Translated by AI

Versione italiana

Entering a pharmacy in Paris with an electronic prescription in hand to buy an antibiotic, the dispensing of which will be automatically recorded in our pharmaceutical dossier. To consult a specialist in Barcelona without carrying paper documents, because that doctor will have direct access to our medical history and health data. Being certain that for a sudden landing in a German emergency room, the triage nurse will be able to quickly consult our summary health profile - diseases, allergies, current therapies - and act in a safe and timely manner. These are the benefits available to the 450 million citizens of the EU, once the European Digital Data Space or EHDS, which came into force on 26 March 2025 and will be progressively implemented by 2028 to arrive at the sharing of the first health data in all Member States by March 2029, is operational.

Priorities

This is a crucial revolution: it means holding together the optimisation and interoperability of data - which for Italia are of excellent quality - but also the protection of privacy and the 'safe' use of artificial intelligence tools, in a context of 'high guard' that each country will have to guarantee by activating its own cybersecurity agencies. The challenge is to build a healthcare system that knows how to use data to cure better, prevent diseases, and carry out cutting-edge research. It is a game to shake one's wrists, but by now Europe "is on the march", as emphasised by Sandra Gallina, Director General of the European Commission's DG Sante, who spoke in Rome at the second Data Summit at which the situation was reviewed, with a focus on Italia's path and an eye on the best practices of Belgium and Finland. "In the year that separates us from the European Health Data Area," Gallina explained, "as the EU we must try to establish interoperability and interconnectivity by defining a European format; the other step is entrusted to the Member States, who are called upon to provide themselves with a competent authority from both a technical and political point of view. An authority that Health Minister Orazio Schillaci has indicated for Italia in Agenas, the Agency for Regional Health Services, 'as the digital health agency, it being understood,' he warned, 'that in such an articulated context, the direction on the use of health data and the consequent function of direction is in the hands of the ministry'.

The project

"The appointment is crucial: with the real storm under way, outside the European Union, being able to exploit data safely and with the protection of the individual will allow us to remain competitive, preventing a brain drain," warned Sandra Gallina.
Two pivotal infrastructures of the European HHEds Space: MyHealth@Eu for the primary use of data - already operational on some functions such as ePrescription and Patient Summary - and HealthData@Eu for the secondary use of anonymised data. The latter, on the research front, will make it possible to pool, on a European scale, the clinical evidence of millions of patients to accelerate the fight against cancer, defeat antibiotic resistance and develop personalised therapies thanks to artificial intelligence models trained on real data. Europe - in short, the experts explain - is preparing with the European Health Data Space for the 'roaming of health data', with a direct impact on prevention, treatment and research.

In the meantime, these three years must be 'managed': the proposal for a 'Data Pact' formulated by Felicia Pelagalli, scientific director of the Data Summit, stems from the need to accompany the transition at national and European level. "The first point," she explained, "is to facilitate the implementation of the Health Data Ecosystem by June 2026 and Italia's adherence to MyHealth@Eu and HealthData@Eu". Other priorities include the full involvement of all stakeholders, from healthcare facilities to universities, from companies to patient associations and authorities. Also, the promotion of public-private partnerships for sharing anonymised data and the development of predictive and generative tools.

Italy: first deadline on 31 March

In Italia it is up to the Ecosystem of Health Data (Eds) to act as a hinge with the European space: the great national infrastructure that - starting from the Electronic Health Record 2.0 refinanced by the National Plan for Recovery and Resilience (Pnrr) - will transform clinical documents into structured and queryable data for 59 million citizens, adopts a 'federated' model. Translated: the data remain in the regional systems where they are produced, but become interoperable through a secure national infrastructure.
The first two 'demos' of the Eds consultation services, developed by the Department for Digital Transformation, will be presented to Europe in a matter of days, on 31 March 2026. While by March 2027, Italia will have to designate - as announced by Minister Schillaci it should be Agenas - the Health Data Access Body (Hdab) for secondary purposes envisaged by the EHDS.

No to data looting

We are therefore not at year zero, especially thanks to the strong impetus given by the NPNR: 'In recent years we have given great impetus to the development of the functionalities of the electronic health record, and today this advanced tool is active for more than 57 million citizens,' recalled Schillaci. The fact remains that many of them still resist consulting the dossier, while often unwittingly disclosing their health data, which go to feed the artificial intelligence supports of big companies. Health data 'cannot become an open-air mine to be plundered,' emphasised Alessio Butti, undersecretary to the presidency of the Council with responsibility for innovation and digital transformation. We would like them to bring wealth to healthcare and not only to those who develop algorithms and platforms. Health data are strategic by definition, they must be guaranteed, and we must guarantee the Italians from this point of view'.

In the meantime, Health Undersecretary Marcello Gemmato looks at possible new applications: 'The electronic health record, artificial intelligence, the Health Data Ecosystem, can serve to improve the performance of our health system also with regard to pharmaceuticals,' he proposes. When drugs are placed on the market and negotiated, real-world data on the drug's efficacy could be taken into account to define the drug's remuneration. If, for example, an anti-tumour drug succeeds in increasing the average life span of a patient, the reimbursement from the SSN would be parameterised to the capacity to cure the patient,' he explained. 'This means anchoring the performance of the drug to its price, optimising pharmaceutical spending overall and improving the sustainability of the National Health Service,' Gemmato clarified, pointing out that 'the proposal should in any case be evaluated with Aifa, the Italian Medicines Agency

Citizens and managers to be 'educated'

"We must do this well and quickly,' concluded Franco Zaffini, chairman of the Senate's Committee on Social Affairs, Health, Public and Private Employment: '2029 is approaching and citizens have the right to have a health system capable of keeping them healthy, also thanks to the full integration of data that will be made possible by the European Health Data Space. For this to happen, however, skills are needed, that is, it is not enough to set up the supply system, as Italy is doing starting with the Electronic Health Record, but we also need to strengthen the demand side, which is made up of healthcare users and facilities, and it needs to be regulated and organised. We must educate Italians in the use of health data,' he said. 'Moreover, in line with the principle of the primary collective interest, with the European Health Data System, consent will no longer be needed but 'non-disagreement' will suffice, which will enable the system to acquire all the data independently. And in view of the innovations introduced by the European Health Data Area, hospital managers must also be trained, as they are called upon to be aware of the basin from which they can draw information on the population, pathologies, and their trends'.

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